OMB Winter Mtg.-February 5-6, 2015

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Draft 6. Note: This document is a draft suggestion only and is not an approved document. Please do not distribute to laboratory staff for use.

Table of Contents

Acknowledgments AOAC Introduction AOAC Background

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1 General Requirements for the Competence of Testing and Calibration Laboratories 2 1. Scope 2 2. Normative References 3 3. Terms and Definitions 3 4. Management Requirements 4 4.1 Organization 4 4.2 Management System 4 4.6 Purchasing Services and Supplies 4 4.8 Complaints and Out of Spec Results 4.13 Control of Records 5 4.14 Internal Audits 6 4.15 Management Reviews 6 5. Technical Requirements 6 5.2 Personnel 6 5.3 Accommodation and Environmental Conditions 7 5.4 Test and Calibration Methods and Method Validation 7 5.5 Equipment 8 5.6 Measurement Traceability 9 5.7 Sampling and Sub-Sampling 9 5.8 Handling of Test Items 10 5.9 Ensuring the Quality of Test and Calibration Results 10 5.10 Reporting the Results 15

Appendix A: Equipment 16 Appendix B: Microbiology

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Appendix C: Chemistry Appendix D: Pharmaceutical Analysis and Legal Standards 21 Appendix E: Legal samples Pages numbers listed in the table of contents need fixed