ISO 13485:2016 Internal Auditor with FDA QMSR (USA/Canada) — 2026 Update
 | Top-selling course | |  | Disponible en Español | Also available in Spanish |
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 | Over 150+ participants have received their Internal Auditor certificate. | |||
Detecting errors in good time through internal audits of medical devices and ensuring quality standards
This course is certified by Exemplar Global.
Get you or your audit team ready for the biggest U.S. medical device QMS shift in decades. This comprehensive course equips internal auditors to assess conformity to ISO 13485:2016 within the new FDA Quality Management System Regulation (QMSR) framework, effective February 2, 2026, which incorporates ISO 13485:2016 and ISO 9000:2015 Clause 3 by reference.
Because internal audits are a mandatory requirement under ISO 13485, the course provides a complete foundation in planning, preparing, conducting, and evaluating internal audits in accordance with ISO 19011:2018. You’ll learn the specific audit requirements of ISO 13485, understand the characteristics of effective medical device audits, and gain confidence responding to different audit situations through practical industry examples and applied exercises.
Beyond ISO alignment, the QMSR retains several FDA‑specific provisions. You’ll learn how to extend audit criteria to verify compliance with UDI (21 CFR 830), Medical Device Reporting (803), Corrections & Removals (806), and Device Tracking (821)—critical elements auditors must now evaluate. The training also clarifies how to audit the Medical Device File (MDF) and how to map legacy structures like DMR, DHF, and DHR into the new terminology and expectations.
Recognizing the realities of the North American market, the course further addresses Canada’s CMDR requirements and essential MDSAP auditing expectations, including licensing, bilingual labeling, PMS, and the role of Auditing Organizations. This ensures your internal audit program is prepared for both U.S. and Canadian regulatory oversight.
By the end of the course, participants will be able to:
- Explain the QMSR effective date, its incorporation by reference of ISO 13485:2016 and ISO 9000:2015 Clause 3, and the resulting implications for internal audits.
- Plan, prepare, and conduct internal audits using ISO 13485:2016 as baseline criteria in alignment with ISO 19011:2018.
- Verify FDA‑retained requirements, including UDI (830), MDR (803), Corrections & Removals (806), and Device Tracking (821).
- Audit the Medical Device File (MDF) and map legacy DMR/DHF/DHR records into QMSR‑aligned documentation structures.
- Assess risk‑based controls across the QMS, including supplier management, CAPA effectiveness, and QMS software validation.
- Evaluate design & development traceability (7.3) and production identification/traceability (7.5.8/7.5.9), including UDI data integrity considerations.
- Verify labeling and packaging inspection controls retained under QMSR and understand access expectations for management review, internal audit, and supplier audit records.
- Recognize CMDR and MDSAP requirements and integrate them into internal audits for full North American compliance readiness.
Important: TÜV SÜD tests and certifies through its Notified Bodies medical devices and their manufacturers. TÜV SÜD Akademie GmbH offers trainings in the field of medical devices.
The neutrality and independence of the conformity assessment procedures carried out by TÜV SÜD must be maintained. In the interest of our customers, hence the seminars of TÜV SÜD Akademie do not contain any product-specific, process-related or company-specific content or solutions that could fulfill the function of individual consulting.
In case of any questions or uncertainties, please do not hesitate to contact us at [email protected].
Professionals in the medical device industry across the U.S. and Canadian markets, including:
- Internal auditors seeking to deepen or broaden their auditing expertise
- Quality managers, senior quality personnel, and Quality Management Officers
- Regulatory Affairs and Quality Affairs specialists
- Supplier Quality Engineers and compliance professionals
- Manufacturing, operations, and production leads responsible for quality system execution
- Product Managers and Project Managers involved in device lifecycle and compliance activities
- Medical device manufacturers, operators, and supplier organizations upgrading their audit programs to align with the QMSR baseline for February 2026
- Executives, specialists, and industry professionals aiming to develop or formalize their capabilities as medical device auditors
Day 1 — QMSR Alignment, ISO 13485 Integration & Audit Fundamentals
- Regulatory & Normative Framework
- FDA QMSR Overview: effective date, scope, incorporation of ISO 13485:2016 and ISO 9000:2015 Clause 3.
