03/28/2024 | Press release | Distributed by Public on 03/28/2024 11:53
In 1987, the International Organization for Standardization (ISO) issued the first version of ISO 9001, a standard intended to define the basic requirements, structure, responsibilities, and procedures required to implement an effective quality management system for manufacturing organizations in general. In 1996, the International Organization for Standardization issued the first version of ISO 13485, "Quality Systems-Medical Devices-Particular Requirements for the Application of ISO 9001," to specify, in conjunction with the application of ISO 9001, the Quality Management System (QMS) requirements for medical device manufacturers. Today, ISO 13485 is used internationally by many regulatory authorities as the foundation for defining regulatory QMS requirements for medical device manufacturers and is utilized in regulatory harmonization programs such as the Medical Device Single Audit Program (MDSAP).
Over time, ISO 13485 has evolved, with the current editions (ISO 13485:2016) becoming more closely aligned with the current requirements set forth in Food and Drug Administration (FDA) 21CFR part 820 QS regulations.
FDA Quality System Regulations: Scope of Changes
The FDA recognizes the similarities between the current Quality System (QS) regulations (21CFR820) and ISO 13485:2016 and is therefore taking the opportunity to harmonize 21CFR part 820 QS by amending sections of the QS for closer alignment with ISO 13485:2016. The revised QS will be renamed the Quality Management Systems Regulations (QMSR). With a couple exceptions, the majority of changes to the QS are intended to align terminology between QS and ISO 13485 regulations.
However, there are some more significant changes as follows:
Interested in learning more on the FDA's final rule overview of quality system regulations/medical device current good manufacturing practices? Check out our Regulatory insights paper below that takes a deeper dive into this discussion.