ISO 13485:2016 Medical Devices – Quality Management Systems – Requirements for Regulatory Purposes

This internationally recognized standard is authoritative for quality management systems in the medical device industry and covers almost all aspects of ISO 9001. It also contains specific requirements for the manufacture and placing on the market of medical devices. Particular focus is placed on product safety and the introduction of risk management. The current DIN EN ISO 13485:2016 revision was published by the International Organization for Standardization on February 25, 2016.

In the EU it also forms the basis for the certification of a quality management system required by the Medical Device Directive by a notified body.

The ISO 13485:2016 revision focuses on the entire life cycle of a medical device. This means that the QMS should also apply after the products have been placed on the market. The new version no longer only affects medical device manufacturers, but also service providers and suppliers. ISO 13485 explicitly requires manufacturers to adopt a risk-based approach to all quality processes, including outsourced processes, and to better structure validation, verification and design transfer. All companies certified according to the 2003 version have three years to convert to the current version.

Chapter 1 – Scope of Application
Chapter 2 – Normative References
Chapter 3 – Terms and Definitions
Chapter 4 – Quality Management System
Chapter 5 – Management Responsibility
Chapter 6 – Resource Managment
Chapter 7 – Product Realisation
Chapter 8 – Measurement, Analysis and Improvement

DHC VISION Compliance-Matrix for ISO 13485

Request AreaDescription Solutions and Products
Chapter 4 – Quality Management SystemAccording to ISO 13485:2016, a risk-based approach must be applied to all processes of the QM System.· Process and Quality Management
· SOP Management
· Change Management
Chapter 5 – Management ResponsibilityRequires determination of the role an organization plays in the regulatory requirement. In addition, the associated processes must be determined.· Process and Quality Management
· SOP Management
· Change Management
· Auditmanagement
· CAPA-Management
· Deviation Management
· Complaint Management
· Training und Learning Success Management
Chapter 6 – Resource ManagmentContains the guidelines for employees to work in accordance with the rules.· Process and Quality Management
· SOP Management
· Training und Learning Success Management
Chapter 7 – Product RealisationSpecifies the requirements and their risk-based implementation for each individual product realization process.· Process and Quality Management
· CAPA-Management
· Deviation Management
· Complaint Management
· SOP Management
· Auditmanagement
Chapter 8 – Measurement, Analysis and ImprovementDescribes the requirements for monitoring and improving processes as well as corrective and preventive measures.· Process and Quality Management
· CAPA-Management
· Deviation Management
· Complaint Management
· SOP Management
· Auditmanagement
· Dashboards, Reports, Analytics