Preparation of an ISO/IEC 17025 assessment
This domain tests assessment preparation: defining scope and criteria, selecting a competent team, reviewing documentation, assessing risk and writing a plan that can actually be executed.
Preparation sequence
- Confirm authority, objectives, scope, criteria and assessment type: initial, surveillance, reassessment or extension.
- Select the team: lead assessor, technical assessors for each scope area, and trainees or observers; check competence and independence under ISO/IEC 17011.
- Review documents: application, scope, organisation chart, procedures, method lists, uncertainty budgets, traceability charts, proficiency testing and interlaboratory comparison records, internal audit and management review records, and previous findings.
- Assess laboratory risk: new staff, new methods, high volume, complaints and prior nonconformities; use this to allocate time.
- Write the assessment plan: dates, sites, activities, clauses, assessors, interviews and witnessing; share it with the laboratory in advance.
- Confirm logistics: access, PPE, safety, sample witnessing and equipment availability.
Worked example
A food microbiology laboratory applies to extend its scope to Legionella testing by culture. The lead assessor reviews the application and sees no proficiency testing record for Legionella and a new biosafety level 2 area. The plan should include a technical assessor with Legionella and microbiology competence, a site walk of the BSL-2 area, review of method validation and uncertainty, witnessing of sample processing, review of proficiency testing enrolment and interviews with the technical manager and analyst. A generic checklist would miss the biosafety and proficiency testing risks. The reasoning: scope-specific risk drives team and plan, not the template.
Traps
- Copying a plan from a previous assessment without adjusting to the scope.
- Choosing a technical assessor whose expertise does not cover the scope.
- Skipping document review and finding basic gaps only on site.
- Not checking prior nonconformities and their closure.
- Planning no time for witnessing and traceability trails.
- Not confirming the exact scope wording.