Monday, May 23, 2022

ISO: 28 Years of Improving the Quality of Medical Laboratories:


In 1994 the medical laboratory world changed.  At the request of an organization in the United States a meeting was convened in Philadelphia, under the authority of the International Organization for Standardization (ISO) to explore the need of a new committee to meet the needs of medical laboratories around the world, with a primary interest in laboratory quality.  While many countries in Europe, North America and Asia had already been developing some national standards for medical laboratory practices, this was (I think I am right on this) the first time that the collective international community of medical laboratory organizations came together for the single purpose of developing a comprehensive document for laboratory quality and competence. 

This was a challenging task and took near 10 years to complete, but in the end ISO15189:2003 Medical Laboratories:  particular requirements for quality and competence was published in 2003.  Over the years the document has gone through a series of revisions, with the next one to come out either at the end of 2022 or early 2023.   I was one of the attenders at the Philadelphia meeting.

The ISO process is one of working in technical committees which include members from participating (P) countries and others from observing (O) countries. The working committee responsible for ISO15189 is enumerated as ISO TC 212 .  The countries that participate tend to grow in number.  When ISO TC 212 started it had about 20 “P” countries.  Today that number has increased to 44 and they are joined by another “O”s.   Some of the P member participants have been attending meetings from the very start, although new people come in all the time, while others leave.  (I personally was very active for about 20 years.  While I am still involved, it is to a lesser extent.)

ISO 15189 is now used all over the world.  In many countries medical laboratorians and accreditation bodies know the number (15189) as synonymous with laboratory quality. 

But what few people know is that ISO TCs are not “one-trick ponies”.  Technical committees, through various Working Groups are constantly creating new revisions and new documents all the time.  ISO TC 212 has now created 47 documents completed and another 17 on the way.  Most are NOT used for accreditation purposes, but all relate to laboratory quality in one way or another.  The most recently published document is ISO/TS 5798 which provides recommendations for the design, development, verification, validation and implementation of analytical tests for detecting the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) using nucleic acid amplification.

Unfortunately, many of these documents are  barely known about at all, which is a shame, because they can all be value in improving medical laboratory services. You can go to the ISO TC 212 website ( and see the list. Your laboratory will benefit.

It would be wonderful to read them all and figure out which ones would work in your laboratory.  You might be able to get access to the documents through your national standards body.  In Canada we have Standards Council of Canada (SCC) in the US they have American National Standards Institute (ANSI) and in the UK they have British Standards Institute (BSI).  I suspect that all countries have such a body. It would be well worth your while to connect with yours.

A warning… ISO standards are not for free; some might say they are expensive, maybe very expensive.  To get access to all the output of ISO TC 212 would cost about $8000… plus.

Maybe you can strike a deal through your National Standards Organization. 

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