Awareness to ISO 9001:2000
Tutor’s Introduction
Course Objectives
Be able to understand and interpret the requirements of the standard Planning to implement the requirements of the standard
Course Structure
Lectures and value added discussions on each topic. Work Worksh sho ops to ena enable ble delegates to increase their understanding regarding ISO 9001:2000 version and to experience Quality Management System implementation practices.
ISO I S SO 1 O 4 0 00 1 0
International Organization for Standardization
ISO 9000 S A8 0 00 0 0 0 O H HS AS 1 S 8 0 0 0 01
4 9 9 6 S 1 T T / S O I S
INTRODUCTION
Origin ISO 9000:87 ISO 9000:94 ISO 9001:2000 BS5750 1979 AQAP1 (NATO) 1970’s MIL-STD-9858 (1940’s)
What is ISO?
International Organization for Standardization
Develops standards do not certify companies
Around 140 countries members
Around 13000 standards produced
Technical Committees are formed to produce standards
TC 176 for ISO 9000
International Organization for Standardization Email:
[email protected] Web: http://www.iso.ch http://www.bsi.org.uk/iso-tc176-sc2.
ISO 9000:2000 Family of Standards
CORE STANDARDS
ISO 9000:2000 Fundamentals and Vocabulary ISO 9001:2000 QMS Requirements ISO 9004:2000 Guidelines for Performance Improvement
SUPPORTING STANDARDS
ISO 10005:1995 Guidelines for Quality Plans ISO 10006:1997 Guidelines for Project Management ISO 10007:1995 Guidelines for Configuration Mgt ISO 10011-1, -2, -3 on Auditing ISO 10012-1 & -2, Quality Assurance for Measuring Eqpt. Eqpt. ISO 10013:1995 Guidelines for Quality manuals
ISO 9000:2000 Family of Standards
ISO/TR 10014:1998 Guidelines for managing economics of quality
ISO 10015 Guidelines for Training
ISO/TR 10017:1999 Guidelines on Statistical techniques
What’s New? 1. New Standard
ISO 9002 and 9003 dropped
ISO 9001 modified
2. New Structure
20 clauses abandoned
Now 8 sections
QMS
Quality Management System A System of coordinated activities which is mean meantt to “dir “direc ect” t” and “c “contr ontrol ol” ” an organization with regard to quality. or
(satisfying your customer by managing your resources, through a standardized system)
Design Control
Corrective & Preventive Actions
Production & Process Controls
Management Human Resource Controls
Records, Documents, & Change Controls
Material, Equipment & Facility Controls
QUALITY MANAGEMENT PRINCIPLES What are they?
The basic principles on which the ISO 9000:2000 standards are based Quality Management
Principles
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PRINCIPLE 1 CUSTOMER-FOCUSED ORGANISATION Organization depend on their customers and therefore should understand current and future customer needs, meet customer requirements and strive to exceed customer expectations.
PRINCIPLE 2 LEADERSHIP
Leaders establish unity of purpose and direction of the organization. They should create and maintain the internal environment in which people can become fully involved in achieving the organization's objectives.
PRINCIPLE 3 INVOLVEMENT OF PEOPLE People at all levels are the essence of an organisation and their full involvement enables their abilities to be used for the organisation’s benefit.
PRINCIPLE 4 PROCESS APPROACH
A desired result is achieved more efficiently when related resources and activities are managed as a process.
PRINCIPLE 5 SYSTEM APPROACH TO MANAGEMENT
Identifying, understanding and managing a system of interrelated interrelated processes for a given objective improves the organization’s effectiveness and efficiency.
PRINCIPLE 6 CONTINUAL IMPROVEMENT
Continual improvement should be a permanent objective of the organization.
PRINCIPLE 7 FACTUAL APPROACH TO DECISION MAKING
Effective decisions are based on the analysis of data and information.
PRINCIPLE 8 MUTUAL BENEFICIAL SUPPLIER RELATIONSHIPS
An organization and its suppliers are interdependent, and a mutually beneficial relationship enhances the ability of both to create value.
Process Any activity that takes “inputs” and converts them to “outputs”
Process Approach The systematic identification and management of these activities and the interaction between activities.
