Management Review

The process covers all quality management system, processes, activities, products and regulatory requirements. The Purpose is to provide the activities to review input data, at planned intervals, to ensure its continuing suitability, adequacy, and effectiveness. The scope is for the South African establishment.

4. Responsibilities

Approval: Bruce Manuel

Changes: Nicholas Gilbert

5. Definitions

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.

6. Abbreviations

PCA - Preventative and Corrective Action

SHEQ - Safety, Health, Environment and Quality

NCR – Non Conformance Record

QMS - Quality Management system

7. References

ISO13485 clauses 5.6

NON CONFORMANCE AND CORRECTIVE ACTION

8. Procedure

MANAGEMENT REVIEW (ISO13485 Clause 5.6)

8.1 PROCESS

At least one formal management review will be held at least quarterly; 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
An agenda is emailed in a meeting request (copy & paste INPUTS below) by the management representative to all the management team, who will RSVP attendance (records of attendees to be recorded in the minutes - attendance roster is completed)
1. After the meeting the Agenda meeting request email is "Respond"ed to all with Minutes of the meeting covering the OUTPUTS below and a copy of the email is saved and placed in a Google DRIVE folder: MOM
2. An ACTION PLAN is generated by the Management Representative for follow up on Actions or a FORM can be generated , which are also covered in the management meeting; the objective of the actions are to ensure company is meeting its targets and objectives and to highlight any areas that require attention or improvement.

8.2 Review input

The input to management review shall include information on;

a) feedback;

b) complaint handling;

c) reporting to regulatory authorities;

d) audits & results;

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.

8.3 Review output

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

9. Risk Based Approach

In the event of non compliance follow SOP NON CONFORMANCE CORRECTIVE ACTION

Risk Based Approach Report

[Risk Assessment to is found in SOP PREVENTIVE ACTION RISK ASSESSMENT refer Document]

9.1 Trend Analysis and Continual Improvement

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.

10. REVISION HISTORY

Revision 2 NG 21.01.2025 Changed Ownership

Revision 1 New HJM 5.09.2024

11. Records

Name Retained by/ in Retention period Hard copies Destroyed by

MOM Google DRIVE indefinite n/a

ACTION PLAN Google DRIVE indefinite n/a

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