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Statement of of conformity

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Guest user Created:   Jun 23, 2023 Last commented:   Sep 26, 2023

Statement of of conformity

Is it compulsory for the laboratory to have statements of conformity and decision rules.

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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 Jun 24, 2023

We need to start by clarifying terminology to understand what is mandatory or not. In the context of an accredited management system such as ISO 17025:2017, “having”, “considering”, “ communicating”, “defining”, “documenting” and “reporting” are all different requirements.

By ISO 17025:2017 requirements, you must consider the impact of measurement uncertainty on results as relates to any conformity statement or interpretation of a result (e.g. pass or fail, if with a tolerance level or out). That is, for each accredited test, you need to do a method risk assessment based on the method performance and measurement uncertainty evaluation. Consider the risk fir example, to the client or the laboratory on a “pass” which would be a “fail” if MU was taken into account.

It is mandatory

  • to define the rule, communicate the decision and risk to the customer, and have their agreement. i.e. they accept the rule and the risk (Refer to clause 7.1.3)
  • take risk into account, document and apply the decision rule (Refer to clause 7.8.6.1)
  • to include the reference to the standard (or regulatory requirement) and the decision rule, clearly associated with each result when there is a conformity requirement (e.g. a quantitative threshold or a condition).
  • to report which specifications/standards or parts were met based on the rule or parts thereof are met or not met (Refer to clause 7.8.6.2)

For more information and links to the Toolkit, have a look at my replies to similar questions:

ISO 17025 queries at https://community.advisera.com/topic/iso-17025-queries/
Statement of conformity at https://community.advisera.com/topic/statement-of-conformity/

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Guest user Sep 22, 2023

Please help me  on how the laboratory will address the regulatory requirement for reporting statement of conformity in the event of a request to calibrate a measuring instrument used for a regulated purpose as per ISO /IEC 17025:2005 CLAUSE 7.1.3

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Tracey Evans Sep 26, 2023

You asked

how the laboratory will address the regulatory requirement for reporting statement of conformity in the event of a request to calibrate a measuring instrument used for a regulated purpose as per ISO /IEC 17025:2005 CLAUSE 7.1.3"

Firstly, it is the requirements of the ISO/IEC 17025:2017, that is the Third edition, need to be met. The requirements for statements of conformity are covered in clauses 7.1.3 and 7.8.6.1. Secondly, understand that the decision rule is a rule that describes how measurement uncertainty is accounted for when stating conformity with a specified requirement. To address the regulatory requirement for reporting a statement of conformity, the calibration laboratory needs to understand the impact to the testing laboratory’s use of the measuring device. That is, the level of risk (such as false pass and false fail) if measurement uncertainty is added to the result or not.  For example,  consider if dealing with an upper tolerance, and the MU is not added, is there a risk of a false pass? Start by determining what the client and regulations require, assess the risk, and then document the decision rule to be applied to calibration results. Finally, remember to reference it in the calibration report.

For more information on ISO 17025 refer to Advisera ISO 17025 – Where to Start? at https://advisera.com/iso-17025/

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