ISO 9001: 2000

1. ISO 9001: 2000 Understanding the Requirements Qimpro Standards Organization www.qimpro.com standards@qimpro.com www.qimpro.com

2. 1. Scope www.qimpro.com

3. 1.1General • Demonstrate ability to consistently provide product that meets customer and applicable regulatory requirements • Enhances customer satisfaction, achieve continual improvement and assurance of conformity to customer and applicable regulatory requirements • Product applies only to the product intended for, or required by, a customer. www.qimpro.com

4. 1.2 Application • Requirements of the standard are generic - applicable to all organizations, regardless of type, size and product provided • Permissible exclusions possible – only for clause 7 (exclusions should not affect ability, or responsibility, to provide product that meets customer and applicable regulatory requirements). www.qimpro.com

5. 2. Normative reference www.qimpro.com

6. ISO 9000: 2000, Quality management systems – Fundamentals and vocabulary. www.qimpro.com

7. 3. Terms and definitions www.qimpro.com

8. Refer terms and definitions given in ISO 9000 • Supplier, organization, customer • The term “organization” replaces the term “supplier” used in ISO 9001:1994, and refers to the unit to which this International Standard applies • The term “supplier” now replaces the term “subcontractor” • The term “product” also means “service”. www.qimpro.com

9. 4. Quality management system www.qimpro.com

10. 4.1 General requirements • Establish, document, implement and maintain a QMS • Continually improve effectiveness of QMS • Identify processes needed for QMS and their application across the organization • Determine the sequence and interaction of these processes • Determine criteria and methods needed to ensure that operation and control of these processes are effective Cont… www.qimpro.com

11. 4.1 General requirements (Cont…) • Ensure availability of resources and information necessary to support the operation and monitoring of these processes • Monitor, measure and analyze these processes, and • Implement actions necessary to achieve planned results and continual improvement of these processes. www.qimpro.com

12. 4.1 General requirements (Cont…) • Organization is responsible for quality of outsourced process/material • Processes include processes for management activities, provision of resources, product realization and measurement. www.qimpro.com

13. 4.2 Documentation requirements 4.2.1 General • Documented statements of a quality policy and quality objectives • A quality manual • Documented procedures required by the standard • Documents needed by the organization to ensure the effective planning, operation and control of its processes • Records required by the standard • Documented procedure - established, documented, implemented and maintained Cont… www.qimpro.com

14. 4.2.1 General(Cont…) • Criteria for extent of the QMS documentation • Size of organization and type of activities • Complexity of processes and their interactions • Competence of personnel • Documentation can be in any form or type of medium – electronic is allowed. www.qimpro.com

15. 4.2.2 Quality manual • Quality manual includes: • Scope of QMS, including justification for exclusions • Documented procedures or reference to them • Description of interaction between processes of QMS. www.qimpro.com

16. 4.2.3 Control of documents • QMS documents must be controlled • Control includes • Approval of documents for adequacy prior to issue • Review and update • Ensure that changes and revision status is identified • Ensure that relevant versions are available at points of use • Ensure that documents remain legible and readily identifiable • Ensure that documents of external origin are identified controlled • Prevent use of obsolete documents • Documented procedure essential. www.qimpro.com

17. 4.2.4 Control of records • Provide evidence of conformity to requirements and effective operation of QMS • Must be legible, readily identifiable and retrievable • Documented procedure essential - identification, storage, protection, retrieval, retention time and disposition of records. www.qimpro.com

18. 5. Management responsibility www.qimpro.com

19. 5.1 Management commitment • Evidence of commitment to development and implementation of QMS and continually improving its effectiveness by: • Communicating the importance of meeting customer and statutory/regulatory requirements • Establishing the quality policy and quality objectives • Conducting management reviews • Provide resources. www.qimpro.com

20. 5.2 Customer focus • Top management must ensure that customer requirements are determined and met • Aim to enhance customer satisfaction. www.qimpro.com

21. 5.3 Quality policy • Top management must ensure that the quality policy: • Is appropriate to the purpose of the organization • Includes a commitment to comply with requirements and continual improvement • Provides a framework for establishing and reviewing quality objectives • Is communicated and understood within the organization • Is reviewed for continuing suitability. www.qimpro.com

22. 5.4 Planning 5.4.1 Quality objectives • Top management must identify quality objectives • Must be measurable and consistent with the quality policy. www.qimpro.com

23. 5.4.2 Quality management system planning • Top management shall ensure that: • QMS is planned to address in 4.1, and quality objectives • Integrity of the QMS is maintained when changes are planned and implemented. www.qimpro.com

24. 5.5 Responsibility, authority and communication 5.5.1 Responsibility and authority • Top management must ensure that responsibilities and authorities are defined and communicated within the organization. www.qimpro.com

25. 5.5.2 Management representative • Must be appointed • Member of management • Irrespective of other responsibilities, must have responsibility and authority that includes: • Ensuring that processes needed for QMS are established, implemented and maintained • Reporting to top management on performance of QMS • Ensuring the promotion of awareness of customer requirements throughout the organization. • Will liaison with external parties on matters relating to QMS. www.qimpro.com

26. 5.5.3 Internal communication • Top management must ensure that communication processes are established to communicate effectiveness of QMS. www.qimpro.com

27. 5.6 Management review 5.6.1 General • Top management must review QMS, at planned intervals, to ensure its continuing suitability, adequacy and effectiveness • Review must include assessment of opportunities for improvement • Need for changes to QMS, including the quality policy and quality objectives must be reviewed • Records from management reviews must be maintained. www.qimpro.com

