ISO 9001:2000 The 1994 version of ISO 9000 series has given way to the ISO 9000:2000 series of standards and guidelines. The new series was released on 15th December 2000. The ISO 9001:2000 standard for Quality Management Systems (QMS) is the most significant of the ISO 9000:2000 series. Organisations that are already certified to one of the ISO 9000:1994 standards need to switch over to the ISO 9001:2000 standard before 15th December 2003, to remain ISO certified. Understanding > Introduction Quality improvement has to be ongoing. This feature characterises the development in quality standards too. The 1994 version of ISO 9000 series has given way to the ISO 9000:2000 series of standards and guidelines. The new series was released on 15th December 2000. The ISO 9001:2000 standard for Quality Management Systems (QMS) is the most significant of the ISO 9000:2000 series. We have already dwelt extensively on the 1994 version ISO 9000 standards. In this module we introduce the universally applicable ISO 9001:2000 standards. How different is it from the previous ISO 9000:1994 standard? The ISO 9001:2000 standard is simplified a nd is applicable across a larger cross-section of industry. The requirements specified are generic and apply to both product and service oriented organisations. We now look at the changes that have been incorporated in it. 1. Integration of standards: The ISO 9000: 1994 version had three standards •
ISO 9001 – Quality model for design, development, production, production, installation and servicing.
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ISO 9002 – Quality model for production, installation and servicing.
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ISO 9003 – Quality model for Final Inspection and Testing. Testing.
Depending on the business they were in organisations got certified to either ISO 9001 or ISO 9002 or ISO 9003. The presence of multiple models was actually confusing to understand or implement. Hence, the new ISO 9000:2000 series integrated all the models under a single ISO 9001:200 0 standard. With the advent of ISO 9001:2000, al l ISO 9000 certified organisations will now have a single QMS certification. Organisations only need to follow the requirements requirements relevant to their area of business and exclude others. Organisations that are already certified to one of the ISO 9000:1994 standards need to switch over to the ISO 9001:2000 standard before 15th December 2003. 2. Reduction in clauses: The 20 clauses prescribed in the 1994 version, caused various problems to the organisation. First, there was an apparent discontinuity in the flow of the clauses. Second, the clauses did not reflect the way business was done. Hence, though the organisations demonstrated compliance to the 20 clauses, their presentation differed from the operational practice. The new standard has brought down the 20 clauses to five broad and comprehensive ones. These are: Clause 4: Quality Management System. Clause 5: Management Responsibility. Responsibility. Clause 6: Resource Management. Clause 7: Product Realisation. Clause 8: Measurement, Analysis and Improvement. 3. Meeting customer requirements: The key objective of ISO 9001:2000 QMS is customer satisfaction. Organisation needs to evaluate customer needs and expectations and ensure that the entire workforce is aware of them. Customer needs should be the basis for defining targets for improvement within the organisation. Focus on customer communication can help in understanding the customer. 4. Adopting the “process” approach: The five clauses of the ISO 9001:2000 standard clearly emphasise on the “process” approach. They focus on: 1.
Identi Identifyi fying ng and conf conform orming ing to cust custome omerr needs. needs.
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Value Value addit addition ion to the the custo customer mer by by the proce processe sses. s.
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Process Process evalua evaluation tion based on perfor performance mance and effec effectiven tiveness. ess.
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Constantly Constantly enhanci enhancing ng the system system based on on objective objective evalua evaluation tion of process. process.
5. The role of management: In the new standard, management role has been widened and reinforced. Top Top management personnel need not take part in the everyday operation of the QMS. They however need to frame the quality policy and quality objectives, perform assessments, ensure adequacy of resources and focus efforts on meeting customer and regulatory requirements. In spite of the reservations regarding management role in quality system, it is usually considered to be the foundation for a successful QMS.
6. Continual enhancement of quality system: This feature was also a part of the previous standard (1994) but reflected only in a few clauses such as corrective and preventive action, and auditing. But the new standard views continual improvement as an important aspect of QMS implementation. It also requires organisations to regularly check, evaluate, redefine, and communicate quality targets. 7. Ongoing information gathering and evaluation: The new QMS emphasises the need for an ongoing process of information gathering and analysis. The organisation should continually analyse information regarding customers, products, processes, a nd suppliers. 8. Reduced rigidity helps customised documentation: The less rigid nature of the standard has given more freedom for organisations to present their documentation. Apart from the quality manual, documentation is specifically required for only six basic areas – control of documents, control of quality records, internal audits, control of nonconforming product, corrective action and preventive action. This does not mean that the organisation neglects the documentation of other areas. Rather the organisation should identify and document all processes and procedures procedures that will ensure an effective QMS. The organisation must consider various factors such as organisation size, the nature of its processes, the difficulty and interdependency of processes and the skill of personnel before documentation. 9. Different Perspectives: The 2000 version has shifted its perspective in the following areas: 1. While the previous version viewed the final product as an outcome of many processes, the newer version views it as a process outcome. 2. The old standard considered quality as total characteristics of a product or service for fulfilling requirements. The newer version expresses quality as the capacity of the product to meet customer and regulatory requirements. 3. The newer version has the terms – organisation, supplier and customer instead of the old standard terms – supplier, supplier, sub-supplier and customer respectively. 10. Exclusions: In the previous version, organisations dealing with production, installation and servicing were registered under ISO 9002. If there was no provision for service in the organisation, it was mentioned in the quality manual. But in the recent version exclusions are permitted only for section 7 (product realisation) requirements, subject to the non-relevance of requirements to the organisation. The organisation must clarify and validate the exclusions. Continue the tour: The Principles Behind ISO 9001:2000 Understanding > The Principles Behind ISO 9001:2000 The ISO 9001:2000 QMS standards are based on 8 principles. These along with the advantages of applying them are li sted below: 1. Customer Focus: Organisations depend on their customers and therefore, should understand current and future customer needs, and strive to exceed customer expectations. This involves •
Better response to market trends.
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Making objectives and operations customer-centric.
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Focussing energies on increasing customer satisfaction.
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Gauging customer satisfaction for further action.
2. Leadership: Leaders establish the organisation’s direction and provide unity of purpose. They should create and maintain an environment in which people can become fully involved in achieving the organisation's objectives. Leadership: •
Promotes harmony in the organisation.
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Drives a single purpose through the organisation.
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Recognizes individual contributions.
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Makes employees responsible and accountable through proper training and empowerment.
3. Involvement of Employees:
Employees irrespective of their position are the essence of an organisation and organisations benefit from their involvement and abilities. Employee involvement ensures their total commitment towards meeting organisational objectives. 4. Process Approach: A desired result is achieved more efficiently when related resources and activities are managed as a process. This helps: •
Recognise important activities in the system.
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Improve important activities through effective utilisation of resources and efficient methods.
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Make output constant, reliable, and fast.
5. System Approach to Management: Identifying, understanding and managing interrelated processes as a system contributes to an organisation's effectiveness and efficiency in achieving its objectives. It •
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Directs processes to achieve organisation’s objectives and to focus on important processes. Develops a system to achieve objectives. Initiates process integration and interdependency through a structured approach. Uses resources effectively depending on capabilities of organisation
6. Continual Improvement: Continual improvement should be a permanent objective of the organisation. The advantage of this endeavour is that it •
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Aligns activities of organisation with the organisational plan. Develops a continual improvement consciousness among the people. Trains Trains people in employing tools of continual improvement. Views continual improvement of the organisation as every employee’s objective.
7. Factual Approach to Decision Making: Effective decisions are based on the analysis of data and information. Thereby •
Data on hand is reliable.
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Analysis of data is accurate.
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Decision-making is effective.
8. Mutually Beneficial Supplier Relationships: An organisation and its suppliers are interdependent and a mutually beneficial relationship enhances their ability to create value. As a result •
Value creation potential increases.
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Clarity of communication improves.
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Resources are pooled for achieving common goals.
Continue the tour: ISO 9001:2000 QMS Requirements
Understanding > ISO 9001:2000 QMS Requirements Every product goes through various stages of production before
the final delivery to the customer. To support this process the organisation needs a structured management system. This approach requires total involvement from the top management. A management system guides an organisation to meet customer needs and also comply with the regulations. In addition to the customer focus, the organisation also has responsibilities towards its stakeholders, staff and society. society. Fulfilling these responsibilities entails specific requirements of a QMS. These requirements form the basis for the ISO 9001:2000 standards.
Clause by clause explanation of ISO 9001:2000 QMS requirements 4. Quality Management System: This clause outlines the requirements of a QMS. 4.1 General Requirements: General requirements state that an organisation must implement a continually improving QMS, meeting meeting the requirements of the standard. What organisations need to do? •
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Determine the processes, required by the QMS that is applied by the organisation. Identify the interdependency of the processes and their occurrence. Recognise the requirements and procedures for effective process operation and control. Ensure availability of all resources required to operate processes.
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Perform process checking, evaluation and review.
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Direct actions for achieving objectives.
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Continually improve on processes.
4.2 Documentation Requirements: This section of the standard deals with the documentation of a
QMS. 4.2.1 General: Documentation requirements for a QMS include: •
Documents for implementing a quality system.
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Documents detailing the organisation’s processes.
4.2.2 Quality Manual: The quality manual is an important part of documentation and deals with •
The span of the QMS.
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Exclusions if any.
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The organisation’s accepted procedures for implementing quality system. Details of process interrelationships within the QMS.
4.2.3 Control of Documents: This relates to the steps involved in document control i.e. maintaining and managing documents. These include: •
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Endorsing documents before distribution. Assessing and re-endorsing documents whenever required. Identifying the existing revised edition of documents including amendments if any. any. Supplying recent versions of required documents and ensuring availability at relevant locations. Maintaining the legibility of documents and making them distinguishable. Replacing or distinguishing obsolete editions to prevent their accidental use.
4.2.4 Control of Records: Records are the proof of an organisation's implementation of a quality management system hence they need to be carefully maintained. This section lists the requirements for managing records starting from their creation till their disposal. 5. Management Responsibility: The success of any QMS is in direct proportion to the role played by the management. This clause features the management role in a QMS. 5.1 Management Commitment: The management should demonstrate their commitment to the establishment and continual improvement of the QMS. They can do this by: •
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Communicating the need to meet customer, customer, statutory and regulatory requirements. Developing a quality framework addressing the above needs. Setting quality objectives and providing necessary resources. Performing management reviews to improve existing systems.
5.2 Customer Focus: This section deals with ways to achieve customer satisfaction. It is the management’s responsibility that customer needs are identified and consistently met, to ensure customer satisfaction. 5.3 Quality Policy: A quality policy is essential for initiating the quality system. This
section provides a framework to the management for building the quality policy. The quality policy should: •
Be aligned with the overall organisational goals.
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Direct the organisation towards continual improvement of the quality system.
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Be established across the organisation.
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Act as a guideline for the setting up and evaluating the quality objectives. Be continually evaluated for relevance.
5.4 Planning: This section highlights the management's role in defining quality objectives and planning the quality system. 5.4.1 Quality Objectives: The management should ascertain that quality objectives are fixed for all the activities and functions of the organisation. The defined quality objectives need to be measurable and aligned with the established quality policy. policy. 5.4.2 Quality Management System Planning: The management should play a role in the planning of the quality system. Planning should be directed towards achieving the basic requirements of the standard and the QMS quality objectives. Any changes planned to the system should be consistent with the system. 5.5 Responsibility, Authority and Communication: This section lists the requirements to be followed by the management while assigning responsibility, responsibility, choosing a representative and promoting communication. 5.5.1 Responsibility and Authority: This part of the clause states that the management must assign responsibilities and make employees at all levels accountable in order to involve the organisation as a whole in the endeavour for quality. 5.5.2 Management Representative: The section details the management representative's role. Appointed by the top management he should: •
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Monitor the processes required by the QMS. Update the management on the QMS's performance and ensure continual improvement. Advance the cause of customer needs across the organisation.
5.5.3 Internal Communication: It is the management's responsibility to see that the information relating to the QMS is communicated well through established channels. 5.6 Management Review: The primary objective of quality management is customer satisfaction. Hence, there must be a continual improvement in the QMS to achieve this goal. This section deals with the need for conducting management reviews and specifies the requirements they need to meet. 5.6.1 General: This section centres on the basic requirements for improving the QMS. The quality system is reviewed at regular intervals for effectiveness. The review aims at identifying possibilities of improvement and changes in the policy and objectives of the QMS.
5.6.2 Review Input: This section lists the aspects that the management must consider while conducting a review. •
Audit results.
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Customer feedback.
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Conformity of product to quality.
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Process performance.
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Precautionary and remedial actions implemented.
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Results of previous management reviews.
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Factors affecting QMS.
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Suggestions for improvement.
5.6.3 Review Output: A management review should work towards: •
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QMS improvement. Increase in product quality on par with the customer requirements. Identifying resources needed for the system.
6. Resource Management: Every system needs specific resources for its success. The QMS sustains itself through the following: 6.1 Provision of Resources: Resources need to be identified and provided so as to: •
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Sustain the QMS and enhance its effectiveness. Fulfil customer needs and increase customer satisfaction.
6.2 Human Resources: Manpower forms a major part of an organisation's resources. This section addresses the requirements for managing human resources. 6.2.1 General: Skilled personnel need to be employed in areas of work that have direct impact on quality. quality. 6.2.2 Competence, Awareness and Training: For effective utilisation of human resources: •
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Establish the levels of proficiency for performing a work that affects product quality. quality. Ensure training of personnel to fulfil these requirements. Regularly evaluate the measures taken to meet the above-mentioned requirements. Ensure that the personnel are aware of the significance of their role in contributing to the quality system. Maintain records of training, awareness programs, qualifications and experience of personnel.
6.3 Infrastructure: An organisation should identify and provide the necessary infrastructure (land, building, equipments, supporting facilities) for maintaining quality. quality. 6.4 Work Environment: The onus of identifying and creating the necessary work environment for maintaining product/process quality lies on the organisation. 7. Product Realisation:
Every product passes through the stages of planning, customer specifications, design, purchasing, production and service, control and monitoring. This clause lists the requirements for each of these stages. 7.1 Planning Product Realisation: The organisation ought to devise and establish processes required for product development. These processes need to be in line with the general requirements of the quality system. The organisation has to: •
Establish suitable quality standards, processes and documents for the product.
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Provide resources for developing the product.
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Establish required process for checking product quality.
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Maintain records to confirm that both the processes and product meet the requirements.
7.2 Customer Related Processes: Customer requirements shape the product. Keeping this in view this section details the stipulations for identifying, analysing and communicating customer requirements. 7.2.1 Determining Product Related Requirements: This section requires that the organisation identify: •
Explicit requirements of customers.
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Implicit requirements of customers.
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Statutory and regulatory product requirements.
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Supplementary requirements established by the organisation.
7.2.2 Review Product Related Requirements: Product requirements should be reviewed by the organisation before taking the responsibility to deliver. This necessitates that •
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Product specifications are clear. Changes made to earlier product specifications are communicated and mutually accepted. The organisation is capable of achieving the specified requirements. Records of the review are maintained.
