This document provides the process for management review in compliance with ISO 13485
(Version at end of page)
Signed V17 ML 10.14.2024
The process covers all quality management system, processes, activities, products and regulatory requirements
“This Policy must be read-with and comply with the Protection of Personal Information Act 04 of 2013, (“POPI”), the Company POPI Policy, PAIA Manual. And processing of personal information envisaged under this Policy must be done in accordance with the aforementioned.”
Approval: Author of the document, Monica Lucas
Changes: General Manager
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
ISO13485 clauses 5.6
NON CONFORMANCE AND CORRECTIVE ACTION
MANAGEMENT REVIEW (ISO13485 Clause 5.6)
At least one formal management review will be held at least annually; 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
The Meeting will be communicated and planned through the issue of a formal Agenda, by email, to facilitate involvement and preparedness.
After the meeting, Management Reviews reports are located in Management Review DRIVE and any actions are recorded in ACTION PLAN
The Administrator will FILL in the activities, who is responsible and closure dates in the column on the Sheet.
Administrator to follow-up, and RECORD feedback, and INSERT closure date in Google Sheet. ACTION PLAN
The input to management review shall include information on;
a) 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.
Records of the management Review meeting, or a report from the meeting, and activities for improvement 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.
The above points may also apply to any adhoc meeting to review any resource requirements or SHEQ (Safety, Health, Environment & Quality) matters.
ACTION PLAN with allocated responsibilities and deadline dates from the management meetings are recorded and followed up at the next management meeting
In the event of non compliance follow SOP NON CONFORMANCE CORRECTIVE ACTION
The Risk Assessment to is found in SOP PREVENTIVE 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 17; 14.10.2024 - ML - Checked and Confirmed. Digitally signed by ML
Revision 16; 20.11.2023 - ML - Checked and Confirmed. Digitally signed by ML
Revision 15; 31.10.2022 - ML - Updated and Confirmed. Digitally signed by ML
Revision 14; 17.10.2022 - ML - Updated and Confirmed. Digitally signed by ML
Revision 13; 02.08.2021 - ML - Addition of POPI clause. Digitally signed by ML
Revision 12; 10.05.2021 - ML - Digitally signed by ML
Revision 11; 22.04.2021 - TNA - New format with Approval / Responsibilities / Scope / Revision History. Changes to Risk Based Approach. Amending links and forms.
Revision 10; Digitally signed 12.11.2018 by ML
Revision 1-9; unknown due to Google Site change to new Google site
Name Retained by/ in Retention period Hard copies Destroyed by
Management Review DRIVE Google DRIVE indefinite n/a
ACTION PLAN Google DRIVE indefinite n/a