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ISO-9001 : 2000 “Lessons learned” from a Quality Registrar’s Perspective Presented by

ISO-9001 : 2000 “Lessons learned” from a Quality Registrar’s Perspective Presented by Bea H. Ng - BVQi(NA) Lead Auditor. ISO-9001:2000 “Lessons Learned”. Major Topics: 8 Quality Management Principles ISO-9001:2000 Interpretations by BVQi(NA). Customer focused.

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ISO-9001 : 2000 “Lessons learned” from a Quality Registrar’s Perspective Presented by

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  1. ISO-9001 : 2000 “Lessons learned” from a Quality Registrar’s Perspective Presented by Bea H. Ng - BVQi(NA) Lead Auditor ISO9001:2000 Lessons Learned

  2. ISO-9001:2000 “Lessons Learned” • Major Topics: • 8 Quality Management Principles • ISO-9001:2000 Interpretations by BVQi(NA) ISO9001:2000 Lessons Learned

  3. Customer focused Determine customer needs & expectations Customer focused: Organisations depend on customers. Requirements Principle 1 Customer satisfaction ISO9001:2000 Lessons Learned

  4. Leadership Leaders establish unity of purpose, direction and internal environment in which people become fully involved. Principle 2 ISO9001:2000 Lessons Learned

  5. Involvement of people • People are the essence of the organisation. • Their full involvement enables using their abilities to the benefit of the organisation. Principle 3 ISO9001:2000 Lessons Learned

  6. Process approach A desired result is more efficiently achieved when resources and activities are managed as a process. Principle 4 ISO9001:2000 Lessons Learned

  7. Process approach New structure • Familiar 20 elements are gone but are identifiable • New structure is process based and more generic • Clearly based on Plan - Do - Check - Act principle • Major clauses: • Management responsibilities • Resource management • Product realisation • Measurement, analysis & improvement • Alignment with ISO-14000 ISO9001:2000 Lessons Learned

  8. Process approach C U S T O M E R C U S T O M E R Quality Management System Continual Improvement S a t i s f a c t i o n Management responsibility R e q u i r e m e n t s Resource management Measurement, analysis, improvement Product realisation Product Input Output ISO9001:2000 Lessons Learned

  9. System approach Identifying, understanding and managing a system of interrelated processes for a given objective contributes to effectiveness and efficiency. Principle 5 ISO9001:2000 Lessons Learned

  10. Continual improvement Continual improvement is a permanent objective of the organisation Quality improvement: “part of quality management focusing on increasing effectiveness and efficiency” (ISO-9000:2000) Principle 6 ISO9001:2000 Lessons Learned

  11. Factual approach to decision making Effective decisions are based on the logical and intuitive analysis of data and information. Principle 7 ISO9001:2000 Lessons Learned

  12. Mutually beneficial supplier relationship Mutually beneficial relationship between organisation and its suppliers enhance the ability of both organisations to create value. Principle 8 ISO9001:2000 Lessons Learned

  13. ISO-9001:2000 “Lessons Learned” ISO-9001:2000 INTERPRETATIONS from a Quality Registrar’s Perspective ISO9001:2000 Lessons Learned

  14. ISO-9001:2000 “Lessons Learned” 1) Standard Requirements - Justifiable Exclusions • 4.2.2 Quality Manual a) the scope of the quality management system, including details of and justification for any exclusions 1.2 Application Where any requirements of this standard can not be applied due to the nature of an organisation and its product, this can be considered for exclusion Where exclusions are made, claims of conformity to this standard are not acceptable unless they are limited to requirements in clause 7, and such exclusions do not affect the organisations ability, or responsibility, to provide product that meets customer and applicable regulatory requirements. ISO9001:2000 Lessons Learned

  15. ISO-9001:2000 “Lessons Learned” • BVQi Interpretation - Justifiable Exclusions • Must be adequately stated in the quality manual if exclusions are taken. Typical exclusions: - 7.3 Design and Development - 7.5.2 Validation of processes for production or service - 7.5.4 Customer property - 7.6 Control of monitoring and measuring devices • Discussion Topics • Any others that may be applicable to your company? • What is a typical statement of exclusion? • Is it OK just to say “not applicable to our method of operation”? ISO9001:2000 Lessons Learned

  16. ISO-9001:2000 “Lessons Learned” 2) Standard Requirements - Documentation • 4.2 Documentation requirements Quality management systems documentation shall include a) documented statements of a quality policy and quality objectives b) a quality manual c) documented procedures required by the standard d) documents needed by the organisation to ensure the effective planning, operation and control of its processes e) records required by this standard • 4.2.3 Control of documents b) to review and update as necessary and re-approve documents ISO9001:2000 Lessons Learned

  17. ISO-9001:2000 “Lessons Learned” • BVQi Interpretations - Documentation • Manual content and design • Structure of the manual and form • Documentation structure • Document control • Discussion Topics • Acceptable form and structure of manuals - Manual reviews • Process interaction description • Flow charts - not a requirement, preferred approach • Review of existing documents, frequency and evidence • Measurable objectives ISO9001:2000 Lessons Learned

