AS/NZS 3905.14:1998
Quality system guidelines - Guide to AS/NZS ISO 9001, 9002 and 9003 for health services
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.
| Get this standard | Prices exclude GST | |
|---|---|---|
| PDF ( Single user document) |
$155.70 NZD
|
|
| HardCopy |
$173.00 NZD
|
|
| Networkable PDF |
Price varies
|
|
| Online Library ( Annual subscription) |
Info
Price varies
Online Library subscription information Online library subscriptions provide a cost-effective solution for organisations of any size to access the latest standards, offering 24/7 access to a personalised catalogue. The service ensures subscribers have have the most up-to-date version of selected standards, incluing automatic updates for any amendments or versions. Pricing is dependent on the chosen standards and the number of concurrent users, with discounts applied from the standards PDF price. For customised subscriptions or further inquiries, contact the Online Library team. |
AS/NZS 3905.14:1998 QUALITY SYSTEM GUIDELINES - GUIDE TO AS/NZS ISO 9001, 9002 AND 9003 FOR HEALTH SERVICES
PREFACE
CONTENTS
FOREWORD
GLOSSARY
SCOPE AND APPLICATION OF THIS GUIDE
Introduction
1 Scope
2 Normative reference
3 Definitions
3.1 product:
3.2 tender:
3.3 contract:
4 Quality system requirements
4.1 Management responsibility
4.1.1 Quality policy
4.1.2 Organization
4.1.3 Management review
4.2 Quality system
4.2.1 General
4.2.2 Quality system procedures
4.2.3 Quality planning
4.3 Contract review
4.3.1 General
4.3.2 Review
4.3.3 Amendment to a contract
4.3.4 Records
4.4 Design control
4.4.1 General
4.4.2 Design and development planning
4.4.3 Organizational and technical interfaces
4.4.4 Design input
4.4.5 Design output
4.4.6 Design review
4.4.7 Design verification
4.4.8 Design validation
4.4.9 Design changes
4.5 Document and data control
4.5.1 General
4.5.2 Document and data approval and issue
4.5.3 Document and data changes
4.6 Purchasing
4.6.1 General
4.6.2 Evaluation of subcontractors
4.6.3 Purchasing data
4.6.4 Verification of purchased product
4.7 Control of customer-supplied product
4.8 Product identification and traceability
4.9 Process control
4.10 Inspection and testing
4.10.1 General
4.10.2 Receiving inspection and testing
4.10.3 In-process inspection and testing
4.10.4 Final inspection and testing
4.10.5 Inspection and test records
4.11Control of inspection, measuring and test equipment
4.11.1 General
4.11.2 Control procedure
4.12 Inspection and test status
4.13 Control of nonconforming product
4.13.1 General
4.13.2 Review and disposition of nonconforming product
4.14 Corrective and preventive action
4.14.1 General
4.14.2 Corrective action
4.14.3 Preventive action
4.15 Handling, storage, packaging, preservation and delivery
4.15.1 General
4.15.2 Handling
4.15.3 Storage
4.15.4 Packaging
4.15.5 Preservation
4.15.6 Delivery
4.16 Control of quality records
4.17 Internal quality audits
4.18 Training
4.19 Servicing
4.20 Statistical techniques
4.20.1 Identification of need
4.20.2 Procedures
APPENDIX A - BRIEF OUTLINE OF A METHOD OF IMPLEMENTATION OF A QUALITY SYSTEM
APPENDIX B - QUALITY AND HEALTH CARE STANDARDS
B1 TERMINOLOGY
B2 QUALITY STANDARDS
B3 MANAGEMENT AND HEALTH CARE STANDARDS
Keep me up-to-date
Sign up to receive updates when there are changes to this standard
Related Information
Similar Standards
-
AS/NZS 10002:2014
Guidelines for complaint management in organizations
-
AS/NZS 2500:2020
Safe use of medical electrical equipment in health care -
AS/NZS 3200.1.8:2005
Medical electrical equipment - Part 1.8: General requirements for safety - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems -
AS/NZS 3551:2012
Management programs for medical equipment
AS/NZS 3905.14:1998 QUALITY SYSTEM GUIDELINES - GUIDE TO AS/NZS ISO 9001, 9002 AND 9003 FOR HEALTH SERVICES
PREFACE
CONTENTS
FOREWORD
GLOSSARY
SCOPE AND APPLICATION OF THIS GUIDE
Introduction
1 Scope
2 Normative reference
3 Definitions
3.1 product:
3.2 tender:
3.3 contract:
4 Quality system requirements
4.1 Management responsibility
4.1.1 Quality policy
4.1.2 Organization
4.1.3 Management review
4.2 Quality system
4.2.1 General
4.2.2 Quality system procedures
4.2.3 Quality planning
4.3 Contract review
4.3.1 General
4.3.2 Review
4.3.3 Amendment to a contract
4.3.4 Records
4.4 Design control
4.4.1 General
4.4.2 Design and development planning
4.4.3 Organizational and technical interfaces
4.4.4 Design input
4.4.5 Design output
4.4.6 Design review
4.4.7 Design verification
4.4.8 Design validation
4.4.9 Design changes
4.5 Document and data control
4.5.1 General
4.5.2 Document and data approval and issue
4.5.3 Document and data changes
4.6 Purchasing
4.6.1 General
4.6.2 Evaluation of subcontractors
4.6.3 Purchasing data
4.6.4 Verification of purchased product
4.7 Control of customer-supplied product
4.8 Product identification and traceability
4.9 Process control
4.10 Inspection and testing
4.10.1 General
4.10.2 Receiving inspection and testing
4.10.3 In-process inspection and testing
4.10.4 Final inspection and testing
4.10.5 Inspection and test records
4.11Control of inspection, measuring and test equipment
4.11.1 General
4.11.2 Control procedure
4.12 Inspection and test status
4.13 Control of nonconforming product
4.13.1 General
4.13.2 Review and disposition of nonconforming product
4.14 Corrective and preventive action
4.14.1 General
4.14.2 Corrective action
4.14.3 Preventive action
4.15 Handling, storage, packaging, preservation and delivery
4.15.1 General
4.15.2 Handling
4.15.3 Storage
4.15.4 Packaging
4.15.5 Preservation
4.15.6 Delivery
4.16 Control of quality records
4.17 Internal quality audits
4.18 Training
4.19 Servicing
4.20 Statistical techniques
4.20.1 Identification of need
4.20.2 Procedures
APPENDIX A - BRIEF OUTLINE OF A METHOD OF IMPLEMENTATION OF A QUALITY SYSTEM
APPENDIX B - QUALITY AND HEALTH CARE STANDARDS
B1 TERMINOLOGY
B2 QUALITY STANDARDS
B3 MANAGEMENT AND HEALTH CARE STANDARDS
AS/NZS 3905.14:1998
Online Library subscription information
Online library subscriptions provide a cost-effective solution for organisations of any size to access the latest standards, offering 24/7 access to a personalised catalogue. The service ensures subscribers have have the most up-to-date version of selected standards, incluing automatic updates for any amendments or versions. Pricing is dependent on the chosen standards and the number of concurrent users, with discounts applied from the standards PDF price. For customised subscriptions or further inquiries, contact the Online Library team.