ISO 13485 Clause 1 and Clause 2
For medical device manufacturers, compliance with ISO 13485:2016 is essential to ensure the quality, safety, and regulatory alignment of their products. The first two clauses of the standard lay the groundwork for understanding its purpose and applicability.
Clause 1: Scope
Defines the intent of ISO 13485, specifying that it applies to organizations involved in the design, production, installation, and servicing of medical devices. It also covers the role of suppliers and other external parties in the quality management system (QMS). Read more below.
Clause 2: Normative References
The QMSR normative references are:
- 21 CFR 820 – lists ISO 13485:2016 and ISO 9000:2015 Clause 3 as normative references.
- ISO 13485 – lists ISO 9000:2015 Clause 3 as a normative reference.
Overview of Changes
QMSR Info Request Form
Definitions
Affected Regulations and Standards
Assembling the Puzzle
Implementation Strategies
Small Manufacturers
Similarities in Scope
Regulatory Intent and Coverage of the Medical Device Life Cycle
Both QSR and QMSR establish requirements for a quality system that governs medical device manufacturing and cover essential lifecycle processes, including design, manufacture, packaging, labeling, storage, installation, and servicing of medical devices.
Coverage of Medical Device Life Cycle Activities
Both regulations apply to design, manufacture, packaging, labeling, storage, installation, and servicing of medical devices. The QMSR expands its scope to distribution, technical support, and provision of related services beyond what is explicitly stated in the QSR.
Exemptions for Certain Activities
In both regulations, some requirements do not apply universally to all organizations. Organizations may exclude certain requirements if justified by applicable local regulatory requirements (e.g., Clauses 6, 7, and 8 of ISO 13485).
Applicability to Organizations
The QSR applies to manufacturers of finished medical devices but excludes component or part manufacturers (though they are encouraged to follow CGMP). The QMSR applies broadly to any organization involved in one or more stages of the medical device life cycle, including suppliers or external parties that provide products or quality management system-related services.
Manufacturers’ Responsibility for Outsourced Processes
Both regulations require organizations to ensure compliance for outsourced processes by monitoring and controlling those activities within their quality system. However, the QMSR places a stronger emphasis on supplier management and contractual agreements, aligning with ISO 13485’s supplier control provisions.
| Aspect | QSR Scope | QMSR Scope |
|---|---|---|
| Regulatory Basis | Based on 21 CFR Part 820 (CGMP). | Based on 21 CFR 820 and ISO 13485:2016. |
| Applicability to Organizations | Applies specifically to finished device manufacturers. | Applies to any organization involved in the medical device lifecycle, including suppliers and external parties providing quality system-related services. |
| Inclusion of Distribution & Technical Support | Does not explicitly mention distribution or related services. | Explicitly includes distribution, technical support, and other associated services. |
| Supplier & Component Manufacturer Coverage | Does not require compliance from component or part manufacturers, though they are encouraged to follow CGMP. | Component and part manufacturers are also not required to comply, but contractual agreements may require adherence to QMSR, aligning with ISO 13485 Clause 0.1. |
Component Manufacturers
A key similarity between QSR and QMSR is that FDA does not require component and part manufacturers to comply with the quality system regulation, despite having the authority to do so. The FDA’s QMSR Final Rule states:
“FDA’s authority to promulgate quality systems regulations for devices extends to the components and parts of those devices, [but] FDA has chosen, in this regulation, not to require components and parts to comply.”
However, contract manufacturers and suppliers may be required to comply through business agreements, as QMSR aligns with ISO 13485:2016 Clause 0.1, which allows organizations to extend QMS requirements through contractual obligations.
Thus, while QMSR does not formally expand enforcement to component manufacturers, it introduces a more structured supplier management approach, meaning that compliance may increasingly be expected in practice.
Conclusion
The shift from QSR to QMSR reflects a move toward international harmonization, bringing the FDA’s regulatory framework in line with ISO 13485:2016. While both regulations aim to ensure the safety and effectiveness of medical devices, QMSR expands applicability to a broader range of organizations involved in the medical device lifecycle, including suppliers and external service providers.
Additionally, QMSR strengthens supplier oversight by integrating contractual compliance expectations, even though FDA does not directly mandate QMSR compliance for component manufacturers. This change aligns U.S. regulations more closely with global quality management standards, fostering a more consistent regulatory environment for medical devices worldwide.
ISO 13485:2016 Clauses
1 Scope
2 Normative references
3 Terms and definitions
4 Quality management system
5 Management responsibility
6 Resource management
7 Product realization
♦ 7.3 Design and development
♦ 7.4 Purchasing controls
8 Measurement, analysis & improvement