28. 5.6.2 Review input • Results of audits • Customer feedback • Process performance and product conformity • Status of preventive and corrective actions • Follow-up actions from previous management reviews • Changes that could affect the quality management system • Recommendations for improvement. www.qimpro.com

29. 5.6.3 Review output • Improvement in effectiveness of QMS and its processes • Improvement of the product related to customer requirements • Resource needs. www.qimpro.com

30. 6. Resource management www.qimpro.com

31. 6.1 Provision of resources • Implement and maintain the QMS and continually improve its effectiveness • To enhance customer satisfaction by meeting customer requirements. www.qimpro.com

32. 6.2 Human resources 6.2.1 General • Personnel performing work affecting product quality must be competent • Competence includes appropriate education, training, skills and experience. www.qimpro.com

33. 6.2.2 Competence, awareness and training • Determine the necessary competence for personnel performing work affecting product quality • Provide training or take other actions to satisfy these needs • Evaluate the effectiveness of the actions taken • Ensure that personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives • Maintain appropriate records of education, training, skills and experience. www.qimpro.com

34. 6.3 Infrastructure • Determine, provide and maintain infrastructure needed to achieve conformity to product requirements • Building, workspace and associated utilities • Process equipment (both hardware and software) • Supporting services (such as transport or communication). www.qimpro.com

35. 6.4 Work environment • Determine and manage the work environment needed to achieve conformity to product requirements. www.qimpro.com

36. 7. Product realization www.qimpro.com

37. 7.1 Planning of product realization • Plan and develop processes needed for product realization. • Planning of product realization must be consistent with requirements of other processes of QMS. • Determine quality objectives and requirements for the product • Determine the need to establish processes, documents, and provide resources (Cont…) www.qimpro.com

38. 7.1 Planning of product realization (Cont…) • Determine required verification, validation, monitoring, inspection and test activities and the criteria for product acceptance • Determine records needed to provide evidence that the realization processes and resulting product meet requirements. • The output of this planning must be in a form suitable for the organization’s method of operations. www.qimpro.com

39. 7.2 Customer-related processes 7.2.1 Determination of requirements related to the product • Requirements specified by the customer, including the requirements for delivery and post-delivery activities • Requirements not stated by the customer but necessary for specified or intended use • Statutory and regulatory requirements related to the product • Any additional requirements determined by the organization. www.qimpro.com

40. 7.2.2 Review of requirements related to the product • Review the requirements related to the product • Review must be conducted before commitment to supply • Ensure that product requirements are defined • Ensure that differences are resolved • Ensure that the organization has the ability to meet defined requirements • Records of the results of the review and actions must be maintained. (Cont…) www.qimpro.com

41. 7.2.2 Review of requirements related to the product (Cont…) • Where customer requirement is not documented, confirm the same before acceptance • Where product requirements are changed, amend documents and inform relevant personnel • In some situations, such as Internet sales, a formal review is impractical for each order. www.qimpro.com

42. 7.2.3 Customer communication • Must determine and implement effective arrangements for communicating with customers • Product information • Enquiries, contracts or order handling, including amendments, and • Customer feedback, including customer complaints. www.qimpro.com

43. 7.3 Design and development 7.3.1 Design and development planning • Must plan and control the design and development of product • Determine the design and development stages • Determine review, verification and validation at each stage • Determine responsibilities and authorities for design and development • Must manage the interfaces between different groups involved in design and development • Planning output must be updated as the design and development progresses. www.qimpro.com

44. 7.3.2 Design and development inputs • Inputs relating to product requirements must be determined and records maintained • Functional and performance requirements • Applicable statutory and regulatory requirements • Where applicable, information derived from previous similar designs • Other requirements essential for design and development • Inputs must be reviewed for adequacy • Requirements must be complete, unambiguous and not in conflict with each other. www.qimpro.com

45. 7.3.3 Design and development outputs • Outputs must be provided in a form that enables verification against inputs • Outputs must be approved prior to release • Meet the input requirements for design and development • Provide appropriate information for purchasing, production and for service provision • Contain or reference product acceptance criteria • Specify the characteristics of the product that are essential for its safe and proper use. www.qimpro.com

46. 7.3.4 Design and development review • Systematic and at suitable stages and as planned • Evaluate the ability of the results to meet requirements • To identify any problems and propose necessary action • Participants must include representatives of functions concerned with the design and development • Records of the results of the reviews and any necessary actions must be maintained. www.qimpro.com

47. 7.3.5 Design and development verification • Verification must be performed as planned • Ensure that outputs have met input requirements • Records of verification and any necessary actions must be maintained. www.qimpro.com

48. 7.3.6 Design and development validation • Must be performed as planned • Ensure that resulting product is capable of meeting requirements for specified application / intended use • Validation must be completed prior to delivery or implementation • Records of results of validation and any necessary action must be maintained. www.qimpro.com

49. 7.3.7 Control of design and development changes • Design and development changes must be identified and recorded • Changes must be reviewed, verified and validated, and approved before implementation • Review of changes must include evaluation of effect of changes on parts and product already delivered • Records of the results of the review of changes and any necessary actions must be maintained. www.qimpro.com

50. 7.4 Purchasing 7.4.1 Purchasing process • Must ensure that purchased product conforms to specified purchase requirements • Type and extent of control on supplier and purchased product will depend on the effect of the purchased product on subsequent product realization or final product • Must evaluate and select suppliers based on their ability to supply product in accordance requirements Cont… www.qimpro.com