7.2.3 Customer Communication: The organisation needs to identify and establish effective methodologies for communicating to customer's information regarding the products, contracts, orders, feedback and complaints. 7.3 Design and Development: Once the requirements are known, the product can proceed to the design stage. This section categorises the design requirements under planning, design inputs, design outputs, design review, design verification, design validation and design change control. 7.3.1 Design and Development Planning: The organisation needs to define the following aspects for design and development of a product. •
The stages of the process.
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The monitoring process at each stage.
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Design and development responsibilities.
The organisation must also put in place systems that augment cooperation between various groups involved in the design a nd development. Proper communication and delegation of
responsibilities facilitates this. Deliverables from the planning process are readjusted to take into account the advancements in design and development. 7.3.2 Design and Development Inputs: The following product design inputs need to be identified and recorded: •
Operational and performance standards.
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Statutory and legal requirements.
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Data from previous designs if any. any.
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Necessary design and development requirements.
7.3.3 Design and Development Outputs: The design and development outputs are checked against the relevant design and development inputs for conformity. The output must: •
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Meet the input criteria. Detail aspects such as procurement, manufacturing and after sales service. List the approval criteria for product quality. quality. Highlight product features vital for safe and appropriate use.
7.3.4 Design and Development Review: Design and development reviews have to be planned and conducted at appropriate intervals. These reviews should ensure that: •
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The progress made in design and development meets the proposed criteria. Problems are detected well in advance and suitable action is taken.
The team conducting the review should consist of personnel across various functions. The details of the review and actions taken thereof should be recorded. 7.3.5 Design and Development Verification: The outputs need to be verified to ascertain that they have met the input requirements. The records of verification and corrective action if any should be maintained. 7.3.6 Design and Development Validation: The organisation should have a process of validation so that the designed product meets the customer requirements for which it is being made. Validation should take place before the product gets into production mode or is delivered to the customer. Records of validation conducted should be documented. 7.3.7 Control of Design and Development Changes: The changes made during the design and development needs to be recorded. They should be examined and confirmed before being applied. A review of these reveals the impact of cha nge on the product. 7.4 Purchasing: This section explains the requirements to be considered for procuring a product from a supplier. 7.4.1 Purchasing Process: Products procured from the supplier should match the purchase specifications laid down. The effort made to do this should correspond to their impact on the final products performance. Suppliers are chosen based on their ability to conform to the organisation’s product specifications. Guidelines for choosing and approving suppliers should be laid down and followed. Details of supplier appraisal conducted along with relevant action taken also should be recorded.
7.4.2 Purchasing Information: The details of product to be purchased need appropriate definition, along with: •
Specifications for acceptance of products, processes, methods and equipment.
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Proficiency of personnel to be deployed, and
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Quality system standards followed.
7.4.3 Verification of Purchased Product: Steps, such as inspection and testing to ensure that the procured product meets the required specifications should be followed. If the organisation plans to verify at the supplier's location, it must be stated in the purchase information. 7.5 Production and Service Provision: This section deals with the organisational requirements with respect to production and service provisions. 7.5.1 Control of Production and Service Provision: The provision for production and service is under restricted conditions that include •
Accessibility of data pertaining to product details.
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Accessibility of work instructions.
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Availability of appropriate equipment.
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Defined procedures for monitoring and measurement along with necessary equipment. Application of steps for approval, delivery and after delivery processes.
7.5.2 Validation of Processes and Service Provision: The organisation should evaluate a nd approve the processes where the output cannot be crosschecked before delivery. delivery. In such cases defects surface only after the product is put to use or a service provided. Validation helps ascertain that the process or product meets the desired objectives. The following factors need to be considered for validation: •
Establishing criteria for assessment and clearance of the processes.
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Clearance of equipment and skill of personnel deployed.
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Defined procedures.
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Control of records.
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Revalidation.
7.5.3 Identification and Traceability: The product should be clearly identified wherever possible in the process of product realisation. The progress of the product realisation should be determined through relevant monitoring and measurement methods. Distinctive identity of products that need to be traced should also be maintained and recorded. 7.5.4 Customer Property: Customer property being used by the organisation should be handled with care. The property must be identified, protected and maintained properly. The customer must be immediately notified and details recorded of any damage or loss of the property. 7.5.5 Preservation of Product: The organisation must maintain the quality of the product till it is delivered to the customer. customer. This includes stages such as storage, packing, transportation and delivery. delivery. 7.6 Control of Monitoring and Measuring Devices: The organisation should establish monitoring and measurement procedures. This includes maintaining appropriate instruments
for ascertaining conformance of the product to the desired specifications. Where appropriate, the measuring instruments should be: •
Calibrated and details recorded.
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Fine-tuned as per requirements.
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Identifiable.
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Maintained and protected to ensure that measurements are error free. Checked to prevent inadvertent changes to measurements taken.
If the instrument does not meet the calibration specifications, the organisation must evaluate its previous measurements. Necessary corrective action should then be initiated. Details of calibration and evaluations conducted should be recorded. 8. Measurement, Analysis and I mprovement: This clause focuses on the need to adhere to the continual improvement objective of the quality system. 8.1 General: The organisation should have in place monitoring, measurement, analysis and improvement processes, including statistical methods for: •
Indicating the conformance of product or service to stipulations.
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Ensuring adherence to the QMS.
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Continually improving the QMS.
8.2 Monitoring and Measurement: This section contains the requirements to be met for monitoring and evaluating the quality system. 8.2.1 Customer Satisfaction: The organisation should determine whether they are satisfying customer requirements through regular customer feedback. It should also devise and define ways for gathering and analysing customer feedback. 8.2.2 Internal Audit: Internal audits should be conducted periodically to ensure that the QMS •
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Meets the ISO 9001:2000 standards and the organisation defined QMS requirements. Is well deployed and sustained. The organisation needs to define and document aspects such as the basis of an audit, the area it covers, its periodicity, periodicity, the people responsible for conducting it , and the approach adopted. It also needs to define and document how the audit results are recorded and utilised. The entire audit process must be unbiased and conducted by someone external to the division or department under audit.
8.2.3 Monitoring and Measurement of Process: Efficient monitoring and measurement methods need to be employed to substantiate the ability of the QMS processes to achieve the desired goals. If the results do not conform to the objectives outlined, appropriate corrective action must be taken. 8.2.4 Monitoring and Measurement of Product: The product should be monitored and measured at various stages of the product realisation to ensure conformity to defined specifications. In case of non-conformity, non-conformity, the product delivery should be stalled unless the concerned customer or authority’s
acceptance is obtained. 8.3 Control of Non-Conforming Product: Products failing to conform to the customer requirements should be identified and accidental use is to be prevented. The organisation can adopt the following approaches while dealing with such products. It should •
Take necessary steps to avert the nonconformity.
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Prevent the product from its intended use.
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Release the product for usage only with the concerned customer or authority’s consent.
Information pertaining to such products and the corresponding action taken should be recorded. If the action was initiated to correct the product, necessary re-checking must be done before approval. If the defect is identified after the product is delivered to the customer, customer, then the organisation must consider appropriate action. 8.4 Analysis of Data: Pertinent data must be gathered and examined to ascertain the relevance of the QMS. The areas where enhancement can be made should also be identified with the help of the information analysis. The data collected from monitoring and measurement activities is one of the sources for such an analysis. The gathered data must provide information about: •
Customer feedback.
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Meeting of established product requirements.
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The tendency of particular processes and products.
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Scope for taking pre-emptive steps.
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Contractors and suppliers performance.
8.5 Improvement: This section lists the requirements for the continual improvement of the QMS (Quality Management System). 8.5.1 Continual Improvement: The effectiveness effectiveness of organisations QMS must be continually continually improved. Striving to meet the principles set by the quality policy, policy, and endeavouring to meet the quality objectives can be one way of achieving this. The opportunities for improvement can be determined by evaluating audit results, analysis of data, and management review. Improvements can be made through corrective and preventive action, or through innovative means. 8.5.2 Corrective Action: Appropriate corrective actions are essential for ensuring that a non-conformance does not recur. recur. Corrective action involves: •
Assessing the nonconformities.
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Identifying the origin of nonconformity. nonconformity.
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Evaluating the necessity of taking action to prevent repetition of nonconformity. nonconformity. Identifying and applying the required action. Maintaining records of actions taken and consequent results. Re -evaluating the corrective action implemented.
8.5.3 Preventive Action: To avoid possibilities of non-conformance, the organisation must take appropriate precautionary or preventive actions. The following procedures for preventive action need to be
documented and implemented: •
Identify probable nonconformities and their origin.
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Assess the necessity of action to avert nonconformities.
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Identify and carryout the necessary actions.
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Document the actions taken and their outcomes.
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Re-evaluate the preventive actions implemented.
Planning and Implementation > Step By Step Implementation Of ISO 9001:2000 QMS The ISO 9001:2000 standard is focussed on accomplishing the following objectives. •
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Achieve customer satisfaction through product or service quality. Develop a process based, systems approach. Create a culture of employee involvement and continual improvement.
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Improve overall performance of the organisation.
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Reduce operational risk.
A few basic steps should be followed to achieve these objectives through implementation of ISO 9001:2000 standard. Summary of steps for implementing ISO 9001 1.
Top mana manage geme ment nt invo involv lvem emen ent. t.
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Choosi Choosing ng and and traini training ng a proje project ct manag manager er..
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The proj project ect mana manager ger prep prepare ares s a proje project ct plan. plan.
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Sett Settin ing g up a stee steeri ring ng com commi mitt ttee ee..
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Cond Conduc ucti ting ng gap gap analy analysi sis. s.
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Commun Communicat ication ion,, aware awarenes ness s and train training ing..
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Formi Forming ng teams teams and assig assignin ning g respons responsibi ibilit lities ies..
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Team re revi ew ew.
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Revie Review w by by the the steer steering ing commit committee tee..
10. System System impleme implementa ntatio tion. n. 11. Inter Interna nall audit audit.. 12. Manage Managemen mentt revi review. ew. 13. Pre-as Pre-asses sessme sment nt audit. audit. 14. Fina Finall audi audit. t. 1. Top management involvement: Any company wide quality program needs total involvement of the top management. The success of the ISO 9001:2000 implementation begins with the commitment of the management. The commitment from the top management sustains and drives the ISO 9001 implementation. The top management must show its commitment by •
Expressing the importance of meeting customer requirements to the organisation.
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Establishing the quality policy.
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Ensuring that the quality objectives are defined.
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Ensuring required resources are available.
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Choosing a management representative.
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Performing management reviews.
2. Choosing and training a project manager: The first concrete step an organisation can take towards implementing the ISO 9001:2000 QMS is to choose a project manager. manager. A project manager chosen should be a key player in the organisation’s management. The top management should appoint him and oversee the implementation of the whole project. He must therefore, have an in-depth knowledge of the organisation’s working, a thorough understanding of essential management principles and clarity about the ISO 9001 requirements. The project manager must have an in-depth knowledge of the ISO 9001 requirements. He should also be provided appropriate training to enable him to determine •
The QMS implementation plan.
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QMS communication strategy·
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The resources needed.
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Training Training and awareness needs.
This training ensures that a skilled professional committed to quality heads the project. 3. Preparing a project plan: Post training, the project manager develops a project plan. The project plan is an outline for the I SO 9001:2000 implementation. The objective of a project plan is to define the various phases of implementation and developing time schedules for accomplishing them. The start of the project could possibly be the process of gap analysis. The gap analysis process, normally takes between 2 to 5 days. It depends on the organisation’s size, number of auditors, auditors’ experience and existing quality system. The immediate objective of the organisation is to get the I SO certification at the earliest possible date. This date is influenced by many factors. It is therefore essential for the project manager to weigh the following when setting the time for achieving certification. •
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The closing date of the project shapes the intermediate deadlines to be met. A shorter time frame for implementation consumes more resources. A longer deadline may cause the organisation to lose momentum.
It is essential to fix a tentative date based on factors driving the organisation towards certification. Consulting with auditors can also prove useful in this regard. Once a tentative date is fixed, the process can be directed accordingly. accordingly. The date can be modified depending on the progress made and the speed of the process. 4. Setting up a steering committee: The project manager chooses a steering committee to assist him in the planning, synchronising and resource mobilisation required for the project. The implementation of the standard necessitates constant review and discussion among the steering team. The steering committee is an essential part of the QMS implementation. Its responsibilities include: •
Choosing team members for each procedure.
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Setting the time limit for each team.
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Determining training requirements for employees and
scheduling training programmes. •
Meeting regularly to assess progress, hold discussions with various teams and assess the various resources required for implementation.
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Reviewing and approving procedures.
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Assessing and selecting a registrar. registrar.
5. Conducting gap analysis: It is essential for the organisation to establish the status of the current quality system. A gap analysis process compares the current quality system with the requirements of the ISO 9001:2000 standard. The result of the analysis provides information about the gap to be abridged for various processes of the existing system. While the above steps are all a part of planning, the actual implementation starts only after the gap analysis. The project manager in consultation with the steering committee could appoint an internal or external team to conduct the gap analysis. 6. Communication, awareness and training: The gap analysis will highlight the deficient processes and the areas for improvement. The steering committee should then determine how to fill the gap and achieve the ISO 9001:2000 requirements. An organisation wide implementation strategy is necessary for this. Organisation wide implementation must begin with conducting ISO awareness programmes. These programmes communicate to the employees what ISO 9001:2000 is all about. It also answers why ISO 9001:2000 is being implemented, how it will affect the objectives of the organisation and the employees, and the role each can play. Once the employees are aware of the ISO 9001 standard, they must be trained to adapt to its requirements. Implementation of the ISO 9001 standard standard affects the the entire organisation. organisation. The training programmes must therefore, be targeted at all the employee categories – senior management, middle management, supervisors and workers. The training of employees include •
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Determining the training needs for QMS specific competencies (such as preparing quality manual, writing directives for procedures and processes, principles of audit). Imparting the required training including new techniques for monitoring, measurement and testing among others. Training Training personnel to manage change brought about by the standard.
