AOAC INTERNATIONAL Guidelines for Laboratories Performing Microbiological and Chemical Analyses of Food and Pharmaceuticals
An Aid to Interpretation of ISO/IEC 17025:2005
A Revision of the ALACC Criteria
Prepared by the
Analytical Laboratory of Accreditation Criteria Committee
of AOAC INTERNATIONAL
Revised March 2010
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
Copyright @ 2010 by AOAC INTERNATIONAL. Softbound.
ISBN 0-935584-81-1.
Stock No. 11543.
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