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QMS is the catch phrase for accreditation and is the backbone of ISO/IEC Standard 17025:2005. Accreditation to international standards is becoming the norm in the global analytical community. Although essentially voluntary, there are many jurisdictions that now require food and environmental laboratories to be accredited to ISO/IEC 17025 in order to participate in regulatory programs. Many laboratories struggle with developing and implementing a functional quality management system that not only complies with the management and technical requirements of ISO/IEC 17025:2005 but also meets their own needs and those of their customers. Once accreditation has been achieved many laboratories have difficulty maintaining the QMS as evidenced by the number of non-conformances cited during the subsequent biannual audits. Why do you want to become accredited? Where do you start? For laboratories that are already accredited, how do you ensure staff adherence and ongoing compliance to minimize corrective actions arising from accreditation audits? The Quality System Manual (QSM) is the bible in a QMS environment because, much like its predecessor, Good Laboratory Practice (GLP), it contains the policies that the laboratory is expected to follow to achieve quality results. It is in fact only the “what to do” component of a QMS. What is also needed are the “how to do it” or procedures and methods and finally the controls or evidence that it was done properly.
Michael Brodsky has been an Environmental Microbiologist for more than 47 years. He is a Past President of the Ontario Food Protection Association, the International Association for Food Protection and AOAC International. He serves as co-Chair for the AOAC Expert Review Committee for Microbiology, as a scientific reviewer in Microbiology for the AOAC Official Methods of Analysis and the AOAC Research Institute. He is a reviewer for Standard Methods for the Examination of Water and Wastewater and a chapter co-editor on QA for the Compendium of Methods in Microbiology. He is also a lead auditor/assessor in microbiology for the Canadian Association for Laboratory Accreditation.