SUPPLIER CONTROLS SOP GROUP

SUPPLIER CONTROLS SOP GROUP

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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$900.00
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)
$125.00
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
$150.00
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)
$150.00

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

$150.00
This SOP explains when a Quality Agreement between a company and a supplier or contract manufacturer is needed and the necessary content (6 pages)
$150.00
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)
$100.00
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)
$150.00
This SOP describes requirements for the approval and control of contract laboratories which provide testing services (2 pages)
$125.00