7. Forming teams and assigning responsibilities: The steering committee then selects employees for creating project teams. These project teams are assigned specific tasks based on the result of gap analysis. Their main role is to upgrade the deficient processes/ procedures and prepare documentation to meet the ISO standard’s requirements. The steering committee assigns responsibilities to individuals and groups. The committee must also allocate necessary resources and set the deadlines for completion of the tasks. Assigning tasks: While assigning tasks the steering committee should •
•
Assess the division of responsibilities to ensure that they are evenly distributed, so that no individual or team is heavily loaded with responsibilities. Identify a leader for each team. It is advisable to have
a member from the steering committee as a team leader. leader. This would enable the team to communicate better with the steering committee. Identifying required resources: The steering committee must determine whether the teams or members require assistance to carry out their responsibilities during implementation of ISO standard. It must also guide the teams and it’s members in accomplishing the entrusted tasks. This may range from providing prepared materials to giving special training. Establishing time limits: The steering committee must set the time limit for the teams to finish the tasks. The biggest factor influencing the time limit is the availability of resources. Hence, the steering team must review the availability of resources and establish intermediate deadlines with respect to it. Time limits must be set considering the sequence of tasks. The steering committee must be clear about the preceding and succeeding tasks to be distributed among all the teams. Deadlines for key activities, which form the basis for other activities, must be set earlier. An estimated time for completion of the project depending on the availability of resources must also be established. The gap analysis sheet can also be referred to determine the exact quantity of work to be acoomplished by the teams. All these will help in determining an approximate time required for the whole process. 8. Team review: A continual review is essential to determine if the implementation project is on the right track. Normally individual team leaders conduct these reviews. They hold team meetings to discuss and modify processes. The meetings are based on the results of gap analysis and the outcomes of the assigned tasks. The team leader reviews these results to determine the team’s progress. The proceedings in a team review can be listed as •
Discussing the process the team is entrusted with.
•
Discussing the gap analysis relevant to the team.
•
•
•
•
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Identifying the required resources by the team for completing the tasks. Establishing deadlines based on the gap analysis sheet. Ensuring that the procedures and the processes match and necessary modifications are made wherever required. Creating and documenting a new procedure if there is no defined procedure available. Listing the requirements that have not been met. An assessment of these requirements is essential for modifying the process.
Depending on this review, processes are modified, resources reallocated and deadlines reset with the approval of the steering committee. The project team then proceeds with accomplishing the assigned tasks. 9. Review by the steering committee: The steering committee directs the implementation project. The steering committee’s review is essential to determine the applicability and effectiveness of the QMS. The review focuses on evaluating the processes for further improvement and the required changes to the processes to effect this improvement. The steering committee assesses the following: •
The role of each project team and the entrusted
responsibilities. •
Whether the targets can be met.
•
Whether the training needs of employees are met.
•
•
The availability of resources as planned or is there a need for alterations. Approval of the procedures and processes developed by the team leaders.
10. System implementation: Once all the tasks assigned to the various teams are accomplished, the organisation is ready to implement the system. All the modified procedures and processes are put into effect. Implementation of the system ensures that the requirements of the gap analysis are fulfilled. The following are the significant characteristics of a successful QMS. •
Top management fully supports the QMS.
•
Current business processes form the core of the QMS.
•
•
QMS documentation is easily accessible to all the employees. Documentation of the QMS i s concise, clear, clear, and easy to use and control.
•
Opportunity for growth through continual improvement is inherent in the organisation.
•
Management representatives are entrusted with critical responsibilities for managing and enhancing the QMS. · Internal audit adds value and is an essential part of the continual improvement objective of the system.
11. Internal audit: Internal auditing is the first step to determine the effectiveness of the implementation project. It is an essential part of the continual improvement objective of the system. Hence, it is critical to choose and train the right kind of internal auditors. The auditors should preferably be from across various functional areas of the organisation. This enables a better understanding of the system during audit. Internal audits are performed to confirm that the implemented QMS: •
•
Meets the ISO 9001 requirements and the quality objectives established by the organisation. Is effective and is continually being improved.
Internal audits must be continued even after the QMS has been implemented and certified. 12. Management review: A management review is conducted when the QMS has been implemented and maintained for about three to six months. This is essential for determining the continual applicability, conformity and effectiveness of the quality system. The review involves evaluating the need for modifications to the QMS and identifying opportunities for improvement. The management review is normally conducted on the basis of: •
Audit results.
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Customer feedback.
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Process performance and product compliance.
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Status of remedial and preventive actions.
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Results of past management reviews.
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Changes impacting the QMS.
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Suggestions for improvement.
13. Pre-assessment audit: The organisation can apply for certification when there are no noticeable non-conformities in the system. However, However, it would be beneficial for the organisation to go for a pre-assessment audit by an external/independent auditor. auditor. This will iron out small deficiencies the organisation might have overlooked. It will also build the confidence of the organisation for the final audit. 14. Audit by the registrar: This is the culmination stage of the whole project. An organisation that has implemented and tested the quality system can apply for an audit from a certifying body. body. A recognised certifying body conducts the audit. Auditing of documents is performed first. An on-site audit of the QMS is conducted if the documentation conforms to the requirements of the ISO 9001 standard. If the functioning of the QMS meets the entire ISO 9001:2000 requirements, the organisation is recommended for certification as ISO 9001:2000 compliant. The certificate is usually valid for three years. During this period the registrar periodically reviews the QMS to ensure its continual improvement. Continual Improvement: Getting certified is not the end of the road for the ISO 9001:2000 QMS implementation in the organisation. It is just the beginning. The organisation needs to continually identify customer requirements and other areas for improvement. It is this process of continual improvement that actually keeps the ISO 9001:2000 certification from becoming obsolete. Gap Analysis > Description One of the first steps steps in implementing ISO 9001:2000 standard Quality Management System (QMS) is to conduct a Gap a nalysis. Gap analysis helps identify the gaps between the organisation’s existing processes to the requirements of the ISO standards. Following are the steps involved in conducting an effective Gap analysis. Form a Team: Normally, Normally, organisations seek the services of an external auditing agency for conducting a Gap Analysis. However, However, if the organisation has personnel who are well versed with the ISO standards with prior experience in conducting gap analysis, then their services are preferred. The team formed to conduct the Gap Analysis should preferably comprise of personnel from different functional backgrounds. The team size depends on how large the organisation is and the complexities involved in the study. Duration of gap analysis program largely depends on the depth of evaluation required and geographical factors. Schedule: Scheduling initially requires a comprehensive understanding of the objectives of the Gap Analysis program. Therefore, an agenda incorporating these objectives is prepared. Scheduling also involves allocating responsibilities to the team members for the various stages of gap analysis and setting the deadline for executing the program. Gap analysis can be conducted either by a process based or area-based approach. Conduct: The conduct phase of gap analysis involves an initial assessment of the existing QMS in order to evaluate the extent of its conformance to the requirements. Remember that the focus should be on what is in place rather than what needs to be in place. Gap analysis uses some effective tools, such as questionnaires, that would help the organisation expedite its
initial review. Gap analysis tools can be listed as: •
Quality management system gap analysis tool.
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Management responsibility gap analysis tool.
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Resource management gap analysis tool.
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Product realisation gap analysis tool.
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Remedial gap analysis tool.
A standard template of questions fills these five sets of tools. Answer to each of these questions could be: Yes, No, and N/A. The questionnaire also has a column for comments and explanations. A Yes implies that the organisation has already met the requirement, a No identifies a gap, while an N/A answer implies that the question is not related to the organisation’s activities. A No requires the team to delve deeper to identify and list items that need to be implemented, redesigned or documented. Questionnaires help in conducting gap analysis (vide appendix). The team members fill the questionnaire by conducting interviews of various process owners or key personnel in various processes. The focus of the gap analysis is both on the processes followed and on the documentation. Reporting: After conducting the analysis the audit results are abridged in the form of a task list. Several types of tasks are detailed. These may include processes that: •
Conform to the standard and are documented.
•
Conform to standard and need to be documented.
•
•
Do not conform to the standard and need to be redesigned. Are required to be in place as per the standard.
Use task list for planning: This involves formulating the corrective actions that need to be taken for filling the identified gaps. The responsibility for developing corrective action plans is assigned to select personnel working in the relevant processes. A time limit is set for for these personnel to accomplish this task. The Gap analysis report forms the basis for the I SO 9001:2000 QMS implementation within the organisation. It acts like a compass to show the direction the organisation needs to move in and the efforts and resources it should expend to become compliant. Continue the tour: Gap Analysis Questionnaire Gap Analysis > Questionnaire
N Y Comm Ye o /A ents s 4.Quality management system:
4.1 General requirements: •
Are the procedures required for implementing ISO 9001QMS in the entire organisation identified?
Is the order and interrelationship between the various QMS processes established? •
•
•
•
Has the basis and approach for properly managing and controlling processes been established? Have the information and resources required for managing the organisations procedures been provided? Are these processes constantly monitored, measured and evaluated? Has the organisation implemented the required measures to realise intended objectives and ensure continual improvement?
4.2 Documentation requirements: 4.2.2 Quality manual: •
•
•
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Does the organisation have a defined and a documented quality manual? Is it well maintained? Does the manual mention the procedures that were documented and maintained for QMS (Quality Management System)? Does it provide details of areas excluded, along with the reasons for the exclusions? Are the exclusions among those permitted by Clause 7? Does the manual provide a cross reference of interrelated QMS processes along with an explanation of kind of interrelationship?
4.2.3 Control of Documents: •
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•
•
•
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Does the organisation have a defined process to effectively manage and control its QMS documents as required by ISO 9001:2000? Are all the documents certified before release by the relevant authorities? Are the documents regularly evaluated and improved? Does the organisation replace documents that are outdated with the current ones? Does it preserve outdated documents for later reference? Are the processes and responsibilities established and maintained according to the modification in the various types of documents? Are the documents clear, distinguishable, dated (with dates), logically arranged, and conserved for a defined period? Are the documents from outside sources well managed and circulated?
•
Is the documentation process effectively implemented and pertiodically evaluated? Is it consistently followed?
4.2.4 Control of records: records: •
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Are the records clear, clear, distinguishable and easily accessible? Is there a defined practice that is consistently followed to assist in managing the records pertaining to classification, preservation and filing? Are these practices documented?
5. Management responsibility:
5.1 Management commitment: •
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•
•
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Has the management ensured that all employees are made aware of the significance of meeting customer and legal requirements? Has the organisation defined its quality policy? Are the quality objectives defined? Does the top management conduct periodical reviews? Is the top management involved in ensuring availability of necessary resources?
5.2 Customer focus: •
Has the top management ensured that the customer needs are identified and fulfilled? Is customer satisfaction the ultimate goal behind these activities?
5.3 Quality Policy: •
•
•
•
•
Is the policy compatible with the vision of the organisation? Does the policy communicate the organisation’s intent to conform to standards and to continual improvement? Does it provide a basis for defining and evaluating quality objectives? Is the policy well communicated? Is the policy evaluated for its organisational relevance on a regular basis?
5.4 Planning:
5.4.1 Quality objectives: •
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Are quality objectives defined for all products and activities the organisation is involved in? Can they be measured and evaluated in the light of the quality policy?
5.4.2 Quality management system
planning: •
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Does the organisation have plans for meeting the general requirements and quality objectives of the QMS? Are the modifications that are planned and executed, aligned to the QMS principles?
5.5 Responsibility, Responsibility, Authority And Communication: 5.5.1 Responsibility 5.5.1 Responsibility and authority: •
Is there a defined structure of roles and responsibilities for implementing the QMS? Is it well documented and effectively communicated?
5.5.2 Management representative: •
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Is a management representative assigned to oversee the QMS implementation and to update the top management on the progress? Does the management representative drive the efforts towards greater awareness of customer needs by the employee?
5.5.3 Internal 5.5.3 Internal communication: •
•
Has an effective communication strategy and approach been developed to communicate information about the QMS within the organisation? Is the progress of the QMS being communicated within the organisation?
5.6 Management review: 5.6.1 General: •
•
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Does top management conduct periodic QMS reviews to evaluate its relevance, sufficiency and usefulness? Does the management review evaluat the scope for continual improvement of the QMS in its quality policy, objectives and targets? Are records of management review created and preserved?
5.6.2 Review input: Which of the following form part of the inputs considered for management review: •
Audit results?
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Customer feedback?
•
•
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Process performance and product compliance? Evaluation of preventive and corrective actions taken? New developments that may have their influence on QMS?
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Employee Suggestions?
5.6.3 Review output: Which of these are the outcome of reviews?: •
•
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Enhancement in QMS and its processes. Enhancement in product characteristics for meeting customer needs. Better allocation of resources.
6. Resource management: 6.1 Provision of resources: •
•
Are the resources, necessary for implementing and improving the QMS, made available? Are resources, necessary for improving customer satisfaction by meeting customer needs identified and made available?
6.2 Human resources:
6.2.1 General: •
Are activities which significantly impact quality, quality, handled by employees with the right competencies and skills?
6.2.2 Competence, Awareness And Training: •
•
•
•
Is there a process in place to identify training needs of various employees playing a part in the QMS? Is relevant training provided to all employees, especially to those whose work has a greater impact on QMS? Are the employees aware of: a) The impact of their work activities in achieving quality objectives and the benefits of improving their individual performances? b) Their role and responsibility in achieving conformance with the requirements of its QMS? c) The consequences of departing from established Quality related processes?
Are the records of o f employee’s competencies and training retained?
6.3 Infrastructure: •
Are the facilities and infrastructure, necessary for ensuring compliance to the process and product requirements, identified and made available? The infrastructure can be in terms of workspace, tools or equipment among others.
6.4 Work environment: •
Has the organisation identified and created the appropriate work environment for product and process compliance?
7. Product realisation:
7.1 Planning of product realisation: •
•
Has the organisation planned and formulated the process for product realisation? Do these plans align with other QMS process requirements? Does the planning for product realisation include: •
Quality objectives
Processes, documentation and • records •
Resources required by the product
Necessary verification, validation, monitoring, measurement and evaluation activities
•
•
Are the plans appropriate to the organisation’s operations?
7.2 Customer-related processes: requirements 7.2.1 Determination 7.2.1 Determination of requirements related to product: Are the following identified: •
Stated customer requirements.
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Implicit customer requirements.Legal requirements.
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Organisation’s voluntarily embraced standards.
7.2.2 Review of requirements related to product: •
•
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Does the organisation review the product requirements? Is this review conducted before conveying willingness to the customer (submitting quotation, accepting an order)? Does the review ascertain if: • Product requirements are clearly specified?
• Modifications to product specifications, if any are mutually accepted?
• The organisation can deliver to requirements?
•
Are the details of the review and consequent measures taken preserved as records?
•
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In cases where customer does not specify his requirements in writing, does the organisation clarify requirements from customer before making a commitment to deliver? Does the organisation modify the documents of the product when the requirements of the product are altered? Are these altered requirements effectively communicated to all the concerned employees
7.2.3 Customer communication: •
Has the organisation developed proper approaches to communicate with customer regarding: Product specifications?
•
Quotations, contracts and
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orders? Customer inputs and grievances? •
7.3 Design and development: 7.3.1 Design 7.3.1 Design and development planning: •
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Does the organisation plan and manage its new product development efforts? Does it include: • Identifying and classifying the phases in the design and development process? • Verification, Verification, validation and review of each phase?
•
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Are the interactions between the various design and development teams managed for better communication and cooperation? Are the sought for results adapted as the design and development advances?
7.3.2 Design and development Inputs: •
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Are the product requirement inputs properly identified and recorded? Do the product requirement inputs include: Features and characteristics of product? Legal and mandatory requirements? Inputs from previous design efforts? Additional inputs required for product design and development?
•
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•
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Are the inputs reviewed for their sufficiency, sufficiency, clarity and contradictions if any?
