This document provides the process for management review in compliance with ISO 13485.
(Version at end of page)
Signed V15 RB 15.07.2024
The process covers all quality management system, processes, activities, products and regulatory requirements. This process ensures continuous improvement and compliance with regulatory requirements.
Approval: Author of the document, Marelize Robertson
Changes: Author of the document, Rachel Belcher
Deviations - Factual approach to decision making, Effective decisions are based on the analysis of data and information.
Review - Activity undertaken to determine the suitability, adequacy and effectiveness of the subject matter to achieve established objectives.
Management Review - A review carried out in order to confirm that the Management System is effective and entrenched and that all elements of ISO 13485 are adhered to. The review will also set-up and assess company goals and objectives.
PCA - Preventative and Corrective Action
SHEQ - Safety, Health, Environment and Quality
NCR – Non-Conformance Record
QMS - Quality Management system
ISO 13485 clauses 5.6
Non-Conformance and Corrective Action
MANAGEMENT REVIEW (ISO 13485 Clause 5.6)
Management meetings will be held quarterly to ensure the effectiveness of the quality management system; however a management meeting may cover a management review at the discretion of management team.
The attendees will be the management team with a quorum of at least 3 persons.
Schedule and Notification: An agenda is emailed in a meeting request (in accordance with inputs below) by the management representative to all the managers, who will RSVP attendance.
A meeting report (meeting minutes) will be filled in by the management representative and / minute taker according to the template in the files section at the bottom of this page.
After the meeting the meeting minutes shall be distributed to all the relevant managers.
A TRELLO action plan is generated by the Management Representative for follow up on Actions and assigning responsibilities, which are also covered in the following management meeting; the objective of the meeting is to ensure that the company is meeting its targets and objectives and to highlight any areas that require attention or improvement.
The input to management review shall include information on;
a) Customer feedback;
b) complaint handling;
c) reporting to regulatory authorities;
d) audits;
e) monitoring and measurement of processes;
f) monitoring and measurement of product;
g) corrective action;
h) preventive action;
i) follow-up actions from previous management reviews;
j) changes that could affect the quality management system;
k) recommendations for improvement;
l) applicable new or revised regulatory requirements.
m) Review of quality policy and objectives as well as the need for changes to the quality management system
Items 1 and 2 are summarised in the Non-Conformance Register. Only unresolved items need be inputs to the management review meeting.
A report from the meeting using the template report in the files section at the bottom of the page, as detailed above with activities for improvement are recorded and monitored by the administrator to ensure timely closure. For any Corrective actions a non conformance maybe followed as per Non-Conformance and Corrective Action.
The output from the management review shall include any decisions and actions related to;
a) improvement needed to maintain the suitability, adequacy, and effectiveness of the quality management system and its processes;
b) improvement of product related to customer requirements;
c) changes needed to respond to applicable new or revised regulatory requirements;
d) resource needs.
e) Decisions and actins related the suitability, adequacy and effectiveness of the quality management system and its processes
f) Decisions related to improvement of product/services in terms of customer feedback
g) Decisions regarding the adequacy of resources provided to the quality management system
The above points may also apply to any adhoc meeting to review any resource requirements or SHEQ (Safety, Health, Environment & Quality) matters.
In the event of non-compliance follow SOP Non-Conformance Corrective Action.
The Risk Assessment to is found in SOP Preventative Action Risk Assessment refer Document.
The analytical reviews of internal audits, and any other quality related matters, are reported through Data Analysis to management and as part of the input to management review.
The Trend analysis may identify any potential and recurring incidents, where corrective action must be reported at the management review to facilitate continual improvement.
Revision 15; 15.07.2024 - RB - Change over to SharePoint Site
Revision 14; 20.02.2024 - MR - 8.1. Updated the location of documentation, meetings should will be held quaterly and not twice a year, and 11. Records
Revision 13; 11.07.2022 - MR - 8.1 Update - DK 11.07.2022
Revision 12; 15.02.2022 - MR - Relink NCCA register 2022
Revision 11; 14.10.2021 - MR - Updated
Revision 10; 10.08.2021 - MR - Reviewed
Revision 9; 22.06.2021 - TNA - amending links and forms. New format for Approval / Scope/ Responsibilities / Risk Based Approach / Revision History
Revision 8; Digitally signed on 29.06.2020 by WJW
Revision 1-7; unknown due to google site change to new google site format
Name Retained in Retention period Hard copies Destroyed by
Management review Agenda's and Reports SharePoint indefinite n/a
Management Review Schedule SharePoint indefinite n/a