ISO 17025
Readiness Checklist

Assessors ask to see current calibration certificates and maintenance logs for every instrument in scope. They want to verify nothing is past due and that out-of-tolerance events triggered corrective action.

Each analyst's training must be documented, current, and tied to specific test methods. Assessors look for gaps between who is authorized to run a test and whose training record supports it.

Assessors pull open CAPAs and look for documented root cause analysis and evidence of closure. A CAPA with no root cause or no verified closure is an immediate finding.

Every out-of-spec result and process deviation must be recorded, evaluated for client impact, and resolved. Assessors check whether you can demonstrate a consistent nonconformance response workflow.

Your LIMS must demonstrate data integrity controls — access logs, change history, backup procedures, and evidence that unauthorized modification is prevented or detected.

Assessors verify that current, approved SOPs are in use — not superseded versions. They check for approval signatures, effective dates, and controlled distribution records.

PT participation records must show enrollment, results received, and that unsatisfactory performance triggered an investigation. Assessors check that your PT program actually covers your accredited scope.

Annual management review meetings must be documented with evidence that required inputs were reviewed (CAPA status, PT results, complaints, resource adequacy) and that outputs drove action.

Internal audit records must show scope, schedule, findings, and follow-up. Assessors look for whether internal audit findings feed your CAPA system — not whether they were found and forgotten.

Documented policies and signed acknowledgments from personnel covering impartiality are required. Assessors check for current signatures and evidence that impartiality risks are actively managed.

Assessors ask how you verify that you can actually perform a test before accepting a sample. They want records showing scope review, any client notifications of deviations, and subcontract decisions.

Documented risk assessments covering your laboratory operations are required. Assessors look for evidence that identified risks have mitigation actions assigned and tracked — not a static document filed once.