• About ISO13485

  Medical devices - Quality management systems - Requirements for regulatory purposes
  
  ISO 13485 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.

Overview of ISO13485:2016

While this is a stand-alone standard, it is based on ISO 9001:2008, which has been superseded by ISO 9001:2015. This third edition of ISO 13485 cancels and replaces the second edition (ISO 13485:2003) and ISO/TR 14969:2004, which have been technically revised. If any requirement in Clauses 6, 7 or 8 of this International Standard is not applicable due to the activities undertaken by the organization or the nature of the medical device for which the quality management system is applied, the organization does not need to include such a requirement in its quality management system.

Comparing ISO13485:2003, ISO13485:2016 is intended to :

• facilitate global alignment of appropriate regulatory requirements
• apply a risk based approach to the control of the appropriate processes needed for the quality management system
• supplement and clarify the requirements for verification, validation and design and development activities
• strengthen the requirements for supplier control and outsourcing process
• emphasize importance of feedback mechanism
• add requirement for validation including the validation of the application of computer software used in the quality management system

Application of ISO13485:2016

Unlike ISO13485:2003, ISO13485: 2016 specifies requirements for a quality management system that can be used by an organization involved in one or more stages of the life-cycle of a medical device, including design and development, production, storage and distribution, installation, servicing and final decommissioning and disposal of medical devices, and design and development, or provision of associated activities (e.g. technical support).