Completing implementation
I have a qeustion and I hope if you could give me the solution
In my organization we have Two systems the first is a laboratory system that has been established in accordance with International ISO /IEC 17025: 2017 and is applied and maintained ,this system have a guide to policies and procedures ,and this guide were mention that the laboratory implements the clause 8.1.2 option A in ISO 17025 , and this guide approved by the General Director of the organization and the Director of the Laboratories , this guide prepared by the quality manager in the Laboratories and after we implement the internal audit and the managemet review ,the lab will request the accredation .
The second system in the organization were applied ISO 9001: 2008 ,and the certificate has been expired , now the presentitive of the management want to transfere to ISO 9001 :2015 , and he request the quality manger of the laboratories to give him all the procedures and forms to make the code of ISO 9001 , is that true or the lab have to refuse to give the management representitive the procedures and forms (template) .and complete implemented the ISO 17025
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I understand you are asking whether the laboratory must provide the documentation you have (part of implemented ISO 17025 QMS) so that the “organization” can apply for ISO 9001:2015 certification. This is a business decision. From the view of developing one or more QMS systems, I don’t see how “refusing” will be considered if the laboratory were to benefit from ISO 9001 certification. Consider what makes up the “organization”. If the “organization” involves just the laboratory activities, then the documents are an essential part of achieving ISO 9001 certification, as the laboratory does not yet have ISO 17025 accreditation. If later you apply for accreditation, you can apply as option B (See the ISO 17025 standard Appendix B, for more information). This will speed the process up. On the other hand, if the “organization” system excludes the laboratory, only other business centers like finance, procurement, and human resources, it could be a simple agreement of collaboration between the laboratory and the larger organization / holding company.
Thank you for the reply . I have a question left. If the manual that contains the policies and procedures for the laboratory is approved by the general manager of the institution and he is seeking to implement the ISO 17025 system for accreditation and is requesting that at this time, is providing the person responsible for the request for transfer to ISO 9001: 2015 not considered canceling the laboratory manual, which has Its models and coding of the SOPs, in addition to the laboratory manual, which is currently applied, indicates that it follows option A and not option B in the ISO 17025 standard.
Are you asking if it is acceptable to keep the laboratory QMS based on ISO 17025, Option A, in other words as if there was no ISO 9001 certification, even if at the same time the organization is applying for ISO 9001?
The answer is for accreditation purposes there is no problem, you do not have to integrate the laboratory QMS into the ISO 9001 certification. This would be in order, even from an operational perspective, if the approach to management requirements is consistent. Otherwise, it will create confusion and gaps in the systems. For example, it would not make sense if the way you address nonconformances and risks in the laboratory as part of ISO 17025 compliance, is different from how it is done for ISO 9001 QMS. My recommendation would be to keep the laboratory registers separate, but the organisations' activities just falling under ISO 9001, (for example finance) should follow a process adapted from the laboratory processes and templates.
Lastly, if the laboratory is seeking accreditation to ISO 17025, there is no need to include the laboratory in the ISO 9001 certification scope as the laboratory is considered to operate in accordance with ISO 9001 principles. Refer to Annex B of the ISO 70125 standard.
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Apr 04, 2023