Please copy this integration script and insert it where you want to integrate it 5 Note: The supplier`s name and customer`s name can be extended to obtain more descriptor information about the company like Company X, a contract manufacturer of medical devices that is properly organized and complies with the laws of the relevant . Definitions, abbreviations and acronyms The following terms are included in this agreement. Precision An indication of how close a measured value is to the actual (true) value. See also the accuracy. Claim A written, electronic or oral notification of deficiencies in the identity, quality, durability, reliability, safety, efficiency or performance of a device after release for distribution. Model for the quality agreement of medical devices Page 4 of 17. Created by Ombu Enterprises, LLC. Concession authorization for the use or release of material that does not meet the specified requirements. 2 8. Targeted acquisitions ..
8. Selected supplier .. 8. Duration of 9. 9. 2 Compliance .. 9. 9. Specification 9. Activity of regulatory authorities, notified bodies or certification bodies ..
9. Third-party quality 10. 3 Manufacturing, packaging and labelling.. 10. Environment 10. 10. Equipment .. 10.
Automated processes .. 11. Inspection, measurement and control devices .. 11. Validation of the trial .. 11. Labeling 11. 12. 4 Documentation and recordings ..
12. Device history 12. Record 12. 5 Storage and shipping .. 12. Storage .. 12. Shipping .. 13. 6 Change Control ..
13. Change 13. Differences.. 13. Other 13. 7 Non-Conformance, CAPA and 14. Model for the quality agreement of medical devices Page 2 of 17. Created by Ombu Enterprises, LLC Disposition. non-compliant material.. 14. Correction 14. Medical Device Control Document Guide Department of Health, Malaysian medical device classification guide gd-xx.
9 The supplier ships the product from one of the sites listed below to the customer. Note: The table is not designed to indicate the relationship between the supplier`s production sites and distribution sites. It can be a relationship to one, one for several or n:1. The entry of a production site and a distribution site into the same line does not necessarily mean a link. Note: If the supplier`s production site or distribution site is outside the United States, a consideration can be made for customs. Supplier Sites that participate in this Quality Agreement Suppliers Production Sites Suppliers Distribution Sites The customer receives the product on one of the sites listed below. The customer websites involved in this quality agreement, the customer reception sites Medical Device Quality Convention Model page 6 out of 17. Created by Ombu Enterprises, LLC. 8 Created by Ombu Enterprises, LLC.ISO 13485:2003 Medical Devices Quality Management Systems Requirements for Regulatory Purposes ISO 14971:2007 Medical Devices Application of Risk Management to Medical Devices Products and Services Covered by this Agreement, This agreement concerns the products listed in the table below. Note: List the products the supplier makes available to the customer.
The list should be specific, but should not contain revision levels or other information at that specific level. For example, it would be better to say feed number: A1234. instead of the feed number: A1234 Revision C. You probably don`t want to re-approve the vendor contract for each product review change. Products covered by this agreement Product Name Supplier Part number Part number of the site (s) the supplier produces the product in one of the sites listed below. – 1 – EUROPEAN COMMISSION DG ENTERPRISE Direction G Unit 4 – Pressurized equipment, Medical Devices, Medical Metrology: MEDDEV Guide 2.4/1 Rev.8 7 QMS Quality Management System Repair Operation on non-compliant equipment, in order to make it acceptable for the intended use of Rework Action on nonconforming material, in order to adapt it to the requirements of the RMS risk management system to non-compliant scrap in order to avoid the supplier`s initial intended.