Template: Document List QMS

Sven Piechottka ISO 13485 Templates Published June 09, 2022

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This is a free template, provided by OpenRegulatory.
If you are a user of Formwork, our eQMS software, you can save a lot of time by choosing “QMS” on the top menu and “OpenRegulatory Templates” on the left menu, then opening the relevant folder to find this template ready to load into Formwork.

If, for some mysterious reason, you're using a different QMS software, you can also simply download this template – specifically, as Word (.docx), PDF, Google Docs or Markdown file. Scroll down for a preview!

The template license applies (don't remove the copyright at the bottom, don't re-use this for commercial purposes).

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Document List QMS

The purpose of this template is to give an idea of the structure. You are much better off not using a word
document, but excel / sheets for this.

Title / Doc-ID Doc Type Version Release Date Last Review Next Review Process Owner Comment
SOP-Document and Record Control SOP 1.0 15.01.2021 15.07.2021 15.07.2022 QMO

Template Copyright openregulatory.com. See template
license
.

Please don't remove this notice even if you've modified contents of this template.

Sven Piechottka avatar

Sven Piechottka

With a background in political and administrative sciences, my way into regulatory affairs started from a different angle. I focused on the promises of precision medicine during my final year of studies and first joined IBM to help leverage healthcare innovation projects across Germany.

I then gained most of my regulatory experience while working for Vara (before: Merantix Healthcare), where we built up a quality management system from scratch. For about three years, I coordinated regulatory affairs, led the ISO 13485 certification and CE certification of an AI-based radiology software, and served as data protection officer and quality management officer of the company.