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.