Free audit checklists
These checklists cover nine ISO, FDA and AS standards — 1357 items in total, each with objective evidence, common nonconformities, and auditor tips. Reading online is free and does not require an email; a PDF of any checklist is one email away.
Internal Audit Checklist
Clause-by-clause questions cover Sections 4 through 8, for internal audits or pre-certification prep.
View checklist → FDA QMSR (21 CFR 820)Audit Checklist
Covers the QMSR transition: section 820.35 records, section 820.45 labeling, and FDA inspection readiness.
View checklist → ISO 9001:2015Gap Analysis Checklist
Runs a gap analysis across Clauses 4 through 10, scoring each requirement as meets, partially meets, or gap.
View checklist → AS9100D:2016Aerospace Audit Checklist
Adds aerospace-specific items beyond ISO 9001: counterfeit parts, first article inspection, configuration management.
View checklist → EU MDR 2017/745Compliance Checklist
Covers technical documentation, clinical evaluation, post-market surveillance, UDI, vigilance, and economic operator duties.
View checklist → MDSAPAudit Checklist
Covers five jurisdictions (FDA, Health Canada, TGA, ANVISA and MHLW) across the audit’s process chapters.
View checklist → ICH Q10PQS Audit Checklist
Covers the Pharmaceutical Quality System: management responsibility, the four PQS elements, and continual improvement.
View checklist → ISO 14971:2019Risk Management Checklist
Covers the risk management process and file: analysis, evaluation, control, and production/post-production monitoring.
View checklist → ICH Q7API GMP Audit Checklist
Covers API GMP across quality management, facilities, materials, production, laboratory controls and validation.
View checklist →Get automated gap analysis
Upload your QMS documents and Aligntra checks them against any of these nine standards in minutes, with findings cited to the page and paragraph.