ISO 13485:2016 A Risk Management Approach
The new ISO 13485:2016 standard provides an effective framework to meet the comprehensive requirements for a medical devices quality management system; for manufacturers and service providers to both comply and demonstrate their compliance to regulatory requirements.
ISO 13485:2016 supports the design of a quality management system that establishes and maintains the effectiveness of a manufacturer’s processes to ensure the consistent design, development, production, installation, and delivery of medical devices, or related services, that are safe for their intended purpose.
The new edition is applicable across the whole supply chain and seeks to address the entire lifecycle of a medical device.
Where the word “risk” was only mentioned twice in section “Product Realization” of the 2003 version, “risk” and “risk management” are identified at every single level of ISO 13485:2016. Every single clause highlights Risk Management: “Introduction”, “Definitions”, “Quality Management System”, “Product Realization and Measurement”, “Analysis and Improvement”.
The organization implementing ISO 13485:2016 is now required not only to implement a risk based approach for the device, but to have this approach for its processes and regulatory requirements implementation: “When the term “risk” is used, the application of the term within the scope of this International Standard pertains to safety or performance requirements of the medical device or meeting applicable regulatory requirements.” (Extracted from ISO 13485:2016 section 0.2).
Learn more About it: NEW ISO 13485:2016 MEDICAL DEVICE QMS TRANSITION TRAINING – RECORDED WEBINAR