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Your Pre-Certification Audit Checklist
May 15, 20264 min readAuditsBy ExceleorQMS Editorial Team
Pre-Certification Audit Checklist
Your certification audit is scheduled. Now what? This checklist will help you prepare thoroughly and avoid the most common pitfalls that delay certification.
30 Days Before
•Complete a full internal audit of all applicable clauses
•Close all major non-conformities from internal audits
•Verify all CAPA actions are completed and effective
•Ensure management review has been conducted
•Confirm all required procedures are documented and approved
14 Days Before
•Brief all staff on the audit process and expectations
•Organize all objective evidence for easy retrieval
•Verify calibration records are current
•Review training records for completeness
•Conduct a mock audit with a colleague
7 Days Before
•Confirm the audit schedule with your registrar
•Prepare the opening meeting presentation
•Set up the audit room with necessary documents
•Ensure key personnel are available during audit dates
•Review your quality policy and objectives — auditors always ask about these
Day of the Audit
•Be on time and professional
•Answer only what is asked
•Show objective evidence, don't just tell
•Take notes on any findings
•Stay calm — auditors are allies, not adversaries
Common Pitfalls
1.Not doing a pre-audit internal audit — This is your dress rehearsal
2.Rushing document reviews — Approve documents with enough time for staff to be trained
3.Ignoring competency records — Every person doing quality-affecting work needs documented evidence of competency
4.Incomplete management review — All ISO-required inputs and outputs must be covered
5.No evidence of corrective action effectiveness — Closing CAPAs without verifying they worked
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