Your ISO 9001 certification audit is scheduled. Now what? The difference between a smooth, first-time certification and a stressful experience with multiple non-conformities is preparation. This comprehensive checklist covers everything you need to have ready for both Stage 1 (document review) and Stage 2 (on-site implementation) audits.
Elite Assured Clients Pass First Time — Every Time
Elite Assured conducts a thorough pre-certification internal audit and helps you close all gaps before the certification body auditor arrives. Our clients have a near-100% first-time certification pass rate because we prepare them completely. This checklist represents what we verify in our pre-audit preparation.
Stage 1 Audit — Document Review Checklist
Stage 1 is typically conducted remotely — the auditor reviews your documents online or via submission. Have these ready:
Core QMS Documents
- ☐ QMS Scope document — clearly defines what is included/excluded
- ☐ Quality Policy — signed by top management, displayed/communicated
- ☐ Quality Objectives — measurable, assigned to owners
- ☐ Organisation chart — current and accurate
- ☐ Process map or process interaction diagram
Risk and Context
- ☐ Interested parties analysis — customers, regulators, employees identified
- ☐ Internal and external issues analysis (SWOT or PESTLE)
- ☐ Risk and opportunity register with treatment actions
Required Procedures
- ☐ Document and records control procedure
- ☐ Internal audit procedure
- ☐ Corrective action procedure
- ☐ Non-conforming output procedure
- ☐ Customer complaint procedure
- ☐ Training and competency procedure
- ☐ Supplier evaluation procedure
Stage 2 Audit — Implementation Checklist
Stage 2 is the on-site audit — the auditor verifies that your QMS is actually working in practice. Evidence to prepare:
Quality Objectives Evidence
- ☐ KPI data collected for at least 3 months
- ☐ Analysis showing trends and whether targets are being met
- ☐ Actions taken where objectives are not being met
Customer Feedback Evidence
- ☐ Customer satisfaction survey results (or other feedback mechanism)
- ☐ Customer complaint register with all recent complaints and resolutions
- ☐ Evidence of customer communication per your procedure
Supplier Management Evidence
- ☐ Approved supplier list
- ☐ Supplier evaluation records for key suppliers
- ☐ Purchase orders and supplier performance records
Production/Service Evidence
- ☐ Work instructions available at workstations
- ☐ Production/service records showing process controls are followed
- ☐ Non-conforming output records with disposal decisions
People Preparation
Certification auditors interview your staff. Make sure:
- Top management — Knows the Quality Policy and can explain quality objectives and their performance
- Quality manager / QMS coordinator — Knows the QMS structure, can navigate to any document
- Operations staff — Knows their documented procedures and where to find them
- All staff — Understand how their work contributes to quality objectives
Conduct a brief QMS awareness session with all staff 2-3 weeks before the audit. Elite Assured can provide this as part of pre-audit preparation support.
Records Checklist
The auditor will ask to see records as evidence of implementation. Have at least 3 months of records for:
- ☐ Training attendance records and competency assessments
- ☐ Calibration certificates for all measuring equipment (current, not expired)
- ☐ Incoming material inspection records
- ☐ Production quality records and inspection sign-offs
- ☐ Delivery and customer order records
- ☐ Customer complaint register (even if no complaints — show the register)
- ☐ Non-conforming output register (even if none — show the register)
- ☐ Corrective action register with status of all open and closed actions
5 Most Common Non-Conformities — Avoid These
| Non-Conformity | How to Avoid |
|---|---|
| Quality objectives not being measured | Collect and document KPI data for at least 3 months before audit |
| Calibration certificates expired | Check all calibration certs 4 weeks before audit; renew any expiring within 3 months |
| Staff unaware of Quality Policy | Display Quality Policy prominently and conduct brief awareness session |
| Supplier evaluation not done | Complete at least one formal evaluation for each major supplier before audit |
| Corrective actions overdue | Review CA register and close all overdue items before audit |
On the Day of the Audit — Do's and Don'ts
Do:
- Greet the auditor professionally and provide a brief company overview
- Answer questions honestly and concisely — extra information is not helpful
- Say "I'll need to check that" if you're unsure — don't guess
- Have someone available to accompany the auditor through the facility
Don't:
- Argue with the auditor about findings — listen, acknowledge, and ask for clarification if needed
- Leave auditors unaccompanied
- Create records on the day of the audit — it is obvious and creates credibility problems
- Have staff absent who are named in key procedures