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.

Building a set? Buy procedures from the same family together and save: 5–9 for 20% off, 10–19 for 35%, 20–39 for 50%, or 40+ for 60%. The discount is applied automatically in your cart, or use Build Your QMS to choose and price a set.

Supplied as one editable Microsoft Word document in a digital download.

Customer contract and market-approval review

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.

Using an eQMS? These editable Microsoft Office files can be imported into any electronic quality management system (eQMS) that manages Word and Excel documents, or used in a paper-based system. Adapt the approval, signature and record steps to your system’s workflow, and validate the eQMS software under your own QMS. See how to use A.P. Lyon procedures in an eQMS.

Practical guide

Read Medical Device Quality Agreements and Consulting Contracts for workflow guidance, a checklist and common mistakes.