How to write the quality management work instruction of medical device company?

Suggestions on the writing outline of quality management work instruction of medical device company.

1. Preface, explaining the purpose of writing.

2. Terms and definitions, and list the core terms and definitions used.

3. Organizational structure, introducing the organizational structure and management system.

4. Quality management system, introducing the company's quality management system and applicable standards.

5. quality objectives and plans, which describe the company's quality objectives and plans, as well as measures in the implementation process.

6. File control and record management, which describes the management methods of files and records, including control and backup.

7. Personnel management, explaining the company's personnel management system, including recruitment, training and assessment.

8. quality risk management, which describes the company's quality risk management strategies and measures, and how to evaluate and control quality risks.

9. From the perspective of supplier control, describe the company's supplier control strategies and measures, and how to evaluate and select excellent suppliers.

1. Production and service process control, describing the company's production and service process control strategies and measures, and how to monitor and improve the production and service process to ensure compliance with standards and customer requirements.

11. nonconforming products and recall management, which describes the company's nonconforming products and recall management strategies and measures to ensure timely handling and control of nonconforming products and ensure the health and safety of users.

12. Internal audit and management review, describing the company's internal audit and management review strategies and measures.