QSR-to-QMSR Implementation Strategy

Medical Devices and Pharma Can Help 

Medical Devices and Pharma LLC has developed a systematic implementation approach to support your transition. Our methodology includes: 

• A “paper audit” and gap analysis by reviewing your quality system documentation 

• Detailed mapping of QSR requirements to ISO 13485 clauses 

• Subsystem-specific strategies for design controls, purchasing, complaint handling, postmarket surveillance, and more 

• Templates, training, and team-based rollout plans focused on long-term regulatory success 

Contact us for more information. We look forward to meeting with you!

Implementation Steps

Quality System Evaluation and Gap Analysis

Begin by conducting a paper audit of your existing QMS. This gap analysis will: 

• Map current procedures to ISO 13485:2016/QMSR clauses 

• Identify conflicts, missing elements, and opportunities for early integration (e.g., risk management, training, and documentation structure) 

• Prioritize tasks based on regulatory risk and implementation feasibility 

A consultant with QSR-to-QMSR transition experience can expedite this process and provide a transition matrix as a baseline planning tool. 

Establish a Cross-Functional Project Team

Form a transition team that includes key representatives from: 

• Quality Assurance (including CAPA, complaint handling, and auditing) 

• Design and Development 

• Purchasing and Supplier Quality 

• Production and Operations 

• Human Resources (training and competence) 

• Regulatory Affairs 

This team will own the transition plan and oversee implementation milestones using the gap analysis report as a reference. 

Team Training: Risk Management and Quality Improvement

If in-house expertise is limited, arrange external training in: 

• ISO 14971:2019 Risk Management 

• ISO 13485:2016 Quality Management Principles 

• Continuous improvement and internal auditing techniques 

Due to cost considerations, you may want to train an internal core group first, who can then train additional team members and serve as mentors throughout the transition. 

Initial Planning and Early QMSR Integrations

Review the gap analysis to identify QMSR elements that can be adopted early without compromising QSR compliance. These may include: 

• Risk management framework development 

• Enhanced documentation controls 

• Nonconflicting vocabulary updates 

• Preliminary continuous improvement initiatives 

Start drafting a QMSR-aligned project plan, including workstreams, timelines, and training schedules. 

Subsystem-by-Subsystem Implementation

Implement changes in logical phases, starting with areas of minimal regulatory conflict. Recommended sequence: 

Human Resources and Training

Update your training program per QMSR Clause 6: 

• Define competency requirements by job function 

• Document evaluation methods and retraining intervals 

• Incorporate risk- and performance-based training needs

Production and Process Controls

Update SOPs and work instructions to: 

• Reflect process validation expectations 

• Include risk-based monitoring and statistical techniques 

• Align labeling, packaging, and installation controls 

Supplier and Purchasing Controls

• Reevaluate supplier qualification processes with risk and quality metrics 

• Update purchasing procedures and quality agreements to reflect QMSR/ISO 13485 language

Design and Development

• Enhance risk management integration throughout the design lifecycle 

• Formalize design validation, verification, and transfer activities 

• Ensure Design and Development Files (DDF) meet QMSR expectations 

Expand Risk Management and Continuous Improvement

Systematically implement: 

• Process and product monitoring (Clause 8.2.5, 8.2.6) 

• Internal audit enhancements (Clause 8.2.4) 

• CAPA strengthening with trend analysis and effectiveness checks 

• Complaint handling and postmarket data analysis aligned with global reporting requirements 

Final System Updates and Full QMSR Readiness

Implement final changes that must wait until QMSR enforcement, including: 

• Rewritten SOPs for document and data control, including electronic systems and data integrity 

• Servicing procedures that capture service-related data (Clause 7.5.4) 

• Postmarket surveillance and vigilance aligned with Clause 8.2.1–8.2.3 

Finalize draft QMSR-compliant documents that will be activated upon the QMSR effective date. Maintain dual compliance documentation where needed. 

Final Audit and Readiness Assessment

Before the QMSR deadline: 

• Conduct a full internal audit to QMSR requirements 

• Evaluate implementation effectiveness, training coverage, and risk integration 

• Identify gaps, corrective actions, and documentation needs 

• Update your Quality Manual and master document index 

Conclusion 

Transitioning to the QMSR is a strategic investment in regulatory resilience and global competitiveness. With careful planning and phased implementation, your organization can improve product quality, strengthen risk controls, and streamline compliance. 

Medical Devices and Pharma is here to support your team at every stage of this transition—from planning and training to implementation and audit readiness. 

Let’s Talk

Feel free to schedule a 15-minute discussion with our CEO Bruce Waldon regarding your QMSR projects.

Comparison of FDA and ISO Quality Management System Requirements

Aspect	QMSR (21 CFR 820.10)	ISO 13485 Clause 4
Documentation Requirements	Requires manufacturers to document a QMS that complies with ISO 13485 and additional FDA regulations.	Requires organizations to document, implement, and maintain a QMS to meet ISO 13485 and applicable regulatory requirements.
Regulatory Compliance	Explicitly ties compliance to FDA regulations (e.g., UDI, traceability, MDR reporting).	Requires compliance with applicable regulatory requirements but does not specify FDA-specific mandates.
Design & Development	Mandates compliance with Clause 7.3 of ISO 13485 for certain device classes.	Requires organizations to define and control design and development processes as part of the QMS.
Risk-based Approach	Indirectly referenced in the application of ISO 13485 requirements.	Explicitly requires a risk-based approach to QMS processes.
Traceability	Additional requirements for unique device identification (UDI) and traceability per 21 CFR 821 & 830.	Requires traceability for implantable devices and risk-based traceability for other products.
Advisory Notices	Manufacturers must comply with 21 CFR 806 (recalls & advisory notices).	Organizations must establish procedures for issuing advisory notices but without referencing specific regulatory bodies.
Reporting to Regulatory Authorities	Explicitly mandates reporting to the FDA per 21 CFR 803 (MDR).	Requires a process for regulatory reporting but does not specify FDA requirements.
Software Validation	Implicitly required through ISO 13485 adoption.	Explicitly requires validation of software used in QMS processes.
Outsources Processes	Must comply with FDA requirements for supplier controls.	Requires organizations to monitor and ensure control over outsourced processes, with proportionality based on risk.
Regulatory Enforcement	Noncompliance renders the device adulterated under the FD&C Act, subject to FDA action.	ISO 13485 compliance alone does not imply regulatory enforcement unless mandated by a jurisdiction.