Does ISO/IEC 17025:2005 require the Laboratory to have separate ISO 9001 Procedures

[morteza]

Hello all
I would be so grateful if someone answer the below question.

Question:
Does ISO/IEC 17025:2005 requires the laboratory which is part of an organization certified to ISO 9001:2008, to prepare a separated set of documents in spite of those provided according to ISO 9001:2008?

Overview for this question:
In our organization which has been certified to ISO/TS 16949:2009, we have a calibration laboratory which is preparing itself to be accredited against to ISO/IEC 17025:2005. But some assessors said us that we shall have a separated set of documents for laboratory despite those we provided for our quality management system. For example, we have a documented procedure for document control (according to ISO 9001 clause 4.2.3) and our laboratory also uses this procedure for controlling its documents. Assessors believe that we shall have an independent procedure (with different identification code) for laboratory regardless of that created for QMS (including laboratory). Assessors have the same idea for other procedures such as internal audit or purchasing.
Thanks in advance.

 

[Stijloor]

Re: Request for clarification

Your internal lab must have a "Scope Statement." The scope statement includes: a listing of the specific tests performed, the devices/equipment used, the applicable standards/references, and the qualifications of the lab personnel.

Hope this helps.

Stijloor.

 

[Hershal]

Re: Does ISO/IEC 17025:2005 require the Laboratory to have separate ISO 9001 Procedur

There is some validity to what you have been told. An ISO9001 manual by itself does not address the requirements for lab accreditation usually. Specifically, things like proficiency testing and inter-laboratory comparison (PT/ILC), traceability, specific requirements for the management review, training required for internal auditors (the auditors must be able to audit the lab operations), and some specifics in other areas like purchasing.

Typically, the lab will have a "supplemental" manual that addresses the requirements for the lab that go beyond 9K. Base as much as possible on the parent's 9K manual, but have the additional for the accreditation requirements.

 

[ananthadd]

Re: Does ISO/IEC 17025:2005 require the Laboratory to have separate ISO 9001 Procedur

Hello all
I would be so grateful if someone answer the below question.

Question:
Does ISO/IEC 17025:2005 requires the laboratory which is part of an organization certified to ISO 9001:2008, to prepare a separated set of documents in spite of those provided according to ISO 9001:2008?

Overview for this question:
In our organization which has been certified to ISO/TS 16949:2009, we have a calibration laboratory which is preparing itself to be accredited against to ISO/IEC 17025:2005. But some assessors said us that we shall have a separated set of documents for laboratory despite those we provided for our quality management system. For example, we have a documented procedure for document control (according to ISO 9001 clause 4.2.3) and our laboratory also uses this procedure for controlling its documents. Assessors believe that we shall have an independent procedure (with different identification code) for laboratory regardless of that created for QMS (including laboratory). Assessors have the same idea for other procedures such as internal audit or purchasing.
Thanks in advance.

Yes Sir beyond doubt you need separate procedures to cover the technical requirements because 17025 is technical standard for calibration and testing. Cl 4 of 17025 will be a direct reflection of system requirements of ISO 9001 while cl 5 will be partly system and mostly technical.

Hope this clarifies

Best Regards

Ananth

 

[bazboy]

Re: Does ISO/IEC 17025:2005 require the Laboratory to have separate ISO 9001 Procedur

It's important to remember what works best for your company and not what the assessors like to see. Having said that I would have a separate 17025 procedure that that only contains processes that are unique to 17025. Much of 17025 can be covered by your 9001 QM eg document control, auditing etc.