Process of implementing ISO 9000 Process of implementing ISO 9000 Implementation of ISO 9000 include 14 steps as follows: Step 1: Top management commitment Step 2: Establish implementation team Step 3. Start ISO 9000 awareness programs Step 4: Provide Training Step 5. Conduct initial status survey Step 6: Create a documented implementation plan Step 7. Develop quality management system documentation Step 8: Document control Step 9. Implementation Step 10. Internal quality audit Step 11. Management review Step 12. Pre-assessment audit Step 13. Certification and registration Step 14: Continual Improvement
Document Control The organization must maintain a document d ocument system to comply with principles of ISO 9000.
Document control is a process of managing the creation, approval, distribution, revision, storage, and disposal of the various types of documentation. Document control should include: • Identification of changes and of the revision status of documents, • Availability of relevant versions of documents at points o f use, • Identification and control of documents of external origin, • Approval for adequacy by b y authorized person (s) before issue, • Review, updating and re-approval of documents by authorized person (s), • Assurance of legibility and identifability of documents, and • Prevention of unintended use of obsolete documents.
Management Review
Step 11. Management Review 1. Purpose of the management review
Purpose of the management reviews are to ensure the continuing suitability, adequacy and effectiveness of the quality management system. 2. Contents of management review
The review should include assessing opportunities for improvement and the need for changes to the quality management system, including the quality policy and quality objectives. 3. Inputs of management review
• Results of audits, • Customer feed back, • Process performance and product conformity, con formity,
• Status of preventive and corrective actions, • Follow-up actions from previous management reviews, • Changes that could affect the quality quality management system, and Recommendations for improvements.
ISO 9000 Awareness Programs Step 3. ISO 9000 Awareness Programs
Purpose of ISO awareness programs is to communicate to the employees the aim of the ISO 9000 quality management system. The awareness program should emphasize the benefits that the organization expects to realize through its ISO 9000 quality management system. These programs could be run either by the implementation team or by expe rts hired to talk to different levels of employees.
Establish ISO Team Step 2: Establish ISO Team
This is second step in implementing ISO 9000. In this step, CEO must establish an implementation team (ISO team) and appoint a Quality Management Representative (QMR) as its coordinator to plan and oversee implementation. Members of ISO team should include representatives of all functions of the organization.
Top Management Commitment Step 1: Top Management Commitment
Top Management Commitment is first step in order to implement ISO 9000. As rules of ISO 9000, the top management (General director, CEO, function directors….) should
demonstrate a commitment and a determination to implement an ISO 9000 quality management system in the organization. 1. Conditions of Top Management Commitment
The top management also should provide evidence of its commitment to the development and implementation of the quality management system and continually improve its effectiveness by: • Ensuring the availability of resources required for the developmen t and implementation of the quality management system, • Appointing a management representative to coordinate quality management system activities, • Conducting management review, • Communicating to the organization the importance of meeting customer as well as statutory and regulatory requirements, • Defining the organization’s quality policy and make this known to every employee, • Ensuring that quality objectives are established at all levels and functions. 2. Types of top management commitment:
• Growth ambitions: desire to exploit market opportunities. • Personal belief in the value of quality as a goal and quality management systems as a means of reaching that goal. • Direct marketplace pressure: requirements of crucial customers or parent conglomerates. • Indirect marketplace pressure: increased quality levels and visibility among competitors. 3. Goals of Top management:
The Top management must set up goals as follows in order to comply co mply with ISO 9000 principle: • Achieve customers c ustomers satisfaction • Increase market share • Improve communications and morale in the organization • Reduce costs and liabilities
• Increase confidence in the production system • Be more efficient and profitable p rofitable • Produce products and services that consistently meet customers’ needs and expectations
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