#ISO15189 : To Be Or Not To Be ?

All #MedLabs dream of being #ISO15189 accredited. But finally, why?

Well, Quality approach is launched to provide a continuous improvement basis to better serving our customers (doctors, patients …). Implementing a quality management system is to set up all the procedures and tools to do things right and to follow that they are well done.

ISO 15189 provided a framework to standardize the quality of work by #MedLab  throughout the world. In contradiction to that philosophy, each country has their own audit organizations defining their own accreditation rules. We can unfortunately state that ISO 15189 doesn’t align global practices.

To provide examples:

  • Between Ontario in Canada (IQMH) and France (COFRAC) : both location has 15189 mandatory, nevertheless both accreditors have different recommendations and guidelines.
  • Between France (COFRAC) and US (CAP) : in term of lab activity, COFRAC gives partial accreditation (for a number of assays then accreditation for a % of activity), while CAP15189 gives accreditation for the entire lab.

Looking at the global market, it is clear that most of the time, accreditation to ISO 15189 is mainly related to legal requirements. In the meantime a quality approach is engaged in most of laboratories willing to develop or work efficiently.

I just came out of a laboratory that I am assisting in its development. This Lab has already obtained its accreditation to ISO 15189. After discussion with the Lab team, I left the lab frustrated by the many barriers encountered due to the accreditation: steps needed to set up new parameters, add or change equipment, change procedures… All the changes we wanted to launch were related to better serving the clients. Nothing was impossible to realize, but in addition to the cost related to the ISO approach, the time to overcome the barriers required an impressive amount of time and energy… Meanwhile, others are running…  

Quality is a necessary evil for the #MedLab organization; quality is a necessary good for #Customers. But does quality require accreditation to a “dummy” standard? In countries not requiring accreditation, some groups have made their choice: « First we focus on our
Bioleen development, then we’ll see for Accreditation »
. Also, for other labs which already have ISO15189 (in locations where it’s not required), question themselves to continue the #ISO15189 approach. But all are following and will continue to follow a Quality Management approach. Quality is fully required to develop and grow.

In my role, my advice would be: position yourself in a continuous improvement process, manage your resources and processes, documentation, inventory, defects … follow your activity…. and listen to your #Customers, listen to your customers, listen to your customers… It is by listening to your customers that you can apply continuous improvement. And this applies with or without ISO 15189!

Therefore, I strongly think that this is the time for IS015189 stakeholders to meet and standardize their methods, simplifying elements, focusing not only on quality of the medical acts but also on all the customer services to allow #MedLab to improve, perform and  survive. ISO 15189 must not prevent you from moving forward….

Bertrand Guillot
Founding Partner & MD at ComeXium Consulting
Paris, France
Visit us : http://www.comexium.com

Want to perform ? +33 6 71 83 15 23

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