7.3.3 Design and development
outputs: •
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Are the outputs capable of being evaluated against the design and development inputs? Are design outputs evaluated and approved before being applied? Does the design and development output: Satisfy the input requirements for design and development? •
• Give necessary information for procuring supplies, production, and servicing of product? • Address the usage and safety aspects of the product?
Provide acceptance specifications? •
7.3.4 Design and development review: •
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Does the organisation conduct reviews at pre-defined stages of the design and development process? Do these reviews: Analyse the potential of the • design and development efforts to satisfy requirements? • Determine specific issues that need to be addressed and recommend solutions?
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Does the review team consist of members from different functions influencing the design and development? Are records of review preserved?
7.3.5 Design 7.3.5 Design and development verification: •
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Are design and development outputs verified against their input requirements? Are the records of the verification preserved?
7.3.6 Design and development validation: •
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Is the design of the product validated for ability to meet intended purpose? Whenever possible, is validation conducted before the making or release of the product?
7.3.7 Control of design and development changes: •
•
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Is there a practice to record design and development modifications? Are these modifications reviewed, verified and validated before being applied? Are the details of review considered while analysing the influence the design
and development modifications will have on the related components and earlier product releases? •
Are the records of review of modifications preserved?
7.4 Purchasing: 7.4.1 Purchasing 7.4.1 Purchasing process: •
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Is it ensured that the product being purchased meets the defined specifications? Are the efforts to manage a supplier and to ensure conformity of purchases, proportionate to the influence they have on the final product output? Does the organisation have defined criteria to choose suppliers? Does this criteria include the supplier’s capability to produce products complying with the organisation’s requirements? Is there a process followed to assess, reassess and choose suppliers? Are the records of assessments and other related activities preserved?
information: 7.4.2 Purchasing 7.4.2 Purchasing information: •
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Does the organisation clearly detail the products to be purchased in its purchase information? Where relevant, does this purchasing information to suppliers include: Specifications for acceptance of products, processes, methods and equipment? Proficiency of personnel to be deployed? Quality system standards followed? •
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•
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Does the organisation ensure sufficiency of purchase information before releasing them to the supplier?
7.4.3 Verification of purchased product: •
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Before receiving product from the supplier does the organisation conduct testing and inspection to ensure its conformance to the defined specifications? When product verification is planned at the suppliers’ site, does the organisation specify details of when and how this will be conducted, and the preparation required on the suppliers part?
7.5 Production and service provision: 7.5.1 Control of production and
service provision: •
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Does the organisation manage and control its production and service operations? Does this include ensuring: Accessibility of data pertaining to the product? Accessibility of work instructions? Availability of appropriate equipment? Defined procedures for monitoring and measurement along with necessary equipment? Application of steps for approval, delivery and after delivery processes? •
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7.5.2 Validation of processes for production and service provision: •
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Does the organisation have defined procedures to evaluate and approve the processes where the output cannot be crosschecked before delivery? Does the validation help ensure that the processes will meet the desired objectives? Are the following factors considered for validation: Establishing criteria for assessment and clearance of the processes? Equipment and skill of personnel deployed? Control of records? Revalidation? •
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• •
7.5.3 Identification and traceability: •
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Does the organisation clearly identity products that need to be traced through the different stages of the product realisation? Is the progress of the product realisation determined through relevant monitoring and measurement methods? Are these details recorded?
7.5.4 Customer property: •
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Does the organisation adequately identify, identify, protect and maintain customer property when it is being used by the organisation or under its control? In the event of any damage or misplacement of the property, is the customer immediately notified and details recorded?
7.5.5 Preservation 7.5.5 Preservation of product: •
Is the quality of the product and its components preserved and maintained by the organisation during all stages
such as processing, storage, packing, transportation and delivery? 7.6 Control of monitoring and measuring devices: •
•
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Has the organisation established monitoring and measurement procedures? Are appropriate instruments for checking the conformance of product with the required specifications maintained? Where appropriate, are the measuring instruments: • Calibrated and records maintained? • Fine-tuned as per requirements? •
Identifiable?
• Maintained and protected to ensure that measurements are error free?
Handled in a way so as to prevent inadvertent change to measurements taken? •
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If the instrument does not match the calibration specifications, does the organisation evaluate the previous measurements taken by it? Is appropriate corrective action initiated on the basis of the findings?
8. Measurement analysis and improvement 8.1 General: •
Does the organisation have in place monitoring, measurement, analysis and improvement processes, including statistical methods for: • Indicating the conformance of product or service to stipulations? •
Ensuring adherence to the
QMS? •
Continually improving the
QMS?
8.2 Monitoring And Measurement: 8.2.1 Customer Satisfaction: •
Is there a defined process or practice for obtaining and evaluating customer feedback on the product or service?
8.2.2 Internal audit: •
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Does the organisation have established procedures for conducting regular QMS audits? Are these audits implemented, evaluated, and improved on a regular basis?
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Do the QMS audits: • Determine if the existing QMS conforms to the ISO 9001:2000 standards? • Determine the extent of implementation and maintenance of the QMS?
Include the information of the results of audits? •
• Concentrate on the organisation’s activities being audited and results of previous audits?
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Does the audit procedure include: •
The scope and frequency of
audits? Standard auditing methodology? •
• Duties of auditors and the parties involved, and reports of audits?
8.2.3 Monitoring and measurement of processes: •
Are proper monitoring and measurement methods employed to substantiate the ability of the QMS processes to achieve intented goals?
•
do not conform to the planned objectives, is necessary corrective action taken? If the obtained results
8.2.4 Monitoring and measurement of product: •
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Is the product monitored and measured at various stages of the product realisation to ensure conformity to defined specifications? In case of non-conformity is the product delivery put on hold until permitted by the concerned customer or authority? Are records maintained specifying who is responsible for approving release of the product?
8.3 Control of non-conforming product: •
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Are nonconforming products identified and prevented from being used accidentally? Are the following approaches a dopted while dealing with such products: • Taking necessary steps to get rid of the nonconformity or nonconforming product? • Releasing the product for usage, but only after acceptance from the concerned customer or authority? •
Preventing the product from its
proposed use? •
•
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Is the information pertaining to such products and the corresponding action taken recorded? If corrective action is taken, is necessary re-evaluation done before approval? If a defect is identified after product is released to the customer, does the organisation consider necessary action in proportion to the impact of the nonconformance?
8.4 Analysis of data: •
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Is pertinent data gathered and examined to ascertain the relevance of the QMS? Are the areas for improvements identified with the help of the information analysis? Does the gathered data include: •
Customer feedback?
• Defined product requirements? • The inclinations of particular processes and products? •
Scope for taking pre-emptive
steps? Contractors and suppliers performance? •
8.5 Improvement: 8.5.1 Continual improvement: •
Does the organisation strive for continual improvement?Does it use the quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions, and management review for this purpose?
8.5.2 Corrective and preventive action: •
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Is appropriate corrective actions taken to ensure that a non-conformance does not recur? Does the corrective action involve: •
Assessing the nonconformity?
• Identifying the origin of nonconformity?
Evaluating the necessity of taking action to prevent repetition of nonconformity? •
• Identifying and applying the required action? • Maintaining records of actions taken and consequent results?
Re -evaluating the corrective action implemented? •
•
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Are appropriate precautionary or preventive actions taken to avoid the possibilities of non-conformance? Are the following procedures for preventive action implemented and documented: • Identifying probable nonconformities and their origin? • Assessing the necessity of action to avert nonconformities?
Identifying and carrying out the necessary actions? •
• Keeping records of actions taken and their outcome?Re-evaluating the preventive actions implemented?
Documentation > ISO 9001:2000 Documentation The documentation requirements for ISO 9001:2000 have been simplified considerably compared to the ISO 9000:1994. This was essential to enable organisations to customise documentation to match their day-to-day processes. Objectives of documentation: The ISO 9001:2000 documentation system mirrors the processes of the organisation and its conformity with the QMS requirements. It is built around the following objectives: 1. Facilitate Information flow: A documentation system acts as a means of communication. It is structured based on various factors such as the business the organisation is in, the processes followed, the existing communication system in the organisation, and the organisational culture. 2. Provide proof of conformity: A documentation system establishes proof of the organisation’s conforming to the QMS standard requirements and achieving the defined objectives. 3. Provide future reference: A documentation system records the organisation’s procedures and processes in conformance to the QMS requirements. This helps in standardising processes across the organisation. It would also be helpful for future reference. (For example, a new recruit can refer to the documentation for instructions on a specific process.) Steps involved in documentation: Documentation plays an important role in all the stages of the ISO 9001: 2000 implementation.Guidelines for developing ISO 9001:2000 documentation in organisations: 1. Conducting gap analysis: Before developing the documentation it is essential to identify the status of the organisation with respect to the ISO 9001 requirements. Gap analysis accurately distinguishes between the existing status of the organisation and the ISO 9001
requirements. ISO 9001:2000 explicitly necessitates the following elements to be documented: •
4.2.3 Control of documents.
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4.2.4 Control of records.
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8.2.2 Internal audit.
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8.3
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8.5.2 Corrective action.
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8.5.3 Preventive action.
Control of nonconforming product.
These documented procedures need to be reviewed, revised and maintained in agreement with the requirements of clause 4.2.3. (Control of documents) These apart there are other documents though not explicitly required by the ISO 9001:2000 standard that can help an organisation improve its QMS performance. Some of these are: •
Process maps, process flow charts and/or process descriptions.
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Organisation charts.
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Specifications.
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Work and/or test instructions.
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Documents containing internal communications.
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Production schedules.
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Approved supplier lists.
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Test and inspection plans.
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Quality plans.
Gap analysis should consider all the existing documents in the organisation, relevant to the ISO 9001 requirements. It should also identify areas where additional documentation is required. This information can serve as a basis for building the QMS documentation. 2. Arranging the information: The final audit and certification is carried out against the processes the organisation lays down in the documentation system. This makes the details in the documentation system extremely critical. Hence, the ISO 9001 QMS documentation needs to be systematically planned, organised and developed. Planning should take into consideration the organisation’s working system and quality objectives. The following need consideration while planning for documentation: •
The document plan must focus on different areas such as objective of the document, organisation resources, and target audience.
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Model for developing the documentation system.
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Distribution and control of documents.
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Inputs from experts and workers directly involved in
areas being documented.
3. Writing the documentation: Once the framework is ready, the next task is creating the actual documentation. The framework of the documentation system is generally viewed as a pyramid structure. This can be divided into four levels. Level 1 – Quality Manual: A quality manual outlines the organisation’s QMS. It contains the quality policy and details the products, processes and other QMS procedures adopted by the organisation. It also provides the interrelationship between the various QMS processes and cross references the other documents related to the QMS. It thus acts as a source of information for employees and customers. Level 2 – Procedures: Procedural level documents deal with the documentation of processes the organisation follows to meet the QMS requirements. The documentation of procedures can be carried out by •
Writing down the existing processes.
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Performing a gap analysis.
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Modifying the processes and documentation to bridge the gap.
Level 3 – Work Instruction: As the name states these documents contain i nstructions for performing various activities and processes. They include general work instructions for operating processes and for testing methods. Level 4 – Forms and records: Records are documents that are used for detailing the results achieved. They are also proof of the organisation’s implementation of processes that have met the requirements.
Forms are used for recording basic information. A few examples are checklists used for auditing purpose and forms used for recording information related to specific processes. Media for documentation:
Documentation can be created and stored both in electronic or paper format. Apart from written content, documentation can also include : •
Photos.
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Drawings, diagrams and sketches.
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Audiotapes and videotapes.
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Product samples and defect sample.
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Paint swatches for colour matching.
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Checklists.
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Flow diagrams.
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Blank-forms.
Many organisations document their processes around ISO 9001. Alternatively, documentation can be structured around the processes implemented by the organisation. Since the employees are already familiar with the existing processes, it would be easier for them to adapt to the system. 4. Conducting peer review: Once the drafts of the documentation are ready, the senior and middle management level participate in a peer review. The group includes all the key people involved and closely related to the processes. Peer reviews are conducted to plug any discrepancies in the documentation system. If enough preparation and research has been done, two or three peer reviews are sufficient to take the documentation to the next stage. 5. Imparting ISO 9001 training: Everyone in the organisation may not be able to read the whole documentation. However, However, employees can be given an overview of the new quality system prior prior to the audit process. process. Training sessions on the importance of ISO 9001 documentation and application in the new quality system would also be beneficial. Such sessions will help in better QMS implementation and smoother audits, as the employees will have a greater understanding of the documentation system. 6. Planning for assessment: The QMS assessment is performed through internal audits. Depending on the availability, the organisation can have a group of lead auditors. Otherwise, the quality manager can be the lead auditor and train a team for performing internal audits. An auditor needs to identify the non-conformities and provide remedial action. Less number of nonconformities implies scope for quicker registration. External auditing is done by a group of auditors from an accredited certifying agency. agency. These a uditors carry out an in-
depth evaluation of the quality system on two fronts. First, they check if the documentation maintained by the organisation matches the requirements of the ISO 9001:2000 QMS standard. Then they check if the organisation is actually following everything as documented. If compliant, they recommend ISO 9001 certification. This certification formally declares an organisation as ISO 9001 compliant. IISO certification involves employee compliance with the documented system. Hence, a well-planned and executed document system is the basis for ISO 9001 standard conformity. conformity. An impeccable documentation ensures ISO 9001 registration. But sustaining the acquired standard calls for implementing the continual improvement aspect of the QMS. Continual improvement results from periodic review and corresponding document control. Continue the tour: Document Control Documentation > Document control Effective documentation calls for a document system that is simple to use, easy to understand and helps an organisation achieve its quality objectives. The above requirements of effective documentation can be met by the ‘Document control’ process. Document control is hence, a vital aspect of documentation to sustain an organisation’s quality pursuit.
Elements of document control: Document control involves the following elements: 1. Approving documents: A document is valid only when if it is approved. Hence, obtaining approval is the first step in controlling documents. There are many ways of approving a document. Authorised persons approve paper-based documents. Electronic documents on the other hand are approved through a typed name or e-mail. Yet care should be taken to prevent false approvals that could occur due to leaked passwords. Generally, some documents are self-declarative, that is the titles under the approved spaces specify the authorised person. In other cases, organisations must decide who should approve the documents. Normally, people who bear the responsibility of tasks described in the document are selected. It is always better to strive for the fewest number of approvals. For example, consider a document containing information regarding more than one department. This document should get the approval of all the managers who are affected by the information contained in it. This can be time consuming. Therefore, minimum approvals that provide buy-in for the information in the document must be pursued. 2. Reviewing, Updating and re-approving documents: ISO 9001:2000 standard requires an organisation to review, update and re-approve the documents periodically to prevent them from becoming inaccurate and outdated. If the documents
are still valid they are approved otherwise they are updated and re-approved.
