Template: Management Review Report

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

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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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Management Review Report

NOTE #1: This template is supposed to give you an idea of the structure. Don't use MS word - this is thought
as an excel / sheets file.

NOTE #2: Think of the sub-sections below as different tabs in your excel sheet.

Overall Assessment

Overall QMS Assessment:

NOTE: Assess the general adequacy, suitability and efficacy or QM system to comply with regulatory
requirements. Also take into account an assessment of the criticality / impact of single processes for
product safety. List a summary of measures derived from the review.

Date of Review XYZ (...)
Participants(Name, Role) XYZ (...)
Signature XYZ (...)

Process Assessment

NOTE: In your excel sheet, you may want to create one tab for every process and include results from
previous Management Reviews for comparison.

SOP Key Performance Indicator Review Input Management Assessment Improvement Measures Evaluation of Previous Measures
Corrective and Preventive Action (CAPA) Quick decision of action plan (goal: max. 1week) Last year: 3 days on average Process is followed and complies with requirements None N/A
Change Management
Document and Record Control
Software Development
Management Review
(...)

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.