Template

Document List QMS

Sven Piechottka · ISO 13485 Templates · Published June 09, 2022

Template download

This is a free template, provided by OpenRegulatory. If you are a user of Formwork, our eQMS software, you can save 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.

Using a different QMS? Download below as Word (.docx), PDF, Google Docs or Markdown. The template license applies (keep the copyright at the bottom, don’t re-use for commercial purposes).

Template preview

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

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Sven Piechottka

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.
More about me