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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

1

AOAC Introduction

1

AOAC Background

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

20

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

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