The International Organization for Standardization (ISO) recently released ISO 13485:2016 Medical devices—Quality management systems—Requirements for regulatory purposes—the first update to the standard since 2003.
The world’s most popular standard for quality management systems for medical device manufacturers underwent revision in response to the latest developments in quality management, technology, and regulatory requirements relevant to the industry.
ISO 13485:2016 explained
ISO 13485:2016 was written to support medical device manufacturers when designing quality management systems that establish and maintain the effectiveness of their processes. It ensures the consistent design, development, production, installation, and delivery of medical devices that are safe for their intended purpose.
The standard identifies the requirements for a quality management system in which an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet both customer and regulatory requirements.
A medical device can be defined as any product intended to be used in the diagnosis, prevention, and treatment of medical conditions and can include wound dressings, dentist chairs, cardiac pace makers, life-support machines, and in vitro diagnostic reagents.
Organizations seeking to adopt the standard can be involved in any stage of the product life cycle, from design and development, production, storage and distribution, installation, servicing, to the provision of associated activities such as technical support.
ISO 13485:2016 can also be used by suppliers or external parties that provide product, materials, or services—including quality management system-related services–to the medical device industry.
Requirements of ISO 13485:2016 are applicable to organizations regardless of their size and type, except where explicitly stated.
Key changes in ISO 13485:2016
Key changes in the revised standard include broadening its applicability to include organizations involved in the product life cycle, greater alignment with regulatory requirements, and more focus on post-market surveillance, including complaint handling. Stronger emphasis on appropriate infrastructure, particularly for the production of sterile medical devices, and more focus on risk management have also been added.
The new standard allows organizations to demonstrate compliance with regulatory requirements, and helps those involved in the development, distribution, and maintenance of medical devices to improve their processes, better manage risk, and ultimately improve the quality of what they do.
Increased efficiency, cost cutting, and monitoring supply chain performance are other potential benefits of implementing ISO 13485. For organizations looking to operate internationally or expand locally, ISO 13485:2016 can also help them to widen market opportunities.
A three-year transition period has been proposed commencing from the date of publication of ISO 13485:2016.
For more information about ISO 13485:2016, click here to visit ISO’s website.