1 - AS/NZS 3905.14:1998 QUALITY SYSTEM GUIDELINES - GUIDE TO AS/NZS ISO 9001, 9002 AND 9003 FOR HEALTH SERVICES
4 - PREFACE
5 - CONTENTS
6 - FOREWORD
7 - GLOSSARY
10 - SCOPE AND APPLICATION OF THIS GUIDE
11 - Introduction
12 - 1 Scope
13 - 2 Normative reference
13 - 3 Definitions
13 - 3.1 product:
13 - 3.2 tender:
13 - 3.3 contract:
14 - 4 Quality system requirements
14 - 4.1 Management responsibility
14 - 4.1.1 Quality policy
14 - 4.1.2 Organization
16 - 4.1.3 Management review
18 - 4.2 Quality system
18 - 4.2.1 General
20 - 4.2.2 Quality system procedures
21 - 4.2.3 Quality planning
23 - 4.3 Contract review
23 - 4.3.1 General
23 - 4.3.2 Review
24 - 4.3.3 Amendment to a contract
24 - 4.3.4 Records
25 - 4.4 Design control
25 - 4.4.1 General
25 - 4.4.2 Design and development planning
25 - 4.4.3 Organizational and technical interfaces
25 - 4.4.4 Design input
25 - 4.4.5 Design output
25 - 4.4.6 Design review
25 - 4.4.7 Design verification
25 - 4.4.8 Design validation
26 - 4.4.9 Design changes
29 - 4.5 Document and data control
29 - 4.5.1 General
30 - 4.5.2 Document and data approval and issue
31 - 4.5.3 Document and data changes
32 - 4.6 Purchasing
32 - 4.6.1 General
32 - 4.6.2 Evaluation of subcontractors
33 - 4.6.3 Purchasing data
34 - 4.6.4 Verification of purchased product
35 - 4.7 Control of customer-supplied product
36 - 4.8 Product identification and traceability
37 - 4.9 Process control
40 - 4.10 Inspection and testing
40 - 4.10.1 General
40 - 4.10.2 Receiving inspection and testing
41 - 4.10.3 In-process inspection and testing
42 - 4.10.4 Final inspection and testing
42 - 4.10.5 Inspection and test records
43 - 4.11Control of inspection, measuring and test equipment
43 - 4.11.1 General
43 - 4.11.2 Control procedure
45 - 4.12 Inspection and test status
46 - 4.13 Control of nonconforming product
46 - 4.13.1 General
47 - 4.13.2 Review and disposition of nonconforming product
48 - 4.14 Corrective and preventive action
48 - 4.14.1 General
48 - 4.14.2 Corrective action
49 - 4.14.3 Preventive action
50 - 4.15 Handling, storage, packaging, preservation and delivery
50 - 4.15.1 General
50 - 4.15.2 Handling
50 - 4.15.3 Storage
50 - 4.15.4 Packaging
50 - 4.15.5 Preservation
50 - 4.15.6 Delivery
52 - 4.16 Control of quality records
54 - 4.17 Internal quality audits
56 - 4.18 Training
57 - 4.19 Servicing
58 - 4.20 Statistical techniques
58 - 4.20.1 Identification of need
58 - 4.20.2 Procedures
59 - APPENDIX A - BRIEF OUTLINE OF A METHOD OF IMPLEMENTATION OF A QUALITY SYSTEM
62 - APPENDIX B - QUALITY AND HEALTH CARE STANDARDS
62 - B1 TERMINOLOGY
62 - B2 QUALITY STANDARDS
64 - B3 MANAGEMENT AND HEALTH CARE STANDARDS