ISO 13485: Evolution of Medical Device QMS Standard

Med Device Quality Management

ISO 13485 is a global standard that spells out quality management system (QMS) requirements for organizations providing medical devices and related services.

As of December 2022, nearly 30,000 organizations are ISO 13485 certified, according to the International Organization for Standardization’s 2022 survey results.

Original Publication

ISO 13485 was originally published in 1996 to differentiate medical device QMS requirements from the general ISO 9001 standard first published in 1987. Unique requirements for the med device industry necessitated separate guidelines. The original edition was based on the 1994 ISO 9001 revision.

ISO 13485:2003

The first revision of ISO 13485 came in 2003. ISO 13485:2003 emphasizes product effectiveness and efficiency.

ISO 13485:2012

In 2012, the governing organization amended the 2003 revision to clarify terminologies and requirements. ISO 13485:2012’s changes were minor.

ISO 13485:2016

A major revision in 2016 addressed changes in technology and regulations. It increased focus on risk management and risk-based decision-making processes. The divergence from ISO 9001 was more stark.

ISO 14971

ISO 13485 is closely related to ISO 14971, which focuses specifically on risk management applications in the med device industry. ISO 13485:2016, the current revision, references ISO 14971 clauses relating to risk management in product realization, risk-based decision making, regulatory alignment, and continuous improvement.

FDA Adoption

In 2022, the U.S. Food and Drug Administration (FDA) proposed using the international standard as the basis for its own regulations regarding quality management systems for med device manufacturers.

21 CFR Part 820

The FDA intends to eventually use the ISO 13485 instead of 21 CFR Part 820, also known as Quality System Regulation (QSR), which was introduced in the 1990s and was largely based on ISO 9001:1994.

International Alignment

During MedCon 2023, the FDA said incorporating ISO 13485:2016 is intended to modernize QMS standards, emphasize integration of risk management activities, and globally harmonize requirements, according to Med Device Online.

“It is interesting to note that the FDA has participated heavily in the development and revision of ISO 13485, yet it was not able to update its own regulation. Also, the FDA participated in the MDSAP audit program4 and accepted audits of the manufacturer’s quality system to ISO 13485:2016 in place of routine FDA QSR inspections. The agency, with its deep knowledge of the ISO standard, apparently is now comfortable using it in place of 21 CFR 820, the Quality System Regulation,” Edwin Bills and Christie Johnson wrote in, “The Intersection of ISO 13485 and ISO 14971 Under the Proposed FDA QSMR.”

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