Quality Agreement Voorbeeld

Model for the Medical Device Quality Agreement, established by Dan O`Leary Ombu Enterprises, LLC. 3 Forest Ave. Swanzey, NH 03446. 603-209-0600. This document should serve as the basis for a supplier agreement for a medical device manufacturer. The document should be tailored to specific requirements based on the product or service purchased, customer performance, supplier performance and the regulatory framework applicable to the medical device. Content 1 Administrative 4. 4. Parties to the 4th Definitions, abbreviations and acronyms ..

4. Referenced documents .. 5. Products and services covered by this agreement .. 6. Site (s) 6. Quality management systems . 7. Quality Assurance System Regulations .. 7.ISO 13485:2003 .. 7.ISO 9001:2008 ..

7.ISO 14971:2007 .. 7. Other standards required .. 8. Use by third parties. 5 Note: The supplier`s name and the customer`s name may be supplemented by other descriptor information about the company, such as.B. Company X, a contract manufacturer of medical devices that properly organizes and which, in accordance with the laws of the list. 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. 1 2 IMDRF/SaMD WG (PD1)/N23R3 3 4 5 6 7 8 9 11 11 11 12 13 PROPOSED DOCUMENT 14 International Medical Device Regulators Forum 15 16 17 18 Titles: Software as a Medical Device (SaMD): Quality Application 2 8. 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 – 1 – EUROPEAN COMMISSION DG ENTERPRISE Direction G Unit 4 – Pressurized devices, medical devices, medical DEVICES measurement means: GUIDE MEDDEV 2.4/1 Rev. 8.

6 A concession is often called the Use-As-Is (UAI) provision. Corrective action to eliminate the cause of non-compliance or other adverse situation found Purchase referred a case in which the customer orders the supplier to receive a service or service from a specific third party. In the case of a targeted purchase, the customer is responsible for the product qualification of the supplier`s qualification etc.