Friday, June 12, 2015

New steps forward in Laboratory Quality

Life in PT/EQA has been very busy in the last while for us in CMPT land.  Lots of changes, and all of them good; renewed certification, new contracts, new staff, and importantly a new accreditation.

As a Quality Partner, it is essential for PT providers to be able to demonstrate that they take their own performance and improvement as important as those that they assess.  ISO17043:2010 (Conformity Assessment -  General Requirements for proficiency testing) has become the cornerstone quality standard specifically designed to address the issues of proficiency testing providers, regardless of the communities and disciplines with whom they work.  The standard addresses the full cycle of PT from the planning of challenges through their development and deportment, and the analysis and reporting of results.  Similar to ISO9001 (Quality Management Systems) to which CMPT also adheres, ISO17043:2010 also closely monitors our own Quality Management processes.  Developed by the International Organization for Standardization, and supported by the broad community of countries, ISO17043:2010 is the recognized as the standard of achievement for proficiency testing by accreditation bodies and PT providers around the world.   CMPT is proud of its recognition of meeting all the requirements to this international standard.

In Canada, accreditation or international recognition is not a requirement at any level of government.  By its voluntary participation in this accreditation assessment, CMPT affirms its continued participation in the international community of proficiency testing providers.

CMPT has for more than a decade has been assessed with respect to our Quality Management System and have had it certified as being in compliance with ISO9001:2008 (soon to become :2015).  We started that early one when there were few choices for formal international recognition, and continued it on because 90 percent of our customers (the laboratories that participate in our programs) perceived ISO9001 as a valued marker of our quality and competence.  It is difficult to argue with those levels of support.  But now we have added in a newer level of assessment with much more focus on the technical/operational aspects of what we do. 

In the world of Proficiency Testing and External Quality Assessment, the rise of ISO17043 has been profound.  The document is only in its fifth year, but has been accepted and adopted in countries all around the world.  Indeed PT programs accredited to the standard can be found on every continent (except Antarctica).  It would be fair to say that I am knowledgeable about a few ISO standards as they pertain to Quality and Medical Laboratories.  I find it stunning how quickly and inclusively our extended community has embraced documents like ISO15189 and ISO17025 and ISO17043.  I think it speaks volumes to the commitments to Quality that we see in the Medical Laboratory and Testing Laboratory communities.  We take our Quality seriously. 

It is our goal, at least for the time being to continue to seek both levels of audit and recognition.  I suspect there will be few programs seeking recognition to both ISO9001:2015 AND ISO17043:2010.   But at a certain level it makes sense.  In my experience 17043 is significantly better as a marker of technical/operational interests while 9001 is similarly superior with respect to customer satisfaction and meeting customer needs.  The combination is powerful. 

Medical and water bacteriology laboratories that work with CMPT can have continued confidence in the rigour of our commitment to our own Quality and to the Quality needs of our participants.

PS: To consider another approach to our commitment to Quality for the medical laboratory, please visit:

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