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AS
AS/NZS 3905.14:1998

AS/NZS 3905.14:1998

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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Quality system guidelines - Guide to AS/NZS ISO 9001, 9002 and 9003 for health services

Available format(s)

Hardcopy , PDF 1 User , PDF 3 Users , PDF 5 Users , PDF 9 Users

Superseded date

30-06-2017

Superseded by

HB 90.8-2000

Language(s)

English

Published date

01-01-1998

Publisher

Standards Australia

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Hardcopy - English
PDF 1 User - English
PDF 3 Users - English
PDF 5 Users - English
PDF 9 Users - English
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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

Provides guidance to organizations that provide health services, and to those involved in the health services sector, on the development and implementation of a quality system based on AS/NZS ISO 9001:1994 (or 9002 or 9003). The application of each requirement is described in terms relevant to health services, and typical examples are included to assist in understanding these requirements.

Committee
QR-002
DocumentType
Standard
ISBN
0 7337 2198 2
Pages
55
PublisherName
Standards Australia
Status
Superseded
SupersededBy
Supersedes

First published as AS/NZS 3905.14:1998.

AS/NZS ISO 8402:1994 Quality management and quality assurance - Vocabulary
AS/NZS ISO 9002:1994 Quality systems - Model for quality assurance in production, installation and servicing
AS/NZS 4804:1997 Occupational health and safety management systems - General guidelines on principles, systems and supporting techniques
AS/NZS ISO 9000.1:1994 Quality management and quality assurance standards Guidelines for selection and use
AS 4390.2-1996 Records management - Responsibilities
AS/NZS 4444:1996 Information security management
AS 4390.3-1996 Records management - Strategies
AS 4421-1996 Guards and patrols
AS 4390.1-1996 Records management - General
AS/NZS ISO 9001:1994 Quality systems - Model for quality assurance in design, development, production, installation and servicing
AS 4083-1992 Emergency responses for health care facilities
AS 4485.2-1997 Security for health care facilities - Procedures guide
AS/NZS ISO 9000.2:1998 Quality management and quality assurance Standards Generic guidelines for the application of ISO 9001, ISO 9002 and ISO 9003
AS/NZS 3816:1998 Management of clinical and related wastes
AS/NZS ISO 9004.1:1994 Quality management and quality system elements Guidelines
AS/NZS 3905.3:1994 Quality system guidelines - Guide for the hospitality industry
AS 4400-1995 Personal privacy protection in health care information systems
AS/NZS 3551:1996 Technical management programs for medical devices
AS/NZS 4360:1999 Risk management
AS 4187-1998 Cleaning, disinfecting and sterilizing reusable medical and surgical instruments and equipment, and maintenance of associated environments in health care facilities
AS 4390.6-1996 Records management - Storage
AS 4146-1994 Laundry practice
AS 4390.5-1996 Records management - Appraisal and disposal
AS/NZS 3009:1998 Electrical installations - Emergency power supplies in hospitals
AS 4485.1-1997 Security for health care facilities - General requirements 1
AS/NZS ISO 9003:1994 Quality systems - Model for quality assurance in final inspection and test
AS 4390.4-1996 Records management - Control
AS 3745-1995 Emergency control organization and procedures for buildings
AS/NZS ISO 10013:1996 Guidelines for developing quality manuals

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