Free MDSAP Audit Checklist Template (Excel)
What's in the MDSAP audit checklist
Audit Checklist comes pre-filled with sample requirements across the core MDSAP process chapters - Management, Measurement Analysis and Improvement, Design and Development, Production and Service Controls, and Purchasing - each with a Chapter dropdown, a Status dropdown (Conforming, Non-Conformance, Observation, Not Assessed), and a Notes field.
Percent conformity below the table only counts rows you've actually assessed - a requirement still marked Not Assessed doesn't drag the score down, so the percentage reflects genuine readiness rather than incomplete coverage.
NC Register is a second tab for tracking every non-conformance found through to closure: date opened, chapter, description, corrective action, status, and target close date, with open and closed counts rolling up automatically.
Free ungated file versus the lead-capture-gated checklists
Every calculating MDSAP checklist found in the current search results - from quality-management SaaS vendors - is gated behind a lead-capture form tied to a platform demo signup. The official FDA and MDSAP.global documents are static PDF forms with no scoring at all.
This checklist is a standalone Excel and Google Sheets file: no signup, no demo request, no data sent anywhere. Download it, fill it in, and the percent-conformity score and NC register work immediately.
It won't replace the quality management software those vendors are selling if you need full document control, e-signatures, or automated CAPA workflows across a large QMS - but for a working audit-prep checklist with a real score, it's a complete, free alternative.
Who this checklist is for
Quality and regulatory teams at medical device manufacturers preparing for an MDSAP audit across any of the participating regulators (FDA, Health Canada, TGA, ANVISA, PMDA) who want a working self-assessment before the formal audit date.
It's a preparation tool you use internally to find gaps ahead of time - not a certification document. Your actual MDSAP certification is issued by an accredited Auditing Organization after a formal on-site audit, not by this spreadsheet.
How to use it
- On Audit Checklist, work through the pre-filled requirements by chapter and mark each Conforming, Non-Conformance, or Observation.
- Check the summary below the table for conforming items, non-conformances, observations, and overall percent conformity.
- Log every non-conformance found on NC Register and track it through to closure.
Download the free Free MDSAP Audit Checklist Template (Excel)
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Quality & Audit Pack
This free MDSAP checklist scores percent conformity from what you've assessed but doesn't track findings beyond a second NC Register tab, and it caps at 60 rows. The paid Quality & Audit Pack ($49) gives you a 120-row Internal Audit Checklist with 46 pre-filled questions and per-clause conformity, plus a dedicated 100-row NC/CAPA Register that tracks severity and root cause and computes aging and overdue flags, and a 30-audit Audit Plan workbook to schedule internal, supplier, external and certification audits. Both build in Excel and Google Sheets, tested to the cent.
See the full versionFrequently asked questions
Is this a certification document?
No. This is a self-assessment preparation tool - your MDSAP certification is issued by an accredited Auditing Organization after a formal audit, not by this checklist.
Can I use this in Google Sheets?
Yes. Upload the downloaded file to Google Drive, then open it and choose File > Save as Google Sheets. Both tabs and every formula keep working.
How is percent conformity calculated?
Conforming items divided by the total of Conforming, Non-Conformance, and Observation rows combined - rows still marked Not Assessed are excluded, so the score reflects only what's actually been assessed.
Can I add my own requirements beyond the pre-filled list?
Yes. The Audit Checklist table has 60 rows total, so add your own chapter-specific requirements below the pre-filled ones using the same Chapter and Status dropdowns.
Does this cover all MDSAP participating regulators?
The checklist structure follows the harmonized MDSAP process chapters shared across FDA, Health Canada, TGA, ANVISA, and PMDA - always confirm any country-specific requirements with your regulatory team.
What's the usage license?
Personal use or use within one business. It's not meant to be resold or redistributed as a template product.