ISO 14971 Risk Management Kit: Plan, Hazard Analysis, FMEA, Benefit-Risk & Report Templates

Not eligible for NQT documentation review.

ISO 14971 Risk Management Kit: Plan, Hazard Analysis, FMEA, Benefit-Risk & Report Templates

Workbook with an editable 5x5 acceptability matrix, a hazard analysis whose risk levels look up that matrix, an FMEA with RPN, control verification and a readiness summary. Plus plan, benefit-risk and report templates.

What's inside:

- 00_Start_Here_README.pdf

- 01_Risk_Management_Workbook.xlsx

- 02_Risk_Management_Plan.docx

- 03_Benefit-Risk_and_Risk_Management_Report.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 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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