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ISO 17025 Quality Manual Option B

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Guest user Created:   Jun 03, 2020 Last commented:   Jul 27, 2022

ISO 17025 Quality Manual Option B

I am working on the Quality Manual for ISO 17025 using the ISO 17025 Academy templates. Section 8 regarding Management Requirements. We are ISO 9001:2015 accredited so we are Option B. My question is do I delete sections 8.2-8.9? or do I just changed "8.1 Unitherm Furnace Complies with "Option B"?
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ISO 17025 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 17025 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

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Tracey Evans Jun 04, 2020

To answer your question - No, don’t delete section 8.2 to 8.9.

As your organisation is ISO 9001:2015 certified; when you implement ISO 17025:2017, Option B provides for the following arrangement - Your laboratory can use your already established ISO 9001:2015 quality management system to demonstrate compliance with the requirements for ISO 17025 clauses 8.2 to 8.9; if it was established to include laboratory activities and if it has been maintained in a manner that supports and demonstrates the consistent fulfilment of Clauses 4 to 7. This means that ISO 17025 requirements must be met in the way that the processes were established, how they are performed, documented and controlled. This would require a gap evaluation to determine to what extent this is met. Unless the ISO 9001 was implemented upfront with ISO 17025 in mind, revision of activities and documentation will be required.  Evidence must be available to demonstrate the effective implementation and maintenance as relates to the laboratory competency.  For example, the Internal Auditing process and programme must be reviewed to include technical audits.

The ISO 17025 Quality Manual serves to document the overall Lab Quality Management System, providing a way to reference and link all the requirements together in one place. Kindly refer to the toolkit document Quality Manual comment at section 8.1. It states “Option B Is available for a laboratory that has already established and maintained a management system in compliance with the requirements of ISO 9001. They are therefore considered to fulfill at least the intent of the management system requirements set out in clauses 8.2 to 8.9 of the ISO/IEC 17025 standard. If the laboratory is part of the parent organization’s Quality Management System, evidence of inclusion of laboratory activities must be present for clauses 8.2 to 8.9.”

Have a look at the article ISO 17025 vs. ISO 9001 – Main differences and similarities at https://advisera.com/17025academy/blog/2019/07/11/iso-17025-vs-iso-9001-main-differences-and-similarities// for some more insight on how ISO 9001 and ISO 17025 compare in scope.

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Robert Downes Nov 11, 2020

Do you need to run 2 manuals for option B? I already have 9001 in place and recently audited, and am working on 17025 for implementation in 4 months time.

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Tracey Evans Nov 16, 2020

You need not have a second manual, however for all the clauses covered in your ISO 9001 manual, you need to review, revise, integrate and demonstrate that you meet the ISO 17025 requirements, and those of your accreditation body.  As examples, the processes in place for ISO 9001 Complaints, Internal auditing and Management Review must cover the ISO 17025 requirements for those activities. A simple process flow and document matrix will be valuable to link the activities together in and between the two quality management systems. I would suggets this could be an expanded Document and record Master List where you include for each document the ISO 9001 and ISO 17025 requirement clauses the activities / processes support. As long as you have tha mandatory douments and processes in place to demostrate compliance with ISO 17025:2017, you can structure the docuemntation / manual as you wish.

The following will assist you confirm that the laboratory has the necessary procedures:

For more information, see the following similiar topic in the ISO 17025 Expert Advice Community
Implementing 17025 from 9001 at https://community.advisera.com/topic/implementing-17025-from-9001/

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Allastair Jul 23, 2022

We are ISO 17025 accredited and have been instructed to implement ISO 9001. Currently on Option A.

Is it better to integrate or have two separate manuals. The chances of having an integrated or combine audit is zero, since it is two separate bodies. There is a strong suggestion to integrate the manuals

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Tracey Evans Jul 27, 2022

Firstly a comment. As laboratories that are already ISO 17025:2017 accredited do not typically seek ISO 9001 certification, I assume you are referring to the larger organisation going for ISO 9001 certification for support departments like HR and Finance ? A laboratory that is accredited to ISO 17025 conforms to the requirements of ISO 17025 clause 8, Management requirements for laboratory activities. As these are the clauses covered in ISO 9001 management, It is considered that the laboratory fulfils the intent of ISO 9001.

You can refer to a similar question and reply, Are there any things in ISO 9001 not covered by ISO 17025? at https://community.advisera.com/topic/are-there-any-things-in-iso-9001-not-covered-by-iso-17025/

You asked

Is it better to integrate or have two separate manuals. The chances of having an integrated or combine audit is zero, since it is two separate bodies. There is a strong suggestion to integrate the manuals”

This is a organisational preference. If top management is the same for the ISO 17025 and ISO 9001 activities, then rather have one manual.  This is simpler, and duplication will be avoided. The argument for two separate manuals can be made if there are different people involved, for different departments, such as HR. I suggest you look at the risks of combining them, versus having them separate in terms of responsibilities for processes such as dealing with complaints and noncomformances, auditing, management review and couemntation.

For more information, see ISO 17025 – Main guidelines at https://advisera.com/17025academy/what-is-iso-17025/  and the article ISO 17025 vs. ISO 9001 – Main differences and similarities at https://advisera.com/17025academy/blog/2019/07/11/iso-17025-vs-iso-9001-main-differences-and-similarities/ for some more insight.

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