Decision Rules and Statements of Conformity

Purpose

To define how the Laboratory selects, documents, agrees with the customer, applies and reports decision rules when a statement of conformity to a specification or standard is provided, taking into account the level of risk associated with the rule, so that conformity statements are unambiguous and the customer understands the probability of a false accept or false reject.

What is inside

10 sections, about 4 pages when printed.

1. 1. Purpose
2. 2. Scope
3. 3. References
4. 4. Definitions
5. 5. Responsibilities
6. 6. Procedure
7. Records generated by this procedure
8. Monitoring and performance indicators
9. Assessment readiness notes
10. Related documents

Records it generates

Applying this procedure produces the following records, which are the evidence an assessor samples.

• –Decision rule agreements
• –Applied acceptance limits and outcomes
• –Default decision rules approval

What an assessor looks for

The document closes with these points, so you can check your own practice before someone else does.

• –Checking that the rule on a sampled certificate matches the agreement in the job file and that the acceptance limits were correctly computed with the job uncertainty.
• –Asking engineers to explain the risk associated with the rule they applied.
• –Looking for certificates with pass / fail but no stated rule, or 'in tolerance' claims based on the CMC rather than the job uncertainty.
• –Checking treatment of borderline results and rounding.

Before you use it

• Replace every square-bracket token, starting with [LABORATORY NAME], [ADDRESS] and [EFFECTIVE DATE]. The full token list is in GD-01 Read Me First.
• Have the content technically reviewed against how your laboratory actually works, then approved by the responsible manager before it becomes a controlled document.
• Update the Word fields after editing so the table of contents and page numbers are correct: select all, then press F9.
• Record the document in your own document register and set its review date.
• Delete the assessment readiness notes if you do not want them in your controlled version; they are guidance for you, not requirements.

Related documents

• QM-01

  Quality Manual

  Top-level description of the management system against every clause of ISO/IEC 17025:2017.

• SOP-18

  Reporting of Results and Calibration Certificates

  Content, review, authorisation, issue and amendment of certificates and reports, including opinions and interpretations.

• SOP-27

  Review of Requests, Tenders and Contracts

  Capturing and reviewing customer requirements, capability, decision rules and deviations before work starts.

• SOP-31

  Use of the Accreditation Symbol and Reference to Accreditation

  Rules for using the accreditation body's symbol and claiming accredited status on certificates and marketing.

• FRM-31

  Contract Review and Quotation Record

  Customer requirements, capability check, decision rule, uncertainty, deviations and acceptance.

• FRM-34

  Decision Rule Agreement Record

  Records the decision rule, guard band and conformity statement format agreed with the customer.

• FRM-29

  Calibration Certificate Template

  Certificate layout containing every element required by clause 7.8.2 and 7.8.4.

• CHK-01

  ISO/IEC 17025:2017 Gap Analysis and Self-Assessment

  Clause-by-clause self-assessment with evidence, gap and action columns.