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?
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?