Checklist · CHK-01
ISO/IEC 17025:2017 Gap Analysis and Self-Assessment
Clause-by-clause self-assessment with evidence, gap and action columns.
Purpose
A clause-by-clause self-assessment of the Laboratory's management system against ISO/IEC 17025:2017, used at the start of implementation (gap analysis), before applying for accreditation, before each accreditation-body visit, and as the master question set for the internal audit programme. Each item states the requirement in summary and the evidence the ValiTrac pack provides; the Laboratory records the actual evidence, the gap and the action.
What it covers
- 4.1 Impartiality
- 4.2 Confidentiality
- 5 Structural requirements
- 6.2 Personnel
- 6.3 Facilities and environmental conditions
- 6.4 Equipment
- 6.5 Metrological traceability
- 6.6 Externally provided products and services
- 7.1 Review of requests, tenders and contracts
- 7.2 Selection, verification and validation of methods
- 7.3 Sampling
- 7.4 Handling of test or calibration items
How to complete it
- 1.Work through every item with the relevant procedure and records open; tick only when objective evidence exists and is in use (not merely a written procedure).
- 2.In the result column record C (conforms with evidence), P (partially - procedure exists but not fully implemented or evidenced), G (gap - no procedure or evidence), NA (not applicable, with justification).
- 3.Record the evidence reference (document ID, record number, date) for every C and P.
- 4.Transfer every P and G to the action plan at the end with an owner and date; re-assess when actions are complete.
- 5.Keep each completed assessment: the trend from first gap analysis to accreditation is useful evidence of improvement at management review.
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-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.
- SOP-04
Management Review
Annual top-management review with every input and output the standard requires.
- SOP-05
Corrective Action and Improvement
Raising, investigating, implementing and verifying corrective actions; capturing improvement opportunities.
- SOP-06
Risk and Opportunity Management
Identifying, evaluating, treating and reviewing risks and opportunities, including risks to impartiality.
- SOP-07
Complaints Handling
Receipt, validation, investigation, response and closure of complaints, independent of the people involved.