Conducting an ISO/IEC 17025 assessment
This domain tests on-site conduct: the opening meeting, evidence gathering by interview, observation and document review, sampling, technical witnessing and writing defensible findings.
Conduct
- Opening meeting: confirm scope, criteria, plan, confidentiality, safety, sampling approach and closing meeting.
- Collect evidence from multiple sources and trace a sample, test or calibration end to end: request, contract review, method, sample receipt, equipment status, environmental conditions, raw data, calculation, uncertainty and report.
- Witness technical work; ask open questions; compare practice with procedure and standard.
- Sample across shifts, sites, staff and scope; follow the risk, not just the available binder.
- Record findings with three elements: requirement, objective evidence and the gap. Avoid opinions and prescribed solutions.
- Keep the auditee informed and escalate significant risks.
Worked example
While witnessing a tensile test, the assessor sees the load cell used on a machine whose calibration due date passed two months ago; the equipment log shows it has been in use. The assessor checks the calibration certificate and equipment record, confirms the date and interviews the technician. Criterion: clause 6.4 requires equipment to be calibrated at specified intervals before use, with records. Evidence: expired certificate, use log and technician statement. Finding: the 100 kN load cell was used after its calibration due date; clause 6.4. This is a nonconformity; the assessor does not simply accept that the error was small. The laboratory must also evaluate the validity of results since the due date under 7.10.
Traps
- Writing findings without the requirement or the evidence.
- Leading questions and accepting the first answer.
- Auditing only documents and never observing work.
- Missing the effect on past results.
- Debating corrective action during the audit instead of recording the finding.
- Changing the plan without recording why.