Closing an ISO 13485 audit
Domain 6 covers the disciplined end of the audit: consolidating findings, running the closing meeting, reporting, and following up corrective action without becoming a consultant.
Consolidating findings
Review the evidence against the criteria with the team, confirm wording, classify each nonconformity and remove duplicates. Each must trace to objective evidence and to a specific requirement. Keep observations and improvement opportunities separate from nonconformities so the count stays honest.
Closing meeting
Present findings, their classification and the audit conclusion. Allow questions, and record any disagreement with the auditor's rationale in the report. Do not propose solutions - that is consulting - and do not promise certification. Agree dates for corrective action submission and verification, noting that effectiveness may only be verified at the next surveillance.
Report and follow-up
ISO 19011 report content: objectives, scope, criteria, team, dates, findings, conclusion and any scope limitations. For certification, the decision is made independently of the audit team. A major nonconformity normally must be corrected and verified before certification, or within a defined window; minor nonconformities have a defined closure period. Appeals and complaints routes must be available to the auditee.
Worked example
The auditee disputes a minor nonconformity against 4.2.4, arguing that the obsolete drawing was in the archive. The evidence shows the drawing was in the production area and in use at the workstation. The requirement concerns preventing unintended use, so the finding stands; the disagreement and the auditor's rationale are recorded in the report rather than argued away.
Traps that cost marks
Softening findings after pushback without new evidence; leaving the closing meeting without documenting who received the report; verifying a correction rather than the effectiveness of the corrective action; letting deadlines lapse unrecorded.