Iso 13485 Supplier Quality Agreement

If you are a medical device manufacturer, you are likely familiar with ISO 13485, an international standard that outlines the requirements for a quality management system. ISO 13485 is often required by regulatory bodies and customers, as it demonstrates a commitment to producing safe and effective medical devices.

One important aspect of ISO 13485 is the requirement for a supplier quality management system. This means that you must have processes in place to ensure that the components and materials used in your medical device meet your quality requirements. To achieve this, you will need to establish a supplier quality agreement with your suppliers.

A supplier quality agreement is a contract between you and your supplier that outlines the quality requirements for the components or materials that they provide. It ensures that your supplier is aware of your quality requirements and that they are committed to meeting them. A supplier quality agreement typically includes the following:

1. Quality requirements: This section outlines the quality requirements for the component or material being supplied. It may include specifications for dimensions, performance, and other characteristics.

2. Testing and inspection: This section outlines the testing and inspection procedures that will be used to ensure that the component or material meets the quality requirements.

3. Non-conforming products: This section outlines the procedures that will be used if the component or material does not meet the quality requirements. It may include requirements for corrective actions or product recalls.

4. Confidentiality and intellectual property: This section outlines the confidentiality and intellectual property requirements for both parties.

5. Termination: This section outlines the conditions under which the agreement may be terminated.

Establishing a supplier quality agreement is an important part of your ISO 13485 compliance. It ensures that you have a system in place to manage the quality of the components and materials used in your medical device. It also helps to mitigate the risk of non-conforming products and product recalls.

In conclusion, if you are a medical device manufacturer, it is important to establish a supplier quality agreement with your suppliers to ensure that the components and materials used in your medical device meet your quality requirements. This will not only help to ensure compliance with ISO 13485, but it will also help to mitigate the risk of non-conforming products and product recalls.