Statement of of conformity

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/