Example - Purchasing Process Inputs Inputs •• Demand Demandfor for material material •• Item Itemspecs specsand and Date Date •• Supplier Suppliersource source •• Suppliers Suppliers capability capabilityto to meet meetour our requirements requirements
Purchasing Purchasing Procedure Procedure
Interactions Interactionsto to
••Storage Storage ••Inspection Inspectionand andTesting Testing ••Manufacturing Manufacturing ••Finance Finance
Outputs Outputs •• Receipt Receiptof of Material Materialon onright right condition condition •• Right RightQuality Quality Right RightQuantity Quantity •• Right RightTime Time
Performance PerformanceMeasurements Measurements •Delivery •Deli very On-ti me, sspec, pec, •Delivery •Deli verystatus status––On-time, On-time, On-ti me,On Onspec, sp ec, etc etc •Supplier •Supplierevaluation evaluation
Process Approach Model CONTINUAL IMPROVEMENT OF THE QUALITY MANAGEMENT SYSTEM
C U S T O M E R
R e q u i r e m e n t s
C
Management responsibility Resource management Input
Service realization
Measurement, analysis and improvement
Output
Product
U S T O M E R
S a t i s f a c t i o n
Important changes •More emphasis on customer satisfaction •Commitment to comply with legal and statutory requirements •Need to review suitability of quality policy •Need to define quantified and measurable quality objective at different functions and levels •More emphasis on human resource management •Re-evaluation of suppliers on the basis of their performance •Analysis of data for continual improvement •Need to maintain suitable work environment •Ter Term m “Subcon “Subcontra tracto ctor” r” rep replace laced d with “Suppl “Supplier ier” ” and “Supp “Supplier lier” ” replaced with “organization” •Exclusions defined
The Structure 0 1 2 3 4 5 6 7 8
Introduction Scope Normative reference Terms and definitions Quality management system requirements Management responsibility Resource management Product realization Measurement, analysis and improvement
System Requirements / Structure of the Standard 4 Quality Management System
5 Management Responsibility
General requirements requirements (4.1)
Management Commitment(5. 1)
Documentation Requirements(4.2)
Customer focus (5.2) Quality policy(5.3) Planning(5.4)
6 Resource Management
Provision of resources(6.1)
Human resources(6.2)
Infrastructures(6.3 )
7 Product Realization
8 Measurement Analysis & improvement
Planning(7.1) General (8.1) Customer related processes(7.2 )
Monitoring & measurement(8.2)
Design & development(7.3)
Control of NCP(8.3) Purchasing(7.4)
Responsibility, authority & communication( 5.5) Management
Work environment(6.4)
Analysis of data(8.4) Production & service provision(7.5) Control of monitoring &
Improvements(8.5)
0.4 Compatibility with other Management Systems
Standard is intended to be compatible with other management systems It is aligned with ISO 14000 to enhance compatibility Standard does not include requirements for other management system such as EMS, OHSM or Financial management
1.2 Applications
Requirements may be excluded if not appropriate due to :
nature of product
customer requirements
applicable regulatory requirements
Exclusions must:
Not affect ability to provide conforming product
Be limited to clause 7
4 Quality Management System 4.1 General Requirements
Establish, document, implement, maintain and continually improve QMS in accordance with the standard.
4.2 General Requirements
To implement the QMS the Organization shall
Identify and manage processes necessary for QMS
Determine the sequence and interaction of processes
Determine criteria and methods to ensure effective operation and control of the process Ensure availability of information needed to support the operation and monitoring of processes Measure, monitor, analyze processes and act as necessary to achieve planned results and continual improvements Manage the process in accordance with the standard
4.2 Documentation Requirements General
Extent
To Include
Size and type of organization
Documented procedures required by standard
Complexity and interaction of processes
Competence of personnel Note3 (Documentation may be in any type of media)
Documents required by organization to ensure effective operation and control process Note 1 (Where the term “documented procedure” appears)
4.2 Documentation Requirements
4.2.2 Quality Manual
The organization shall establish a Quality Manual that include:
Scope of QMS
Documented procedures or reference to them
Description of interaction between the process of QMS
4.2 Documentation Requirements
4.2.3 Control of Documents Documents required by the QMS shall be controlled Approve, Review, Ensure current & relevant version, Identification of external origin documents, Prevent unintended use of obsolete documents. 4.2.4 Control of Quality Records Documented Procedure shall be established for identification, storage, protection, retrieval, retention time and disposition. Records shall be: Established and maintained to provide evidence. Legible, readily identifiable and retrievable.
