ISO 13485 Contract Review Procedure

The ISO 13485:2016 Contract Review Procedure establishes the process used for review of contracts, verification of product approvals by region, authorization of pricing and delivery, and contractual requirements for distributors.

The review checks whether contract terms are clear and the company can meet the requirements, including price, quantity, delivery dates, expiration dates and special requests. It also addresses resolving differences before acceptance, verifying authorization for commercial release in the destination region, and establishing communication channels for contractual issues.

The review process checks a customer order or contract against the organization's ability to provide the specified product and service. It addresses requirements that differ from a quotation, technical and delivery commitments, pricing handoff, amendments and communication to the functions that must fulfill the order. Distributor traceability is also considered. The resulting review record helps prevent an unrecognized requirement from reaching production or shipment.

Supplied as an editable Microsoft Word document as a digital download.