Ensuring the Validity of Results

Purpose

To define how the Laboratory monitors the validity of its results through a planned programme of internal quality control and participation in proficiency testing (PT) and interlaboratory comparisons (ILC), records the data so that trends are detectable, analyses the data, and acts when results fall outside pre-defined criteria.

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.

• –QC plans and control charts with monthly reviews
• –Intermediate check records
• –PT / ILC plan and participation records including submissions, reports and evaluations
• –Investigations and corrective actions

What an assessor looks for

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

• –Asking to see the control chart for the discipline being witnessed and whether the last review signature is recent.
• –Checking that the PT plan covers every scope area over the cycle and that gaps are justified.
• –Examining how an unsatisfactory or warning result was investigated and what happened to customer work.
• –Confirming PT items were handled through the routine process by routine staff.

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-30

  Intermediate Checks of Reference Standards and Equipment

  Checks between calibrations that maintain confidence in the calibration status of reference standards.

• FRM-27

  Proficiency Testing and ILC Plan and Participation Record

  Four-year PT/ILC plan by scope area and the record and evaluation of each participation.

• FRM-28

  Quality Control Chart Log

  Check-standard results plotted against warning and action limits, with trend review.

• CHK-01

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

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

• SOP-01

  Control of Documents

  Creation, review, approval, issue, change and withdrawal of internal and external documents.

• SOP-02

  Control of Records and Technical Records

  Identification, storage, protection, retention, amendment and disposal of quality and technical records.

• SOP-03

  Internal Audit

  Planning, conducting, reporting and following up internal audits of the management system and technical activities.