ISO 13485 - Quality agreement for subcontractor

A Quality Agreement sets out the framework for a reliable, transparent, and well-controlled cooperation between the Manufacturer and the Subcontractor. Its purpose is to define responsibilities clearly, communication channels, documentation requirements, and quality expectations for all outsourced activities that may affect the medical device or any of its components. This is particularly important in the medical device field, where any outsourced part of the manufacturing process must be performed with the same level of quality, control, and regulatory compliance as if it were carried out by the original Manufacturer itself, in accordance with ISO 13485, Regulation (EU) 2017/745, and any other applicable requirements. Although certain activities may be subcontracted, the original Manufacturer remains fully responsible for the final medical device and for ensuring that it is safe, compliant, and consistently produced to the required standard, regardless of where a specific part of the process or product is performed. For this reason, the Quality Agreement plays an essential role in ensuring alignment between the parties, maintaining product quality, and building mutual trust and confidence throughout the cooperation. You can see a part of the Quality agreement on the following link: https://advisera.com/13485academy/documentation/quality-agreement-for-subcontractor/