Software Quality Agreement Template

April 12, 2021

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. The supplier must track the third-party`s performance metrics and report them to the customer. FIFO First In, First Out IM-TE Precision Inspection, Measurement and Control Devices A statement on the repeatability of a code. See also, accuracy. Product product is the output of a process and includes, but not limited to, goods, services, software, documentation and consulting. Immediately, unless otherwise stated, immediately within ten business days. . 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. 10 Quality Management Regulations The supplier and the customer each have a quality management system (QMS) that meets the requirements of the FDA Quality System Regulation (QSR) in accordance with Standard 21. CFR Part 820. If the supplier finds that a requirement of 21 CFR Part 820 is not appropriate or applicable to the product delivered, the supplier must notify the customer within 30 days of this decision. The list of requirements that are not suitable or applicable is listed in Appendix 1.

ISO 13485:2003. The supplier and customer each have a quality management system (QMS) that meets ISO 13485:2003 requirements. The supplier resists the QMS with a registrar acceptable to the customer. The supplier must provide the customer with a copy of the registration certificate. 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 contract, the customer reception convention customer convention medical device quality Model Page 6 of 17. Created by Ombu Enterprises, LLC. 5 Note: The supplier`s name and customer name may be supplemented by other descriptive information about the company, such as X.B, a contract manufacturer of medical devices that properly organizes and in accordance with the laws of the list of .