Medical Device Quality Agreement Template

Posted by Admin on Sep 27, 2021 in Uncategorized |

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. 6 ISO 13485:2003 Medical devices Quality management systems Requirements for regulatory purposes ISO 14971:2007 Products Medical devices Application of risk management to medical medicine 1.5 Products and services covered by this agreement This agreement applies to the products listed in the table below. Note: List the products that the supplier makes available to the customer. The list must be specific, but must not contain revision levels or other information at that specific level. For example, it would be better to say power part number: A1234, rather than power number: A1234 Revision C You probably don`t want to re-assign the supplier agreement for each product modification. Products covered by this Agreement Product name Supplier part number Customer part number 1.6 Part(s) Location(s) The supplier produces the product at one of the sites listed below. The supplier sends the product from one of the sites listed below to the customer. Note: The table is not intended to indicate the relationship between the supplier`s production sites and the distribution sites. It can be a one-for-one, one-to-the-other, or a much-to-one relationship.

If you enter a production site and a distribution site on the same line, there is not necessarily a connection. Note: If the supplier`s production or distribution site is outside the United States, customs consideration may be undertaken. Supplier sites participating in this quality agreement Production sites suppliers Distribution sites The customer receives the product at one of the sites listed below. Customers who participate in this quality agreement Customers Quality receipts for medical devices Model Page 6 of 17 Note: The name of the supplier and the name of the customer can be extended to include additional descriptor information about the company, for example.B. Company X, a manufacturer of medical devices that are properly organized and according to the laws of . . .

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