Report from Berlin: ISO TC 212

I have been in Berlin for our ISO Technical Committee 212 meeting.  This represents 19 consecutive years of direct involvement.

From my perspective it was a not-so-busy but in the long run a very successful meeting; but mostly it was a vocal meeting.  I talk a lot at meetings, usually with a “polite” assertiveness (some might say aggressiveness), but I come with an agenda and have a goal to have my issues addressed, preferably successfully.  Personally I see little value in traveling long distances to attend a meeting only to spend my time being quiet and passive and not addressing the issues that are important to me.  

A good friend, a successful senior bureaucrat, taught me his secret; set your agenda, and push hard for what you think is important.  Celebrate your successes and walk away from your failures knowing that you tried.  You won’t win them all, but you can’t win any if you don’t step up to the plate.

As a side note I have a lot of empathy for the folks who attend the meeting with English not being a fluent language.  For them, making their issues understood is unfairly very difficult, considering that these are international meetings.  I would like to think that there could be an easy and effective and equitable solution.  

The final international vote on the next iteration of ISO 15189 is underway.  It is an OK document, not a perfect document,  with the same mistakes and errors carried forward for another 5 years.  Changing words with changing content, in my opinion, is not what standards development should be about.

But with respect to the issues that I consider important, I pushed hard to promote the newest iteration ISO 15189 to respect the ISO CASCO neutrality principle when it comes to recognition of third-party organizations including both certification bodies and accreditation bodies.  This would have significant positive ripple effect for Canadian standards development.  We hopefully will get a senior level ISO opinion on our position soon.  Maybe this can get squeezed in as a last moment editorial change.

For a long time I have advocated that Measurement Uncertainty should be recognized as a useful laboratory tool, but only as one of a variety of techniques to measure variation rather than as the sole and mandated requirement.  Requiring laboratories to perform complex statistical analysis like MU for the sole purpose of satisfying an accreditation body requirement is probably one of the best examples of Poor Quality Practices and generally a total waste of time and effort.  

At this meeting I think we had a major step forward with respect to MU.  While I was not able to get everything I wanted written into the next version of the standard, the other options are going to be included within a new international MU implementation guide being developed within the technical committee.   It should carry a lot the weight, so that is a good thing.

Another important development is that for the first time, TC212 is going to be writing a document that extends beyond the traditional scope of the laboratory and diagnostics manufacturers.  The plan is to re-develop our document on the use of Point-of-Care instruments for organizations that are not directly affiliated with the medical laboratory.  Consider the use of breathalysers and drugs-of-abuse testing and full blood chemistry by police, pharmacies, and schools.  A guidance document that explains appropriate quality control and assessment will be very useful.   

More importantly this writing committee will have consumer representatives from ISO COPOLCO [see http://www.medicallaboratoryquality.com/2012/01/protecting-our-consumers.html ].  We talk about patient's interests; now we are involving their voice.  That is a big step forward.

It is important for laboratorians to remember that all organizations, even including the august and respected International Organization for Standardization are the sum total of volunteers efforts, usually well-intended and well-meaning but all  with their own competitive biases and influences and memory lapse foibles.  Consensus is not always easy to come by, and sometimes document development does not follow in a straight line.  We had a good example with a document being approved as a work project in last years’ meeting only to be rejected this year.  It makes some people wonder about why they put effort into developing documents; that is never a way to encourage participation.  I expect that the decision will be addressed yet again.

The problem is a combination of long intervals between meetings, vague minutes, not so diligent project tracking, and a general short term approach.  It may be just “human factor” at work or play, but somehow I think we should be able to do better, including myself. 

By bottom line: ISO is big and clumsy and vulnerable to human foible.  It is also the only organization that can create truly international guidance.  It is a real opportunity to work with them.  

Oversight of the Quality Partners: survey results.

