ISO 13485:2016

Safety and quality are non-negotiables in the medical devices industry. Regulatory requirements are increasingly stringent throughout every step of a product’s life cycle, including service and delivery. More and more, organizations in the industry are expected to demonstrate their quality management processes and ensure best practice in everything they do.

ISO 13485, Medical devices – Quality management systems – Requirements for regulatory purposes, is an internationally agreed standard that sets out the requirements for a quality management system specific to the medical devices industry. It has recently been revised, with the new version published in March 2016.

Why was ISO 13485 revised?

All ISO standards are reviewed every five years to establish if a revision is required in order to keep it current and relevant for the marketplace. ISO 13485:2016 is designed to respond to latest quality management system practices, including changes in technology and regulatory requirements and expectations. You will have three years to transition from ISO 13485:2003 and the associated European Standard EN ISO 13485:2012.

ISO 13485:2016 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.

The processes required by ISO 13485:2016 that are applicable to the organization, but are not performed by the organization, are the responsibility of the organization and are accounted for in the organization’s quality management system by monitoring, maintaining, and controlling the processes.

Some of the key changes to ISO 13485:2016 include:

  • Alignment of global regulatory requirements
  • Inclusion of risk management and risk based decision making throughout the quality management system
  • Additional requirements and clarity with regard to validation, verification, and design activities
  • Strengthening of supplier control processes
  • Increased focus regarding feedback mechanisms
  • More explicit requirements for software validation for different applications
  • Alignment of global regulatory requirements
  • Validation using pre-clinical and clinical evaluations
  • Validation of packaging and distribution requirements
  • A feedback section, including a new complaint-handling section and other guidance for customer communications
  • Additional improvement measures: adding the use of post-market surveillance, risk-based decisions, and timelines

QSG has your training objectives covered! The following workshops will be available soon?

  1. Transition to ISO 13485:2016
  2. ISO 13485:2016 Overview
  3. ISO 13485 Lead Auditor Training
  4. ISO 13485:2016 Internal Auditor Training
  5. ISO 14971: Introduction to Risk Management

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