ISO 13485 is a management systems standard specifically developed for the manufacture of Medical Devices. ISO 13485 contains requirements that are essential for any organization operating at any tier in the medical device and pharmaceutical supply chain. It is especially relevant to manufacturers that wish to demonstrate applicable regulatory requirements, and by organizations whose services support medical device manufacturers. The primary objective is to facilitate harmonized medical device regulatory requirements.
The standard contains specific requirements for manufacture, installation, and servicing and calls for: implementation of a Quality Management System with several enhancements, risk management approach to product development and product realization, validation of processes, compliance with statutory and regulatory requirements, effective product traceability, and recall processes. ISO 13485 represents the requirements that medical device manufacturers must incorporate into their management systems.
Though based on ISO 9001, ISO 13485 does not include 9001s emphasis on continual improvement and customer satisfaction. In its place is an emphasis on meeting regulatory as well as customer requirements, risk management and maintaining effective processes, namely the processes specific to the safe design, manufacture, and distribution of medical devices. ISO 13485 is in part designed to produce a management system that facilitates compliance to the requirements of customers and various global regulators. While being certified to 13485 does not fulfill all requirements of either the FDA or foreign regulators, the certification aligns an organizations management system to the requirements of the FDAs Quality System Regulation (QSR) requirements as well as many other regulatory requirements found throughout the world. Therefore, 13485 certification serves to create a management system that can be thought of as a framework on which to build compliance to various regulatory and customer requirements.
ISO 13485 requires that risk management must be thoroughly documented and conducted throughout the product lifecycle, from initial concept to delivery and post-delivery. However, the standard leaves the specifics to a related standard, ISO 14971, Application of Risk Management for Medical Devices. Currently, owing to implementation of 2012 versions of ISO 13485 and 14971 in the EU only, four sets of standards are needed to satisfy the EU and other worldwide regulatory bodies.