In a previous entry I raised that I created a survey of my proficiency testing program participants about their opinions about whether accreditation bodies, proficiency testing providers and medical device suppliers should seek official recognition either as a certification or accreditation process.
I picked these 3 because in each instance there is an ISO document that is used on a regular basis for establishing recognition.  Most Education providers, at the university or college level are accredited, but there is no single process for that and so I chose to not include them.  

An electronic survey went out and over a period of about 10 days I got back at response from about 40 percent of participants, which I think is a decent response.  Every province and region was represented.   Responders included laboratory directors, administrators, head technologists, supervisors, bench technologists, quality managers, and pathologists.  Responses included both the clinical laboratories and the water environmental laboratories.  From the clinical side, they included both hospital and non-hospital facilities. So while the responses were not random, they are well and representatively distributed.   
I intend to do a second response solicitation which will likely take the over-all result to to greater than 50 percent, but I suspect  there would be few changes or surprises in the collective results.  The only thing that might change is that some of the values might start to take on statistical significance.  But since this survey is not going to result in changes in regulation or legislation, I doubt a few p-values are going to have much of an impact.


First the mechanics.  The survey was designed using an on-line web-based electronic survey program.  The questions were of two categories: demographics and the specific challenges.  The questions were self-designed, but were vetted for clarity  through a reference group.  Most responses were through drop down tables or serial buttons.  There was sufficient space left of comments.  The time to completion was somewhere between 3-5 minutes.

There was one question that I blew entirely.  It was about laboratorians knowing that CMPT is certified to ISO9001:2008.  The question was so convoluted that when I looked at it myself, I wasn’t sure how to answer it.  So it got dropped.

There are 5 analyzable questions
Do you believe that Accreditation bodies should be accredited?
Do you believe that Equipment and Supplies providers should be accredited?
Do you believe that Proficiency Testing providers should be accredited?
Does knowing  that CMPT participates in regular voluntary oversight increase your confidence?
Does knowing  that CMPT participates in regular voluntary oversight increase program value?

Each question response was in the form of a 7 point Likert Scale from Strong Agreement to Indifferent to Strong Disagreement.

Question	Strong or General Agreement	Somewhat Agree Indifferent Somewhat Disagree	Strong or General Disagreement
Accredit Accreditation Bodies	84%	14%	2%
Accredit Suppliers	90%	10%	0
Accredit PT	91%	7%	2%
Oversight increases CMPT confidence	86%	14%	0
Oversight increases CMPT value	90%	8%	2%

 
When I looked at cross tabulations using demographic information (location, profession, whether the laboratory was in a hospital, whether the laboratory was accredited) there were no significant differences, although when we looked at the profession of the responder, our harshest critics were Microbiologists or Pathologists.  With respect to laboratories being accredited, it is important to note that only 3 percent of laboratories said they were not accredited.

Of interest, to me, in Canada we have stark regional differences with some provinces and regions strongly endorsing accreditation for clinical laboratories, while in others it is not mandated, or even recommended.  When I looked at the results of the questionnaire, I was surprised there was barely any impact of regional attitude.  In the same vein, most water laboratories are accredited to ISO17025, while clinical laboratories have a province level accreditation.  Despite that difference, their attitude towards accreditation of Quality Partners was essentially the same. 
If we had a larger representation from non-accredited laboratories it would be interesting to see how they would perceive the value of oversight.



Additionally, while none of the differences here are statistically significant, but the comments on the General and Strong Disagreements are interesting in that one person commented  that the oversight process needs to end somewhere and accrediting the accrediters is over the top.  
The most interesting was the comment “ISO accreditation is not a guarantee of quality but does indicate that the bearer is taking it seriously and is improving all the time.”  That shows really solid insight.


I was a little surprised by the results, although not flabbergasted.  I would have thought that laboratorians would be more demanding of their quality partners. While 85-90% expectation is high expectation, I would have guessed higher.  As in “if we have to go through this, then you sure are going to as well!”  From my personal point of view, I would be outraged if I thought that the bodies that could make decisions that impact on my reputation were not prepared to publicly demonstrate their own commitment to quality. 
The themes of "walking the walk" or "putting up or shutting up" come to the very front of my mind.


