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Table of ContentsPREFACE
CHAPTER 1 : MANAGEMENT RESPONSIBILITY
1. Define and document a quality policy, and ensure that the policy is understood and implemented by all personnel at all levels.
2. Define and document the responsibility, authority, and interrelation of key personnel who manage, perform, and verify work affecting quality.
3. Provide adequate resources for implementing and maintaining the quality system.
4. Appoint a management representative for ISO 9000, and define his or her authority.
5. Conduct scheduled management reviews of the quality system.
CHAPTER 2 : QUALITY SYSTEM
6. Develop a quality manual defining the policies, scope and structure of the quality system.
7. Develop documented procedures instructing how to carry out activities comprising the quality system.
8. Implement the documented quality system.
9. Define in a quality plan how requirements for quality are achieved and verified.)
CHAPTER 3 : CONTRACT REVIEW
10. Review contracts and orders to ensure that customer requirements are clearly defined and any differences and ambiguities are resolved.
11. Verify the capability and capacity to meet contract or order requirements.
12. Define and document how amendments to contracts are made and how changes are communicated to functions concerned.
CHAPTER 4 : DESIGN CONTROL (does not apply to ISO 9002)
13. Plan design activities, define organizational and technical interfaces, and assign qualified personnel.
14. Identify, document, and review the design input.
15. Document the design output so that it can be verified against design input requirements, and specify acceptance criteria.
16. Review and approve design output documents before release.
17. Plan and conduct formal design reviews for each phase of the design.
18. Verify design at appropriate stages to ensure that the design-stage output meets the design-stage input requirements.
19. Validate the design to ensure that product conforms to defined user needs and requirements.
20. Identify, document, review and approve design changes.
CHAPTER 5 : DOCUMENT AND DATA CONTROL
21. Establish a document control system and define the types of controlled documents.
22. Review and approve documents prior to issue.
23. Identify documents with their revision level, and maintain a master list with current revision status of documents.
24. Ensure that current documents are available at all locations where they are needed.
25. Remove obsolete documents from points of use and identify retained historical copies of obsolete documents to prevent unintended use.
26. Review and approve changes in documents and authorize reissues of revised documents.
27. At distribution, highlight changes in revised documents. (In subsequent chapters specific requirements are not listed for lack of space)
CHAPTER 6 : PURCHASING
CHAPTER 7 : CONTROL OF CUSTOMER SUPPLIED PRODUCT
CHAPTER 8 : PRODUCT IDENTIFICATION AND TRACEABILITY
CHAPTER 9 : PROCESS CONTROL
CHAPTER 10 : INSPECTION AND TESTING
CHAPTER 11 : CONTROL OF INSPECTION, MEASURING AND TEST EQUIPMENT
CHAPTER 12 : INSPECTION AND TEST STATUS
CHAPTER 13 : CONTROL OF NONCONFORMING PRODUCT
CHAPTER 14 : CORRECTIVE AND PREVENTIVE ACTION
CHAPTER 15 : HANDLING, STORAGE, PACKAGING, PRESERVATION AND DELIVERY
CHAPTER 16 : CONTROL OF QUALITY RECORDS
CHAPTER 17 : INTERNAL QUALITY AUDITS
CHAPTER 18 : TRAINING
CHAPTER 19 : SERVICING
CHAPTER 20 : STATISTICAL TECHNIQUES
APPENDIX : List of required documents and records