ISO 9001 vs. ISO 17025 - And - Accreditation vs. Registration

[jill]

If a software provider tell you that their package will provide versatility by allowing your lab to attain iso 17025 accreditation and iso 9001 registration.... are you really benefiting since the 9001 requirements are covered mostly in the 17025 requirements? Please clarify if you can.
Thanks

 

[Marc]

What is the purpose of the software? Is it a gage tracking program? Document control program?

 

[Al Dyer]

Jill,

They are 2 stand alone entities, although if you implement a quality system that encompasses all of the requirements of both, you could be audited to both at the same time and be accredited/registered to both as a combined "quality system"

I have no idea about the costs involved in such an endeavor, but you would need a registrar/auditor that is "allowed" to audit both entities.

Call a couple of registrars and see what the process would entail, they are looking for business and could be very helpful.

ASD...

 

[jill]

I appreciate everyone's replies. Thank you for the help.

 

[Graeme]

Here is the key difference as I see it:

• ISO 9001:2000 - Describe and document your commitment to quality, your processes, and procedures. (The familiar process of say what you do, do what you say, prove that you did it, show that you are improving it, and show what your customer thinks of it.)
• ISO 17025 - if you are a testing or calibration laboratory, then in addition to the above prove that you are capable by actually doing the work and having it verified.

Software by itself is not the whole answer. Software does not do the testing or calibration. The testing or calibration process may include the software, but it also includes the environment, equipment, methods and people. All of these work together to produce a result, and one of the parts of laboratory accreditation is proving that the result is correct, at least to within your stated limits of uncertainty.

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Graeme C. Payne
ASQ Certified Quality Engineer