Re: ISO 9000 certification

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Date:Mon, 16 Aug 1999 15:28:39 EDT
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Hi Marilyn,

I am going to share what I have learned about ISO 9000 certification.  This 
info may not be completely up to date, but I am think it is pretty close to 
the mark.

ISO 9000 first entered into the laboratory marketplace somewhere around 
1996-7 with an emphasis on the Blood Bank.  The BBs are traditionally heavily 
regulated industries which produce, market, and sell a "product".  By 
definition then, ISO 9000 seeks to regulate the production, not the product.  
ISO 9000 is actually a series of certificates (9001, 9002, etc.) which relate 
to the organization, NOT the product itself.  They accredit your "quality 
management systems", and can deal with small 1 person organizations all the 
way to huge high tech corporations (i.e. Saturn I think is advertised as ISO 

The necessary ISO 9000 elements you must meet number 20.  This is in contrast 
to the AABB quality system quality control points which number 10.  The last 
I knew these elements were organized into a triangle containing 4 levels to 
include: Policies, Quality System Procedures, Work Insturctions, and 
Records/Forms.  You would use these areas to tightly control how your 
"product" is manufactured.  Your organization uses this to ensure that the 
purchased product conforms to specified requirements.

So, why would you attempt ISO 9000 certification?   It adds value to the 
organization and product.  It could help identify and fill gaps within your 
"production system".  It could support your lab's committment to a 
standardized and high quality "product".  It could build customer 
(pathologist!) confidence and provide an additional means to document 
external accreditation.  Only you can decide why you want ISO 9000, and what 
goals you hope to meet by achieving it.  I have heard that there are some 
consultants out there who help you walk through this--I understand it is a 
lengthy and costly preparation and accreditation.  The only US lab I knew of 
(2 years ago) who received ISO 9001 accreditation was in San Antonio, I 
believe.  Perhaps other Texas HTs can help with this information.

I have been told that ISO 9000 overlaps with many existing standards--I don't 
know which (ASCP, CAP) specifically this applies to.  It would seem to me 
that ISO 9000 could also cover some other areas that CAP, etc. doesn't 

A long time ago, I spoke with Jim Elsam of the HTEQA Services in England.  If 
I remember, he said there is an additional British standards with a similar 
angle.  What say you, Jim?

Sue Lewis, BS HTL(ASCP)
University of Iowa

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