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Laboratory Certifications for ISO9001 and 17025

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Guest user Created:   Apr 13, 2023 Last commented:   Apr 13, 2023

Laboratory Certifications for ISO9001 and 17025

One of our customers has mandated ISO9001 and also 17025 in specific areas. Are these two separate certifications or can they be combined?

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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 Apr 13, 2023

Both ISO 9001 and ISO 17025 are quality management systems. ISO 9001 is focussed on the quality of service delivery while ISO 17025 focus is on technical competency. ISO 7025 and ISO 9001 are assessed by different bodies. An accreditation body assesses the performance and awards ISO 17025 accreditation to laboratories that show competence to produce consistent valid test or calibration results. Certification bodies audit organisations and award ISO 9001 certification if the QMS requirements are met. This typically includes non laboratory departments, for example finance, procurement and Human resources. If the laboratory is not seeking ISO 17025 accreditation, they can apply for ISO 9001 certification, however it does not provide confidence in the technical competence of the laboratory. If the customer requires the organisation as a whole to be ISO 9001 certified, with ISO 17025 accreditation for the laboratory, the management of the systems can be integrated with common approaches to for example, complaints and risk analysis; however the assessments will be separate.

For more information on the purpose of ISO 17025 as well as Option A and B for laboratories, see https://community.advisera.com/topic/completing-implementation/  and the articles  
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/
What is ISO 17025? at https://advisera.com/17025academy/what-is-iso-17025/ and the white paper
Clause-by-clause explanation of ISO 17025:2017 available at https://info.advisera.com/17025academy/free-download/clause-by-clause-explanation-of-iso-17025

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Apr 13, 2023

Apr 13, 2023

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