ISO 13485

ISO 13485 is a version of the standard developed for the Medical Device Industry. It contains most of the requirements of ISO 9001 plus several additional requirements specifically for the Medical Device. It also eliminates sections of ISO 9001. ISO 13485 (and variations such as DIN EN ISO 13485) is an internationally recognized quality standard which states the requirements of the Quality Management System (QMS) for the design and manufacture of Medical Devices. While it remains a stand-alone document, ISO 13485 is based on ISO 9001 with some additional clauses as well as the removal of some requirements.

ISO 13485 is an ISO Standard, published in 2003. The ISO 13485 was designed for organizations that provide medical devices or related services. It provides the requirements for a comprehensive management system for the design and manufacture of medical devices. ISO 13485 is generally harmonized with the ISO 9001 standard, though it is a stand-alone document. ISO 13485 removes ISO 9001’s emphasis on continual improvement and customer satisfaction though it has been developed based on ISO 9001. It lays 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.

The primary objective of ISO 13485 is to facilitate harmonized medical device regulatory requirements for quality management systems. To ensure this, it includes some particular requirements for medical devices and excludes some of the requirements of ISO 9001 that are not appropriate as regulatory requirements. Organizations whose quality management systems conform to this International Standard cannot claim conformity to ISO 9001 unless their quality management systems conform to all the requirements of ISO 9001 because certain points have been excluded in ISP 13485.

Once you get ISO 13485 certification, it will help your organization do business in this highly regulated sector. It will demonstrate that your organization is committed to quality, customers, and is willing to work towards improving efficiency. ISO 13485 promotes harmonization of regulatory requirements for manufacturers of medical devices on an international scale.