Assuring quality and competence

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Contents

SECTION I – GENERAL

Preface
Contributors
Definitions

SECTION II – CLAUSES

Introduction to Clauses 4 and 5
Introduction to the Quality Manual
Clause 4 Management Requirements
4.1 Organization and Management Responsibility
4.2 Quality Management System
4.3 Document Control
4.4 Service Agreements
4.5 Examination by Referral Laboratories
4.6 External Services and Supplies
4.7 Advisory Services
4.8 Resolution of Complaints
4.9 Identification and Control of Nonconformities
4.10-11 Corrective Action and Preventive Action
4.12 Continual Improvement
4.13 Control of Records
4.14 Evaluation and Audits
4.15 Management Review
Clause 5 Technical Requirements
5.1 Personnel
5.2 Accommodation and Environmental Conditions
5.3 Laboratory Equipment, Reagents, and Consumables
5.4 Pre-examination Processes
5.5 Examination Processes
5.6 Ensuring Quality of Examination Results
5.7 Post-examination Processes
5.8 Reporting of Results
5.9 Release of Results
5.10 Laboratory Information Management

SECTION III – APPENDICES

Laboratory Biosafety Manual
List of Abbreviations
Bibliography
Acknowledgments
Resources
Index