A periodic review of documents is essential to ensure compliance with the standard. standard. The frequency of these reviews depends on the organisation’s priorities. Since document review is also a critical task, organisations need to employ discipline to ensure it is performed periodically. Business triggers like introduction of new products, equipment and processes and real-world events such as new technologies, affect the documentation system. In such instances, documents must be reviewed accordingly. Document review in these conditions introduces a sense of urgency. Organisations Organisations intending to implement this method must define the business triggers and responsibilities in the document control procedure. It is the duty of document administrator to monitor these business triggers and ensure that relevant documents are reviewed, updated and re-approved re-approved as needed. 3. Identifying changes and revision status: Documents must include revision changes. If a document is on revision for the fifth time, it will track the changes that differentiated it from the fourth version. This helps the document approvers and users to identify the changes in the documents easil y. To identify chan ges: •
Maintain change logs at the end of the document.
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List the changes on the cover sheet.
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Underline, italicise or highlight changes throughout the document.
Revision status denotes a document’s new version, generally indicated by a revision number, letter or date placed directly on the document. This helps the users to check whether they possess the latest version. (This is essential for paper-based documents.) For electronic documents knowing revision status is not essential because the current version is provided to all the users automatically. 4. Making documents accessible to users:
ISO 9001:2000 specifies that the current versions of documents must be accessible to all the users. Every user need not posses a copy of the document. It is sufficient if one can access the document whenever it is needed. Some organisations distribute documents that include an “acknowledgement of receipt” sheet signed and returned. However ISO 9001:2000 does not require such procedures because they will slow down the system. Organisations must thus maintain a perfect balance between control and simplicity. 5. Making documents legible and identifiable: An organisation must develop documents that are clear and understandable to all the users. Suppose, a group of employees can understand only Spanish then the documents must be written in Spanish. Otherwise, they can develop graphic documents (including photographs or drawings), which can be understood by every one irrespective of language. Every document must be provided with a title, document number, or a unique identifier, which differentiates it from others. Many organisations follow the ISO 9001 numbering system to identify documents. ISO 9001 series is reviewed and revised every 5 years along with the numbering system. A good numbering system would be one that best suits the organisation’s processes and operations. It should be appropriate for the employees and not become obsolete. 6. Controlling External Documents – As per ISO: 9001:2000: Organisations also use external documents (documents published outside the organisation). The procedure to determine whether an external document requires control is similar to that of internal documents. External documents that may require control are: •
Troubleshooting Troubleshooting and/or calibrating manuals published by equipment manufacturers.
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Test procedures, specifications and /or engineering drawings published by customers or other bodies.
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Instructions, specifications and/or procedures published by suppliers.
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Standards published by industrial organisations applicable to that organisation.
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International standards such as ISO 9001:2000.
External documents need identifiers for controlling its distribution. Usually, the source that published the document takes care of the identifiers like title or document number or any other unique identifier. The organisation merely adopts it. Most external documents are in paper form. Controlling their distribution is thus necessary to control the information contained in them. A distribution list simply includes the number of copies available at present and their location. The copies are numbered such that they match the locations shown on the
distribution list. This makes retrieval of old copies easy. 7. Controlling obsolete documents: As per the requirement of ISO 9001:2000 all the obsolete documents in an organisation must be identified and prevented from use. But organisations often keep obsolete documents to preserve knowledge. These are used while comparing an existing process to the previous ones like those used some five years ago. If an organisation wants to retain obsolete documents, then they must be given labels like obsolete or uncontrolled to avoid their inadvertent usage. The simplest way to prevent use of the obsolete documents is to just remove them from circulation. For this their exact location must be known. Distribution lists for all paper-based documents, external and internal will help in identifying the location of documents. 8. Controlling forms: Controlling forms is crucial for quality improvements. They are very easy to control. The two common methods of controlling forms are: •
Controlling forms as “attachments” to documents: In this method forms are included as the last page of the documents that describe their use. Approving a document thus automatically approves the form. The same is true with revising and identification. For control purposes the form is treated like any other page in the document. It can be reproduced if needed, independent of the document. The main disadvantage in this method is that organisations need to revise the entire document while revising the form.
•
Forms controlled individually: In this method, forms have separate numbers and revisions. Their approval may be placed on the original copy or on a master approval sheet. This sheet indicates the latest version of the form. As soon as the form is
revised users are informed through a memo or e-mail or other means. Organisations usually print forms in large numbers. Even a small change renders them useless. When the form does not relate closely to the activities of the organisation it should be discarded. Organisations should hence manage their inventory and avoid waste. 9. Document formatting: ISO 9001 does not specify any particular format for documents. Organisations have the liberty to select the best suitable format for their mode of operation. Adherence to one particular type of format is not obligatory. However, a standard format provides a standard appearance for the documents. Most organisations specify only the content of document headers, and cover sheets, while others specify purpose, scope, responsibilities, equipment, and the like. These decisions are left to the organisation’s discretion. The document control procedure must clearly define the style and format of the document. A document control procedure also defines the control of documents and helps document development. Document control is an important quality assurance principle and hence leads organisations towards better quality products.
Selecting the documents to be controlled: Every organisation holds hoards of documented information. Controlling all these documents is an uphill task. Selecting the documents to be controlled is thus essential. For selection it must be determined whether the document: •
Guides the production of products/services of the organisation.
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Contains information related to i nspection, verification or testing process followed by the organisation.
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Defines customer or product requirements.
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Useful in the controlling processes.
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Useful in decision making by production personnel.
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Is useful in gathering the data required for decisionmaking.
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Contains information crucial for organisation’s success.
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Contains information related to requirement from ISO 9001:2000 QMS.
If the answer is “yes” to one or more of these questions, the document needs to be controlled. Some documents that need to be controlled are: •
Consider an interoffice memo posted in the fabrication department shop floor containing functional and packaging requirement of the product being fabricated. This information is necessary for decision making, customer satisfaction and thus is related to ISO 9001:2000. If not controlled it could lead to disagreement between the information on the memo and the information in the control specifications. Therefore, the organisation should either control the memo or discard it.
•
•
Training departments develop videotapes on proper set up and operation of production lines to train newly recruited personnel and the existing employees. They define process control, guide the production and thus relate to training requirements of ISO 9001:2000. Hence, they need to be controlled.
Defective product samples are displayed in a lighted glass cabinet. They are used when quality personnel have doubts about product criteria. criteria. They point out the limits of various defects that can be accepted by the customers. Presently the display cabinet is labelled “for reference only”. Despite this declaration it is necessary to control these samples as they define customer requirements.
•
Organisations employ checklists to store the results of product identification. The unfilled spaces in a blank checklist depict what’s to be inspected. Blank checklists need to be controlled controlled as documents and the filled ones as records.
Tips for designing document control: Tips for effective document control 1. Keep it concise: Handling a lesser number of documents is always easier. Document control process begins from the design stage itself. If possible the organisation must insist on the authors to create brief and versatile documents. The organisation must also conduct periodic reviews to ensure that there is no redundancy and unused documentation. Wherever possible similar documents can be merged. This will keep the documentation concise.
2. Follow a structure: The documentation must have a structured format. The details of the structure have been discussed in the document writing section. This helps establish a relationship between the different levels of documentation. It also defines the span of control at each level. 3. Cross-link documents: A document is not necessarily built from the scratch. It may have to depend on other documents to fulfil l its objective. It borrows various references from other documents. These references may not be detailed in the same document, but may only be linked to a specific document. For e.g. an amendment document details only the changes made to the original document. It does not provide the entire document. It only refers to the original document and specifies the changes. Often, a document may need reference from an entirely different functional area. In such cases, the document provides a reference to the required information from a specific document. This increases the accessibility of the required topic and at the same time helps in decreasing redundancy. But the disadvantage of cross-linking is obvious when a document needs to be revised. All the references must be carefully reviewed and updated to comply with the revised documentation. A few other options to cross-referencing could be
•
Designing an effective numbering system for the document.
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Having a main document displaying the relationships between documents.
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Employing an electronic document management system that helps in quick accessibility of documents and manages the document relationships.
4. Review of document: While preparing documentation it is always advisable to take inputs from those directly related to the process being documented. Incorporating a review would help in enhancing the quality of the final document. But the approach adopted for review depends on the organisation. It could be each individual signing in his approval or a group consensus after all the involved employees giving their opinions. Measurement and Data Analysis > Measurement, Analysis and Improvement When compared to the ISO 9000:1994 standard there are some differences in the requirements for Measurement, Analysis And Improvement. In the ISO 9001:2000 version Planning, Internal audit, Measurement and Monitoring of processes and products, Control of nonconformity, and Corrective and Preventive action have been retained. At the same time Customer satisfaction, Analysis of data, and Continual improvement are the new areas added to the Measurement, Analysis And Improvement section. Requirements that have been added in ISO 9001:2000 1. Customer satisfaction (Clause 8.2.1): Customer satisfaction is the final verdict of an organisation’s quality management system. Hence, there is a need to constantly measure and evaluate customer satisfaction. The organisation must have a defined procedure for acquiring information from the customer. customer. Customer feedback is an important method of obtaining information. Measuring customer satisfaction gives an organisation the exact picture of its performance and the extent of improvement necessary. Achieving customer satisfaction depends on: •
The organisation’s ability to learn.
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It’s relationship with the customer. customer.
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Application of effective measurement techniques.
As most products and services are customer-specific, it pays to have a customer-centric approach to all activities in the organisation. 2. Analysis of data (Clause 8.4): The measurement process is a source of data. Organisations need to gather this data and anal yse it for determining the performance of the quality system. This helps in understanding whether customer requirements have been met. Data analysis also supplies information on whether the new initiatives taken, have contributed to the improvement in the product, process and QMS. 3. Continual Improvement (Clause 8.5.1): The ISO 9001:2000 standard insists on continually improving the QMS. The organisation must define the quality policy and quality objectives to lead it on the path of continual improvement. It must utilise information from audit results and data analysis to effectively direct future actions. The corrective and preventive action taken must also contribute to continual improvement. Curt De Vries manager ISO 9000 of Polaroid declares that his company established metrics for measuring the greatest valueaddition required by the quality system and used other components of the quality system to support it. Requirements that remain the same: 1. Planning (Clause 8.1): Though measurement and improvement of the system is widely spoken of, many organisations organisations lack a definite plan for the process. Organisations must clearly establish a process for monitoring, measurement analysis and improvement. They must also plan how they are going to implement the measurement process and put the plan to effect. Application of statistical techniques and other effective methods should also be considered. 2. Internal audit (Clause 8.2.2): Internal audit must include the audit process, roles and responsibilities of the audit personnel and the audit results. Audit results are significant as they are used as input for the management review and hence form an integral part of the continual improvement process. The audit should be based on a process approach and involve personnel from across various functions. 3. Measurement and monitoring of processes and products (Clauses 8.2.3 & 8.2.4): The measurement and monitoring of processes and products should be clearly defined. It must also show documented evidence that the processes and products are conforming to the established criteria. 4. Control of nonconformity (Clause 8.3): Organisation might face situations wherein the product does not meet the defined specifications. In such cases they must make every effort to prevent the use of that product. But if the noncompliance is identified after it has been delivered, the organisation must notify the customer and take necessary action to offset the effect of non-compliance. In case the noncompliance is rectified, the product should undergo reverification. 5. Corrective and Preventive action (Clause 8.5.2 & 8.5.3): Corrective and preventive actions are used as a means to achieve continual improvement. These also form inputs to the management review of the quality system. Corrective and preventive actions aim to prevent the occurrence of nonconformity in the future products and processes. Since ISO 9001:2000 is all about documentation, organisations
must use simple and easy to understand formats, for documenting the corrective and preventive actions. The usual approach for documenting corrective and preventive actions consists of •
Problem definition.
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Analysing the cause of the problem.
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Defining the corrective and preventive measures.
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Implementing the corrective and preventive measures.
•
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Following up by verifying whether the product/process now meets the requirement. Documenting the whole process.
This documentation forms the input for management review. Barriers for implementation of Measurement, Analysis and Improvement: The biggest difficulty that organisations face is to analyse the data and find significant information. All organisations may not be well equipped to extract the right information from the available data. Gathered data must be viewed from the point of what it could imply, rather than what it directly states. For e.g. while dealing with nonconformity reports, organisations should look at –the frequency of occurrence, whether it occurs with the same product or customer, customer, when it occurs etc. This will give the required information for taking preventive action. Another possible area where organisations might find difficulty is the continual improvement process. Most organisations do not identify the ISO requirements as a part of their daily operations. Measuring results only to fulfil bare minimum ISO 9001 requirements will in no way benefit the organisation. The earlier an organisation adopts the QMS as a part of its daily operations the faster it will progress with continual i mprovement. What do auditors look for? The main focus of auditors in the auditing process will be on whether the organisation is following the continual improvement philosophy. philosophy. Auditors will closely examine management’s role in adopting the continual improvement process. They evaluate if management has utilised the quality policy, quality objectives, audit results, and corrective and preventive actions to facilitate continual improvement. They also inspect the management review records for the documented actions and achievements. For checking conformance to the analysis requirements auditors examine how the data was gathered, the nature of the data, how it was reported and how it was used for evaluating the effectiveness of the quality management system. Customer satisfaction measurement requirements are also examined based on how the organisation has gathered information from the customers, interpreted it and converted it into useful information for continual improvement. In Conclusion: The main objective of ISO 9001:2000 i s to make continual improvement a part of an organisation. Measurement and analysis are performed and the results are utilised for continual improvement. ISO 9001:2000 also states that customer satisfaction is a distinctive performance measurement feature. ISO 9001:2000 will be very useful to organisations planning to implement a QMS. Organisations that have trouble in implementing these systems will also find it supportive. Organisations that have implemented ISO 9001:1994 successfully, successfully, will find a marginal improvement in the quality system, and a marked improvement in the restructuring of the quality management system.
Organisations need to analyse and restructure their existing documentation to comply with the requirements. This is the biggest challenge, as organisations must analyse how they will deal with the revisions. Organisations that follow the requirements with an intention of just obtaining a certificate will find it difficult to comply with these requirements. Whereas those that seek value in a QMS will find the requirements as a challenge that wil l open prospects for improvement. Organisations normally acknowledge the importance of management review, customer satisfaction, and continual improvement. But it is the management’s responsibility to integrate them all to promote an outstanding quality management system. Tools Deployed > ISO 9001:2000 Tools Organisations worldwide are busy implementing ISO 9001:2000. Those that already have the ISO 9000:199 4 version certification are also preparing for the changeover/transition to the new quality standard. Various tools can be used by organisations during the implementation of ISO 9001:2000 QMS. The pertinent tools in the various stages of the implementation process are presented. Gap Analysis: •
Comprehensive questionnaire on gap analysis in QMS, Management responsibility, Resource Management, Product realisation, Corrective actions.
Quality policy establishment: •
Brainstorming Technique.
Document control: •
Fagan Document Inspection.
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Document Management System.
Customer Focus: •
Customer surveys.
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Comment cards.
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Field reports.
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Customer Satisfaction Assessment.
Planning •
PERT.
