Monday, February 12, 2018
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.