This SOP group describes procedures for controlling purchasing and vendor/ contract manufacurer activities including audits and control of changes traveling between company and vendor.

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This SOP group describes procedures for controlling purchasing and vendor/ contract manufacturer activities including auditing and control of changes between company and vendor.

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This SOP describes procedures for the purchase of materials for medical device development and manufacturing so that COMPANY is in compliance with FDA requirements. (5 pages)
This SOP describes activities related to Vendors: selection and approval, establishing an Approved Vendor List, auditing and maintaining vendors on the list. 11 pages + 4 report forms: vendor audit plan form vendor audit report form vendor selection and approval form request to reevaluate vendor status form
This document is a detailed checklist that lists questions to be asked of a vendor to assure that their Quality System is adequate for medical device development and manufacture (6 pages)

This SOP describes methods to select, approve and control a medical device contract manufacturer. (11 pages + multi page quality survey form).

Webinar slides explaing in detail this SOP is available

This SOP explains when a Quality Agreement between a company and a supplier or contract manufacturer is needed and the necessary content (6 pages)
This SOP describes the procedure for receipt, handling and internal delivery of incoming material, including damaged material. Critical and non-critical items are discussed. (7 pages)
This SOP describes a procedure for controlling design changes that originate in one facility but impact related design activities at other facilities. A logical method for approval and transfer of design changes between company and supplier is explained.(13 pages+ 2 forms)
This SOP describes requirements for the approval and control of contract laboratories which provide testing services (2 pages)