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Question about clause 4 of ISO17025:2017

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Guest user Created:   Jan 26, 2022 Last commented:   Feb 07, 2022

Question about clause 4 of ISO17025:2017

I want to ask a question about the impartiality clause in the ISO17025:2017 standard. I understand all the requirements about the impartiality, but as an auditor of the laboratory i want to ask you, How should i audit this clause of the standard? Which document or information should i be looking for to make a decision if the laboratory is compliant to this clause. The same goes with confidentiality.
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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 Jan 28, 2022

You need to look for evidence of management commitment, organizational and operational structure and management that ensures conformity to impartiality and confidentiality is achievable. This is shown through organization authority and responsibility for activities been given to personnel and operational personnel being on the same page when it comes to quality (for example production are not authorised to put undue pressure on the laboratory to take shortcuts, or procurement not forcing the use of inferior quality materials that could impact results).

Management commitment is also shown through management establishing suitable policies and enforcing them through acknowledgement and contractual (legal) obligation of personnel. Further evidence would be of management providing awareness sessions or training with personnel.  

Further evidence would be of management provided awareness sessions or training with personnel.  Look for evidence that the laboratory considers risks to impartiality and confidentiality during activities such as personnel recruitment, procurement, client contracts and external provider evaluations. These processes are established to safeguard impartiality and confidentiality and identify risks at the time, while assessment and review of these activities during internal audits and management review allows for the review of risk identification and response to risks. Evidence to look include records relating to audits, personnel recruitment, procurement, client contracts and external provider evaluations as well as risk assessments, management review discussion and results.

Have a look at my replies to similar questions:

For more information on Impartiality, also have a look at the article How to ensure impartiality in an ISO 17025 laboratory at https://advisera.com/17025academy/blog/2020/10/12/ensuring-impartiality-in-an-iso-17025-laboratory/ 
and the ISO 17025 toolkit at https://advisera.com/17025academy/iso-17025-documentation-toolkit/

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Guest user Feb 04, 2022

Could you tell me more about the requirement of clause 6.4.10?

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Tracey Evans Feb 07, 2022

This requirement refers to the need for intermediate checks on equipment to be performed according to a procedure. For certain equipment, external certified calibration (as per ISO 17025 calibration requirements), is required to conform the equipment is suitable for use and to provide metrological traceability and a measurement uncertainty for that step in the testing process (for example the use of a balance to weigh a sample). For equipment which could impact the validity of test results, intermediate checks (i.e. verifications) must be performed inhouse at suitable intervals until the next external calibration to confirm the equipment is still in calibration (i.e. has not deteriorated or drifted). This maintains confidence in the performance of the equipment. This is achieved by using traceable reference materials, or artifacts (such as certified weight pieces). The procedure could be a written work instruction or diagram, for example for the Daily verification of analytical balances.

For more information see the question and response to Are intermediate checks required for calibration laboratories? at https://community.advisera.com/topic/are-intermediate-checks-required-for-calibration-laboratories/ There are alse some useful links on that page that will assist you.

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