AAMI News May 2016

Spotlight on Standards: Major Revision to Quality Management Standard Completed

A comprehensive and crucial standard dealing with quality management systems (QMS) has been updated for the first time in 13 years in response to the latest developments in quality management, technology, and regulatory requirements related to the medical device industry.

ANSI/AAMI/ISO 13485ANSI/AAMI/ISO 13485:2016, Medical devices—Quality management systems—Requirements for regulatory purposes, is intended to help organizations design a quality management system that establishes and maintains the effectiveness of their processes. This standard is meant to be used throughout a device’s life cycle, from initial concept through post-production, including final decommission and disposal. The updated version of 13485 also covers aspects such as storage, distribution, installation, and servicing, as well as the provision of associated services.

“13485 reflects a strong commitment to continual improvement and gives customers confidence in its ability to bring safe and effective products to market,” said AAMI Standards Director Wil Vargas, secretary of ISO/TC 210, the technical committee responsible for the revision.

According to Vargas, the new version of 13485 places greater emphasis on risk management and risk-based decision making for processes outside the realm of product realization, including the risks associated with the safety and performance of devices. In addition, the standard asks organizations to be more stringent when it comes to outsourcing processes by putting specific controls in place, such as written agreements, for assessing their suppliers.

“The goal of these important changes is to help organizations ensure that they have a QMS that provides the highest probability for safe and effective medical devices that meet customer requirements and appropriate regulatory requirements,” Mark Swanson, principal consultant at H&M Consulting Group, LLC, in Becker, MN, wrote in an AAMIBlog post. Swanson was very active in contributing to the revision of 13485.

Increased regulatory requirements affecting organizations across the medical device supply chain necessitated a broadening of the standard’s application to encompass organizations involved in design and development or repair and maintenance of medical devices; supply of raw materials, components, or subassemblies; performance of services, such as sterilization, logistics, or calibration of measurement equipment; and the importation or distribution of medical devices.

The update also reflects:

  • A greater emphasis on appropriate infrastructure, particularly for the production of sterile medical devices, and additional requirements for the validation of sterile barrier properties.
  • More focus on postmarket activities, including complaint handling and regulatory reporting.
  • Additional requirements in the design and development of medical devices, taking into consideration their usability, the use of standards, and more robust planning for the verification, validation, transfer, and records maintenance of these activities.
  • Harmonization of validation requirements for different software applications, such as QMS software, process control software, and software for monitoring and measurement.

“Not only will this update allow organizations to demonstrate compliance with regulatory requirements, but it will also help all organizations involved in the development, distribution, and maintenance of medical devices improve their processes, better manage risks, and ultimately improve the quality of what they do,” Vargas said.

The transition period for application of the standard will begin with publication (expected June 2016), and certifications to the 2003 versions will be valid for up to three years. It is anticipated that most certification bodies will require any new certification or recertification issued in the second half of 2018 to conform to the requirements of the standard.