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Templates ISO 13485 Templates

Updated June 9, 2022

Template: Management Review Report

Sven Piechottka

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This is a free template, provided by OpenRegulatory.

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Related Documents

The following templates are Documents or SOPs related to this template. That means that they mention this template somewhere and (most likely) contain instructions on how and when to fill it out.

Template preview

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 (…)
(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          

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