QUALITY REQUIREMENTS

A. SUB-TIER CONTROL

The supplier shall be responsible for flow down of the requirements and provisions of the Pos-T-Vac Medical purchase order applicable to the supplier’s sub-contractors. Additionally, the supplier shall comply with special processor requirements when imposed (e.g. – NADCAP, AMS, Customer approvals, etc.).

B. RIGHT OF ACCESS

During the performance of this purchase order, your Quality Assurance or Inspection and Manufacturing process are subject to review, verification and analysis by Pos-T-Vac Medical, Pos-T-Vac Medical customers, and/or Government/Regulatory Agency representative(s). This requirement is applicable to your facilities where Pos-T-Vac Medical products and services are processed as well as your sub-tier’s facilities. This ‘Right of Access’ must be flowed down to the sub-tiers that you utilize in performance of the contract.

C. SUPPLIER NON-CONFORMANCE APPROVAL REQUESTS

The supplier shall notify Pos-T-Vac Medical of non-conforming material. Requests for any departures from drawings, specifications, or other purchase order requirements must be submitted for consideration by Pos-T-Vac Medical in writing. Pos-T-Vac Medical will in turn either approve or deny approval of the request in writing. Non-conforming material may NOT be shipped to Pos-T-Vac Medical without such written approval. Non-conforming material shipped on an approved non-conformance must be accompanied by a copy of the signed Pos-T-Vac Medical approval document.

D. RECORDS RETENTION

The Supplier shall maintain adequate records of all aspects of the fulfillment of the purchase order for a period of not less than ten (10) years from the closing of the purchase order unless stated otherwise on the purchase order.

F. PROCESS CHANGES

Any changes to the product, process, suppliers, or facility that could impact ability of product to meet Pos-T-Vac Medicals requirements must be communicated to Pos-T-Vac Medical.