By Neelank Tiwari in FDA — 13 Dec 2025

QMSR Terminology Glossary: Old vs New Definitions

One of the most practical challenges in QMSR transition is vocabulary. After years of speaking QSR, you suddenly need to speak ISO 13485. Your procedures say "establish," the standard says "document." You've always had a DMR, now you need an MDF.

Reading time: 10 minutes | Last updated: December 2024

This glossary provides a complete reference for QMSR terminology changes—what terms changed, what stayed the same, which definitions take precedence, and how to use the new vocabulary correctly.

In this article:

Terms that changed names
Terms with changed definitions
Terms that stayed the same
The definition hierarchy (what takes precedence)
Downloadable terminology reference card

Understanding the Definition Hierarchy

Under QMSR, definitions come from multiple sources with a priority order:

Priority 1: FD&C Act
Definitions in the Federal Food, Drug, and Cosmetic Act take precedence over everything else.

Priority 2: FDA Regulations (21 CFR)
Definitions in FDA regulations, including QMSR itself (820.3), supersede ISO definitions where they conflict.

Priority 3: ISO 13485:2016
Definitions in ISO 13485 apply unless superseded by FDA sources above.

Priority 4: ISO 9000:2015
ISO 13485 incorporates ISO 9000:2015 Clause 3 definitions by reference. These apply unless superseded by higher-priority sources.

Practical example: ISO 13485 defines "medical device." FDA regulations define "device." The FDA definition prevails for regulatory purposes, though the practical meaning is similar.

Terms That Changed Names

QSR Term	QMSR/ISO 13485 Term	Notes
Device Master Record (DMR)	Medical Device File (MDF)	Broader concept including regulatory conformity evidence
Design History File (DHF)	Design and Development File	Essentially equivalent content
Device History Record (DHR)	Batch Record / Medical Device Record	Production records per 7.5.1
Management Representative	Top Management	Higher organizational level implied
Quality System	Quality Management System	Equivalent meaning; "management" added
Corrective and Preventive Action (CAPA)	Corrective Action + Preventive Action	Two separate requirements
Finished Device Testing	Product Monitoring (8.2.6)	Integrated into broader monitoring
Critical Device	N/A	Concept removed; risk-based approach instead

Terms with Changed Definitions or Emphasis

Top Management vs. Management Representative

QSR (820.20): Required a "management representative" with defined responsibility and authority for the quality system. Could be delegated.

ISO 13485 (Clause 5.1, 5.5): "Top management" must demonstrate commitment, ensure policy/objectives, conduct reviews, and ensure resources. Implies higher organizational level with personal accountability.

Practical impact: Executive engagement expected, not just delegation to a quality manager.

Establish vs. Document

QSR: "Establish" often meant document and implement.

ISO 13485: "Establish" generally means to implement. "Document" is used when documentation is specifically required.

Practical impact: Pay attention to whether ISO 13485 says "establish" (implement) or "establish and document" (implement and document).

Feedback vs. Complaints

QSR (820.198): Focused on complaint handling—reactions to customer-reported problems.

ISO 13485 (8.2.1): "Feedback" is broader—proactive collection and analysis of information about product performance, customer satisfaction, and market experience. Includes but extends beyond complaints.

Practical impact: You need both reactive complaint handling and proactive feedback collection.

Corrective Action vs. Preventive Action

QSR (820.100): Combined requirement allowing integrated "CAPA" processes.

ISO 13485 (8.5.2 and 8.5.3):

Corrective Action (8.5.2): "Action to eliminate the cause of a detected nonconformity or other undesirable situation" to prevent recurrence.

Preventive Action (8.5.3): "Action to eliminate the cause of a potential nonconformity or other potential undesirable situation" to prevent occurrence.

Practical impact: Different triggers, different evidence, separate processes or clearly separated sections.

Terms That Stayed the Same (Or Nearly So)

Term	QSR Reference	ISO 13485 Reference	Notes
Design Controls	820.30	7.3	Substantially equivalent
Design Input	820.30(c)	7.3.3	Equivalent
Design Output	820.30(d)	7.3.4	Equivalent
Design Review	820.30(e)	7.3.5	Equivalent
Design Verification	820.30(f)	7.3.6	Equivalent
Design Validation	820.30(g)	7.3.7	Equivalent
Design Transfer	820.30(h)	7.3.8	Equivalent
Design Change	820.30(i)	7.3.9	Equivalent
Purchasing Controls	820.50	7.4	Substantially equivalent
Process Validation	820.75	7.5.6	Substantially equivalent
Traceability	820.65	7.5.9	Equivalent; risk-based extent
Calibration	820.72	7.6	Equivalent
Complaint	820.198	8.2.2	Equivalent handling requirements
Internal Audit	820.22	8.2.4	Equivalent; records now inspectable
Nonconforming Product	820.90	8.3	Substantially equivalent

New Terms Under QMSR

Medical Device File (MDF)

Definition: A compilation of records and documents for each medical device type demonstrating conformity to regulatory requirements.

