Decision Rule Agreement Record

Purpose

Records the specification and the decision rule agreed with the customer for statements of conformity, including the customer's acknowledgement of the associated risk, per clause 7.1.3 and SOP-29. It may be completed per job or once per customer and referenced on each FRM-31.

What it covers

• Specification against which conformity will be stated
• Decision rule
• Customer acknowledgement

How to complete it

1. 1.Present the Laboratory's rules (SOP-29 section 6.2) and recommend Rule A unless the customer's context suggests otherwise.
2. 2.Record the specification precisely (document, edition, clause, confidence level, tolerance values or formula).
3. 3.Record the rule selected, the guard band, the form of statement (binary / non-binary) and how borderline results will be reported.
4. 4.Obtain the customer's acknowledgement in writing (signature, e-mail reference or order clause).

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.

Related documents

• QM-01

  Quality Manual

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

• SOP-27

  Review of Requests, Tenders and Contracts

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

• SOP-29

  Decision Rules and Statements of Conformity

  Selecting, agreeing, applying and reporting decision rules, guard bands and conformity statements.

• FRM-31

  Contract Review and Quotation Record

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

• CHK-01

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

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

• FRM-01

  Master Document Register

  Register of every controlled internal and external document with revision, status and distribution.

• FRM-02

  Document Change Request

  Request, impact assessment and approval of a change to a controlled document.

• FRM-03

  Records Retention Schedule and Disposal Log

  Retention periods by record type and a log of authorised disposals.