Contract Manufacturers Inc


External Provider Quality Requirements

1. CMI requires that the External Provider shall maintain the proper identification and revision status specifications, drawings, process requirements, inspection/verification instructions and other relevant technical data.

2. CMI reserves the right of final approval of product and services, methods processes and equipment, and the final release of products and services.

3. CMI requires that competent qualified personnel must perform all special processes required by a purchase order.

4. CMI shall identify the requirements for interaction with our external providers including.

4.1 The use of interactive documentation.

4.2 The use of Email/Fax

4.3 Documented confirmation methods of all verbal interactions.

5. CMI shall monitor our external provider’s performance including.

5.1 Supplier Risk

5.2 Quality of product or service delivered.

5.3 On time delivery of product or service.

6. CMI can designate requirements for verification or validation activities that we or our customer, intend to perform at the external providers’ premises

7. CMI can approve or specify any designs, tests, inspection plans, verifications, criteria for design and development required by our organization from an external provider.

8. CMI shall approve or specify any special requirements, critical items, or key characteristics

9. CMI shall approve or specify any test, inspection, and verification (including production process verification)

10. CMI shall approve or specify the use of statistical techniques for product acceptance and related instructions for acceptance by our organization.

11. CMI can require the need from External providers to:

11.1 Implement a Quality Management System and we reserve the right to review and approve the External Providers Quality Management System.

11.2 Require that the External Provider use customer-designated or approved external providers, including process sources (e.g., special processes)

11.3 Require the External Provider to notify our organization of nonconforming product or services immediately upon discovery, and obtain our organizational approval for nonconforming product disposition.

11.4 Wherever applicable CMI reserves the right to require external providers to show evidence of processes to prevent the use of counterfeit parts.

11.5 The External Provider is required to Notify CMI of changes in product and/or process, changes of suppliers, and changes of manufacturing facility locations; our organization reserves the right to approve such changes.

11.6 All External Providers are required to Flow down to the supply chain the applicable requirements including customer requirements.

11.7 CMI reserves the right to require External Providers to provide test specimens for design approval, inspection/verification, investigation, or auditing.

11.8 CMI reserves the right of access by the organization, their customer and regulatory authorities to the applicable areas of facilities and to applicable documented information at any level of the supply chain.

11.9 External providers are required to apply appropriate controls to their direct and sub-tier external providers to ensure that requirements are met.

12. The external providers must ensure that persons working on CMI products are aware of the following:

12.1 Their contribution to product or service conformity.

12.2 Their contribution to product safety.

12.3 The importance of ethical behavior.

13. The external provider shall retain CMI documented information for a total of 5 years after shipment. After the duration, the external provider shall dispose of the documents in a manner maintaining record confidentiality.