Sunday, July 10, 2011

OFIs for ISO9004:2009

For the last few presentations I made the argument that ISO 9004: 2009 provides a valuable second look at its parent document ISO9001:2008 and suggests a way that Quality Management can be used  not only as a way to improve policy and procedure, but also to lead to a level of sustained success in meeting long term objectives.    

Learning through preventive action, and evidence-finding and focussing on the people in the organization not only makes sense, it also has a track record of success, at least from my personal experience within a small R&D compact Quality oriented organization.
Even if it is not an accreditation or certification document, I suggest that it is worth a look at by medical laboratory qualitologists and management.

But clearly, as much as many or maybe even most ISO documents come from a solid basis of consensus, there is always room for improvement. 

The first sentence of the introduction in 9004 says that the document provides guidance to support the achievement of sustained success for any organization by a quality management approach.  I think that sentence is supposed to mean that organizations can achieve sustained success by doing the right things. 

But sustained success is not something that any organization can have total control over. 

Consider Research in Motion (RIM) the pioneer in the smart phone environment; the creator of the BlackBerry.  For the longest period of time, there was only one smart phone, of at least a few models, but they all were variations of the BlackBerry.  BlackBerry defined the gadget market.    Life at RIM was good.   
But RIM got caught with its “pants down” when all of a sudden Apple decided to enter the market with a better smart phone, the iPhone (is the “I” in iPhone for  “innovation”), and then pulled off “innovation-squared” (I2) with the iPad.  S
hort of industrial espionage, I don’t think that there was anything that RIM could have done to quickly respond to this undeniable stroke of marketing genius. 

Today RIM stock is down about 70% from its highs.  Profits are still being made, but nothing like they were like before.  Shareholders are trying to force out the co-CEOs.  Rumors abound about RIM becoming a target of take-over.

All the study and adherence to 9001 and 9004 in the world would not have protected or prevented another company deciding to take a run at the Blackberry market and win.     
So in regard to ignoring the impact of competition on long term success, ISO 9004:2008 leaves a pretty big gap.

So as to not confuse the issue about the role and impact of competition as a success determinant for our Canadian publically funded medical laboratories, I also recognize the reality is that there is no competition in the medical laboratory field.  What we have instead is a Mafia-like carving up of communities which results in Medical laboratories have locked-in clientele without any form of competition.  Even if the laboratory was completely unresponsive to the needs of clinicians and patients, it would take almost divine intervention to have a competing laboratory allowed to provide testing in competition.  Personally I see this as a real weakness to our laboratory system.  The issues that prevail against competition are essentially the same as those that make it difficult for medical laboratories to define and measure success.  And absence of measures of success contributes to lacklustre activity.  Think about the problems as manifested at its most egregious level in Eastern Health in Newfoundland.

My other main concern about 9004, as well its parent (9001) and sister document (15189) is that they expect top management have control over resources and infrastructure.  Top management is expected to establish and provide sufficient resources, infrastructure and work environment to meet the needs of sustained success.  Well best of luck with that. 
I can’t imagine any organization being able to ensure sufficient money, personnel and resources to do all the things that think are necessary and lead to innovation, learning and sustained success.  Well maybe some provincial and federal ministers can do that for their personal offices can pull that off, but I don’t expect that as a realistic reasonable recommendation for any private sector organization (Microsoft or Google excluded) or the public sector, and certainly not a medical laboratory.

The reality is that throughout near the whole of the economy, budgeting is pretty much a wish-list exercise with too many variables and moving parts.  No one can ensure that appropriate money and resources are available.  The best we can do is try to focus something approximating real needs and then try to look at what has to be done to stop the bleeding of money that results from poor quality losses.

So what does all this mean? 

ISO 9004:2009 has some overly idealist points of view with respect to self-sufficiency and supply side resources.  It makes certain excessive assumptions on what top management can and cannot do.  It overstates what is achievable. 
Nonetheless I still see it as a valuable contribution.  It is not an accreditation requirement, and it is not a legal requirement, but it provides an interesting and valuable approach for organizations interested in adopting and working within a quality management approach.

Overall this is still a very good thing, even for the for the medical laboratory.


  1. I want to add some additional thoughts to Michael's somewhat negative posting, being a "glass half full" person. While it's true that laboratories in Canada cannot compete in the true sense, they can and do have to compete with others for funding. This links to the comments about budgeting. I am addressing hospital laboratories, who have to compete with the likes of pharmacy, diagnostic imaging and rehab services to ensure sufficient funding for delivery of services and especially to add new services. Dr Fred Swaine, CEO of EORLA has studied this problem and decided that a key component of budgeting is to align the strategies of the laboratory with those of the hospital. This includes selecting indicators to track that provide evidence of the laboratory's contribution to clinical services. Fred will be sharing he experiences at the 2011 Executive Edge conference in Toronto on October 3 & 4. For more information go to

  2. The argument that more competition would increase laboratory quality is, at best, weak. Apple may have a more consumer friendly product, but is it of better quality? Blackberries work pretty well. More to the point, there are many examples in computers, cars, hedge funds and children’s toys, all competitive sectors, that have produced terrible quality: think pinto, Microsoft millennium 2000, dell batteries, firestone tires and cadmium. Further to the point, health care is not like other consumer products and it is hard to argue sectors of health care that are not competitive, like hospitals or the NHS have poorer quality, though they certainly can be imporved. In the 1970’s when Ontario’s community laboratory sector was very competitive quality was poor, so much so that a series of conservative governments felt compelled to bring in regulations to improve quality and reduce competition. Your example of Newfoundland pathology testing ignores the fact that similar problems have occurred in the United States with a competitive laboratory market and in Ontario, Manitoba and BC with multiple laboratory providers. The effect of more competition in the provinces with multiple laboratory providers has been increased secrecy, a barrier to improved quality, and decreased pre-analytic and post analytic quality. Based on the evidence it is hard to sustain the argument that more competition will increase quality: the sounder argument makes the opposite point.

  3. Thanks Ross.
    It is not my intent to paint myself a complete advocate for introducing all competition into the medical laboratory system all the time.
    But there is little doubt, at least in my mind, that competition spawns innovation and creativity in a variety of ways.

    In the Olympics the mantra is "faster higher stronger". In Baldrige they talk about achieving "best-in-class levels of performance". The Nobel prize is "a reward for the most important pioneering discoveries or works in the field of knowledge and progress, and many organizations compete in all sorts of ways to achieve that level of recognition.
    Yes there are examples in all of these where the result was not perfect, but their existence in their respective fields has been a huge incentive to improvement and innovation and quality.

    With regard to competition in provinces leading to increased error and a barrier to quality, you might be talking about non-medical laboratories,because across Canada there is no real competition in the medical laboratory field. Where laboratories are located and the number of locations is highly controlled and regulated, and well over 98 percent of their funds come from a common source, both in the public and the private sectors. Funding for all institutions is formulaic based mainly on size of the community served and to a lesser degree on the complexity of patient care issues.

    I understand Sheila's comment about internal cross-departmental competition for a larger piece of the budgetary pie, but I am not convinced that that level of competition is about higher or faster or stronger or excellence or best-in-class or pioneering discoveries.

    Ross, your comment about competition resulting in error and diminished quality intrigues me. I would appreciate if you could cite one example in the laboratory arena where that would be the case, recognizing the hazards of intruding on confidentially and privacy.

  4. Hi Quality Doc, a place to start would be a book I recently wrote on medical laboratories in Canada. Links can be found at my blog:

    Quality was not the focus of my work but when you are looking at cost and integration it is hard to ignor certain quality considerations. Ross.


Comments, thoughts...