- Implications for internal audits and compliance programs under QMSR.
- Legal and normative foundations: ISO 13485 requirements, key audit‑relevant clauses, and comparison with EU expectations.
- ISO 19011:2018 & Audit Program Essentials
- Principles of auditing; risk‑based audit program planning.
- Audit types, frequency, and planning of internal audits.
- Auditor competence and requirements for internal auditors.
- Sampling strategies and documentation expectations.
- Practical Audit Preparation & Execution
- How to prepare audits in a practical, structured way.
- Audit questions, audit procedures, checklists, and documentation.
- Conducting audits: opening meeting, interviewing techniques, communication with auditees, and closing meeting.
- Audit trails for risk‑based QMS topics: supplier controls, software validation, CAPA effectiveness.
- Documentation Auditing Under QMSR
- MDF vs. DMR, DHF, DHR: how to audit design & production documentation in a QMSR environment.
- Design & production traceability (ISO 13485 7.3, 7.5.8, 7.5.9).
- UDI foundations and their impact on traceability audits.
Day 2 — FDA Retained Requirements, Canada Regulations & Applied Audit Skills
- FDA‑Retained Requirements Under QMSR
- UDI (21 CFR 830), MDR reporting (803), Corrections & Removals (806), Tracking (821).
- Labeling & packaging controls retained by FDA.
- How to audit retained requirements using checklist‑driven approaches.
- Access expectations: internal audits, supplier audits, and management review under the QMSR framework.
- Canada CMDR & MDSAP Essentials for Internal Auditors
- Canadian licensing, labeling/IFU bilingual requirements, and PMS obligations.
- MDSAP expectations: scope, Audit Objectives (AOs), and practical implications for internal audits.
- Integration of CMDR/MDSAP checkpoints into internal audit programs.
- Managing Audit Results & Post‑Audit Activities
- Evaluation of audit findings, grading, documentation.
- Determination and tracking of corrective actions.
- Effective follow‑up strategies to ensure closure and continuous improvement.
- Extensive Workshops, Case Studies & Final Assessment
- Scenario‑based case studies covering QMSR, ISO 13485, FDA retained items, and CMDR/MDSAP.
- Role‑play exercises: interviewing, evidence gathering, communication challenges.
- Full audit simulation from planning to reporting.
- Final knowledge assessment
Why now? On Feb 2, 2026, FDA will enforce the QMSR, modernizing 21 CFR 820 by incorporating ISO 13485:2016 and ISO 9000:2015 Clause 3. Internal audits must therefore use ISO 13485 clauses as the baseline while verifying the FDA‑retained requirements that remain outside ISO—particularly UDI, MDR, Corrections & Removals, and Device Tracking.
Terminology matters. The QMSR adopts ISO terminology, consolidating legacy FDA record types (DMR, DHF, DHR) into the ISO‑defined Medical Device File (MDF). We show you how to audit MDFs effectively and how to maintain clear cross‑references to legacy structures during the transition.
Risk and traceability are elevated. Under QMSR, FDA emphasizes risk‑based thinking across the entire QMS, not just product design risk. You’ll practice auditing a risk‑based approach to supplier controls, software validation, CAPA effectiveness, and internal audit planning—plus bidirectional design traceability and production identification/traceability (ISO 13485 §§7.3, 7.5.8, 7.5.
What remains uniquely FDA? You’ll use actionable checklists to evaluate labeling & packaging controls that FDA retains to strengthen label verification, and you’ll learn the updated inspection posture for management review, internal quality audits, and supplier audit records under QMSR.
Canada readiness. Finally, you’ll align internal audits to ISO 13485 + CMDR and the MDSAP process so your teams are audit‑ready for U.S. FDA inspections and Canadian MDSAP AO surveillance.
- Gain the competence to perform effective internal audits in the medical device industry, contributing directly to process improvement and organizational compliance.
- Be fully prepared for FDA’s QMSR enforcement (February 2, 2026) by learning to audit ISO 13485:2016‑aligned quality systems while also verifying FDA‑specific retained requirements, including UDI (21 CFR 830), MDR (803), Corrections & Removals (806), and Device Tracking (821).
