Wednesday, February 23, 2011

Preparing for ISO inspection

It is commonly said that when your quality management system is in place it doesn’t matter when the assessment visit occurs because you are always ready.  I’ve been at this game for a long time and I have to say that to date we have never achieved that level of perfection.  Indeed I suspect that this is one of those statements that if you are feeling generous you call hyperbole or overstatement.  If you are in a sour mood words like B*** S*** come to mind. Today I am somewhere in the benign middle and focus on it as a statement of aspiration.

What having a good quality system in place does do is reduce both the stress and the time frame for visit preparedness.  

I have mentioned before that our proficiency testing program (Clinical Microbiology Proficiency Testing program or CMPT) is annually assessed against ISO9001:2008 Quality Systems.  This is a Certification process, not an accreditation process (ISO17043:2010 is the accreditation option), although in my experience it is difficult to distinguish between the two in a real life exercise.  But I digress.  This is a big deal issue in the Quality arena, and will come back to again at some time.

Our site visit will be in April and I am putting the finishing touches on my Management Review cycle.  Today I was reviewing our Opportunities For Improvement program.  CMPT is a small program and so we can combine our non-conforming events record with our OFI program.  The NCE record is a small group of one-off events, either clerical or technical.  It would be easy in a pre-Quality era to write them off as “not a big deal”.  But for a proficiency testing program they are all indeed potentially a very big deal.  When we make a slip, a laboratory or maybe a group of laboratories can have an event that can impact on their quality process.  If we don’t take that seriously, then how can we expect laboratories to take us and quality assessment and indeed maybe even  quality management seriously.  Not to be too over the top, medical laboratories have a long history and tradition of not taking quality management too seriously.  

Perhaps my taking our Management Review more seriously is one small way that we can impact and improve medical laboratory care, at least in our little corner of the world.  

In a related note as part of our spring time customer survey we queried laboratorian believe about accreditation and quality partners.  Very early results, 95% of respondents believe that strongly or generally believe that accreditation bodies should in themselves undergo an oversight evaluation (accreditation, certification).  100% believe the same about proficiency testing providers and equipment/reagent suppliers.   About 90% believe that CMPT’s voluntary participation in oversight increases their confidence in our program and increases our value.
The survey will run for a few more weeks, and the values will undoubtedly tighten.

More on this later.

I have not talked about our POLQM Quality Weekend Workshop recently.  Today we putting the final touches on an additional breakout session.  We will be announcing it next week.  We have started to receive paid registrations, and more inquiries.  I am looking forward to a good crowd.


  1. "Not to be too over the top, medical laboratories have a long history and tradition of not taking quality management too seriously"....

    (takes a deep breath...)

    "Quality Management" (IMHO) is seen to be all about making sure trivial paperwork is completed in the right colour ink.

    Were those who tout the "Quality Management" honest and called the thing "trivial paperwork" then I would take the subject more seriously. But from my thirty years of experience in medical laboratories, "Quality Management" is something that gets in the way of providing high quality blood test results.

    It should not be that way. Would that "Quality Management" actually benefitted me professionally, rather than hindered me...
    (Going to lie down now!!)

  2. In one respect I can understand the point of view. For too long medical laboratories' view of quality was largely about Red Pens and no White Out allowed.
    But that is not Quality Management.

    On the other hand we have had decades of "My lab does high quality work. Trust me, trust me."

    Sorry Manky, but the public is less inclined to trust you any more, unless you can demonstrate that your quality is intact.

    Managing your Quality is the only way that laboratories can demonstrate their excellence and monitor their continual improvement.

  3. I have done a lot of reading on ISO, CLSI, and Quality Management in general over the last few weeks. In one of my readings (and it may have been "Quality Without Tears" by Crosby - but don't quote me on it as everything is starting to run together) I have come across the well known proverb:
    "if you talk the talk, then walk the walk"
    Why would proficiency testing be any different? If they believe so much in their 'product' and the theory behind it, then wouldn't it stand to reason to also be either accredited or certified??? - Just a thought.

  4. First, I congratulate you on your reading list. You are no doubt well along the way to becoming a well informed qualitologist.

    I absolutely agree with you. Indeed I would go one step further. I personally think that of all the Quality Partners, Accreditation Bodies and Proficiency Testing Providers have a double obligation to undergo oversight on a regular basis. To avoid oversight especially for these two groups in essence says "Do as I say, not as I do". To avoid oversight demonstrates, again in my opinion, incredible arrogance.
    That is why we undergo external assessment annually.

    In Canada we are allowed a certain flexibility as to how we have our oversight performed because there is no mandated requirement. We use ISO9001:2008 because we find it exacting and our assessor competent. Another organization uses the new ISO document 17943:2010 which is another excellent choice. We are considering adding the new assessment as well. Both are broadly based and internationally sound.

    Our survey is at:

    Any one from any laboratory is invited to respond to the survey. Multiple responses from an individual laboratory are acceptable. In this survey we are more interested in people's opinion than in institutional opinion.

    Again, as the data comes in, we will comment further.

  5. I agree entirely with your sentiment - but re-read this article. Or any article about "Laboratory Quality". It's all about satisfying legislations.

    Where does the actual and tangible improvement in laboratory results come into the equation?

  6. I call that a healthy libertarian streak.
    When a good idea becomes adopted by regulators, I agree that it can get complicated, but the underlying theme is still a good idea.

    Quality Management is based on principles introduced now close to 100 years ago based on defining what constitutes error, monitoring for error, sorting out the reasons for the error and correcting them. and then repeat and repeat. And make a record so that you remember which problems have occurred and how you have addressed them.
    Pretty simple stuff. And that is where the quality improvement takes place.

    Unfortunately lots of evidence to support that many medical laboratories around the world never actually bother to check for error.

    If you regularly do, that is great.
    Then the public has less to worry about. If you don't then this is a good way to begin.

    Accreditation, Proficiency, Continuing Education are partners whose mission it is to help laboratories go through the process of continual improvement.

    Litigators, and the media are the partners whose mission it is to remind you of the consequences of ignoring continual improvement.

  7. Manky this is exactly how many of us felt in 2003 when mandatory accreditation was introduced in the province of Ontario. We were already good analytical laboratories with decades of proven efficient quality control and a world class external quality assessment program, so why did we needed this quality management program. Eight years later I can assure you that since introducing quality management principles my laboratory has significantly better standardized policies, processes and procedures, we now actively control the pre-examination and post –examination phase of testing, we have mechanisms in place to ensure client satisfaction and continuous quality improvement initiatives. Implementing a quality management system does not guarantee an error free laboratory, but it detects errors that may occur and try to prevent them from recurring. Satisfying legislation would probably be last on my list of reasons to introduce quality management systems.


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