ISO 9001:2000 Implementation in a Clinical Laboratory



Iso 9001:2000 Implementation In The Clinical Laboratory

:bigwave: I would like to introduce the idea, and solicit opinions in the process of implementing ISO 9001:2000 in the Clinical Laboratory setting of a major metropolitan hospital. Anybody interested in, or having been through the process, I would like to request your input.


O.K. I'll ask!

Why just the Clinical Lab in the Hospital? What would that do for the hospital as a whole? I'm not being facetious, but I'm thinking that's akin to a Department in a manufacturing setting deciding that they want to go for registration without the rest of the Company. Is your Clinical lab a separate entity? Maybe you can expand on the reasons and the situation as it is now. There's plenty of assistance here and "Welcome to the Cove" :smokin:

David Mullins

Scope the project by ascertaining the standards that best apply

hospitals have a variety of standards they could apply.

ISO 17025 is a 9001-esque lab specific standard being applied in hospital labs.

In a broad manner of speaking (give me some licence here folks) 17025 is to labs as QS-9000 is to auto, TL 9000 to telecom, AS 9001 to Aerospace, etc (by way of some comparison).


I agree...

I would suggest you to do such thing....

The lab certified by ISO 45000, or even better (not to be upgraded within a year) by ISO 17025

The hospital certified by ISO 9001!

The systems integrated (also can use the word "merged") together. Basically all instructions/procedures that apply to ISO 17025 are stated in ISO 9001 Quality Manual as fulfilling ISO 9001 standard requirements.

And thats it. And everyone is happy.
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