Supplier Quality Agreement Template Iso 13485

Both iso 13485 european notified bodies and the fda are requiring companies to create detailed agreements with their key suppliers the ghtf supplier guidance document is now an.

Supplier quality agreement template iso 13485. European suppliers must also comply with ce marking requirements of the medical device directive mdd medical device regulations mdr as appropriate. Detailed supplier qa agreements with key suppliers whether standalone or part of a larger supplier agreement are becoming essential as more medical device companies are looking to increase their outsourcing. Management system that conforms to the requirements of the fda s quality system regulations iso 13485 and iso 14971. Supplier quality agreement template iso 13485 category of templates you can also download and share resumes sample it. Kari miller regulatory and product management leader pilgrim quality solutions an iqvia company the global economy is often the topic of blogs articles and macroeconomic discussions.

Purchasing documents shall include where possible an agreement that the suppliers contractors and consultants agree to notify the manufacturer of changes in the product or service so that manufacturers may determine whether the changes may affect the quality of a. Supplier and quality agreements should be kept at least somewhat separate because supplier agreements often require legal review approval by a company officer and may exist. This is an obligatory agreement that needs to be signed with all suppliers that provide critical component of a service. Contrary to iso 13485 it explicitly mentions a quality assurance agreement. Learn about iso 13485 2016 supplier quality agreements and how supplier management and purchasing processes have updates at reducing risk across the board.

Quality or quality assurance qa agreements are best kept separate from supplier agreements although they are usually included by reference in the main supply agreement. Supplier shall inform cci of any changes to supplier s quality management system or certifications. Iso 9001 and or iso 13485 or successor standards or their equivalent at all times in manufacturing and delivering the products under this agreement and will provide a copy of the certificate to cci. Quality agreement for critical supplier.