Chapter 3 explains the first three foundational clauses of ISO 13485 and how they are embedded in the QMSR.

Clause 1: Scope

Clause 2: Normative references

Clause 3: Terms and definitions

Clause 1 (Scope)

Clause 1 clarifies that ISO 13485 applies to any organization involved in the medical device lifecycle – design, production, storage, distribution, installation, servicing, and disposal – as well as relevant suppliers and external parties.  

It emphasizes that organizations must identify their regulatory roles, determine which regional regulations apply, and integrate those requirements into their QMS. 

And its implementation is a strategic choice shaped by the organization’s context, products, processes, and size, and ISO does not prescribe a rigid documentation format or force companies to mirror the clause numbering. 

Clause 2 (Normative references)

Clause 2 is simple but important. The QMSR formally incorporates ISO 13485:2016 and ISO 9000:2015 (Clause 3) as normative references via 21 CFR 820, which means those standards are not “nice-to-haves” but part of regulatory expectations. 

Clause 3 (Terms and definitions)

Clause 3 is where the QMSR modernizes the language. The chapter explains how FDA realigns terminology with ISO 13485 and ISO 9000 while preserving statutory definitions from the FD&C Act. Key QSR terms are replaced or updated. 

The section first covers FDA’s hierarchy of definitions (FD&C Act first, then 21 CFR 820, then ISO 13485, then ISO 9000) and gives concrete examples of definitions by source (component, finished device, remanufacturer, implant, labeling, manufacturer, organization, rework, safety and performance, etc.).  

The core message: terminology is now harmonized with global standards, and manufacturers must understand which source “wins” when definitions overlap. 

Chapter 1

Chapter 2

Chapter 3

Chapter 4

Chapter 5

Chapter 6