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Critical Path Analysis.
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Gantt Charts.
Awareness and Training: •
Skills Gap-Analysis Technique.
Process Control: •
Process Analysis.
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Process Capability Analysis.
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FMEA.
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Reliability Technique
Problem identification and rectification: •
Cause and Effect Diagram.
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Problem Analysis.
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Solution Effect Analysis.
Design and development of a product: •
CAD software.
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Design for Manufacturability.
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Simulation.
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Design of Experiment.
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Quality Function Deployment.
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Poka Po ka yok yoke. e.
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Loss Function Analysis.
Delegation of responsibilities: •
Arrow Diagrams.
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Flowcharts
Monitoring and Measurement: •
Control charts.
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Pareto charts.
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Histograms.
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Check sheets.
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Scatter diagrams.
Corrective and Preventive action: •
Potential Problem analysis (PPA).
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Problem Prevention plan.
Best Practices > Making the transition to ISO 9001:2000 Organisations that have been ISO 9000:1994 standard certified, often find the transition to ISO9001: 2000 challenging. The success stories of two organisations that have successfully made the transition are discussed here. Introduction: On 15 December 2000, the revised and improved ISO 9001:2000 standard was drafted to replace the three ISO 9000:1994 standards, thereby becoming the only certification standard of the ISO 9000 quality system. The ISO 9001:2000 standard is completely restructured and emphasises on continual improvement and customer focus. This standard focuses on the systems approach i.e. identifying, understanding and controlling interrelated activities as a system, thereby enhancing the organisation’s efficiency in attaining its goals. Organisations that are already certified to one of the ISO
9000:1994 standards are busy implementing the transition to the ISO 9001:2000 standard. This is necessary to meet the deadline for implementing the transition to the new standard, which is December 2003 To many organisations that have successfully incorporated the ISO 9000:1994 standard, the transition to ISO9001: 2000 is challenging. This revised standard emphasises on achieving customer satisfaction that was not a priority in the earlier standard. The challenges that organisations face include directing the entire organisation towards a common objective (i.e. transition to ISO 9001:2000), focusing on continual improvement, involving people/workforce people/workforce at all stages of the transition process, and shifting from a procedure-based approach to a process based approach. Since the transition involves streamlining existing processes to conform to the ISO 9001:2000 standards, it might also require a transformation for many organisations. While many organisations have successfully made the transition there are a many more still finding their way. way. The success story of one such organsiation is discussed below. Successful transition to ISO 9001:2000 in Silberline Inc: Silberline Manufacturing has successfully registered itself to the ISO 9001:2000 standards. It manufactures aluminium pigments and special performance materials to be used in coatings, inks, and plastic industries. Silberline is one of the first U.S. companies to have successfully accomplished the changeover to ISO 9001:2000 certification. Silberline has been ISO 9001 certified since 1998. In October 2001 it improved its Quality Management System (QMS) to the more developed standard ISO 9001:2000. Since the implementation of ISO 9000 standards in 1998, the management focused on the continual improvement and assessment of the existing quality management system. This in a way helped Silberline to go in for a smooth transition, which would otherwise have been difficult. Silberline's quality assurance department was given the responsibility of implementing and directing the requirements for ISO 9001:2000. A selected internal audit coordinator ensured that the internal auditing system was well organised and effective. Silberline gave all its employees an opportunity to participate in the auditing process. Those employees who voluntarily desired to become internal auditors were trained in the requisite auditing skills. This helped the organisation to expedite its internal audit process and also allowed the employees to get an insight into the requirements of the ISO 9001:2000 quality management system. Silberline emphasised on making its employees more conversant with the process approach (wherein the various activities are managed and controlled as part of a process, so that they are in accordance with the set standards). The changeover to ISO 9001: 2000 helped Silberline to reassess the entire quality management system that was a lready in place. It found that the evaluation and measurement of customer dissatisfaction was being effectively handled. Silberline used Customer satisfaction information to keep track of customer-focused activities. Customer satisfaction information consists of data on failures in functional areas, the rate of service-calls and analysis of the customer mind-set about the quality of products. Customer satisfaction information also helps the organisation enhance quality. quality.
Silberline’s management felt that market surveys remain ineffective unless they are structured and spread in an organised manner. manner. It felt that the detailed marketing research done would help identify customer requirements that would other wise seem to crop up suddenly. Silberline also reviewed its internal communication system and changed its format. Initially, two of the senior executives in Silberline presented the annual report on the status of the QMS to the managers. This proved ineffective since many questions/queries posed by the managers overseeing the various departments were not addressed. Then Siberline came up with a unique idea. It allowed eight employees from different departments to present a 10-min ute report on the effectiveness and efficacy of the respective quality management system in their departments. This helped enhance the internal communication process apart from the efficiency of the reporting system. No significant changes were made in the product development except for the presentation of all the stages of the production process in a flowchart. This flowchart is a constituent of the QMS that is in place in Silberline and gives a clear picture of the product development process. Redrafting the organisation’s quality assurance manual was the most tedious of the entire changeover process of ISO 9001:2000 implementation. Initially, Silberline tried to relate ISO 9001:1994's 20-element model to the requirements of the ISO9001: 2000 standard by referencing one standard with the other standard. This was confusing and tedious process. Silberline decided to redraft the manual on the basis of the Process approach. Process approach involves a well-structured identification and control of the various internal processes in order to realise the organisations business objectives. The entire quality manual was thus rewritten. The new quality manual was checked and circulated through out the organisation in order to realign all the existing procedures, quality plans and records with the new manual. Modifications required were implemented. This enabled Silberline to develop an effective and well-organised QMS manual that is auditor friendly. The changeover/transition, accomplished by a steering committee, lasted from April 2000 to April 2001.The committee allocated various responsibilities to different employees. Silberline now intends to utilise the ISO 9001:2000 standard for continual system improvement. Some of the steps Silberline followed to implement a smooth changeover: •
•
•
•
•
•
An initial review or gap analysis of the existing quality management system was conducted. The transition was made in a very short duration. The management was committed throughout the changeover and completely supported its employees in carrying out their responsibilities. Large numbers of employees were encouraged to participate in the cha ngeover process. An Inter departmental steering committee was developed. The next case study explains in detail the successful
transition to ISO 9001:2000 by Central Industrial supply (CIS), Houston in United States of America. Continue: Successful transition by CIS Best Practices > Successful transition by CIS
CIS Houston while revising and reorganising its ISO 9002 system to the requirements of the ISO 9001:2000 standard was simultaneously restructuring its assembly and distribution units into customer oriented business units. Central Industrial supply (CIS) is a leading manufacturer of electromechanical components and assemblies for popular high-tech OEMs. It is headquartered in Grand Prairie, Texas. CIS’s assembly and distribution complex in Houston exemplifies how a process approach and employee participation helps an organisation to adapt to various changes in the system. In 2000, CIS Houston while revising and reorganising its ISO 9002 system to the requirements of the ISO 9001:2000 standard was simultaneously restructuring its assembly and distribution units into customer oriented business units . Also for the first time it established Enterprise Resource Planning System (ERP). (ERP) . ERP provides the basis for joining together enterprise-wide information systems. These systems link all aspects of a company's operations including HR, financial planning, manufacturing, and distribution, besides connecting the organisation to its customers and suppliers. While working at the transition, CIS Houston had to cope with the absence of the quality manager in charge who was away due to terminal illness during the ISO 9001:2000 audit. Despite all these difficulties CIS Houston’s transition to ISO 9001:2000 was successfully accomplished. It was registered to the new standard on April 20, 2001. This restructuring of the organisational units resulted in a major telecommunications hardware manufacturer becoming the main customer of CIS Houston. It also helped CIS Houston retain its key customers including a leading information technology server manufacturer. Some steps taken by CIS Houston to revise its quality management system: •
Mapped/recorded the processes.
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Started with the collection of different process flows to get a clear insight.
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Considered the ISO 9000 quality standard as a valuable component of the organisational activities.
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Developed a robust enterprise resource planning system. Without an ERP system in place, collecting data would have been a difficult process and the reliability of the results/outcomes is doubtful. The use of ERP systems enables customers and the management to readily access the required information. The information in the ERP system is updated regularly and played a vital role in revising and reorganising the quality management system to ISO
9001:2000 standards. CIS Houston focused on the process approach. The customer was the priority for this organisation. Customers expect the product they buy to function as per their requirements. CIS Houston took utmost care not to dissatisfy the customers in this aspect. Customers’ changing needs and expectations from the products they buy were noted and analysed. In CIS, Houston the product design begins with market research. Product design converts the customer requirements into detailed engineering and quality features, which can be called design specifications. specifications. Design engineers in CIS Houston have have basic knowledge desired by the customers. In short, CIS adheres to a logical and sequential series of activities needed to complete a specific task (i.e process flow).
In CIS Houston when a new process/operation is implemented the front-line assembly personnel determine the method of manufacturing the product in conformance with the customer specifications. A series of measurements and corrective actions are performed within a process to ensure that the output of the process conforms to the relevant specifications. The front-line assembly personnel continually record/map the existing processes. This ensures that the improvements in the processes or any deviations in terms of customer requirements are clearly indicated in the process flow maps. After the restructuring of the organisation into a customer oriented business unit, the managers of all the departments within CIS started meeting on a monthly and weekly basis. This was done to generate ideas and discuss the red,yellow and green light report. The red light report signified the presence of a hindrance or a problem in a specific activity. activity. The yellow light cautioned the team and the management of an impending problem. The green light report on the contrary signified taht the process/activity was in control and can be implemented. These reports consisted of the output produced by the ERP system. They also included the objectives and targets set during the planning phase, weekly production schedules, safety indicators, customer satisfaction indicators, the previous week's or month's performance, and the extent of conformance to the requirements. At CIS corrective action is implemented in one meeting and evaluated in the next. This enables allocation of responsibilities to the appropriate employees. ISO 9001:2000 is being utilised by CIS, for continual system improvement. Conclusion: CIS, Houston attributes its successful transition to ISO 9001:2000 to the focus on customer satisfaction, continual improvement and implementing process approach even before the new standard was officially drafted on December 15 th 2000. This helped them to changeover to the new standard requirements with ease. Continue: Teaching - The ISO 9001:2000 Way
Best Practices > Teaching-The ISO 9001:2000
way The following case study details how the ISO 9001:2000 quality management system can be implemented in an university.
Introduction: ISO 9001 standards provides a structured approach for an organisation to define a customer oriented quality system. It supplements TQM by viewing quality as a controllable process and by providing a framework for continual improvement. The following case study details how ISO 9001 QMS was implemented in an educational institute to ensure that its teaching and learning processes maintain commendable standards of quality. quality. It explains how the ISO model helped the institute achieve excellence in its teaching and learning processes. Organisation under study: Faculty of Management and Human Resource Development (FPPSM) in Teknologi University, Malaysia (UTM) is the case in study on applying ISO 9001 in Teaching and learning processes
Need for QMS: The following were the key reasons for Teknologi University to go in for the ISO 9001:2000 QMS in its teaching and learning process •
•
•
Graduates performance falling short of required standards. Mounting competition and increasing regulations requiring conformance of implementing the quality system. The success of ISO quality concept in other sectors.
Methodology followed for implementation: Implementation of ISO 9001:2000 QMS in other sectors differs from that in Higher educational institutions (HEIs). There are two areas that need to be managed in an HEI. One is academics and the other is administration.
Implementing ISO 9001 in administration is easier compared to the academic sector, which demands individual modifications to the system. The process-based model (9001:2000) includes factors like customer needs and customer satisfaction that guide the university to achieve best practices in teaching and learning processes. This was the strategy that FPPSM embarked upon to achieve superior performance in its teaching and learning activities.
Process-based model: ISO 9001:2000 QMS, focuses on customer and process approach. approach. This model stresses the need for identifying and comprehending the customer needs and anticipations to make sure that the customer
requirements are satisfied. Reports of customer satisfaction are then collected and analysed to verify the fulfillment of their requirements. The inherent elements of “process based model” (customers, their requirements, product realisation, customer satisfaction and consistent enhancement) in the context of the present case study are explained below: In the educational scenario, customers normally fall into broad categories: External and Internal. External Customers are the parents of the students and the organisations that provide employment to the output of the institute (i.e graduates). Internal Customers are the direct beneficiaries of the education and the quality system in the institute i.e the students. Customer-driven best practices in teaching and learning: Best practices in teaching and learning using ISO 9001:2000 process based model needs to focus on customer (external customers). This should include: •
•
•
Identifying the needs of the customer and using it a s an input in the teaching and learning process. Delivery of the teaching and learning services or processes, which refers to product realisation. Output from the best practices of the teaching-learning process that fulfils the identified requirements stipulated by the customers.
External Customer- Requirements: Market demands were periodically accessed and evaluated to ascertain what an external customer wants from a graduate. gradua te. Techniques Techniques such as feedback, market analysis, and needs analysis were used to identify the needs of the external customers.
The marketability and the credibility of the University lie in recognisz recogniszingthe ingthe external customer requirements and including them in the new curriculum design. FPPSM identified the need for designing a comprehensive curriculum that indicated the knowledge and the skills required by an external customer customer (employers of graduates). It recognised the need for periodical update and consistent enhancement to maintain its relevance with the industrial developments.
Teaching and learning process (Product realisation): In order to ensure that the best practices were applied, FPPSM followed a defined procedure for managing the 3-Ps of the university. university. These include people, process, and product. The curriculum design ascertained that the customer requirements were successfully handled.
In addition, the other elements for achieving best practices in the system as management practice, management of non-conformance product were given due consideration in designing the curriculum. Focus on 3P’s:
People: People in the context of the present case study refer to university lecturers and students who are involved directly in the teaching-learning process. Focus on people helped in developing innovative capabilities among the students and cultivating enhanced teaching capabilities in the lecturers in their respective fields.
Flexibility was provided in the use of technology. The staff was given the freedom to use suitable techniques for effective student-lecturer communication. Techniques like printed materials, CDs, online journals, and Internet were generally used for this purpose. Policies were set in accordance to the teaching and learning environment. Although no precise instructions and rules were specified for classroom activities, the course content and the syllabus was prepared to be in line with the requirements of the university and external stakeholders. Process: Process, involves all the teaching and learning activities that help produce quality graduates. Thus, the new curriculum design involved identifying iden tifying activities that had to be controlled throughout the process.
Activities like preparation of syllabus and examination papers that directly impact the production of quality graduates were rigidly controlled and inspected to ensure that the mentioned specifications and needs were met.
Stern and detailed procedures with guidelines were provided for such activities. For instance, examination papers were monitored in 3 stages: •
Board of subjects level.
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Respective department level.
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Faculty level.
Flexibility was provided for activities that do not significantly influence quality. As in academic a cademic advisory where the decisions might change from one advisor to another. Product: Graduates are the final products and the process in this “product” involves the examination papers, the undergraduate projects, practical training reports, and course work materials. The University ensured that the products i.e. graduates consistently met the customer requirements. Non-conforming products were returned for correction before being allowed to move to the next stage. Management practice: The University implemented a power-sharing structure that defined the roles and responsibilities of the key personnel (such as Heads of o f panel, course coordinators, and coordinators of other teaching-learning related committees).
