The new ISO 13485:2016 standard is published

Introducing the new ISO 13485 Medical devices. Quality management systems. Requirements for regulatory purposes.

The latest edition of ISO 13485, the internationally recognized quality management systems standard for the medical device industry, with over 27,000 certificates globally, has been published, March 2016.

The 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.

The standard 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.

The requirements in ISO 13485 are used by suppliers or other external parties providing products or services to medical device manufacturers. By using ISO 13485, organizations will be able to demonstrate compliance with regulatory requirements, manage risk, ensure best practice for quality and safety, improve processes and provide confidence to patients.

The publication concludes over four years of work by experts around the world, to bring the standard up to date with the evolving European requirements and other international regulatory changes that have occurred since the previous revision in 2003.

Some of the key changes to ISO 13485 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

Anne Hayes, Head of Market Development for Governance and Risk at BSI said, “The regulatory landscape for medical devices is a rapidly changing one, and with that comes the evolution of ISO 13485. Today, we have to consider the supply chain and associated risks, so it is necessary to have transparent pathways in place - where all the development stages of a medical device can be observed, and any issues managed correctly.”

Existing BSI certification customers have three years to transition from ISO 13485:2003 and the associated European Standard EN ISO 13485:2012. BSI has developed a suite of materials, services and courses to help make the transition as smooth as possible, which can be found on this web page.

BSI has proposed plans for the process of certifying customers to ISO 13485:2016 including customers who need to transition from the 2003 version of the standard. BSI is in the process of confirming these plans with the appropriate accreditation bodies and will communicate certification arrangements in the near future.