ISO 17025 Standalone or Must Have ISO 9001 Companion

T

TomKOK

#1
I am trying to find out if 17025 can be stand alone or must we also be 9001 certified.

Our scale company is currently both 9001 and 17025 certified, but the boss wants to drop 9001. I too, would like to drop 9001. So the question is, can we?

Any response would be graciously appreciated,

Thanks,
TomKOK
 
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S

Sturmkind

#2
Re: 17025 Standalone or Must Have Companion

I think your boss is correct as 17025 also has quality management system requirements. Interestingly, many gage shops in Oldcastle, Ontario of elected to drop 17025 but kept their ISO9001 because 17025 is so expensive. However, when our assembly plant had to have product 3rd party verified, we insisted on an ISO17025 registered CMM lab because of that certification credibility with our OEM customers.
 
D

dv8shane

#3
I am trying to find out if 17025 can be stand alone or must we also be 9001 certified.

Our scale company is currently both 9001 and 17025 certified, but the boss wants to drop 9001. I too, would like to drop 9001. So the question is, can we?

Any response would be graciously appreciated,

Thanks,
TomKOK
http :// www. nist. gov/pml/nvlap/upload/2009-01-08_IAF-ILAC-ISO-communiqu-C3-83-_ISO-IEC17025_-1.pdf (BROKEN LINK UNLINKED) basically says if you are 17025 you are meeting the requirements of 9001. There is nothing you can change about this. You do not have to change your QMS to drop the 9001 even though some good CB's automatically issue 9001 when accrediting a 17025 lab.
 
Last edited by a moderator:
#4
2009-01-08_IAF-ILAC-ISO-communiqu-C3-83-_ISO-IEC17025_-1.pdf basically says if you are 17025 you are meeting the requirements of 9001. There is nothing you can change about this. You do not have to change your QMS to drop the 9001 even though some good CB's automatically issue 9001 when accrediting a 17025 lab.
I believe, if you look in the introduction to ISO/IEC 17025 it says differently!

Furthermore, it is rare (in the USA) for a CB to be a lab accreditor. Most lab accreditation bodies are NOT ISO 9001 registrars/certification bodies. I recognize this might be different in Canada.
 
G

George Weiss

#5
Sometimes the money doesn't matter. Look at Agilent for example.
Here is an ISO 9001 and 17025 organization, which tops off the list with Z540.3 certification. I am sure they could have just performed as well without the Z540.3 flag, but it sure makes a statement. They are big and on top of the quality equipment manufacturing pile it seems. And don't forget the ISO 13485 for medical devices. The list just goes on and on.
 
G

Graeme

#6
I believe, if you look in the introduction to ISO/IEC 17025 it says differently!
Actually, the Joint IAF-ILAC-ISO Communique of January 2009 was issued to directly address this issue. Many accredited labs had customers requiring ISO 9001 in addition to ISO/IEC 17025, which was duplicating effort and driving up costs. The statement of the communique supersedes the statement in 17025.

Remember that ISO/IEC 17025 has two main parts: section 4, quality management system requirements; and section 5, technical requirements. What the Joint Communique is saying is that a laboratory that is accredited to ISO/IEC 17025 meets the intent of ISO 9001 specifically because of the requirements in section 4.

Remember: IAF (International Accreditation Forum) is the top-level organization for conformity assessment accreditation bodies. (This includes the organizations which in turn accredit QMS registrars.) ILAC (International Laboratory Accreditation Cooperation) is the top-level orgainzation for conformity assessment accreditation bodies that perfrom accreditations of calibration and testing laboratories. ISO (International Organization for Standardization) is a top-level standards publishing organization, especially for publishing standards on conformity assessment (of which quality management system auditing is a subset.)

Therefore, this Joint Communique was issued by the three top-level authorities in the process. I take that as pretty strong authority that it means exactly what it says.

Graeme


 
D

dv8shane

#7
a laboratory that is accredited to ISO/IEC 17025 meets the intent of ISO 9001 specifically because of the requirements in section 4.

Therefore, this Joint Communique was issued by the three top-level authorities in the process. I take that as pretty strong authority that it means exactly what it says.

Graeme


I actually used this in reverse when I had to defend for not having an internal audit to 9001:2008, as I chose to do it to 17025 just prior to my registration audit. I was successful in my defense.

Shane
 
#8
Actually, the Joint IAF-ILAC-ISO Communique of January 2009 was issued to directly address this issue. Many accredited labs had customers requiring ISO 9001 in addition to ISO/IEC 17025, which was duplicating effort and driving up costs. The statement of the communique supersedes the statement in 17025.

Remember that ISO/IEC 17025 has two main parts: section 4, quality management system requirements; and section 5, technical requirements. What the Joint Communique is saying is that a laboratory that is accredited to ISO/IEC 17025 meets the intent of ISO 9001 specifically because of the requirements in section 4.

Remember: IAF (International Accreditation Forum) is the top-level organization for conformity assessment accreditation bodies. (This includes the organizations which in turn accredit QMS registrars.) ILAC (International Laboratory Accreditation Cooperation) is the top-level orgainzation for conformity assessment accreditation bodies that perfrom accreditations of calibration and testing laboratories. ISO (International Organization for Standardization) is a top-level standards publishing organization, especially for publishing standards on conformity assessment (of which quality management system auditing is a subset.)

Therefore, this Joint Communique was issued by the three top-level authorities in the process. I take that as pretty strong authority that it means exactly what it says.

Graeme


Interesting and, apparently, valid points. I wonder how, nevertheless, those people who had purchased a copy of both standards would know these august bodies had made such a 'ruling'...the 17025 standard hasn't been changed!
 
G

Graeme

#9
Interesting and, apparently, valid points. I wonder how, nevertheless, those people who had purchased a copy of both standards would know these august bodies had made such a 'ruling'...the 17025 standard hasn't been changed!
Great question. I know I found out about it first through an ISO/IEC 17025 Lead Assessor training course, and again at an annual training meeting for one of the accreditation bodies I work with. From that (especially the AB annual training) I would assume that most assessors know about it.

Of course, we also know that "assume" and "most" are two of the more dangerous words we can use! :rolleyes:
 
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