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Decision Rule Sop

This document outlines the procedure for implementing decision rules when assessing conformity. It discusses when and how to apply decision rules according to ISO 17025, including when determining if measurement results are valid, during contract reviews, and when reporting statements of conformity. The key aspects covered are using measurement uncertainty to determine if results comply with specifications, applying decision rules when requested by customers, and authorizing those who assess conformity statements. Exemptions from using ISO 17025 decision rules are also described.

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Nageswara rao
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2K views

Decision Rule Sop

This document outlines the procedure for implementing decision rules when assessing conformity. It discusses when and how to apply decision rules according to ISO 17025, including when determining if measurement results are valid, during contract reviews, and when reporting statements of conformity. The key aspects covered are using measurement uncertainty to determine if results comply with specifications, applying decision rules when requested by customers, and authorizing those who assess conformity statements. Exemptions from using ISO 17025 decision rules are also described.

Uploaded by

Nageswara rao
Copyright
© © All Rights Reserved
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd
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Page 1 of 4

REF.NO:VPL/SOP-

DESCRIPTION
Procedure for Decision rule

SOP NO. TITLE ISSUE NO.


Procedure for Decision rule 0.0

Effective Date:

NAME DESIGNATION FUNCTION SIGNATURE DATE


Manager-Technical Preparation
Manager-QA Review & Approval

Revision History

ISSUE NO. EFF. DATE


3.2 REVISION SUMMARY

Distribution of this current issue:

Quality Manager, Work Place

PURPOSE

PROCEDURE FOR DECISION RULE Doc.No. VLP/SOP –


SOP No.: Issue dated:
Page 2 of 4

REF.NO:VPL/SOP-

DESCRIPTION
Procedure for Decision rule

Decision Rule is a statement of rules describing how you will use the Measurement Uncertainty (MU) in
relation to the measurement results and tolerance to come up with a pass or failed decision.

2. SCOPE

This procedure is applicable to statement of conformity in all the test reports issued by the
laboratory.

3. RESPONSIBILITY

Technical Manager is responsible person for issuing of the verified reports.

4. REFERENCES

Clause 3.7 & 7.1.3 of the Quality Manual

PROCEDURE

5.1.1 Decision Rule Implementation is mentioned or implied to be implemented in various activities


such as in contract review, reporting of results, interpretation of results, verification process, and
conformity assessment.

Whenever we hear or read the term conformity assessment or statement of conformity, it is


referring to the decision rule to determine conformance with specifications – the pass or fail decision.

The following are some of the related activities (with clauses) that prompt us when to implement the
decision rule as per ISO 17025.

1. When it is required by a customer as part of the contract review as per clause 7.1.3.


– The initiation of a decision rule implementation starts when a customer requests it. Therefore, it
is our job to ensure that we get the request of the customer regarding their tolerance and the
decision they want to use, on the other hand, it should be clear for us (and the customer) that the
customer has NOT required it.
2. When the uncertainty of measurements has an effect on the validity of the measurement results
(clause 7.8.3.1c) – This is the main requirement of a decision rule, accounting for the
measurement uncertainty to determine the validity of measurement results. During the
interpretation of results to determine compliance with specifications a decision rule that will be
displayed in the report based on interpretations of the lab.
3. The certificate shall include where relevant, a statement of conformity with requirements, or
specifications 

PROCEDURE FOR DECISION RULE Doc.No. VLP/SOP –


SOP No.: Issue dated:
Page 3 of 4

REF.NO:VPL/SOP-

DESCRIPTION
Procedure for Decision rule

4. During the reporting of Statements of conformity – it should be clear what decision rule is used
during the interpretation of results for conformity assessment.
And in connection with this, any person that is assigned to assess a statement of conformity should be
authorized.

When Not to Apply ISO 17025 Decision Rule?

1. If there is a standard guide or method that we follow, usually prescribed by regulatory bodies like
ASTM standards and government-provided acceptance criteria, there is no need to implement the
decision rule prescribed by ISO 17025. 
2. When a customer requires a conformity assessment without accounting the Measurement
Uncertainty (MU).
3. When MU is negligible that it is not needed to be included in the Decision Rule – this happens
when you have very accurate instruments. But in reality, this is difficult or very expensive to
attain.

6. REFERENCE

LAC_G8_09_2019_Guidelines on decision rules and statements of conformity

PROCEDURE FOR DECISION RULE Doc.No. VLP/SOP –


SOP No.: Issue dated:

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