Must your reference standard provider be ISO17034 certified to meet your testing lab's ISO 17025 certification requirements?

[catty_corner]

Hello All,
Recently I had a Quality Manager at an ISO 17025 certified Testing Lab tell me that the only way they could keep their 17025 certification was to show that ALL their reference standards were purchased from an ISO 17034 certified producer. They stated that they had received an audit finding for this from their certification body.

I am looking for thoughts on this.

In 17025 it says:

"6.5.2 The laboratory shall ensure that measurement results are traceable to the International System of Units (SI) through:
a) calibration provided by a competent laboratory; or
NOTE 1 Laboratories fulfilling the requirements of this document are considered to be competent.
b) certified values of certified reference materials provided by a competent producer with stated metrological traceability to the SI; or
NOTE 2 Reference material producers fulfilling the requirements of ISO 17034 are considered to be competent.
c) direct realization of the SI units ensured by comparison, directly or indirectly, with national or international standards.
NOTE 3 Details of practical realization of the definitions of some important units are given in the SI brochure."

I read this to say that having ISO 17034 is called out as a way for your reference supplier to show they are "competent", but not that it is the ONLY way to show competency. It says a competent producer with stated metrological traceability to the SI - can that not be achieved without having ISO 17034?

Please let me know your thoughts!
Carrie

 

[Marc]

a Quality Manager at an ISO 17025 certified Testing Lab tell me that the only way they could keep their 17025 certification was to show that ALL their reference standards were purchased from an ISO 17034 certified producer.

I would say that Quality Manager was not prepared to be able to show that their supplier(s) are "competent". I read it like you do - There are other ways for them to show their supplier(s) are competent.

Disclaimer: ISO 17025 laboratories are not my field of expertise - I do not know how providers of reference standards prove their competence. I'm sure it would be dependent upon the type of reference standard.

 

[dwperron]

ISO 17034 is the automatic, guaranteed way to show traceability of reference standards to National labs and for proficiency test providers to show competency.

Correct, you do not need to use 17034 accredited providers, but you must then be able to establish a traceability chain from your reference materials to a national lab, including measurement uncertainties. This can be a great deal of work, and there is the risk of discovering a "missing link" in the chain. You can get reference materials from NIST or a National lab as well.
For most labs it is not worth the risk to use other suppliers, they use 17034 suppliers for convenience and safety.