I am intrigued that around 15% (one in 8 laboratorians) are indifferent about having expectations for Quality Partners.  I don't know if that apathy or acceptance. Fodder for another series of questions. 



So memo to self: 
Most laboratories are pleased that I take the extra step to have voluntary oversight of my program.  For many it increases their confidence in my program, and increases their perception of our value.  Those are pretty powerful reasons for leaving those programs in place.  

Measuring ISO Objectives

In the world of standards development there are folks that participate at every level, from institutional, to regional, to provincial to national to international.  At each level the documents developed become more generalizable, more applicable in a greater cross-section of environments.  That doesn’t necessarily make them better, but it does create a closer connection to international truth.  

At the top of the pyramid is the International Organization for Standardization.  
The ISO has been the crown of the standards development structure since 1946 (or 1926, depending on when you start counting).  It has as one of its mandates to create voluntary consensus standards that once applied assist the World Trade Organization promote international trade in the absence of non-tariff barriers.   I have been a volunteer Canadian representative on ISO technical committees since 1995 and am currently a member of ISO TC 212 (the committee responsible for 15189) and ISO TC 176 (the committee responsible for 9001).  Over the years I have seen both the positives and challenges of developing high level documents.  

Which brings me to the recent publication of the official ISO magazine known as ISO Focus+. This is a great magazine that I suspect most of you have never seen or heard of, much less read.  It is available at www.ISO.org, or is available through your national standards body.  In Canada that is the Standards Council of Canada (SCC); in the US it is the American National Standards Institute (ANSI).  The January 2011 issue is all about the ISO Strategic Plan for 2011-2015.  Within it are the defined strategic objectives that ISO has set for itself over the next 4 years.  

If you are interested in Quality, you need to read this magazine.  

ISO has defined the following objectives.

1: ISO deliverables meet customer needs
2: Promote innovation and provide solutions to address global challenges
3: Enhance capacity and participation of developing countries in international standardization.
4: Reach out to and engage with stakeholders.
5: Foster partnerships that increase the value of international standards
6: Improve ISO processes
7: Improve understanding of the general public, stakeholders and customers of value of voluntary international standards.

But for those of us that have set objectives for our own organizations in the past, we recognize that objectives need to meet a number of tests:
A: Are they appropriate? Are they consistent with the organization’s Quality Policy?
B: Are they measurable?  Can you by the end of the time period objectively document if you met the objective?
C: Are they achievable?  Does the organization have the resources and capabilities required to meet the objectives in the time frame that has been defined?

So how, in my opinion, do the new objectives measure up, and what will ISO need to do to meet the objectives successfully.

Objective	Quality Policy	Measurable	Achievable	CHANGE MANAGEMENT
Meet customer needs	YES	YES	YES	Process improvement
Promote innovation	YES	YES	YES	Process improvement
Developing Countries	YES	YES	NO	Communication
Engage stakeholders	YES	YES	YES	Communication
Foster partnerships	YES	YES	YES	Communication
Improve processes	YES	YES	YES	Process Improvement
Improve understanding	YES	YES	YES	Communication

Most of the work that ISO needs to do focuses on improved communication.  ISO certainly needs to do that.  The organization has become elite and presumes far  too often that the world will come banging on their door  Congratulations on recognizing that is not how it works any more.  

The other changes will come from acknowledging tat ISO has some internal work to do to tidy up its own processes.  Where there are rules, ISO needs to make sure that (A) they make sense, (B) the communicate them and (C ) they are applied consistently.

About the “NO”.  ISO can ask developing countries to be involved, but small countries don’t have the resources to attend and participate meetings. Fixing that is by-and-large outside the power of ISO.

So congratulations to the ISO.  This is a big step forward.

We will watch to see if this is "just words" or a "call to action".

m