ISO 13485 Medical Equipment Management System

What are the most important points to consider in designing SOPs working procedures according to FDA requirements in relation to companies suppliers of medical devices, equipment and supplies in the Kingdom according to the data of international standard ISO 13485 to manage medical devices, equipment and supplies?

 

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The Saudi Food and Drug Authority requires clear procedures to verify the integrity of working procedures in the quality management system of companies specializing in the supply of medical devices and equipment and medical supplies. The actions required include:

1. Verification procedures for the use of ERP systems, applications or software used in the company’s quality management system.
2. Procedures for the control and archiving of documents.
3. Procedures for controlling records.
4. Procedures and minutes of management audit meetings.
5. Procedures for establishing, recording and evaluating competence, training and outreach activities.
6. Procedures for monitoring and controlling the working environment.
7. Procurement procedures.
8. Procedures for medical device maintenance activities and after-sales and warranty services.
9. Product identification and identification procedures.
10. Tracking procedures.
11. Procedures to maintain the conformity of the product with the customer’s requirements and with local regulations.
12. Procedures for control and calibration of equipment.
13. Procedures for collecting customer feedback.
14. Procedures for dealing with complaints.
15. Reports to the NCMDR’s National Center for Health Care Services.
16. Internal audit procedures.
17. Control procedures for incompatible products and analysis of causes, corrective and preventive actions.
18. Procedures for issuing safety alerts.
19. Data analysis procedures.
20.  Procedures for correction, prevention and continuous improvement.