Template: List of Qualified Suppliers

Sven Piechottka ISO 13485 Templates Published June 09, 2022 Supplier Management

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This is a free template, provided by OpenRegulatory.
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The template license applies (don't remove the copyright at the bottom, don't re-use this for commercial purposes).

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List of Qualified Suppliers

> NOTE: 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. Also, write your categories as columns and suppliers as rows -
> this template is reversed due to formatting reasons.

Supplier Documentation Supplier #1 Supplier #2 (...)
Supplier Name: ABC Medical Content GmbH XYZ Medical Content GmbH
Purchase Description: Writing Clinical Evaluation Writing Clinical Evaluation
Supplier Status: Approved Blocked
Quality of Products / Services 3 0
Timeliness / Punctuality 3 3
Cooperation 3 3
Payment Terms 3 3
Average Score: 3 1,8
Date of Last Evaluation: 01-04-2021 01-04-2021
Completed By: Jack Smith (QMO) Jack Smith (QMO)
Non-Disclosure Agreement (NDA) <if existing, link here> <if existing, link here>
Supplier Certification <if existing, link here> <if existing, link here>
Quality Assurance Agreement (QAA) <if existing, link here> <if existing, link here>
Supplier Auditing <if existing, link here> <if existing, link here>
Other Measures

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.