For the first time in 13 years, we will have an update to the backbone quality management system (QMS) requirements document for medical device organizations: ANSI/AAMI/ISO 13485:2016, Medical devices – Quality management systems – Requirements for regulatory purposes, will be released on March 1.
The revision contains numerous clarifications and additions to this important standard, including:
- Requirements related to risk-based thinking within the medical device organization’s QMS and other areas in addition to product realization (e.g., complaint handling, corrective and preventive action, competency of personnel and supplier controls).
- A greater emphasis on the responsibilities of management to review information related to the suitability, adequacy, and effectiveness of the QMS and to assess opportunities for improvement.
- Clarification that to “document” a procedure or process requires the organization to establish, implement, and maintain that process in addition to providing appropriate documentation.
- Planning requirements related to documentation of the necessary infrastructure (particularly for the production of sterile medical devices).
- Reinforcement of the importance of competency of personnel.
- The need to validate software for its application, including QMS software, process control software, and software used in monitoring and measurement.
- Clearing up that the scope of the standard includes the QMS-related activities of any organization participating in in any stage of a medical device’s life cycle.
- A greater emphasis on supplier controls.
- The use of standards and regulatory requirements as an input to product design and development.
- An additional focus on feedback with new requirements related to complaint handling and regulatory reporting.
- The explicit requirement to take corrective action without undue delay.
- The inclusion of annexes to explain the changes and connect ANSI/AAMI/ISO 13485:2016 to ISO 9001:2015.
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.
The transition period for application of the standard begins with publication of the standard, and certifications to the 2003 versions will be valid for up to three years (March 2019). It is anticipated that most certification bodies will require that any new certifications or recertification issued after two years (March 2018) from the date of the standard’s publication will have to conform to the requirements of ANSI/AAMI/ISO 13485:2016.
AAMI serves as the secretariat for the technical committee (ISO TC 210), which is the home for this standard and other standards that affect the medical device industry. We are excited for the release and stand ready to help organizations understand the requirements of this revised standard.
Mark Swanson is principal consultant at H&M Consulting Group, LLC, in Becker, MN.