5 Management Responsibility
5.1 Management Commitment
5.2 Customer Focus
5.3 Quality policy
5.4 Planning
5.4.1Quality objectives 5.4.2 Quality Planning
5.5 5.5 Resp Respon onsi sibi billity, ity, aut autho hori rity ty and communication
5.5.1 Responsibility & authority
5.5.2 Management representative
5.5.3 Internal communication
5.6
Management Review
5.6.1 General
5.6.2 Review input
5.6.3 Review output
5.1 Management Commitment
Provide evidence of commitment to the development and improvement of QMS by:
Communicating the importance of meeting customer and legal/regulatory requirements. Establishing quality policy and objectives. Management Reviews Provision of resources.
5.2 Customer Focus
Top Management shall ensure that customer needs & expectations are determined, converted into requirements & fulfilled with the aim of achieving customer satisfaction
5.3 Quality Policy
Appropriate to the purpose of organization.
Commitment to meeting requirements and continual improvements
Frame work for establishing and reviewing quality objectives
Communicated and understood at appropriate levels
Is reviewed for continuing
5.4 Planning 5.4.1 Quality Objectives
Establish quality objectives at relevant functions and levels
Objectives must be measurable and consistent with the quality policy including the commitment to continual improvement
Include those needed to meet requirements for product
5.4 Planning 5.4.1 Quality Objectives (Cont) Quality Objectives should be: • S pecific • M easurable easurable • Achievable Achievable • R ealistic ealistic / Related • T ime ime Bound
5.4.2 Quality Management System Planning
Identify and plan processes needed to achieve quality objectives •
Plan the development of QMS
•
Plan the implementation of QMS
•
Plan the improvement of QMS
5.5 Responsibility, Authority and Communication 5.5.1 Responsibility and authority
Functions and their interaction, responsibilities and authorities shall be defined and communicated to facilitate effective quality management
5.5.2 Management Representative
Member of the management who has responsibility responsibility and authority for ensuring that processes of the QMS are established and maintained Reporting on performance of QMS including needs for improvement Promoting awareness of customer needs and requirements Note: Responsibilities may include liaison with external parties in relation to QMS
5.5.3 Internal Communic Communication ation
Ensure communication between various levels and functions regarding the processes of the QMS and their effectiveness
5.6 Management Review 5.6.1 General
Review of QMS by top management at planned interval to; suitability, y, ensure QMS suitabilit adequacy and effectiveness Evaluate the need for changes to QMS including policy and objectives Records from Management Reviews shall be maintained (see 4.2.4).
5.6.2 Review Input
Review performance and improvement opportunities related to: Audit results Customer feedback Process performance and product conformance Status of preventive and corrective actions Follow up actions from earlier reviews Change that could affect the QMS Recommendations for improvement
5.6.3 Review Output
Output to include actions related to
improvement of the effectiveness QMS and its processes
improvement of product related to customer requirements
resource needs
6 Resource Management
6.1
Provision of resourses
6.2
Human resources
6.2.1 General
6.2.2 Competence, awareness and training
6.3
Infrastructure
6.4
Work environment
6.1 Provision of Resources
The organization shall determine and determine the resources needed for :
implement and maintain the QMS and continually continually improve its effectiveness. effectiveness.
Enhance customer satisfaction by meeting customer requirements.
6.2 Human Resources 6.2.1 General
Those who have responsibilities defined in the QMS must be competent on the basis of appropriate education, training, skills and experience
6.2.2 Competency, Awareness and Training
Identify competency needs Provide required training Evaluate the effectiveness of training provided Ensure staff is aware of relevance and importance of their activities and contribution to achieving quality objectives Maintain appropriate records of education, training, qualification and experience
6.3 Infrastructure
Identify, provide and maintain the infrastructure needed to achieve product conformity This shall include :
Workspace & associated utilities
Equipment, hardware and software
Supporting services (transport or communication)
6.4 Work Environment
The organization shall determine and manage the work environment needed to achieve conformity to product requirements.
