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    AS/NZS 3905.14:1998

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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    Superseded date:  30-06-2017

    Language(s):  English

    Published date:  01-01-1998

    Publisher:  Standards Australia

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    Table of Contents - (Show below) - (Hide below)

    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

    Abstract - (Show below) - (Hide below)

    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.

    General Product Information - (Show below) - (Hide below)

    Committee QR-002
    Document Type Standard
    Publisher Standards Australia
    Status Superseded
    Superseded By
    Supersedes

    History - (Show below) - (Hide below)

    First published as AS/NZS 3905.14:1998.

    Standards Referenced By This Book - (Show below) - (Hide below)

    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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