Supplier Quality Agreement Medical Device Template

The supplier`s quality agreement is a comprehensive written agreement (usually supplemented by a checklist) that defines and defines the quality and GMP (Good Manufacturing Practice) obligations of the design owner and the supplier. A quality agreement is an important part of a supplier qualification program, but it does not replace supplier qualification processes (including audits if necessary) or understanding of the supplier, its processes and competencies. A quality agreement should not contain commercial or liability terms that should only be addressed in a supply agreement. 7 QMS Quality Management System Repair measure of non-compliant material to make it acceptable for the intended use of non-compliant material to meet RMS requirements Risk Management System Scrap Action on non-compliant material to exclude its original intended use Supplier The supplier delivers the product to the customer. The term supplier includes, but is not limited to, contractors, consultants, sister organizations and parent organizations. Referenced Documents 21 CFR Part 820 Quality System Regulation GHTF/SG3/N15R8 Implementation of risk management principles and activities within a quality management system GHTF/SG3/N17:2008 Quality management system Medical devices Instructions for the control of products and services Suppliers receive ISO 9001:2008 Quality management systems Requirements Medical devices Quality Model page 5 of 17. 12 3.8 Packaging operations The supplier packages and packages the product with the agreed methods or best practices to protect the product from deterioration or deterioration during processing, storage, handling and shipping. 4 Documentation and Records 4.1 Device History Record The supplier and customer agree on the party that manages the selected portions of the device history dataset required by 21 CFR This list also contains installation reports (21 CFR) and maintenance reports (21 CFR). Responsibilities are defined in the table below. Device History Data Set Responsibility Data Set Applicable Supplier Custom Records Device Specifications Production Process Specifications Quality Specifications And Labeling Specifications Packaging Specifications Installation Specifications Installation Procedures and Methods Maintenance Records Maintenance Procedures and Methods Maintenance Records Maintenance Procedures and Methods Supplier s registrations within two working days. . .


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