7 Product Realization
7.1 Planning of product realization
7.2 Customer related processes
7.3 Design & development
7.4 Purchasing
7.5 Production & service operation
7.6 Control of measuring & monitoring devices
7.1 Planning of Product Realization
Sequence of process to achieve product
Consistent with QMS and documented to suit method of operations
Quality objectives and requirements for the product
The need for processes, documentation, resources and facilities specific to the product
Verification and validation activities and acceptance criteria
Records
7.2 Customer Related Processes
7.2.1 Determination of requirements related to the product
7.2.2
Review of product requirements
7.2.3
Customer communication
7.2.1 Determination of requirements related to the product
Product requirements specified by the customer including requirements for delivery and post-delivery activities Requirements not specified but necessary for intended or specified use Obligations related to product, including regulatory and legal requirements any additional requirements determined by the organization
7.2.2
Review of requirements related to the product
Review identified requirements and ensure before commitment to supply product that;
Product requirements are defined
For verbal orders requirements are confirmed
Difference between tender and contract are resolved
Organization has ability to meet the requirements Records of the results arising from the review shall be recorded.
7.2.3 Customer Communication
Identify and implement arrangements for communication with customers relating to:
product information
inquiry, contract or order handling, including amendments
Customer feedback including complaints
7.3 Design & Development
7.3.1 Design & development planning
7.3.2 Design & development inputs
7.3.3 Design & development outputs
7.3.4 Design & development review
7.3.5 Design & development verification
7.3.6 Design & development validation
7.3.7 Control of design and development changes
7.4 Purchasing
7.4.1
Purchasing process
7.4.2
Purchasing information
7.4.3
Verification of purchased product
7.4.1 Purchasing Process
Purchased product meets requirements
Type & extend of control depends on effect purchased product may have on realization processes and their output
Selects suppliers based on their ability to supply conforming product
Define criteria for selection and periodic evaluation and re-evaluation of suppliers
Results of evaluation and follow up actions must be recorded
7.4.2 Purchasing Information
Purchasing information shall describe the product to be purchased, including where appropriate:
Requirements for approval of product,procedures, product,procedures, processes and equipment.
Requirements for qualification of personnel.
Quality management system requirements.
7.4.3
Verification of Purchased Product
Identify and implement activities needed to verify purchased product
Where organization or its customer purpose verification at supplier premises, organization organization must specify in purchasing information:
verification arrangements
method of product release.
7.5.1
Control of production and service provision
7.5.2
Validation of processes for production and service provision
7.5.3
Identification and traceability
7.5.4
Customer Property
7.5.5
Preservation of Product
7.5.1 Control of production and service provision Control production & services operations through: Availability of information specifying product characteristics Work instructions available where necessary Use and maintenance of suitable equipment Availability & use measuring and monitoring devices Implementation Implementation of monitoring activities Implementation Implementation of defined processes for release, delivery and post delivery activities
7.5.2 Validation of Processes Validation arrangements must be defined and must include as applicable qualification of the process qualification of equipment and personnel use of defined methodologies & procedure requirements ts for record requiremen re-valuation
7.5.3
Identification & Traceability
Where appropriate identify product through all stages of operations
Identify status with respect to measurement & monitoring requirements
Where traceability is required control & record unique identification of product I can not remember
7.5.4 Customer Property
Care for customer’s property being under organization’s control or being used by organization
Identification, verification, protection & maintenance of customer property provided for use or incorporation
Any customer property that is lost, dama damage ged d or foun found d unun- suitab suitable le must must be be recorded & reported to customer
Customer Property tangible / intangible
7.5.5
Preservation of Product
Preserve conformity of product during internal processing and final delivery to intended destination
Include identification, handling, packaging, storage and protection
This applies to constituent parts of product
7.6 Control of monitoring & measuring devices
