1. quality manual: the quality manual is the core document of the whole quality management system, which should include a description of the organization's quality policy, quality objectives, the scope of the quality system and related processes.
2. Standard Operating Procedures (sop): Prepare sop covering all aspects, including operating procedures such as design and development, procurement, production, quality control, equipment maintenance and corrective and preventive measures.
3. Work guidance: provide employees with documents of operation guidance to ensure that they know how to perform various tasks according to sop.
4. Recording and recording: keep records of various quality management activities, such as internal audit records, management review records, training records and customer complaint handling records.
5. Risk management documents: documents including risk analysis, risk assessment and risk control to ensure the safety of your medical devices.
6. Equipment verification and verification documents: documents used to verify and verify your production equipment and process.
7. Supplier evaluation and management documents: for suppliers, record their evaluation, selection and management.
8. Internal audit plan and report: plan and record regular internal audits to ensure the effectiveness of the quality management system.
9. Management review report: records the top management's review and decision on the quality management system.
10. Training plan and training record: record the training of employees to ensure that they understand the quality management requirements and can correctly perform related tasks.
To apply for ISO 13485 certification, the following conditions must be met:
1. Suitable for enterprises in all walks of life;
2. The system has been running for not less than three months;
3. Companies that require ISO900 1 certification and registration must have production/quality management records for at least three consecutive months, including complete records of internal review and management review.
The above contents are for reference only, and the specific requirements can be changed according to the actual situation. It is recommended to consult relevant institutions for specific circumstances.