For the first time since 2003, the International Organization for Standardization (ISO) has revised its medical devices standard, ISO 13485:2016 Medical devices—Quality management systems—Requirements for regulatory purposes.
The standard provides the requirements for a quality management system for organizations in the medical device industry. What does this standard require and what’s new in ISO 13485:2016?
What is ISO 13485:2016?
ISO 13485 provides the framework for organizations involved in the design, production, installation and servicing of medical devices to create a quality management system to meet customer and regulatory requirements. Medical devices are products, such as an instruments, machines, implants or in vitro diagnostic reagents, intended for use in the diagnosis, prevention and treatment of diseases or other medical conditions.
The requirements of ISO 13485:2016 apply to organizations of any size or type, except where explicitly stated. The standard may also be used by suppliers or external parties that provide products or quality management system-related services to such organizations in the medical device industry.
Certification is not a requirement of 13485:2016. However, certification of an organization’s quality management system by a third party may assist an organization in demonstrating the safety and quality of the devices or services the organization provides.
ISO 13485:2016 Revision
All ISO standards are reviewed every five years to determine if a revision is required. In this case, ISO/TC 210, the technical committee responsible for the revision, has revised ISO 13485:2016 to reflect developments in technology, regulatory requirements, and quality management relating to the medical device industry.
Among the revisions to the standard is a greater emphasis on infrastructure, especially in the production of sterile medical devices. Other changes include:
- More focus on risk management
- Greater emphasis on risk-based decision making
- Broadened applicability to include all organizations involved in product life cycle
- Increased alignment with regulatory requirements
- Greater focus on post-market surveillance such as the handling of complaints
Organizations with a quality management system that meets the requirements of 13485:2003 have three years in which to update their quality management system meet to the requirements of the revised standard.
Find more information or purchase ISO 13485:2016 at www.ISO.org.