The various responsibilities assigned to different personnel in the structure are: 1.Head of panels: Approving teaching and learning methods, selecting final examination papers, developing and deciding on course content. 2.Course co-ordinators: Selecting, validating and recommending appropriate staff to administer key activities. 3.Coordinators: Establishing contacts with third parties. Non-conformance product management: Students were examined so they met the requirements of the standards set. Nonconformance products (students) were thus returned back (students who show signs of not meeting the required standards) to the system for correction. However, it should be noted that this
non-conformance product did not include the final product i.e. the graduates, rather they the y were the students who are on the path pa th of the process. The academic advisor was assigned the responsibility of helping the students in selecting subjects and making them comfortable with their workload. He also encouraged the students to seek the guidance of the lecturers. Motivational seminars were conducted periodically to motivate students. Instilling TQM (Continual Improvement): The academic activities were periodically evaluated for continaul improvement. This necessitated the use of analytical/statistical tools and indicators. Evaluating process capability helped in process improvement, while indicators helped to discover the need for training, and the manner in which it should be provided.
Evaluation generated a progressive, contemporary curriculum that took into account the key requirements of the external customer and society. This helped to enhance the process performance towards accomplishing the desired standards. Thus overall evaluation helped to increase customer satisfaction and more significantly win the loyalty of all stakeholders involved. Customer Satisfaction:
External customer satisfaction: External Customer Satisfaction was inspected and evaluated by means of different techniques. These include market surveys for every two years, needs analysis during design state of the course/curriculum, and questionnaires to gather the opinions of the external customers. The techniques used were based on different criteria like: •
Knowledge in the respective field of study.
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Leadership qualities.
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Communication skills.
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Teamwork.
The suggestions and complaints made by the external customers were examined and incorporated into the process.
Process-focus best practices in teaching and learning: The process-focus best practices in teaching and learning focuses on the internal customers (students):
Internal customer requirements: The internal customers (students) benefit the most from this teaching-learning process. Hence, in general, they are expected to know how these processes are to be conducted effectively. effectively. The process involves lectures, practical training, project supervision, course work, lab work, and final exams. The students in the university however, were unable to specifyhow the teaching-learning practices should be conducted or evaluated to increase theri effectiveness. Internal customer satisfaction: In spite of the student’s student’s lack of ability to provide necessary suggestions on the manner in which the teaching and learning activities should be carried out, their inputs and viewpoints on these activities were considered valuable insights for continual improvement of these activities. a ctivities. To To promote this feedback, the students in each semester were required to answer a set of questions (OMR forms) to gather the following information: 1.The preparation levels of the lecturers : This addresses the use of adequate teaching/learning materials, maintenance of materials, and utilisation of teaching assisting equipments. 2. The way the lecturer delivers lectures : Involves the diversity of teaching learning processes, self-confidence, and how interesting the lecture is. 3. Lecturer’s assessment technique : Includes the mode of assessment, which was completely based on their lectures. 4. Teaching organisation: organ isation: Covering distribution of course outline during first week, keeping of schedule, on time delivery of lectures. 5. Lecturer- student relationship : Accessibility and willingness of lecturers to listen to students’ suggestions, tolerance and the relation lecturers
maintain with the students. This evaluation was used to identify the performance of individual lecturers and the overall faculty performance. Conclusion: Thus, the inclusion of customer requirements and the reports of customer satisfaction in the curriculum design enabled the university to increase the quality of graduates (students) to meet the needs of the industry and the external customer. customer. Thus best practices in case of a HEI involves: •
•
•
•
Evaluation of customer requirements and the integration of those requirements in the design of teaching and learning process. Inspection of quality in the final product (graduates), examining product at every stage of the process and the people who participate in the process. Top-management support to smoothen the path for implementation of the teaching and learning processes. Managing resources for the effective use and continual improvement of the quality system to accomplish world-class standard.
Continue: Standardising Diplomacy
Best Practices > Standardising Diplomacy The American Embassy at Governor Square, London has many distinctions. distinctions. It is the largest embassy in the world. More importantly it is the first embassy of any nationality in the world to achieve ISO 9001:2000 certification. certification. The American Embassy at Grosvenor Square, London has around 750 people working in its various departments out of whom half are Americans. It has achieved ISO 9001:2000 certification for its administrative department, the General Service Office (GSO). GSO is the largest and the most diverse department within the embassy employing over 100 employees. Catering to the requirements of the American employees is the main job of the GSO. The responsibilities of GSO include providing efficient service to the Americans when they are in UK –from transporting their luggage to looking after the repair of their lawn movers.
The diverse roles in the department generally include purchasing, transportation, storekeeping and providing
various other services. Thus the department maintains its own personnel to conduct training sessions for plumbers, carpenters and electricians. It also maintains its own interior design and fine arts specialist.
Need for QMS: Customer service is highly valued in USA. GSO wanted to provide customers with the same level of service that they experienced at home and this was the main driving force for the embassy to look to ISO 9001:2000 certification. The American employees in the embassy are generally on interim postings on an average of three years. Then they either get transferred to another post or return to the US. Such frequent shifting makes it hard to retain the optimum levels of performance in services. Every individual has a unique way of thinking and performing tasks. Therefore, the management system had to be streamlined to provide standardised service.
There were no defined or established operating procedures in the Embassy. Though most of the people were familiar with the method of doing their job, nothing was recorded. For instance, the embassy had quite a lot of people in one particular section performing the same job. However, when they were asked to explain how they performed performed their jobs each one had a different different approach. This was despite the fact that they worked together and met frequently. In addition the quality assurance manager found that considerable amount of time was being wasted by the new staff in learning the job(nearly a year and a half in their short period of 3 or 4 years). Therefore a procedure procedure to track or establish the activities
that were being done was needed. Thus the quality assurance manager decided to have a structured format that would help standardise the way things were done.
Developing the QMS: The quality assurance manager was assigned the responsibility responsibility of developing the quality system. Review of the existing procedures was done in the first phase. This review took into consideration the viewpoints of all the personnel in the embassy. It not only helped in improving employee involvement but also assisted in developing effective and efficient procedures. Widespread interviews were conducted with all the groups within the embassy to identify customer requirements and satisfaction. Results of this analysis were then considered in conjunction with the organisations organisations detailed service standards, the International Collective Administrative Administrative Support Services (ICASS). ICASS is a means by which the US government splits and distributes the costs of common administration support services around the world. ICASS was introduced in 1990s by the US government to enhance efficiency globally. It helps to pinpoint the services provided to each agency, and delegate a cost and a time limit for that service to be delivered. The quality assurance manager was convinced with the ability of ICASS standards in enhancing quality. Hence, ICASS was taken as a standard for the embassy QMS. Every written procedure was attached with an ICASS service reference number. This would give a better understanding of the procedure in terms of: Who is meant to do the work? What is the timescale? At what cost?
The interesting thing here is that GSO neither aimed for ISO 9001:2000 certification nor was any pressure from customer or external demand for certification. certification. They just planned to introduce the formal ICASS standards to enhance the level of quality in their services. However, concerned authorities in GSO recognised recognised the various benefits involved in ISO 9001:2000 certification. They realised that there would be no extra burden for the Embassy. They discovered that certification would enable them to establish their defined procedures, and assess their quality system against an international standard.Moreover, the concerned authorities thought that the external auditing involved in certification process could provide an outside perspective on their system. Thus they opted for ISO 9001:2000 certification. Implementation Implementation of the ISO 9001:2000 QMS took over a year. A total of about 50 employees were provided ISO 9001:2000 training of whom 12 have even completed the internal auditor course. Care was taken that the training focused on the activities that influenced their quality performance. A careful study was conducted to discover the activities in GSO that could bring about improvement and were successfully successfully acted upon. An ‘e-room’ was established to monitor and enhance the implementation of the project.
Certification: Lloyds Register Quality Assurance (LRQA) that was selected as the registrar to certify the GSO’s QMS. LRQA examined the practical application application of the ISO 9001 standards the embassy was interested in. This included property, purchasing, transportation transportation and facilities management management services. LRQA was quite content content with the
QMS and thus awarded the American Embassy GSO ISO 9001:2000 certification in August 2002.
Benefits: An immediate result of the certification process was the improvement in the consistency of service provided. Operational procedures became more efficient and thus made life easier for those on short-term short-term postings. More importantly, customers were provided with the service they were familiar with and the service they expected. Conclusion: GSO has opened new vistas for other sections of the American Embassy in London to achieve certification. The benefits accrued, encouraged the concerned authorities to broaden the scope of certification for the embassy’s entire administrative administrative affairs section (financial management centre, information systems department, human resources and visitors unit) by the summer of 2003. This certification was the first of its kind in an Embassy of any country. The successful accomplishment of certification and the benefits thereafter were carefully observed by the embassies across the world. Similar programs are right now underway in the American embassies in Brussels, Warsaw and Vienna. Case studies > Documentation- The Genesis of a transformation Genesis Telecommunication transforms from ISO 9002 1994 to ISO 9001 2000. Genesis Telecommunication Telecommunication was established in 1990, in London, Manchester and Wokingham as a supplier and maintenance company for the telecommunication industry. Today, it is a leading telecommunication equipment supplier to reputed companies like Sony, Oracle, Slaughter and May. Genesis has always been convinced of the need for a reliable QMS. According to Genesis the ISO 9002:1994 certification worked well for them. Genesis viewed the ISO certification as a QMS enhancement tool that helped improving its business performance.
Genesis was one of the pioneers to recognise the need to transition to ISO 9001:2000 compliance. When the deadline was announced as December 15 2003, Genesis took all the necessary steps required to be ISO 9001:2000 compliant. Documentation to achieve ISO compliance: The first step was the documentation process. Genesis Telecommunication, initially assumed that by incorporating changes in the existing quality manual ( A quality manual reveals quality polices and objectives) objectives ) prepared for the ISO 9002:1994, they could achieve ISO 9001:2000 certification. However, However, the differences in documentation required, convinced them otherwise. Instead of just changing their quality manual, Genesis Telecommunication realised that it had to first implement the main ISO 9001:2000 management principles i.e. the process approach. approach. This differentiated ISO 9001:2000 from ISO 9002:1994. The process approach: To achieve ISO 9001:2000 compliance, the documentation must reflect a process approach to the QMS that focuses on meeting customer requirements by improved quality. The process approach for the QMS focuses on •
Meeting customer requirements.
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Value addition to customers.
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Achieving process improvements as desired, and
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Continual improvement of the QMS.
Since the process approach was a new principle in ISO 9001:2000, companies found it difficult to cope with it. In order to avoid confusion, Genesis Telecommunications Telecommunications incorporated a Process mapping software protocol called the Process Expert Professional (PSP). With the help of PSP, PSP, Genesis defined its business functionality in the form of process maps and linked it to existing documentation. Further, Further, with the PSP software employees could now read and write information from their servers. This avoided the tedium of scanning huge printed documents. According to Genesis, the approach to ISO 9001:2000 disproved their prior misconception of mere enhanced documentation. The journey towards ISO 9001:2000-compliance saw Genesis realise the flaws in its existing systems. This helped it achieve an international standard QMS. Genesis believes that with the PSP, PSP, its existing electronic mapping communication systems were eliminated. The PSP software helped Genesis unite all its centres into one single hub that contained vital information about its overall quality management and business. Encompass hidden quality systems: The biggest challenge that Genesis faced was encompassing all systems that were related to its QMS in some way or the other. other. This required expanding its documentation to cover all such systems. On the path to accomplishing these objectives were many issues such as customer preferences and product marketing. Consequently, Consequently, these were also included as a part of the quality management initiative. This highlighted the impact of customer preferences on Genesis’s business. Its managers worked in harmony to drive in a high-level of customer satisfaction. Learning and benefits: According to Genesis, being ISO 9001:2000 compliant has vastly improved its level of quality along with customer satisfaction. This is because ISO 9001:2000 facilitates the inclusion of all systems related to quality, thereby enhancing the QMS.
The benefits of a superior QMS at Genesis, is a true reflection of the fact that ISO 9001:2000 is ‘not’ just another benchmark entity that organisations need to flash. If the approach to ISO 9001:2000 is correct then it can help organisations iron out major problems that impede its QMS. Continue: Building on Quality Case Studies > Building on Quality One of Building Product Design (BPD)'s polices was to ensure high quality to its customers. Hence it decided to opt for the new certification quite early. Like all other industries, the construction industry also requires a robust Quality Management System (QMS) and hence the need for international quality standards. Established in the early 1980s by the construction company Willan Group, UK, Building Product Design (BPD) , erstwhile William Building Services was involved in designing and developing roof ventilation systems. In 1991 it was ISO 9000:1994 certified. Building product activities were classified into four distinct areas to facilitate better market invasion, comprehensive marketing and better understanding of customer preferences. These were: •
Roofing.
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Natural ventilation.
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Cavity trays and
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Louvre systems.
