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.

• MS Word Format

• Instant Download Digital Content

ISO 13485:2016 Contract Review Procedure Overview

The ISO 13485:2016 Contract Review Procedure ensures that all contracts are reviewed to ensure there is a clear definition as to the terms and to ensure the company is capable of meeting the defined requirements. Terms may include price, quantity, delivery dates, expiration date requirements, special requests. The ISO 13485:2016 Contract Review Procedure ensures differences in requirements and contract will be resolved prior to acceptance. The ISO 13485:2016 Contract Review Procedure ensures the product must be authorized for commercial release in the region specified (i.e. applicable FDA clearance or approval, CE marking, or other required market authorization). The ISO 13485:2016 Contract Review Procedure ensures communication channels are established for resolving contractual issues and managing contract requirements.