It’s Never Been Easier to Get Into Quality Assurance
ISO 13485 Lead Auditor Training: The Bridge Between Compliance and Confidence
In the world of medical devices, quality isn’t just a goal, it’s a regulatory expectation. Whether you’re aiming to lead, audit, or advise in the wide world of medical devices, it helps to know how the registrar thinks. Anyone looking for their first step into the industry needs to look no further than APEX QA’s ISO 13485 Lead Auditor course.
This isn’t just another class, it’s TPECS-paced, Exemplar Global-approved, with live feedback all rolled into a convenient package. Our curriculum is designed to prepare you for work outside internal audits. When the registrar arrives to renew your certifications, it’s important to know exactly what they’re looking for: how they interpret standards, structure audits, and make determinations that can impact millions of dollars.
What Is TPECS and Why Does It Matter?
TPECS stands for Training Provider Exemplar Global Certification Scheme. This specific approach to quality training represents a standardized, internationally recognized framework for auditors. Our newly-certified ISO 13485 course is fully TPECS-aligned and consists of three modules:
- MD (Medical Devices) – Focusing on ISO 13485:2016, the internationally accepted standard for medical device quality management systems.
- AU (Auditing) – Covers the fundamentals of management system auditing, including planning, execution, reporting, and follow-up.
- TL (Team Leader) – Preparation for someone looking to lead audits on systems, handle gaps, delegate roles, and drive objective audit outcomes and CAPA.
With each module, you build a foundation, layering knowledge from standard interpretation to effective audit leadership.
Built for Flexibility, one of the greatest advantages of the TPECS framework is that it adapts to future training. If you’ve taken a TPECS course aligned to another standard, such as ISO 9001, you don’t need to repeat the full course; instead, you take certain portions containing new information.
Here’s an example of how it works:
Imagine you’ve already completed AU and TL; going forward, you’ll only need to take the MD module, training that typically lasts one to two days.
Inversely, if you’ve only completed the MD module and want to wade into the world of audit leadership, you’d just need the AU + TL modules.
Save your time and your sanity. Instead of sitting through four days of content you’ve already mastered, you can build on your existing knowledge efficiently and still walk away with a full, certified lead auditor credential.
Still, the merits of an occasional review cannot be understated. Leading quality professionals take special care in review and recall for all modules.
What You Can Do With an ISO 13485 Lead Auditor Certification
An Exemplar Global certification isn’t just a feather in your hard hat or lab coat, it’s a powerful, practical tool that can:
- Qualifiy you to conduct third-party audits or be employed as a registrar
- Support your organization in the identical training of registrars responsible for FDA inspections and ISO audits
- Equip you to lead internal audits or supplier audits with confidence and credibility.
- Advance your career toward roles in regulatory affairs, quality systems leadership, or consulting.
While these are the building blocks to a successful auditing career, our lessons are also designed to keep you on the cutting edge of the quality assurance world. This preparedness starts with recent updates to the standards and processes.
Recent Update: 21 CFR 820
In addition to the benefits listed above, our curriculum contains information relevant to 21 CFR 820: a new addition to the FDA’s required learning list.
In 2024, the FDA finally announced the harmonization between 21 CFR Part 820 and ISO 13485:2016. This change aligns the ISO standard and the FDA regulation are now more tightly than ever before.
Our course is built around that alignment. We cover how ISO 13485 serves as a roadmap for compliance with 21 CFR 820, while also calling out the critical nuances and differences:
- FDA-specific requirements for complaint handling, reporting, and CAPA (Corrective and Preventive Actions).
- The role of risk management throughout the product lifecycle.
- Differences in documentation expectations, terminology, and enforcement.
Audit Like a Registrar
Most internal auditors see audits from the inside of a system. This course flips that perspective on its head, teaching you to see the process the way a registrar does. What questions they might ask, how they verify effectiveness, and what red flags they look for.
With these insights, you’re sure to do the following:
- Write better procedures.
- Build stronger quality systems.
- Coach your team toward audit readiness.
- Avoid costly nonconformities before they happen.
Ready to Get Certified?
Whether you’re taking your first step into medical device auditing or expanding your credentials from another standard, this course was built with your growth in mind. You’ll leave with a globally recognized certification, a deeper understanding of ISO 13485 and FDA QSR, and the confidence to lead.
Already have TPECS experience? Let us know when you register, we’ll let you know the schedule so you’re only taking the modules you need.
