In responding to Comment #30 in the preamble of the QMSR1, FDA addressed the term “establish.” Under the former QS Regulation, “establish” was defined as define, document, and implement. Commenters asked FDA to retain that definition in QMSR.
FDA disagreed. The agency pointed to Clause 0.2 in the Introduction section of ISO 13485, which explains that when the standard uses the term “document,” it encompasses the activities of establishing, implementing, and maintaining. That means the practical expectation has not been lowered. A documented process is not merely a written procedure. It must be established, implemented, and maintained.
This is also an important lesson for QMSR readiness: ISO 13485 should be read as an integrated QMS framework, not just as a checklist of requirements beginning in Clause 4. Many organizations focus almost entirely on the normative clauses and treat the Introduction as background. But FDA’s response to Comment #30 points directly to Clause 0.2 to explain how a key term should be understood.
Under QMSR, “documented” should not be read as paper-only. It includes establishing, implementing, and maintaining the process.
This reinforces why simple QS-to-ISO mapping can miss the point. If a manufacturer only asks, “Where did the old QS definition go?” it may overlook how ISO 13485 explains the concept within the structure of the standard itself.
FDA is signaling that QMSR requires more than word substitution. It requires understanding how ISO 13485 uses terms across the whole quality system framework.
So, think about this question and share your opinion in the poll below:
👉What is the biggest risk when “documented” is treated as paper-only?
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