AOAC INTERNATIONAL Guidelines for Laboratories Performing Microbiological and Chemical Analyses of Food and Pharmaceuticals - Revised 2010 Edition - An Aid to Interpretation of ISO/IEC 17025:2005

AOAC INTERNATIONAL Guidelines for Laboratories Performing Microbiological and Chemical Analyses of Food and Pharmaceuticals, An Aid to Interpretation of ISO/IEC 17025:2005 provides detailed criteria to aid in assessing the essential requirements for performing these types of analyses. This document closely follows ISO/IEC 17025 and provides a section-by-section interpretation of the general ISO/IEC 17025 requirements. Contents Acknowledgements ISO 17025 Foreward ISO 17025 Introduction AOAC Introduction AOAC Background General Requirements for the Competence of Testing and Calibration Laboratories 1. Scope 2. Normative References 3. Terms and Condtions 4. Management Requirements 4.1 Organization 4.2 Management Systems 4.3 Document Control 4.4 Review of Requests, Tenders and Contracts 4.5 Subcontracting of Tests and Calibrations 4.6 Purchasing Services and Supplies 4.7 Service to the Customer 4.8 Complaints 4.9 Control of Nonconforming Testing and/or Calibration Work 4.10 Improvement 4.11 Corrective Action 4.12 Preventative Action 4.13 Control of Records 4.14 Internal Audits 4.15 Management Reviews 5. Technical Requirements 5.1 General 5.2 Personnel 5.3 Accommodation and Environmental Conditions 5.4 Test and Calibration Methods and Method Validation 5.5 Equipment 5.6 Measurement Traceability 5.7 Sampling 5.8 Handling of Test and Calibration Items 5.9 Ensuring the Quality of Test and Calibration Results 5.10 Reporting the Results Annex A: (Informative) Nominal Cross-References to ISO 9001:2000 Annex B: (Informative) Guidelines for Establishing Applications for Specific Fields Appendix A: Equipment Appendix B: Food Microbiology 1. Organisms and Certified Reference Materials 2. Media 3. Reagents/Kits/Identification Systems 4. Autoclave Sterilization 5. Other Means of Sterilization and Decontamination 6. Standards for Laboratory Grade Water Appendix C: Pharmaceutical Analysis and Legal Standards Bibliogaphy