Accreditation for Microbiological Laboratories

1 Accreditation for Microbiological Laboratories Second Edition 2013 Accreditation for Microbiological Laboratories Eurachem Guide AML 2013 Page i Acknowledgements This document has been produced primarily by an ad hoc Eurachem Working Group in collaboration with the EA (European co-operation for Accreditation ) Laboratory Committee. The editors are grateful to all these individuals and organisations, and to others who have contributed comments, advice and assistance. Accreditation for Microbiological Laboratories Second edition This document has been produced by Eurachem.

2 It provides Microbiological Laboratories with appropriate information and guidance on how to be prepared in order to fulfil the requirements of ISO/IEC 17025. Editors Mary Eleftheriadou, European University Cyprus Kyriacos C. Tsimillis, Cyprus Accreditation Body Composition of the ad hoc Working Group M. Eleftheriadou, European University Cyprus K. C. Tsimillis, Cyprus Accreditation Body G. T. Papageorgiou, State General Laboratory, Cyprus N. Pissarides, State General Laboratory, Cyprus A. Varnava-Tello, State General Laboratory, Cyprus Recommended citation This guidance should be cited* as M. Eleftheriadou and K. C. Tsimillis (Eds), Eurachem guide: Accreditation for Microbiological Laboratories , Second edition (2013), ISBN: 978-91-87017-92-6.

3 Available from *Subject to journal requirements Accreditation for Microbiological Laboratories Eurachem Guide AML 2013 Page iii Accreditation for Microbiological Laboratories English edition Second edition 2013 ISBN: 978-91-87017-92-6. Copyright 2013 Enquiries regarding the translation, and production and distribution of new editions of this document should be directed to the Eurachem secretariat. The text may not be copied for resale. Accreditation for Microbiological Laboratories Eurachem Guide AML 2013 Page iv CONTENTS 1 Introduction and scope of the document.

4 1 2 Standards for Accreditation of Microbiological Laboratories .. 2 3 Personnel .. 2 4 Environment .. 3 Premises .. 3 environmental 4 Hygiene .. 4 5 Validation and Verification of test methods .. 5 Selection of test methods .. 5 Validation .. 5 Verification .. 5 6 Uncertainty of measurement .. 6 7 Equipment maintenance, calibration and performance verification .. 7 Maintenance .. 7 Calibration and performance verification .. 7 Temperature measurement devices .. 7 Incubators, water baths, ovens .. 7 Autoclaves, including media preparators .. 7 Weights and balances .. 8 Volumetric equipment .. 8 Thermal cyclers .. 8 Other equipment .. 8 8 Reagents and culture media .. 9 Reagents .. 9 In-house prepared media .. 9 Ready-to -use -media.

5 9 Labelling .. 10 9 Reference materials and reference cultures .. 11 Reference materials .. 11 Reference cultures .. 11 10 Sampling .. 12 11 Sample handling and identification .. 13 12 Disposal of contaminated waste .. 13 13 Quality assurance of results/quality control of performance .. 14 Internal quality control .. 14 External quality assessment (proficiency testing) .. 14 14 Test reports .. 15 Appendix A Glossary of terms .. 16 Appendix B General use of reference cultures .. 18 Appendix C Guidance on calibration and calibration checks .. 19 Appendix D Guidance on equipment validation and verification of performance .. 20 Appendix E Guidance on maintenance of equipment .. 22 References .. 23 Accreditation for Microbiological Laboratories Eurachem Guide AML 2013 Page v Accreditation for Microbiological Laboratories Eurachem Guide AML 2013 Page 1 1 Introduction and scope of the document The general requirements for Accreditation are laid down in the International Standard General requirements for the competence of testing and calibration Laboratories (ISO/IEC 17025 2nd Ed.)

6 , 2005), hereafter referred to as ISO/IEC 17025 [1]. All of these requirements must be met by Laboratories seeking Accreditation . This guide provides Laboratories carrying out Microbiological testing with appropriate information on how to fulfil the requirements of ISO/IEC 17025, giving detailed guidance on such requirements for those undertaking the examination of materials, products and substances. The guidance is applicable to the performance of all objective measurements, whether routine, non-routine, or as part of research and development. Although this guide is written primarily for food, water and environmental Microbiological testing, the general principles may be ap plied to other areas. Furthermore, it may also be of use in medical Laboratories where ISO 15189 [2] applies, as well as in R&D Laboratories .

7 ISO/IEC 17025 remains the authoritative document and, in cases of dispute, Accreditation bodies will adjudicate on unresolved matters. However, attention should be paid to additional requirements regarding Microbiological tests in the medical field, safety requirements, specimen handling, personnel qualifications. The guidance given in this document may also be of use to those working towards registration under other quality standards such as GLP (Good Laboratory Practice [3 ]) , GMP (Good Manufacturing Practice [4], and GCP (Good Clinical Practice [5]) . This guide can be considered as a guidance document for Microbiological testing as set out in Annex B of ISO/IEC 17025, taking into account EA MLA (EA Multilateral Agreement) requirements.)

8 It has been produced by Eurachem in collaboration with EA LC (EA Laboratory Committee) as a means to facilitate Microbiological Laboratories in com ply ing with Accreditation requirements through a better understanding of the provisions of both the Accreditation standards and specific sectorial standards as applicable. Microbiological testing is taken to include sterility testing, detection, isolation, enumeration and identification of micro-organisms (viruses, bacteria, fungi and protozoa) and their metabolites in different materials and products, or any kind of assay using micro-organisms as part of a detection system as well as the use of micro-organisms for ecological testing. It follows that some of the guidance given, such as on laboratory environment, will need to be interpreted accordingly.

9 This document can also provide guidance to Laboratories using techniques in areas related to microbiology, such as biochemistry, molecular biology and c ell culture, although there may be additional requirements for such Laboratories . This guide is concerned with the quality of test results and is not specifically concerned with health and safety matters. However, laboratory practices should conform to national health and safety regulations. It is important to note that in some cases health and safety issues may have an effect on the quality of testing and the laboratory will be required to take this into account. Th is version of the guide takes into consideration recent trends in microbiology, real time PCR (polymerase chain reaction) techniques for the detection of micro-organisms.

10 Molecular methods are, nowadays, very important in Microbiological analyses, either as confirmation/identification steps, or as alternative detection methods. Definitions of the terms used are given in Appendix A. Accreditation for Microbiological Laboratories Eurachem Guide AML 2013 Page 2 2 Standards for Accreditation of Microbiological Laboratories Main Standards used for laboratory Accreditation ISO/IEC 17025, General requirements for the competence of testing and calibration Laboratories [1] ISO 15189, Medical Laboratories R equirements for quality and competence [2] Terminology ISO 9000, Quality management systems Fundamentals and vocabulary [6] ISO/IEC Guide 99, International vocabulary of metrology Basic and general concepts and associated terms (VIM 3)