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Tuesday, December 7, 2010

Implementing ISO 15189:2007

For folks interested in medical laboratory quality, it is not necessary to explain the number 15189.  In the area of medical laboratory quality it is probably the most significant harmonizing document ever created.  ISO 15189:2007 entitled "Medical laboratories - particular requirements for quality and competence" sets out a clear and comprehensive set of quality requirements for medical laboratories.  Initially published in 2003 and is in place both for laboratory and accreditation body usage in over 70 countries.  It is being used on every continent, with the possible exception of Antarctica. 
Unfortunately, ISO 15189 shares many characteristics with other documents created by the International Organization for Standardization, and lots of other standards development bodies; it can be a challenge to understand and interpret, even in English, because, as they say, the devil is in the details, and understanding the details may require a certain subtlety and appreciation for nuance. 

Enter the implementation guides.

There are a variety of implementation guides to assist with understanding this document.  Some are in the form of courses, both on-line and in-person.  Others are in the form of text books.  One of the first published was created by the Canadian Standards Association (CSA) and was known as ISO15189:2003 Essentials.  Written by members of the Canadian delegation that were actively involved in the creation of the standard, it was a small but extremely well received book, purchased and used around the world.  It suffered from some editing issues, but the content was reviewed and supported by folks in the US, UK, and Australia.
Well, time went by and in 2007, the standard was republished, with some minor text changes.  With passage of time and increasing usage of the standard, a lot of the content was open for revised interpretation and guidance and implementation advice. 

So now, the 2nd edition is available through the Canadian Standards Association.  The full title is:  The ISO 15189:2007 essentials - A practical handbook for implementing the ISO 15189:2007 Standard for medical laboratories. 
Again written and supported by the Canadian delegation to ISO TC 212 Working Group 1, it still contains the content of the standard, interpretation and guidance and tips on implementing the requirements.  The guides and tips are designed for use in laboratories with a range of size and complexity.  It will be helpful and useful for medical laboratories in many countries

Most or all of the editing issues that needed addressing in the first edition have been much improved. The book contains both table of contents, and an index, and contains all the annexes. 
So the book is worth a read.  It is a good book and I will be using it as part of the UBC Certificate Course in Laboratory Quality Management (see www.POLQM.ca).

It is available through the Canadian Standards Association web-site (www.ShopCSA.ca) at a fair and reasonable cost.  

One of the themes that I have raised before is that in many countries, medical laboratory accreditation is NOT a requirement, and in some places where it is a requirement,  there are allowable options for accreditation to requirements other than ISO15189:2007.  But in many countries, medical laboratorians recognize the value of implementing this standard on a voluntary basis because of its superior quality management and its international application. 
Some who go through voluntary implementation go further by applying for voluntary accreditation. 
Both these steps provide great value to the laboratory that makes the commitment because ISO quality implementation and accreditation can be the basis of international recognition, business opportunity and all the benefits that accrue: higher satisfaction, lower costs, improved patient safety.  
I declare my personal connection with the book.  I was the co-author of the first edition and the principle author of the new edition.   It was written under a fixed contract though the University of British Columbia.  Neither I, nor the UBC Program Office for Laboratory Quality Management, or the university receives payment in the form of royalties for present or future sales.  

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PS: A third iteration of 15189:XXXX is underway and may be available in 2013.  

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