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ISO 13485:2016 QM Handbook Tool-Kit and Records Template

  • download product
  • Over 95 pre filled out templates for QM-System documentation of ISO 13485:2016
  • easy to use for everybody
  • only ad your job titles and adjust your processes
  • the template is complete, it describes all processes. The processes that do not apply only need to be deleted. 
  • With this template to can do the documentation within 1 or 2 month, instead of minimum one year
  • This investment saves you a 5 figure sum
  • your cost- and time saving tool kit 
  • do not create the documents with a volume of 400 pages by yourself. Use the short-track.
  • avoid NC by verifying your own QM system with this proffessional tool kit
  • never forget anything in the future
  • pass your audit with exam 
  • all pages in a docx-file, easy to edit


With the purchase, the buyer waives the right of return since this is a digital product. The reproduction of individual pages or the entire work is strictly prohibited. The buyer may use a purchased product only once for himself, a reproduction is strictly prohibited.

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from 11/02/2023 on