Featured Post

Healthcare Customer Satisfaction: More Talk AND More Action

Healthcare Customer Satisfaction: More Talk AND More Action Customer satisfaction (Voice of the customer) is a recurrent th...

Monday, February 12, 2018

Quality upside down and backwards

Warning:  This entry is deeply in the weeds.  If you are not a ISO-wonk or Qualitologist, this will drive you crazy.  For a quick read, jump down to the last two paragraphs.

The International Organization for Standardization (ISO) is a crafter of standards, but NOT creator of original thought.  Ideas exist, usually from other international organizations, but taken to their origins, from true original thinkers.  For example ISO/IEC 17025 first came to life as ILAC Guide 25, a document created so that international accreditors could have a single source against which to assess laboratories.  Similarly ISO9000 was derived from a combination of a British Standards Institute document and a UC Military Standard and another from the Canadian Standards Association, but ultimately they were derived from the teachings of Deming and Juran and Crosby.

The concepts of Plan-Do-Study-Act, Risk, Document Control, Corrective Actions all long proceeded their appearance in documents published by ISO.  Think of ISO as the iterator or popularizer or disseminators of ideas rather that a creator.

In my laboratory when we actively decided that this stuff called TQM or Quality was something that we should look at, we learned  about it through books (read Ray Bartlett’s classic Microbiology Laboratories: Quality, Cost and Clinical Relevance) and guidelines many from the organization then known as NCCLS (now CLSI). 
We had looked at the recommendations and guidelines on how to write an SOP or how to set up document control.   The nice part was that the books and guidelines that I learned from were written as books and guidelines whose primary task was to teach.  And importantly there was no pressure.  

I could take the information as given or fiddle with it or ignore it.  My laboratory, my choice.   

Today it doesn’t work like that.  Today laboratories generally don’t start from scratch.  They start from the perspective of what is written in ISO standards or from the expectations of an accreditation body.  And that is tough because ISO standards are not, were not and never will be designed as tools from which to learn.  They are designed as documents for rules setting. 

So here is my problem.  

For the last 17-18 years we have taken the view that the way developing laboratories need to learn about implementing Quality is NOT to start from the perspective of basic components, but rather to start from obeying the dicta of ISO.  And so far that idea is not working particularly well.  And further when we assess their progress we do it against an accreditation level standard.  

Recently I was in conversation with a person very involved in monitoring progress of laboratories in a developing country and was told that the laboratories were not doing particularly well by their measurements as assessors.  I knew what the problem was; it’s was not that they had no written SOPs, it was that their SOPs did not meet the requirements of ISO.  So what!!!

These laboratories are just learning about quality management and importantly, there were no small laboratories from developing or evolving countries that participated in any part of the ISO process.  They had no opportunity to object and make the point that the standard as written was not designed or intended for them.  This is really a round hole-square peg situation.  

We should be promoting them to learn and discover Quality in the same way as we did; start from having a purpose and finding a solution.  Allow them to play around with different versions of document management, or risk, or SOP production.  Allow them to discover and appreciate value and then refine.

 We should NOT be using ISO standards to promote quality in these laboratories.  
And ANY person who answers a question by saying “we do it this way because that is what is said in ISO15189” should be thanked for their service and shown the door.    


  1. Thank you Professor Noble for your total dedication to Laboratory Quality Management. You have put in so many years in the introduction of Quality in laboratories in the developping countries under PEPFAR and you are still engaged now in other ways. It is generally said that change is difficult to implement because there is strong resistance to change by employees who are afraid of what it might bring to their overall welbeing. Quality in the medical laboraties of developing countries has come a long way and still has a long road ahead.
    According to Dr. Sambo, L.G (n.d), the WHO AFRO Stepwise Laboratory Accreditation preparedness scheme was launched in Kigali in 2009. These initiatives led countries to actively invest in strengthening their laboratories. The countries adopted quality assurance and management tools in preparation for enrollment in the WHO AFRO Stepwise Laboratory Improvement Process Towards Accreditation (SLIPTA). In July 2011, key stakeholders for SLIPTA met in Nairobi, Kenya, to reach consensus on the WHO AFRO SLIPTA Policy Guidance and Checklist documents. The purpose of this meeting was to set up a framework for improving quality of public health laboratories in the African region aimed at achieving ISO 15189 standards. Based on the principles of affordability, scalability, measurability, and accessibility, SLIPTA will promote country ownership of the process and sustainability of the improved quality of the laboratories.
    Dr. Sambo reported that a considerable number of laboratories had enrolled in the program and had started implementing SLIPTA. These SLIPTA-empowered laboratories were making marked improvement in accurate and timely diagnosis of disease and patient care, transforming the landscape of health systems, one laboratory at a time. In this optimistic view, there was general agreement of close collaboration with all stakeholders, including the African Society for Laboratory Medicine (ASLM), the Clinton Health Access Initiative, and the US Centers for Disease Control (CDC), to continue to promote WHO AFRO SLIPTA throughout the region and turn the tides on laboratory systems in the Region. If after almost 10 years, it is believed by some stakeholders that there is very little improvement in the laboratories, what can we say happened?
    For a full review of Dr. Sambo’s foreword to WHO Guide for the Stepwise Laboratory Improvement Process Towards Accreditation in the African Region (with checklist), see http://www.who.int/tb/laboratory/afro-slipta-checklist-guidance.pdf

  2. Dickson
    I apologize for the delay in writing back to you. I hope you get a chance to read this.
    Without wanting to be the grumpy-old-guy, I have found, unfortunately too many organizations have taken on mentors and advisors that have become far too rigid about what ISO or SLIPTA says, as opposed to understanding the underlying Quality concepts. And more to the point this rigidity leads directly to dogma that makes no sense. "I require you to do it this way, because that is what I want you to do". That message does not communicate understanding or growth, it is just dogma. And no one learns from dogma, in either the short or long term.

    I will tell you a story. Recently my laboratory was being accredited and an assessor found a private note in an unofficial file that had some white-out and went CRAZY.
    I told the person that I didn't care what my staff did or did not do, on their own documents. But since she had raised the issues of possible deception by using white out, I was going to have to ban her using her computer to make any notes in my laboratory because backspacing and cut-and-pasting were far more likely to hide errors on a permanent basis.
    She was so locked into concerns from 30 years ago, that she was totally missing the point that all Quality requires is simple documents that are available and easy to read, and that if in the process someone makes an error and scribbles it out, or paints it out or cut-and-pastes it out, it is the end document that is important.
    So we need to chill-out and climb down from our seats of authority and start promoting Quality concepts, not accreditation requirements.