Compliance Checklists
Expert-level, interactive audit checklists with objective evidence requirements, common nonconformities, and auditor tips. Free to use online — PDF export available.
Internal Audit Checklist
Clause-by-clause audit questions covering Sections 4 through 8. Use for internal audits, management reviews, or pre-certification preparation.
View Checklist → FDA QMSR (21 CFR 820)QMSR Transition Checklist
Verify your QMS alignment with the FDA's Quality Management System Regulation. Covers QMSR transition, §820.35 records, §820.45 labeling, and FDA inspection readiness.
View Checklist → ISO 9001:2015Gap Analysis Checklist
Systematic gap analysis covering Clauses 4 through 10. Identify where your QMS meets, partially meets, or gaps against ISO 9001:2015 requirements.
View Checklist → AS9100D:2016Aerospace Audit Checklist
Aerospace-specific requirements beyond ISO 9001: counterfeit parts prevention, first article inspection, configuration management, special processes, and product safety.
View Checklist → EU MDR 2017/745EU MDR Compliance Checklist
European medical device regulation covering technical documentation, clinical evaluation, post-market surveillance, UDI, vigilance, and economic operator obligations.
View Checklist → MDSAPMDSAP Audit Checklist
Multi-jurisdictional audit program covering FDA, Health Canada, TGA, ANVISA, and MHLW requirements across 7 process chapters plus cross-jurisdictional gap analysis.
View Checklist → ICH Q10ICH Q10 PQS Audit Checklist
Pharmaceutical Quality System covering management responsibility, the four PQS elements (process performance and product quality monitoring, CAPA, change management, management review), and continual improvement across the product lifecycle.
View Checklist → ISO 14971ISO 14971 Risk Management Checklist
Medical device risk management covering the risk management process and file, risk analysis, risk evaluation, risk control, overall residual risk evaluation, the risk management review, and production and post-production monitoring.
View Checklist → ICH Q7ICH Q7 API GMP Audit Checklist
Good Manufacturing Practice for active pharmaceutical ingredients — quality management, personnel, facilities, equipment, documentation, materials management, production controls, packaging, laboratory controls, validation, change control, complaints and recalls, contractors, plus APIs from cell culture/fermentation and for clinical trials.
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