Preparing for Accreditation
What this domain tests
The pathway from a functioning laboratory management system to an accredited scope, and the roles of the accreditation body and the ILAC arrangements.
Core rules
- The accreditation body operates to ISO/IEC 17011; the laboratory is assessed against ISO/IEC 17025. ILAC P10 (traceability) and ILAC P9 (proficiency testing) are the policy documents assessors apply.
- Readiness precedes application - the system must have operated long enough to produce records: at least one full internal audit covering all clauses, one management review, corrective actions closed, PT participation with satisfactory performance, and traceability evidence for every method in the intended scope.
- Application - submitted with the proposed scope (tests/calibrations, methods, locations), quality documentation and legal entity evidence.
- Assessment sequence - document review, often a pre-assessment, then the assessment: opening meeting, interviews, witnessing of activities, review of technical records and uncertainty budgets, and traceability checks.
- Findings - nonconformities are graded by the AB's own rules; the laboratory submits root cause, correction, corrective action and objective evidence within the AB's stated timeframe.
- Decision - an independent decision-maker grants, extends or refuses accreditation; the certificate carries a schedule defining the accredited scope. Surveillance and reassessment then follow the AB's cycle.
- ILAC MRA - signatory ABs' accredited results are recognised internationally; the laboratory may use the accreditation symbol only within the accredited scope and per the AB's rules.
Worked example
The AB raises a nonconformity: statements of conformity are issued without a documented decision rule. A weak response is to delete the statements from reports. A strong response states the root cause (7.8.6 not translated into the report template), corrects affected reports, defines and documents the decision rule including uncertainty treatment, retrains authorised signatories, and provides evidence from the next ten reports.
Traps that cost marks
- Applying before a full audit-and-review cycle has been completed.
- Assuming accreditation covers all laboratory activities rather than the listed scope.
- Responding to findings with generic commitments instead of cause analysis and evidence.
- Using the accreditation symbol on reports outside the accredited scope.