- Strengthen your ability to audit updated documentation structures, including the Medical Device File (MDF), and understand how it replaces legacy constructs such as DMR/DHF/DHR under QMSR terminology.
- Develop strong risk‑based auditing skills, including supplier controls, CAPA effectiveness, QMS software validation, lifecycle documentation, and other high‑impact ISO 13485 and QMSR requirements.
- Increase your organization’s readiness for regulatory oversight, including U.S. FDA inspections and Canadian CMDR/MDSAP surveillance activities (licensing, bilingual labeling, PMS, and AO expectations).
- Improve your communication techniques to conduct professional, confident, and effective audits, engaging both audit teams and auditees with clarity and structure.
- Ensure product quality and safety by applying audit results to identify gaps, prevent issues, and support continuous improvement across the QMS.
- Enhance your professional credibility with training backed by TÜV SÜD Academy expertise, aligned with the most current North American regulatory and auditing expectations.
TÜV SÜD has achieved Exemplar Global Accreditation as a Recognized Training Provider. This accreditation confirms our commitment to providing the highest quality services and demonstrates our expertise in our industry.
As a professional, it's important to have recognition for your skills and knowledge. Exemplar Global Accreditation provides this recognition, giving you a competitive edge in the marketplace. With over 30 years of experience building certification programs, Exemplar Global is the leading authority in accreditation for the conformity community.
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- Access to Exemplar LINK
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- One self-coaching assessment
- Extended learning content
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- The chance to look into alternatives for employment and career advancement
- A TÜV SÜD / Exemplar Global Graduate Certificate
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- Instructor‑led virtual classroom format, combining live expert teaching, demonstrations, case studies, group exercises, and guided practice—mirroring the methodology used in TÜV SÜD’s accredited programs.
- Participants engage in scenario‑based audit simulations to apply ISO 13485:2016 and QMSR requirements to realistic audit situations.
- Interactive sessions include discussions, audit evidence review, traceability walkthroughs, supplier evaluation scenarios, and document‑review mini workshops.
- Learners must access the ISO 13485:2016 standard during the course; references are built into exercises and learning materials.
- Course delivered by one of TÜV SÜD's leading industry experts
- Small class sizes enhance trainer-delegate relationship
- Receive globally recognised TÜV SÜD certificate upon completion
Instructor-led training in a virtual classroom. This means the course is Live Online. Participants will learn through online teaching. Lectures, case studies, group exercises, discussions, problem solving, examples with explanation, assignments and/or quizzes happen in the virtual classroom training. Participants need to connect to the class from any internet accessible location. Each module is delivered live using webinar technology, creating a virtual classroom learning environment. Live sessions provide you with direct access to the trainer so you can ask questions, understand complex concepts and share ideas with peers. Webcam and microphone are REQUIRED to interact with the instructor and/or other participants.
The course content and structure are designed by the domain experts from TÜV SÜD. With immense experience and knowledge in the relevant standards, our team of product specialists and technical experts at TÜV SÜD, developed the course content based on current business landscape and market requirements.
Certificate of participation from the TÜV SÜD Academy
Learners must obtain a copyof the ISO standard to be referenced during the course. The standard may bepurchased through the American National Standards Institute (ANSI) (www.ansi.org) and/or American Society for Quality (ASQ) (www.asq.org).
Basic knowledge of ISO 13485
QMSR stands for Quality Management System Regulation, which is the U.S. FDA's updated rule for medical device manufacturers, replacing the older Quality System Regulation (QSR) and aligning with the international ISO 13485:2016 standard for greater global harmonization. Effective February 2, 2026, the QMSR streamlines requirements, integrating international best practices into U.S. regulations for a more consistent approach to device quality.
Key aspects of QMSR:
- Harmonization: It brings U.S. medical device regulations closer to those in Europe and other regions, making it easier for manufacturers to comply globally.
- Replaces QSR: QMSR officially changes the name and content of the FDA's Quality System Regulation (21 CFR Part 820).
- ISO 13485 Foundation: It incorporates the requirements of ISO 13485:2016, a widely recognized quality standard for medical devices.
- Focus on Risk: It emphasizes a risk-based approach to quality management.
In essence, QMSR is the FDA's strategic move to modernize its quality regulations for medical devices by adopting international consensus standards, notes.