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Sunday, March 6, 2011

Preparing for ISO inspection - continued


As mentioned previously, CMPT is heading for its re-certification to ISO 9001:2008.  This is the continuation of a process that has become pretty much a tradition since 2004.  As mentioned before, this has pretty much become a win-win situation.  CMPT has found that the process has lead to error reduction, more consistent practices, and strong evidence of customer satisfaction, as demonstrated by our recent survey.  Eighty-six percent of responders report that certification increases their confidence in our program and 90% report that certification increases our value.
This is a good example of what Boiral and Amara would define as effective certification (see QMJ V16 N3, 2009).

As I spent some time re-reading their manuscript it got me to thinking about laboratories and accreditation.  I understand that Boiral and Amara did not look at accreditation and that in Canada, most laboratories have mandated accreditation rather than voluntary certification, but the concept of external evaluation underlies both.

My personal experience with laboratory accreditation is that the following are probably all true for many (most?) medical laboratories in North America:
A - Most laboratories have not developed or sustained a Non-conformity Events (NCE) or Critical Incident (CI) program,  and thus they can not document that the accreditation process has resulted in error reduction.
B - Many laboratories have increased the bureaucratic procedures of quality on an irregularly irregular frequency, and thus can not document that the accreditation process has resulted in sustained quality.  
C - Most laboratories do not monitor customer satisfaction or complaints on any sort of a regular basis and thus they can not document that the accreditation process has resulted in an increase in satisfaction. 
By the classification of the aforementioned paper, this would be defined as ineffective.

So if I am right, why has the experience been so successful for my laboratory and less so for many others.  A few variables come to mind.  First and foremost, we got into the process on a voluntary basis because we saw an opportunity for customer satisfaction improvement.  Once we got started we saw that implementation lead to improved quality processes (planning, and studying results and implementing for improvement).
Second, because we are a small (very small) organization, we were all able to see that improvements had a direct impact on everyone’s work load and work satisfaction level.  Certification led to the establishment of a sustainable Culture of Quality.  
Third, because we received positive vibes from the process we were able to develop a positive working relationship with our Quality Partners.  
Fourth, through the better relationships with our clients and our improved procedures we were able to develop a sustained reduction in costs of poor quality and improved financial health.  

This is pretty consistent with what the authors wrote: “This study supports the fact that it is not so much the standard or the moment of implementation that has a positive impact on performance, but rather the way [it] is implemented, what the standard represents for respondents, and above all, the reasons explaining its adoption.”

So is this a testable hypothesis, or am I just feeling pumped as we get ready for another visit?

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