Supplier Quality Agreement Template Iso 13485

Supplier Quality Agreement Template Iso 13485

If you are a medical device manufacturer, it is crucial to establish a strong supplier quality agreement (SQA) with each of your suppliers. This agreement ensures that all sourced materials and components are of the highest quality and meet the required standards. An SQA also outlines the responsibilities of both the manufacturer and supplier, including inspection, product testing, and documentation. ISO 13485 is a quality management standard specifically designed for medical device manufacturers, and it is important to ensure that your SQA adheres to its specifications. Here is a template for a supplier quality agreement that complies with ISO 13485.

1. Purpose and Scope

This section outlines the purpose of the agreement and its coverage. It should include any specific products, services, or materials that are covered by the agreement. It should also define the roles and responsibilities of the manufacturer and supplier.

2. Quality Management System

This section outlines the requirements for the supplier`s quality management system. It should require that the supplier has a documented quality management system that complies with ISO 13485. It should also require that the supplier demonstrates ongoing compliance with the standard.

3. Quality Requirements

This section outlines the requirements for the quality of materials and components supplied by the supplier. It should require that the supplier meets all applicable regulatory requirements and that the supplied materials and components are free from defects. It should require that the supplier conducts testing and inspection to ensure the quality of the supplied materials and components.

4. Inspection and Testing

This section outlines the requirements for inspection and testing of the supplied materials and components. It should require that the supplier provides documentation of the inspection and testing results. It should also require that the manufacturer has the right to inspect and test the supplied materials and components.

5. Nonconforming Materials

This section outlines the procedures for handling nonconforming materials and components. It should require that the supplier reports any nonconforming materials or components to the manufacturer. It should also require that the manufacturer has the right to return nonconforming materials or components to the supplier.

6. Documentation

This section outlines the requirements for documentation related to the supplier quality agreement. It should require that the supplier maintains records of its quality management system and its inspection and testing results. It should also require that the supplier provides the manufacturer with all necessary documentation.

Conclusion

Establishing a strong supplier quality agreement is essential for ensuring the quality and safety of medical devices. This template for an SQA that complies with ISO 13485 provides a framework for creating a robust agreement that protects both the manufacturer and the supplier. By adhering to the requirements outlined in this template, you can ensure that all sourced materials and components meet the required quality standards.


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