Furthermore, BPD operated with distinct company names relevant to each area, Glidevale Limited, Passivent Ltd., Z-Led Ltd, and Kingfisher Louvre Systems. Each of these subcompanies had their own designers, contractors, architects, and managers. However, However, with its sub-companies, BPD was operating towards the same goal of a high quality property construction company. Unlike other industries, the construction industry was not too obsessed with ISO certifications. Customer orders poured in anyway. anyway. So, construction companies seldom attempted to reach international standards. Nevertheless, BPD took the decision to render its Quality management system (QMS) ISO 9001 2000 compliant. But why? Post ISO 9000:1994 certification in 1991, BPD saw huge improvements in its quality and customer service. During the 1990s when the ISO 9000:1994 standards was being at BPD, its top management was fully involved in the enhancement of its QMS. Hence, when the latest version of ISO was announced, BPD’s top management had little problem in setting up programmes to achieve ISO 9001:2000 certification. certification. They were certain that that ISO 9001:2000 would prove beneficial to their business economy. Consequently, Consequently, they set up management programs to help employees and managers understand the requirements for ISO 9001:2000 certification. With four operational companies, BPD had two choices. First, the ISO 9000:1994 certified QMS be continued. Then design and develop a new QMS for each of the four companies based on the new ISO 9001 2000 standard the next year. year. The alternative was to just revise the old QMS to suit the four companies. BPD adopted the former approach. Once this decision was made, along with Lloyd’s Register Quality Assurance Ltd (LRQA) their ISO consulting agency, BPD chalked out the aims and objectives
to achieve ISO 9001:2000 compliance. By co-ordinating with LRQA, BPD devised its QMS to suit the new standards. Since one of BPD’s polices was to ensure high quality to its customers, it decided to opt for the new certification quite early. LRQA provided a service wherein its clients could avail a service called the Advance Compliant Statement (ACS). In short, a company with an ACS can claim to be ISO 9000:2000 certified on the day ISO 9001:2000 standards are officially launched, which was on 15th December 2000. BPD’s managers conducted a gap analysis and concluded that they were ready for ISO 9001:2000. T he LRQA executives/auditors inspected BPD in September 2000. They confirmed that BPD be given the ACS and awarded ISO 9001:2000 which would be valid from December 15th 2000. Benefits: BPD believes that ISO 9001:2000 compliance has helped them bag many customer orders. It believes that its QMS is good enough to provide value for money to its customers. Today, BPD is capable of planning, designing and meeting customer expectations to a very high degree of accuracy, thanks to its QMS that is ISO 9001:2000 certified. BPD believes that ISO 9001:2000 has allowed it to become more robust internally as well. Owing to ISO 9001:2000 BPD has standardised its departmental procedures, which account for better work scheduling and ultimately high quality. According to BPD ISO 9001:2000 standard is more practical, straightforward and reflective. This along with added features such as better customer focus, process approach and continual improvement has the potential to be a benchmark. It measures not only quality but also organisational performance. Furthermore, it helps organisations identify and rectify critical non-conformities and drive appraisals more judiciously. Conclusion: It is prudent to say that QMS is critical to organisational success. Quality management systems are the main source for added value to customers. Achieving ISO 9001 2000 compliance is definitely the way to ensure a co-ordinated approach towards continual improvement and business excellence. Continue: Albion Redesigns its QMS Case Studies > Albion redesigns its QMS Design was an entirely new aspect not present in the previous QMS (ISO 9002) that Albion pursued. Albion Design and Fabrication, the Bedfordshire based manufacturer of display and shop-fitting products achieved I SO 9001:2000 certification in October 2002. It is one of Europe’s leading manufacturers of display systems, queuing systems and audio-video support equipment. This case study explains Albion’s fundamental approach to ISO 9001 QMS. More precisely it explains the transition pursued by Albion for changing over from ISO 9002 to the new ISO 9001:2000 QMS. Case under study: Albion Design and Fabrication Company was established in 1989 at Bedfordshire, UK. The company is renowned for its rope and rod-based hanging display systems and its comprehensive range of support systems for audio-visual equipment. Albion has extensive manufacturing and warehouse facilities in the UK, a sales and logistics operation in Germany, Germany, and a worldwide network of distribution partners. Some 72 employees work in its Bedfordshire plant. Background:
The company had formally defined and established practices to ensure effective quality in the production, installation and servicing of its products. It also had ISO 9002 QMS certification, which was achieved in 1997. The established procedures procedures for production and archiving that relate to quality were robust and strictly followed. The quality management system was contributing value as a basic framework to the company’s longterm quality targets. However, However, in order to renovate the plant as a whole the company opted for ISO 9001:2000 standard. In addition, the topmanagement felt at that quality related procedures, confined to assurance of quality in the products was not sufficient. They wanted to utilise these quality related procedures for improving their business and hence decided to implement the ISO 9001:2000 QMS. Developing the system: Albion Design and Fabrication plant pursued a comprehensive and evolutionary approach to meet the requirements of ISO 9001:2000 QMS. PDCA (Plan, Do, Check, and Act) cycle approach was the base for every aspect of the company’s certification process. These processes included activities from setting up of goals to the evaluation and enhancement of the quality related procedures. Design was an entirely new aspect not present in the previous QMS (ISO 9002) that the company pursued. Therefore, there were neither previous procedures to assist in the design aspect of the QMS. Hence, Albion identified the need to initially conduct a company wide training program. The program aimed at making its employees aware of the new quality system and involved them in the new process. An external consultant was hired to train the employees on the new ISO 9001:2000 standards. The various steps that were followed are detailed below: Formation of a Task-force: The primary step taken towards the company’s changeover programme was the formation of a six-member taskforce. This team represented individuals from different areas of business. As a result, a diverse range of opinions was collected. A quality assurance manager with the help of quality assurance co-ordinator headed the team. Training: The cross-functional taskforce team was then provided with adequate training for superior understanding and better implementation of the new QMS. Initially, the top-management was not certain of the organisations ability to meet the required ISO 9001:2000 standards. Unable to comprehend the system they decided to comprehensively allocate their time for better understanding and implementation of the ISO 9001QMS. Thus, before undertaking the training course the topmanagement went through an extensive reading program that could keep them abreast of the new standards. A two-day training session followed. Training Training helped the taskforce tea m develop a structured approach to ISO 9001:2000 standard in setting up targets and in specifying time limits. The training session also provided a platform for the management to explain what was expected from the team members. Implementation: The taskforce team started meeting for two hours each week to decide upon the targets, and discuss and exchange views on quality related issues. Duration for each meeting was fixed and the team started integrating the outcome of the meetings to
identify possible developments and changes to the quality manual. Depending upon the requirement, they amended the manual. Wherever required, new pages were added and the obsolete ones were deleted. The quality manual wa s subjected to periodic revision to further examine the scope of enhancement. In this way a basic structure was developed to assist in the implementation of the new quality system. Care was taken such that the new quality system included all the quality related activities in the organisation like process mapping, the company’s motto, its targets, vision of the quality system, and the new policy statement. Also the revised quality manual ensured that all the valid procedures in the old quality manual, were retained. In this manner the first copy of the revised manual was completed. They endeavoured to keep the manual as simple as possible. Complicated terminology was avoided and the manual was made user friendly. The task force team then identified the need for a new and effective auditing process to demonstrate the organisations compliance to the required standards. Hence, another in-house training camp was conducted. This camp was aimed at i mparting skills for auditing effectively, effectively, and to demonstrate organisations compliance to the standards. Transitional issues: Time had proven to be the major issue of concern for Albion in its transition process. The top-management was very busy as usual. However the Albion management ensured that no matter how busy they were, they set a side time each week for the quality system. This ensured that all the employees was focussed, interested and involved in the quality process. Albion found demonstrating customer satisfaction a tough task to handle. The quality assurance department identified the inadequacy or inability of the customer questionnaires to efficiently perform their task. They identified the need to improve their customer communication approach so that more customers answered the questionnaires. In order to solve this problem sales people, who generally have direct contact with the customer, customer, were asked to specifically seek customers’ willingness to complete the questionnaire, before faxing them. This improved the response rate. Cost involved in the transition process was the other issue that was thought of before starting the quality program. Albion identified that the major cost involved was in the training programs to be conducted, and in the hiring of the consultant. At the same time, they discovered the importance of training and the benefits it could bring. So it decided in favour of hiring a consultant for providing training and guiding the company in the transition process. Certification: LRQA (Lloyds Register Quality Assurance) was selected as the external consultant to provide necessary training to develop ISO 9001 QMS as well as to certify the organisations new QMS. The certifying agency conducted a wide inspection of the plant and found that the new QMS completely satisfied ISO 9 001:2000 standard requirements. Consequently, Consequently, the plant was awarded ISO 9001:2000 certification in October 2002. LRQA specifically appreciated the commitment of the top-management in the company’s certification process. Albion’s tips for transition: 1.
Commit Commitmen mentt of of the the top-ma top-manag nageme ement. nt.
2.
Formation Formation of a cross-f cross-functi unctional onal taskforce taskforce for the transition process.
3.
Sugge Suggesti stion on and suppo support rt from from externa externall consult consultant ant// people, aware of the standards with prior experience in implementing the ISO 9001:2000 QMS.
Online Navigator > Understanding 1. ISO 9000:2000 – An Introduction: This document gives an explanation of •
Why ISO changed from 9000:1994 to 9000:2000.
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Changes that are made to the 199 4 version.
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The ISO 9000:2000 family members, and
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The 8 management principles involved in the ISO 9000:2000 series.
http://www.normapme.com/eLearning/From%20ISO%20900X1994%20to%20ISO%20900X-2000-EN.pdf 2. What is ISO 9000:2000: This Document explains what ISO 9000:2000 is and also provides information regarding the implementation, improvement and certification process involved in ISO 9000:2000 QMS. http://www.cqual.co.uk/whatisiso.html 3. A Complete Guide to Understanding and Implementing ISO 9000:2000: This document is a guide to the understanding and the implementation of ISO 90001:2000 requirements. http://www.oxebridge.com/CompleteGuidetoISOProcessApproac hv2.pdf 4. ISO 9001:2000 Understanding: Link to download a sample quality manual. http://www.qualisysgroup.com/management-iso9001-case.htm 5. Interpret the Requirements: This document provides an interpretation for the ISO 9001 2000 standard. http://www.mapwright.com.au/Quality_Matters.html Continue Online links to Implementation and Documentation Online Navigator > Implementation and Documentation A list of online links that relate to Implementation and Documentation in ISO 9001:2000. Implementation: 1. What Is ISO 9000:2000 Implementation? This document gives a comprehensive explanation of the implementation process for the revised ISO 9001 standard. http://www.kamtechassociates.com/iso9k1.pdf 2. An Eight Step Approach to ISO 9000 Implementation This document provides an 8-step approach to the implementation of ISO 9000. http://www.caliso9000.com/page4.html 3. Tips For Implementation Provides some tips for implementing ISO 9001 standard effectively. http://www.orioniso.com/Pub/AboutORI/NewsBankDocs/Continuous%20Improve ment/Dcutter-Implementing%20ISO%209000%20Process.pdf 4. Common Pitfalls In The I mplementation Process This document lists out the issues organisations mostly face in the implementation process of ISO 9000:2000. http://www.hkbu.edu.hk/~samho/tqm/tqmex/iso.htm 5. Increasing profitability, quality and compliance with
ISO 9000 This document details the steps necessary for realising the benefits of implementing the ISO 9001 standard http://www.rosternetwork.com/bna/iso_9000_white_paper.htm Documentation 1. ISO 9000:2000 Documentation - Guidance This document provides guidance for meeting the documentation requirements of the ISO 9001:2000 standard. http://isotc176sc2.elysium-ltd.net/Documentation.doc 2. ISO 9000:2000 Documentation – A complete complete understanding Explains the planning necessary for the documentation process. http://www.stc.org/intercom/PDFs/2002/200202_17-21.pdf Continue Online Links to Additional Reading Online Navigator > Additional Reading Following are some online links relating to Additional Reading in ISO 9001:2000. 1. http://www.holeton.com/casestudies.htm This link provides case studies of ISO 9000:2000 for different sectors of business namely- Aerospace manufacturing, Electrical sensor manufacturing, Energy systems, Service division and Insurance brokerage. 2. http://clientele.epicor.com/tools/case.asp?ID=281&P - A case study of ISO 9001 implementation by Cimworks – a Computer integrated manufacturing products provider. provider. 3. http://www.staffingtoday.net/memberserv/9804ct/usingiso.html - A case study on using ISO for technology implementation. 4.http://www.qualisysgroup.com/management-iso9001case.htm - This page provides downloads for the sample quality manual, requirements of ISO 9001:2000 and some frequently asked questions. 5. http://www.iqa.org/information/iso9k2kworkbook.html - A guide to the adoption of ISO 9001:2000 standard. 6. http://www.siem.gob.mx/siem2000/spyme/promcalidad/paginas /plena04.ppt - This presentation deals with the issues related to transition from 1994 version to the 2000 version. 7. http://www.asq509.org/Library/ISO%209001%20at%20NASA.p pt - A detailed power point presentation that makes a journey into the implementation of ISO 9001 at NASA. 8. http://www.aidic.it/italiano/congressi/esrel2001/webpapersesrel 2001/337.pdf -- This document deals with the quality 2001/337.pdf improvements related to the ISO 9001 2000 standard. 9. http://www.iso.ch/iso/en/iso900014000/articles/pdf/viewpoint_4-98.pdf – 14000/articles/pdf/viewpoint_4-98.pdf – This document is an argument against ISO 9000. 10. http://praxiom.com/ This site gives a clear explanation of all the standards and the guidelines present in the ISO 9000:2000 series. 11. http://www.borcom.bc.ca/EXBP/ISO%209001_2000_Guideline_r
ev2.0.pdf - This document starts with a summary of ISO ev2.0.pdf 9000:2000 and then explains the key clauses involved in it. It also answers some frequently asked questions on ISO 9001. 12. http://www.isoeasy.org/illustrated.pdf - This link provides an illustrated document that explains the ISO 9001 standard in a simple way. Service Providers Providers > ISO 9001:2000 Consultants Given below is a list of ISO 90011:2000 Consulatants with a brief on each of them as posted in their websites. 1. Advantage ISO Consulting http://www.advantage-iso-consulting.com/ Advantage ISO consulting firm assists organisations in complying with the ISO 9001 2000 requirements. It offers help in developing, implementing and maintaining the quality system. It also supports in creating the necessary documentation for ISO certification. It also helps in conversion from ISO 9000 1994 to ISO 9000 2000. 2.Drysdale Consulting http://www.drysdaleconsulting.com/ Drysdale consulting provides assistance for implementing ISO 9001 2000, ISO 14001 systems. It also helps provides training, consulting and auditing services. It assists in transition from one system to other and also in integration of systems. 3. FY Consulting http://www.fyconsulting.com/iso9000.html FY Consulting offers assistance in upgrading to and complying with the ISO 9001 2000 requirements. It also helps in complying with the ISO 14000 requirements and provides the necessary documentation system. 4. Jan Roovers Associates Inc http://www.janroovers.com/ Jan Roovers Associates Inc. provides training and consulting for ISO 9001. It also provides support in upgrading from ISO 9000 1994 to ISO 9000 2000 , documenting and implementing the system. 5. Global Tech Ltd Management Consultants http://globaltechca.com/ Global Tech Ltd. uses a process driven approach to enable the quality management system to comply with the ISO 9001 2000 requirements. The firm develops the system around the existing environment of the organisation. This enables a smooth transition of the quality system to the ISO standards. 6. Opim Consultants Inc. http://www.terra-tech.nb.ca/ OPIM is an innovative training firm committed to providing consulting and training services that produce short-term measurable benefits in the industrial and services sector. OPIM inc. has managed and completed numerous training projects around the globe in several sectors. These sectors include: forestry, forestry, industrial management, sciences, ISO quality systems, manufacturing systems, operation improvement techniques, maintenance, telecommunications and international procurement. 7. Orion Canada Inc. http://www.orioncanada.com Orion Canada offers services covering various aspects of quality. quality. It offers assistance ranging from finding the cause of quality problems to designing quality management systems that comply with requirements. Services include internal audits, measuring customer satisfaction, maintaining quality system etc. 8. Q-Pro Consulting http://members.shaw.ca/qpro/home.html Q-PRO consulting provides consulting services in quality
management systems, quality control, and quality audit related to manufacturing and service sector. sector. 9. Sigma Affliates, Ltd. http://www.sigmafil.com/ Sigma Affiliates Ltd. is a quality consulting and training firm. It assists organisations develop their quality system and comply with the ISO 9001 requirements. 10. Directory Of Consultants http://www.iso9000commerce.com/htm/consultants.htm This site gives a complete list of consultants in the United States and also provides a link of consultants in the international arena who assist organisations in the ISO 9000 certification process.
