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Documents for measurement systems

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Guest user Created:   Oct 08, 2021 Last commented:   Oct 10, 2021

Documents for measurement systems

Let say our lab have 2 type of measurement system, do we need to provide document for both the system? If in the future we have additional system for other measurement, do we need to reapply for the certification? By the way, the information you share with me is very useful, thanks a lot

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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.

Expert
Tracey Evans Oct 10, 2021

Laboratories apply for ISO 17025 accreditation once they have implemented the requirements of ISO 17025 into their management system. Because ISO 17025 is a competency standard, the laboratory must show technical competency for all the methods applied for, i.e. methods on the Scope of accreditation to ISO 17025.That means for each test or calibration method, the laboratory must meet the technical requirements including a suitable method to meet the need of the client, method validation, internal quality control, and proficiency testing. Once initial accreditation is obtained, the laboratory can “extend the scope” by adding addition test methods. Note in some cases the test methods may be in a different discipline and accreditation program, for example a labortory may initially only include chemistry and then later add Microbiological methods. for accredition. This may require you to meet other regulatory requirements and specific requirements from the Accreditation Body for that program.

Then note that in some cases a laboratory can apply for a “flexible scope of accreditation”. This means that after initial accreditation and the scope of accreditation is published by the accreditation body (i.e. competency was demonstrated),  the laboratory can add additional activities that are considered to be within scope of accreditation without applying for extension of scope. This mechanism is applicable as a example, to a specific methodology / technique that is accredited for certain analytes and then the laboratory can develop the technique to add further analytes using the same methodology. FO example . The degree of flexibility will vary between technical disciplines and conformity assessment activities, so the laboratory must adhere to the policies of the Accreditation body.

For more information on flexible scopes, guided by ILAC, see ILAC G18:04/2010 Guideline for the Formulation of Scopes of Accreditation for Laboratories (under revision) available from https://ilac.org/publications-and-resources/ilac-guidance-series/. I suggest you then contact your accreditation body for specific requirements.

For more information on ISO 17025 see What is ISO 17025? at https://advisera.com/17025academy/what-is-iso-17025/ and the Free webinar – What are the steps in the ISO 17025 accreditation process? at https://advisera.com/17025academy/webinar/what-are-the-steps-in-the-iso-17025-accreditation-process-free-webinar/

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Oct 08, 2021

Oct 10, 2021

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