Quality POLICY

1. Purpose

The Quality Policy is written by Top Management that summarises the goal of the organisation, enabling everyone in the organisation to understand how the medical devices will be created and distributed to customers.  

2. Approval

(Version at end of page)

Signed V14 RB 15.07.2024

3. Responsibilities

It shall be the responsibility of the Top Management Team to establish and maintain policies and procedures and to bring these procedures into effect. 

It shall be the responsibility of the CEO to ensure implementation of these policies and procedures.

Approval: Author of the document, Marelize Robertson

Changes: Author of the document, Rachel Belcher 

Quality Policy letter updated 2022/07/28

4. Definitions

5. Abbreviations

6. References

6.1. ISO 13485:2016 Clause 5.3

6.2. Quality Manual - 8.4.3 Quality Policy, 8.4.4. Quality Management System Planning and 8.4.5. Quality Objectives

7. Procedure

7.1.  How to write a Quality Policy 

7.1.1.  The Quality Policy needs to meet standard requirements.

7.1.2. Define a framework for setting quality objectives.

7.1.3.  Establish the commitment to meeting all the requirements.

7.1.4.  Establish the management commitment to meeting all the requirements, all risks will be minimised to ensure a safe and effective medical device.

7.1.5.  Communicate the Quality Policy.

7.1.6. Ensure the regular review of the Quality Policy to ensure it remains applicable to the organisation's goals and the expectations of interested parties.

7.1.7.  Adapt the policy to the organisation - the policy needs to be related to what the scope of the organisation.

7.2. Review 

7.2.1. State the Quality Policy.

7.2.2. Determine if the change meet the company goals if yes continue with the actions, if no discontinue the actions.

7.2.3. Review the requirements of customers and interested parties.

7.2.4. Review the requirements of internal parties.

7.3.  Communicating the Quality Policy

7.3.1.  The Quality Policy will be distributed via email to all the employees.

7.3.2.  Training will be offered and made available upon request.

7.3.3.  Training register of the employee's requesting training is available.

8. Risk Based Approach

9. Revision History

Revision 14; 15.07.2024 - RB - Change over to SharePoint Site

Revision 13; 18.10.2022 - MR -  DK 18.10.2022 - Added nr. 1 Purpose section;  Added nr. 2 Approval;  Added nr 3 Responsibilities (Approval and Changes);  Added Section number 4-8

Revision 12; 28.07.2022 - MR - DK 28.07.2022 - Updated the Quality Policy

Revision 11;  14.10.2021 - MR - Updated 

Revision 10; 05.08.2021 - MR - Reviewed

Revision 9; 22.06.2021 - TNA - updated format to new google site format

Revision 8; 02.12.2019 - WJW

Revision 1 - 7 ; unknown as changed from Classic google site to new google site

11. Records

Name       Retained in Retention period Hard copies Destroyed by

Quality Policy Google DRIVE indefinite n/a