How it differs from DMR: Broader scope explicitly including regulatory conformity evidence, not just manufacturing specifications.

Customer Communication (7.2.3)

Definition: Documented arrangements for communication with customers about product information, inquiries, contracts, order handling, amendments, and feedback.

New requirement: No equivalent explicit requirement in QSR.

Process Interaction (4.1)

Definition: Documentation of how QMS processes interact—inputs, outputs, and interfaces between processes.

New emphasis: QSR implied this; ISO 13485 explicitly requires documentation.

Outsourced Process (4.1)

Definition: A process that the organization has identified as needed for its QMS but chooses to have performed by an external party.

New emphasis: Explicit requirement to identify outsourced processes and apply risk-based control.

QMS Software Validation (ISO 13485 Clause 4.1.6

Definition: Validation of software used to operate the quality management system.

Requirement: ISO 13485:2016 Clause 4.1.6 requires organizations to validate software used in monitoring and measurement of the QMS. This is more explicit than QSR 820.70(i) automated process validation requirements.

Terms Removed or De-emphasized

Critical Device

QSR: Implied concept driving different documentation requirements for critical versus non-critical devices.

QMSR: Removed. Risk-based approach replaces categorical distinctions.

Finished Device Testing (820.90)

QSR: Standalone requirement for acceptance activities on finished devices.

QMSR: Integrated into product monitoring (8.2.6). Not removed as a concept, but no longer separately emphasized.

Definition Quick Reference by ISO 13485 Clause

Clause 4 Terms

Quality Management System (4.1): Documented system to manage quality
Medical Device File (4.2.3): Product documentation demonstrating regulatory conformity
Document (4.2.3): Information and its supporting medium
Record (4.2.5): Document stating results achieved or evidence of activities performed

Clause 5 Terms

Top Management (5.1): Person or group directing the organization at highest level
Quality Policy (5.3): Overall quality intentions and direction
Quality Objective (5.4.1): Something sought related to quality
Management Review (5.6): Formal evaluation of QMS suitability and effectiveness

Clause 6 Terms

Competence (6.2): Demonstrated ability to apply knowledge and skills
Infrastructure (6.3): System of facilities, equipment, and services needed
Work Environment (6.4): Set of conditions under which work is performed

Clause 7 Terms

Product Realization (7.1): Processes needed to provide the product
Design and Development (7.3): Set of processes transforming requirements into specifications
Purchasing (7.4): Obtaining goods and services from external providers
Production (7.5): Creating the product
Traceability (7.5.9): Ability to trace history, application, or location

Clause 8 Terms

Feedback (8.2.1): Information about customer satisfaction and product performance
Complaint (8.2.2): Written, electronic, or oral communication alleging deficiency
Internal Audit (8.2.4): Systematic evaluation of QMS effectiveness
Nonconforming Product (8.3): Product not meeting specified requirements
Corrective Action (8.5.2): Action eliminating causes of detected nonconformity
Preventive Action (8.5.3): Action eliminating causes of potential nonconformity

Practical Guidance on Terminology Transition

What You Should Do

1. Update your Quality Manual
Acknowledge terminology equivalence. State that your DMR serves as the Medical Device File, etc.

2. Don't mass-rename documents
You can keep calling your DMR a "DMR." The content matters more than the title.

3. Train personnel on key changes
Focus training on terms that affect behavior: Top management accountability, CAPA separation, feedback vs. complaints.

4. Reference both when helpful
"Medical Device File (DMR)" is perfectly acceptable during transition.

5. Learn ISO 13485 clause structure
FDA inspectors will reference clause numbers. Know where to find requirements.

Download: QMSR Terminology Quick Reference Card

We've created a printable reference card with the most important terminology mappings for quick reference during transition and inspections.

Download: QMSR Terminology Reference Card (PDF) →

Questions about QMSR terminology?

QMS.Coach can help you navigate the terminology transition and update your documentation efficiently—without unnecessary renaming exercises.

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QMS.Coach LLC | neel@qms.coach