Calibrate & adjust measuring and monitoring devices at specified intervals as prior to use Traceability to international or national standards. Where no such standard exist record the basis Safeguard MMD from adjustments invalidating calibration Protect MMD from damage or deterioration during handling, maintenance or storage Record results of calibration Assess validity of previous results when devices found to be out of calibration
8 Measurement, Analysis and Improvement
8.1 8.1 General ral
8.2 8.2 Moni Monito tori ring ng & Measurement
8.3 Control of nonconforming product
8.4 Analysis of data
8.5 Improvement
8.2.1 Customer satisfaction
8.2.2 Internal audit
8.2.3 Monitoring and measurement of processes
8.2.4 Monitoring and measurement of
8.5.1 Continual improvement
8.5.2 Corrective action
8.5.3 Preventive action
8.1 General
Define, plan & implement measurement and monitoring activities needed to assure conformance and achieve improvement
This include determination of the need and use of applicable methodologies and statistical techniques techniques
8.2 Monitoring and Measurement 8.2.1 Customer Satisfaction
Organization shall monitor information on customer satisfaction and /or dissatisfaction
The methodologies for obtaining and utilizing such information must be determined
8.2.2 Internal Audit
Conduct periodic internal audit to determine determine if QMS: Conforms to the requirements of the standard Has been effectively implemented & maintained Plan the audit program considering: Status and importance of the activity results of previous audits Define audit scope, frequency and methodologies performed by personnel not performing audited work
8.2.2 Internal Audit
The documented procedure must cover: Responsibilities & authorities for conducting audits Ensuring independence Recording results and reporting to management Timely corrective actions Follow up to verify & report implementation of verification verificatio n results
8.2.3 Measurement and Monitoring of Product
Apply suitable methods for measurement and monitoring of those realization processes necessary to meet customer’s requirements.
8.2.3 Measurement and Monitoring of Product
Measure & monitor product characteristics to verify conformance at appropriate stages of realization processes
Evidence of conformity with the acceptance criteria must be documented, records must indicate the authority responsible for release of product
D Release 5or must not proceed until 0 1deliveryP L / A O H S S 9/ 1 E D have been all I F the E D specified activities I E F R V E completed unless otherwise approved by the customer
8.3 Control of of No Non co conforming Product
Documented procedures for control of non conforming product to prevent unintended use or delivery
Non conforming product shall be corrected
Re-verify after correction
If non-conformance detected after delivery take appropriate action
It is often required that the proposed rectification be reported for concession to the customer, the end user, regulatory or other body
8.4 Analysis of Data
Collect & analyze data, determine suitability and effectiveness of QMS and to identify improvements that can be made Data from measurement & monitoring & other related sources Analyze data provide info on:
Customer satisfaction and/or dissatisfaction Conformance to customer requirement Process, product characteristics and their trends Suppliers
8.5 Improvement 8.5.1 Continual improvement
Planning for Continual Improvement The organization must plan and manage processes necessary for continual improvement of the QMS Facilitate continual improvement using:
quality policy objectives audit results analysis of data corrective actions preventive actions
8.5.2 Corrective Action
Organization Organization must take corrective action to eliminate the causes of non-conformance to prevent recurrence Action appropriate to the impact of problem Documented procedures shall define requirements for: identifying non conformities determine the causes evaluating the need for corrective action determine corrective action needed and implemented Recording results of action
8.5.3 Preventive Action
Organization must identify preventive action to eliminate the causes of potential non conformances to prevent occurrences Actions appropriate to the impact of potential problem Documented procedures must define the requirements for Identification of potential nonconformances conforman ces and their causes Determining and ensuring implementation of preventive action needed Recording results of action taken
Situation Warranting Corrective Action
Identification of major non-conformance.
Large number of minor non-conformities.
The reoccurrence of a problem with a process or activity.
Non-conformities observed during audits.
Customer Complaints.
Non-conforming deliveries from vendors .
Stages of Corrective & Preventive Action
REPORTING
INVESTIGATION
ACTION
FOLLOWUP
CLOSING
EXPECTED BENEFITS Transparency in working at all level Data availability : Hidden Factors are open Accountability Creates Accountability Planning & scheduling improved Rework & Rejection are known and being controlled Customer feedback through regular surveys Employees Participation enhanced Continuos Improvements Program launched Market Reputation
Thank You
