Free QMS Gap Check: ISO 13485, ISO 9001, Food Safety, HACCP and More
Getting ready for an ISO 13485, ISO 9001 or food safety audit, or an FDA inspection? This free gap check shows where your quality system stands in about 5 minutes.
Choose your standard, answer about 20 questions with Yes, Partly, No or N/A, and get an instant report: a readiness score, your gaps by clause, and the A.P. Lyon procedures that close each one, with current prices. Your answers stay in your browser. There is no sign-up and nothing is sent to us.
What the gap check covers
ISO 13485 and FDA QMSR (21 CFR Part 820): 29 questions, from document control (4.2.4) and design controls (7.3) to complaint handling, medical device reporting under 21 CFR 803 and CAPA (8.5.2)
ISO 9001:2026: 24 questions across clauses 4 to 10, including context and climate change, design, external providers, nonconforming outputs, internal audit and management review
ISO 22000 and FSSC 22000: 28 questions on prerequisite programs, allergens, environmental monitoring, hazard analysis, the HACCP and OPRP plan, the FSMA food safety plan under 21 CFR 117, food defense and food fraud
HACCP: 11 questions for seafood (21 CFR Part 123), meat and poultry (9 CFR 416 and 417), juice (21 CFR Part 120) or restaurant specialized processes (FDA Food Code 3-502.11 and 8-201.14)
Dietary supplements (21 CFR Part 111): 16 questions, from specifications and identity testing to batch records, the quality control unit and serious adverse event reporting
Cosmetics (ISO 22716 and MoCRA): 14 questions on facility registration, product listing, adverse event reporting, safety substantiation and cosmetic GMP
How to read your results
Yes means the requirement is written down and you have records to show it. Partly means the work is done but the procedure or records are incomplete. Both Partly and No answers appear as gaps, with the clause, the requirement and the procedure that addresses it.
Your report then compares two ways to close the gaps:
Buy only the missing procedures. Pick them in Build Your QMS and the volume discount applies automatically: 20% off 5 to 9 procedures, 35% off 10 to 19, 50% off 20 to 39 and 60% off 40 or more.
Start from a complete system. When you have many gaps, a complete system often costs about the same and gives you one consistent set of documents. See the ISO 13485 systems, ISO 9001 systems, food safety systems, HACCP programs, dietary supplement systems and cosmetics systems.
You can print the report or save it as a PDF to share with your team.
Before you rely on the results
This self-check is a starting point for planning, not an audit. It does not establish compliance or certification. A certification body, notified body or FDA investigator will look at how your procedures are implemented and at your records, not only at whether a procedure exists. A.P. Lyon documents are editable Microsoft Word and Excel files that you adapt, approve and implement for your own organization.
Related guides: FDA 483 Citations library and ISO 9001:2026 Gap Assessment Checklist.
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