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Section
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Contents
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i
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Title Page
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ii
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Quality Manual Release Authorization
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iii
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Amendment Sheet
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iv
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Contents
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1
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Scope
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2
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References to other documents
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3
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Terms and Definitions
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3.1
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Definitions
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3.2
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Abbreviations
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3.3
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Distribution List
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4
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MANAGEMENT REQUIREMENTS
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4.1
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Organization and Management Responsibility
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4.2
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Quality Management System
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4.3
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Document Control
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4.4
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Service Agreements
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4.5
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Examination by Referral Laboratories
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4.6
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External Services and Supplies
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4.7
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Advisory Services
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4.8
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Resolution of Complaints
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4.9
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Identification and Control of Non Conformities
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4.10
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Corrective Action
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4.11
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Preventive Action
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4.12
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Continual Improvement
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4.13
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Control of Records
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4.14
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Evaluation and Audits
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4.15
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Management Review
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5
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TECHNICAL REQUIREMENTS
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5.1
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Personnel
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5.2
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Accommodation and Environmental Conditions
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5.3
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Laboratory Equipment, Reagents and Consumables
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5.4
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Pre-examination Processes
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5.5
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Examination Processes
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5.6
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Ensuring Quality of Examination Results
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5.7
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Post-examination Processes
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5.8
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Reporting of Results
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5.9
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Release of Results
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5.10
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Laboratory Information Management
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