FDA QMSR Transition Kit: 21 CFR 820 to ISO 13485 Gap Assessment, Transition Plan, Records Matrix

Not eligible for NQT documentation review.

FDA QMSR Transition Kit: 21 CFR 820 to ISO 13485 Gap Assessment, Transition Plan, Records Matrix

22-row gap assessment mapping the old QSR to the QMSR and ISO 13485, with status, action and overdue flags; a readiness summary; a records matrix covering 820.35 and 820.45; and a transition plan.

What's inside:

- 00_Start_Here_README.pdf

- 01_QMSR_Gap_Assessment_and_Records_Matrix.xlsx

- 02_QMSR_Transition_Plan.docx

Written by Matt Norman: 15 years as a U.S. Navy aviation structural mechanic, then 3 years at SpaceX as a Falcon 9 quality inspector and QA supervisor, with hands-on experience working under ITAR and DoD compliance requirements. Norman Quality Tools is Veteran-Owned & Operated.

License: one company, all sites. Word/Excel 2016+, Microsoft 365, LibreOffice. No macros.

Templates, not regulatory advice.

Norman Quality Tools is not affiliated with or endorsed by ISO or the U.S. FDA, or any other standards body, government agency or company named in this description. Standards are cited by number only; buy the official standard from its publisher.

Not affiliated with or endorsed by SpaceX or any other current or former employer of the author.

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