Why This Matters in the QMSR Transition
U.S. Manufacturers Adopting ISO 13485 Will Need a Quality Manual
While QMSR does not mandate a Quality Manual, ISO 13485 compliance does—meaning manufacturers aligning with QMSR will likely need to create one. Many U.S. medical device manufacturers previously operating under QSR did not have a Quality Manual and will need to develop one for ISO 13485 alignment.
It will Help with Global Market Access
The Quality Manual simplifies audits by consolidating key processes in one document. It is essential for manufacturers selling in Europe, Canada, Australia, and other markets that require ISO 13485 certification.
FDA Expectations on Documentation
Even though the FDA does not require a Quality Manual, inspectors may expect to see comprehensive QMS documentation under QMSR, especially for compliance with ISO 13485 Clause 4.2.
Final Takeaway
While the current QSR does not formally introduce a Quality Manual requirement, ISO 13485 does. This makes it a best practice for manufacturers aiming for full compliance and global market access, another key documentation shift U.S. manufacturers must consider under the new QMSR framework.
Overview of Changes
QMSR Info Request Form
Definitions
Affected Regulations and Standards
Assembling the Puzzle
Implementation Strategies
Small Manufacturers
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
Quality Manual Requirements
| Aspect | ISO 13485 Requirement | QSR (21 CFR 820) / QMSR (21 CFR 820.10) |
|---|---|---|
| Quality Manual Requirement | Mandatory – Organizations must document and maintain a Quality Manual that includes the scope of the QMS, documented procedures, and a description of interactions between processes. | Not explicitly required – QSR and QMSR require documented procedures and quality planning, but they do not mandate a Quality Manual. |
| Purpose | Establishes a centralized document that defines how the organization meets QMS and regulatory requirements. | Relies on separate quality system procedures and policies without requiring a single consolidated manual. |
| Integration of Regulatory Requirements | The manual must outline regulatory compliance strategies applicable to the organization. | QMSR requires compliance with FDA-specific regulations (UDI, traceability, MDR reporting), but without requiring a unified document for these processes. |
| Harmonization with Business Processes | ISO 13485 encourages a holistic, process-based approach that aligns the QMS with operational workflows. | QMSR focuses on regulatory enforcement and compliance rather than an overarching quality strategy. |