  18. ISO-9001:2000 “Lessons Learned” 3) Standard Requirement - Measurable Objectives • 5.4.1 Quality objectives Top management shall ensure that the quality objectives, including those needed to meet requirements for product are established at relevant functions and levels within the organisation. The quality objectives shall be measurable and consistent with the policy. • 5.4.2 Quality Management system planning a) the planning of the QMS is carried out in order to meet the requirements given in 4.1, as well as the objectives, and b) the integrity of the QMS is maintained when changes to the QMS are planned and implemented ISO9001:2000 Lessons Learned

  19. ISO-9001:2000 “Lessons Learned” • BVQi Interpretations - Measurable Objectives • Established at relevant function and levels • “relevant” functions may include; purchasing, RI, sales marketing, customer service, design/R&D, servicing, etc. • Must be measurable and consistent with the policy • Process and Product related • Discussion Topics • Where have you seen objectives documented and controlled? If contained in meeting minutes, is this acceptable? • How do we determine if objectives are linked to the policy? How do people answer the policy questions? Do they know their objectives (Reference 6.2.2 d)? • Planning activities related to the achievement of objectives ISO9001:2000 Lessons Learned

  20. ISO-9001:2000 “Lessons Learned” 4) Standard Requirement - Continual Improvement • 8.5.1 Continual Improvement The organisation shall continually improve the effectiveness of the quality management system through the use of the quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions and management review. • ISO 9000-2000 definition -- recurring activity to increase the ability to fulfil requirements • NOTE: THE PROCESS OF ESTABLISHING OBJECTIVES AND FINDING OPORTUNITIES FOR IMPROVEMENT IS A CONTINUAL PROCESS THROUGH THE USE OF AUDIT FINDINGS AND AUDIT CONCLUSIONS, ANALYSIS OF DATA, MANAGEMENT REVIEWS OR OTHER MEANS AND GENERALLY LEADS TO CORRECTIVE ACTION OR PREVENTIVE ACTION. ISO9001:2000 Lessons Learned

  21. ISO-9001:2000 “Lessons Learned” • BVQi Interpretations - Continual Improvement • Significant new requirement • Distinction between continuous and continual • Significant or sustained lack of improvement must be met with corrective action, unless the undesirable condition is expected/predicted, resulting from a conscious/deliberate decision be management. • Discussion topics • What if efforts do not result in improvement? • Does the improvement activity need to be documented? • Where and how deep into the organization do improvement efforts need to be made (drivers)? • If they are not showing improvement, can an organization stay certified? ISO9001:2000 Lessons Learned

  22. ISO-9001:2000 “Lessons Learned” 5)Standard Requirement - Process Approach • 4.1 The Organization shall • a) identify the processes needed for the QMS and their application throughout the organization • b) determine their sequence and interaction of these processes • c) determine criteria and methods needed to ensure that both the operation and control of these processes are effective • d) ensure availability of resources and information necessary to support the operation and monitoring of these processes • e) monitor, measure and analyse these processes, and • f) implement actions necessary necessary to achieve planned results and continual improvement of these processes ISO9001:2000 Lessons Learned

  23. ISO-9001:2000 “Lessons Learned” • BVQi Interpretations - Process Approach • Process Identification • BVQi auditors will expect to see the process model that explains the key processes of the business and how each relates and links to others. • Sequence and interaction • The organization is not required to produce system maps, flow charts, lists of processes etc., as evidence to demonstrate that the processes and their sequence and interactions were identified. Such documents may be used by an organization should they deem them useful, but are not mandatory. • Discussion topics • What do we expect to see and how can we determine compliance? Minimum description requirements in the manual. • Referencing a separate document in the manual to describe/show sequence and interaction, is this acceptable? ISO9001:2000 Lessons Learned

  24. ISO-9001:2000 “Lessons Learned” 6) Standard Requirements- Competency • 6.2.1 General Personnel performing work affecting product quality shall be competent on the basis of appropriate education, skills, and experience • 6.2.2 Competence, awareness and training a) determine the necessary competence for personnel performing work affecting product quality b) provide training or take other action to satisfy these needs c) evaluate the effectiveness of the action taken ISO9001:2000 Lessons Learned

  25. ISO-9001:2000 “Lessons Learned” • BVQi Interpretations - Competency • Determine the necessary competence • The organization should determine knowledge and/or skills an employee would need to be considered competent, in their opinion, to perform a particular job. • Evaluate the effectiveness of the actions • The new requirement is aimed at ensuring that the training or other activity has produced a competent employee. …. Effectiveness of other actions may be evaluated by a variety of means & organizations should select what best suits their needs. • Discussion topics • Job descriptions for competency determination. • Training effectiveness vs... competence decisions. • Operational personnel & supervision/management expectations. • Do internal auditors need external training? ISO9001:2000 Lessons Learned

  26. ISO-9001:2000 “Lessons Learned” 7) Other Sub-Clauses: • Customer Focus (5.2) • Customer Communication (7.2.3) • Customer Property (7.5.4) • Customer Satisfaction (8.2.1) • Analysis of Data (8.4) • Any others? Questions?? ISO9001:2000 Lessons Learned

  27. ISO-9001:2000 “Lessons Learned” Thank you and Good Night !! Happy Auditing Drive Safely from Bea H. Ng and Jim Rivas ISO9001:2000 Lessons Learned

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