ISO 13485 Medical Device QMS Starter: Quality Manual, 10 Procedures, DHF/DMR/DHR, ISO 14971 Risk File, CAPA & Complaints

Not eligible for NQT documentation review.

ISO 13485 Medical Device QMS Starter: Quality Manual, 10 Procedures, DHF/DMR/DHR, ISO 14971 Risk File, CAPA & Complaints

Quality manual with paraphrased clause map, 10 core procedures, DHF/DMR/DHR templates, a 14971-structure risk file, CAPA and complaint forms, and a workbook (risk analysis, trace matrix, CAPA log, complaint log with MDR clocks, training).

What's inside:

- 00_Start_Here_README.pdf

- 01_Quality_Manual_ISO13485.docx

- 02_Core_Procedures_QP01-QP10.docx

- 03_DHF_DMR_DHR_Templates.docx

- 04_Risk_Management_File_ISO14971_Structure.docx

- 05_CAPA_and_Complaint_Forms.docx

- 06_ISO13485_QMS_Workbook.xlsx

ISO 13485/14971 paraphrased; clause numbers only. Not regulatory advice.

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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