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Posted on 04 Oct,2025


Decision Rules in ISO/IEC 17025: What Labs Must Know

One of the key requirements of ISO/IEC 17025:2017 is the application of decision rules when reporting statements of conformity (e.g., pass/fail, compliance/non-compliance). This ensures that laboratories make technically valid and transparent judgments based on measurement results and associated uncertainty.

???? What are Decision Rules?

A decision rule is the rule or criterion used by a laboratory to decide whether a test or calibration result conforms to a specified requirement. It defines how measurement uncertainty is considered when comparing results against specification limits.

???? Why are Decision Rules Important?

ยท         They reduce the risk of false acceptance or rejection of results.

ยท         Provide consistency and transparency in reporting.

ยท         Help customers understand the confidence level behind conformity statements.

???? ISO/IEC 17025 Requirements (Clause 7.8.6.1 โ€“ 7.8.6.2):

ยท         Labs must apply appropriate decision rules when stating compliance with specifications.

ยท         If no decision rule is prescribed by the standard, regulatory body, or customer, the lab must agree on the decision rule with the customer.

ยท         The decision rule used must be clearly communicated in the test/calibration report.

???? Common Types of Decision Rules

1.      Simple Acceptance Rule: Result is directly compared with the specification limit (ignores uncertainty).

2.      Guard Banding: Adjusting acceptance limits to account for measurement uncertainty, reducing the risk of false decisions.

3.      Shared Risk Approach: Assigning a certain probability of compliance (e.g., 95% confidence level).

???? What Labs Must Do

ยท         Understand customer and regulatory requirements.

ยท         Evaluate and document the measurement uncertainty.

ยท         Define and agree on the decision rule before testing/calibration.

ยท         Apply the rule consistently and record it in reports.

โœ… Key Takeaway

Decision rules ensure that laboratories not only provide accurate results but also make defensible compliance decisions considering measurement uncertainty. For ISO/IEC 17025 accredited labs, mastering decision rules is crucial for credibility, customer trust, and compliance with the standard.


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