ISO/IEC 17025:2017 Clause 8 & Annex B

[Douglas E. Purdy]

I have performed a Google search and I have searched Elsmar Cove for reference materials by CBs for the changes to the requirements. I am wanting verification as to my understanding of the Management system requirement - particularly a clear understanding of Option A VS. Option B.

Option A ["minimum requirements for implementation of a management system in a laboratory" - Annex B.2]. is pretty much a listing of eight (8) Management System Clauses worded very closely to those in the Second Edition 2005 that had 15 Management Requirements Clauses. Clauses 8.2 - 8.9 that govern Option A in the Third Edition [not including Clause 8.1.2] contains 26 'shall's with an additional 46 sub-conditions identified [e.g., a), b), etc.].

Option B ["Laboratories that implement Option B of Clause 8 will therefore also operate in accordance with ISO 9001. Conformity of the management system within which the laboratory operates to the requirements of ISO 9001 does not, in itself, demonstrate the competence of the laboratory to produce technically valid data and results. - Annex B.3] has no 'shall's.

Annex B.4 "Both options are intended to achieve the same result in the performance of the management system and compliance with Clauses 4 to 7."

Does this mean that if Option A is chosen, that Clauses 8.1.2 and 8.2 - 8.9 will be audited in concert with a Registration to ISO/IEC 17025:2017 Third Edition? Whereas if Option B is chosen the Management system will not be audited in concert with a Registration to ISO/IEC 17025:2017 Third Edition - only as those deficiencies in 9001 affects compliance with Clauses 4 to 7?

 

[Le Chiffre]

re: ISO/IEC 17025:2017 Clause 8 & Annex B

The provision for an option B has been problematic for Accreditation Bodies, partly due to the unclear wording around the use of ISO 9001 instead of the clauses in section 8.
The understanding has been to assess either the Management System clauses in 17025 or 9001 as preferred by the laboratory. In practice, most opt for A as it has fewer requirements, but in neither case does the assessment skip the auditing of management system requirements.

 

[Douglas E. Purdy]

Yes, Thanks Le Chiffre for your response - coming from an Accreditation Body. That is what I would expect and want to hear. But with the Certification VS Compliance movement, the Third Edition certainly does not say it clearly. That is why I had to ask the question.

I guess if a laboratory is successful and goes through the rigors of obtaining certification to ISO/IEC 17025:2017 then they would choose Option A, unless the laboratory is within a Quality Management System that is certified to ISO 9001:2015 - then they might choose Option B.

I would presume if a laboratory is successful [I can't imagine how] and has gone the Compliance to ISO/IEC 17025:2017 route there would not be any need to choose either option and I guess it is up to the laboratory's client(s) and/or customer(s) to know this laboratory is not being monitored by a Certifying Body or an Accreditation Body to the ISO/IEC Standard.

 

[Douglas E. Purdy]

I guess if a laboratory is successful and goes through the rigors of obtaining certification to ISO/IEC 17025:2017 then they would choose Option A, unless the laboratory is within a Quality Management System that is certified to ISO 9001:2015 - then they might choose Option B.

I guess my follow-on question would be, when Option B is chosen, does the Certifying Body audit all the ISO 9001:2015 requirements - or just review the status of the laboratory's Certifying / Registrar's results for those deficiencies in 9001 that affects compliance with Clauses 4 to 7?

 

[Douglas E. Purdy]

Yes, Thanks Le Chiffre for your response - coming from an Accreditation Body. That is what I would expect and want to hear. But with the Certification VS Compliance movement, the Third Edition certainly does not say it clearly. That is why I had to ask the question.

ISO/IEC 17025:2017
1 Scope - 3rd PAR
"Laboratory customers, regulatory authorities, organizations and schemes using peer-assessment, accreditation bodies, and others use this document in confirming or recognizing the competence of laboratories."

Please correct me if I am not reading / understanding this statement in the scope correctly. but doesn't the scope of the standard seem to allow the Compliance movement to "use this document in confirming or recognizing the competence of laboratories"? It would appear that the ISO & IEC organizations meant to leave it open for laboratories that do not register their Management System to Registration & Accreditation Bodies. I would think that at a minimum a 'compliant' laboratory to ISO/IEC 17025:2017 would have to have "a scheme using peer-assessment."

 

[dwperron]

This all goes back to the time when ISO 9001 certification became important in the calibration world. You had customers that required it. It cost money, but you justified that as a cost of doing business.

Then 17025 came along. It had its own management system requirements. Most customers, however, still were looking for ISO 9001 certification, not ISO 17025. So laboratories began to ask themselves why they were going through the cost and effort to support two separate management systems.

In an effort to resolve this conflict ILAC, the international accrediting overseer, issued a communiqué that stated " The management system requirements in ISO/IEC 17025 are written in language relevant to laboratory operations and operate generally in accordance with the principles of ISO 9001. " It was a way for labs to eliminate having to seek both 17025 and ISO 9001 certifications. This letter was accepted by some ISO 9001 customers, but not all, so many labs continued to seek both certifications.

The 2017 revision of 17025 now directly addresses this issue. If a lab chooses to maintain ISO 9001 certification it is considered adequate as a management system for 17025 accreditation. This is taking Option B.

If they choose not to go with ISO 9001 then the lab must produce a management system consistent with the 17025 requirements. This is Option A.

 

[dwperron]

Also, a 17025 "compliant" lab is self policing.
They are not accredited, There has been no review of their program.

Unless a customer makes the effort to determine how "compliant" the lab is to 17025 they will never know. They will not get the accreditation logo on their certificates. They do not get the benefit of assured measurement traceability.

 

[Le Chiffre]

To be clear, even if a lab has a 9001 certificate and chooses Option B, the 17025 assessment will still include the management system, and findings could be cited against 9001 clauses or the labs own policies.

Personally I find this inefficient and against the spirit of the MLA/MRA principle, in the case where the 9001 certificate was issued by an accredited certification body.

 

[Douglas E. Purdy]

...
The 2017 revision of 17025 now directly addresses this issue. If a lab chooses to maintain ISO 9001 certification it is considered adequate as a management system for 17025 accreditation. This is taking Option B.

If they choose not to go with ISO 9001 then the lab must produce a management system consistent with the 17025 requirements. This is Option A.

Would love to accept your statement here regarding Option B, but I do not see where ISO/IEC 17025:2017 requires the laboratory to maintain an ISO 9001 certification [Within a Registrar / Accreditation Scheme]. That is why I think the 3rd PAR in the Scope needs revision. If ISO & IEC wants Compliance Movement Laboratories to "use this document in confirming or recognizing the competence of laboratories" I would think that the laboratory would have to have a scheme 'using peer-assessment' as a minimum. Just my thought in revising the Scope.

 

[dwperron]

Sorry if I led you to the wrong conclusion, but 17025 does not require ISO 9001 certification. Section 8 of 17025 says:

"The laboratory shall establish, document, implement and maintain a management system that is capable of supporting and demonstrating the consistent achievement of the requirements of this document and assuring the quality of the laboratory results. In addition to meeting the requirements of Clauses 4 to 7, the laboratory shall implement a management system in accordance with Option A or Option B."

ISO 9001 is not required, it is one of the options available for producing an acceptable management system. Annex B of 17025 explains this even further, including the rationale behind the options.