One of the most important and often overlooked aspects of QMSR is the hierarchy of definitions established by the FDA.

The QMSR Hierarchy of Definitions

One of the most important, and often overlooked, aspects of QMSR is the hierarchy of definitions established by the FDA. When QMS terms overlap or conflict, the following hierarchy applies.

FD&C Act (Highest Authority)

Definitions in the Federal Food, Drug, and Cosmetic Act take precedence over all others. These include foundational terms such as Device, Manufacturer, and Label / Labeling. These definitions are legally binding and cannot be overridden by ISO terminology.

21 CFR Part 820 (QMSR-Specific Definitions)

The QMSR retains certain FDA-specific definitions necessary for regulatory clarity and enforcement. Examples include Component, Finished device, Remanufacturer, Rework (with FDA-specific limitations), and Human cell, tissue, or cellular/tissue-based products (HCT/Ps).  

These definitions often reflect FDA enforcement priorities and distinctions not captured in ISO standards.

ISO 13485:2016

ISO 13485 provides the primary structure and vocabulary for quality management systems. Examples include Risk and risk management, Complaint, Post-market surveillance, Supplier and purchased product, and Sterile medical device. These definitions form the operational backbone of the QMS.

ISO 9000:2015 (Supplemental)

ISO 9000 serves as a supporting reference for general quality management terminology. Examples include Audit, Continual improvement, Documented information, and Objective evidence. ISO 9000 terms are typically referenced when additional clarity is needed beyond the definitions provided in ISO 13485.

FDA-Specific Terminology Considerations

While QMSR aligns with ISO standards, the FDA has deliberately retained or modified certain definitions to preserve regulatory intent. Key examples follow.

Rework

FDA limits “Rework” to products not yet released for distribution. Post-release corrections are handled under different regulatory frameworks. This distinction is critical during inspections.

Finished Device

A device may be considered “Finished” even if not packaged or sterilized. If it can function, it meets the definition. This impacts traceability, device records, and regulatory classification.

Organization vs Manufacturer

ISO uses the term “Organization,” which FDA aligns with “Manufacturer.” This difference is important to understand when interpreting responsibilities under the QMSR.