Get 2 Documentation Toolkits for the price of 1
Limited-time offer – ends March 28, 2024

Expert Advice Community

Guest

Statement of conformity

  Quote
Guest
Guest user Created:   Mar 02, 2021 Last commented:   Mar 02, 2021

Statement of conformity

we are into calibration Lab, is it possible to give statement of conformity in our calibration certificates without considering the Measurement uncertainty on a request note of the customer.

1 0

Assign topic to the user

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 Mar 02, 2021

Simply stated, measurement uncertainty cannot be ignored when it comes to conformity statements reported under accreditation. During contract review a laboratory must confirm with the customer that it can meet the requirements for accuracy and are able to perform the measurements. The issue of Measurement uncertainty must be discussed and evaluated to avoid the risk of false pass (acceptance), as the uncertainty could result in the measurement reported being larger than the specification, due to the uncertainty component,

If the expanded measurement uncertainty is smaller than the accuracy requirements of the regulators or client, then the agreed decision rule could, for example, be: “PASS” indicates that the test method conforms with the accuracy requirements of the testing standard. The expanded measurement uncertainty (k = 2 ,95 %  probability) is not greater than the accuracy requirements defined as <value>. You could also refer to a table.

For more information, refer to the ILAC guideline G8:09/2019 Guidelines on Decision Rules and Statements of Conformity available for download from https://ilac.org/publications-and-resources/ilac-guidance-series/ and refer to your accreditation body requirements. A good example of a guideline from an accreditation body is the UKAS Lab 48 Decision Rules and Statements of Conformity, available from hhttps://www.ukas.com/resources/publications/laboratory-accreditation/

Quote
0 0

Comment as guest or Sign in

HTML tags are not allowed

Mar 02, 2021

Mar 02, 2021

Suggested Topics

Guest user Created:   Sep 05, 2023 ISO 17025
Replies: 1
0 0

Calibrating laboratories

Guest user Created:   Jun 23, 2023 ISO 17025
Replies: 3
0 0

Statement of of conformity

Guest user Created:   Aug 17, 2020 ISO 17025
Replies: 1
0 0

Clause 7.2.1.3