Congratulations to us. Our proficiency testing program as been internationally assessed and again our quality management program was recertified as in compliance with ISO 9001:2008. This makes for 11 consecutive years. For 10 of these 11 assessments (including this year) we were found to have no non-conformances. There were two minor opportunities for improvement, both of which we were able to address on the spot. We are pretty pleased with our accomplishment. And when we last checked with our laboratory customers. As mentioned previously near 90 percent of survey responders said that our meeting the standard demonstrated a commitment to quality and increased our credibility. So that makes a win-win for us and our customers.
In conversation, some suggest that the problem with our standard is that while it makes comment on our paperwork, it doesn’t prove that we are actually competent. They say that a 9001 assessment does not speak to competency assessment. They say that only an accreditation body can do make that judgement, to which I say “horse feathers!”. Actually I usually say a lot more than that, but for purposes of keeping this web journal at an appropriate level of professionalism and decorum, I will leave it as “horse feathers”.
We as comfortable with our recognition as are our customers.
I know there is another standard for proficiency testing programs entitled ISO 17043:2010 Conformity assessment -- General requirements for proficiency testing. It is an excellent standard, one for which I participated in the development. And one day we will probably look at it. The document shares with 9001 the intent to help assure other organizations that the assessed program is competent with Quality being the prime objective. That is a laudable goal. My concern is not in either document, but is in the people doing the assessment. I don’t have a lot of confidence that many assessment bodies have either the knowledge or experience to do a proper accreditation audit.
The body that audits us every year for the last 11 years knows us, knows what we do, and knows our strengths and areas in which we can improve. We have gone through this experience together and have mutually learned during the past decade. We have worked with three different assessors from the company, and while each was a different person with individual personality and traits, over the years and we have found a consistency in their approach to our assessment. We understand that we are not their only client and that they are not our coach or mentor. But we understand them and they seem to understand our operation.
Certification bodies must have hundreds if not thousands of organizations wanting to be assessed to ISO 9001:2008, and they all get tons of opportunity and experience. They know and understand the conventions of standard interpretation. They understand and appreciate the subtleties and nuances. They also know how to put context to the document. They know it, they eat and breathe it. Put simply, they know what they are doing, and they do it well.
On the other hand, there are very few proficiency testing programs in the world, and there are likely far more accreditation bodies than there are proficiency testing providers. It is doubtful that any single accreditation body has done more than one or two (maybe 3) assessments to ISO17043. It is doubtful that many of them have had the opportunity to learn and understand the nuances of the requirements of the standard, and for certain they are not in the position to appreciate the differences or subtleties of different organizations. Getting assessed in that sort of situation increases the risk of individual interpretation, and that in my mind is a lot at risk, indeed too much risk for too little reward. Frankly I would rather let them learn on other people and hone some understanding before letting then come to us.
Its kind of like having a choice between a surgeon who done a procedure a hundred times, one that read about it.
Congratulations on your continued re-certification. You continue to not only talk the talk but walk the walk.ReplyDelete
Manager, Accreditation and Research Development
Diagnostic Accreditation Program of BC
Jorge de Sá Peliteiro
Quality Management Lead Auditor
= Portugal =
Many thanks all.ReplyDelete
We are already starting to look at some changes before next year. Will write on these soon.