Medical device quality path · ISO 13485 · FDA QMSR
Audit to ISO 13485 and the FDA QMSR. Then fix what you find, and prove it held.Be the one they trust when FDA walks in. Audits that hold up. CAPAs that stay closed.Part 820 now points at ISO 13485. Be the one who knows what FDA checks.
Audit a device QMS to ISO 13485 and what Part 820 adds, and write findings an investigator can follow. Then take one problem to a cause you can prove and a fix you can show worked, with Coach Q at your side.
For quality and regulatory staff at device makers and their suppliers.
- 2 live courses, in order
- 4 more on the way
- Step 1: about 11 hours
- Coach Q in every course
Sound familiar?
If you own quality at a device maker, you've heard these.
We audit it with our old ISO 9001 checklist.
ISO 13485 keeps a management representative, preventive action and more documented procedures, and the QMSR adds FDA's own requirements on top. A copied 9001 checklist walks past them. In ISO 13485 Internal Auditor you build a clause checklist with the QMSR add-ons in it.
The supplier handles sterilization. It's their problem.
An outsourced process stays your responsibility, controlled in proportion to risk, with a written quality agreement. ISO 13485 Internal Auditor shows you how to audit what your company still owns.
Retrain the operator. Again.
Three CAPAs, three operators, the same fix. When the action names a person, the cause is still in the process. Root Cause and CAPA takes you past operator error to a cause you can prove and an action that doesn't depend on someone remembering.
It closed two weeks after the fix. Then it came back.
A training record proves the action was done, not that it worked. Root Cause and CAPA has you set the success criteria and the window before the fix goes in, and close only when the data says it held.
What it does for you
Become the one they trust with the audit and the CAPA.
Audit reports that hold up when read cold
Requirement, evidence, gap, written so someone reading it months later sees what you saw. When FDA can ask for the report, the person who writes it that way is the one people trust with the program.
CAPAs that close once
A cause you can prove and data that shows the fix held. Every repeat pays for the sort, the scrap and the investigation again, and leadership notices who made the repeats stop.
Proof you can put in front of anyone
A certificate anyone can verify online, plus the audit program, findings and CAPA work you drafted along the way. It's evidence for your next review or interview, and it's yours to keep.
No course can promise you a raise or a title. What you'll have is the skill, the work to show for it and a certificate anyone can verify. That's what those conversations run on.
Why it matters
When a device problem gets reported, your records answer for it.
Each year, FDA receives over 2 million medical device reports of suspected device-associated deaths, serious injuries and malfunctions.
Source: FDA, Medical Device Reporting (MDR): How to Report Medical Device Problems, updated March 2025
Manufacturers are mandatory reporters. As an auditor, you don't make the reporting call. You prove the company made it, on time, on the record, with a reason a regulator can follow. A file marked 'not reportable' with no date and no reason is what you write up.
Since February 2, 2026, Part 820 incorporates ISO 13485:2016 by reference, and FDA can inspect your management review, internal audit and supplier audit reports. The people who can audit that trail, and close a CAPA with data that shows it held, are the ones a device company leans on.
The full path
Audit it first. Then fix what the audit finds.
Start with the audit, because it shows you where the system is weak, then learn to prove the cause and the fix. Each course stands alone, so start where your job is.
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Step 1 · Audit to ISO 13485 and the QMSR
ISO 13485 Internal Auditor with FDA QMSR
ISO 13485:2016 clause by clause, plus what Part 820 adds: 820.35 complaint and servicing records, 820.45 labeling and packaging, and the MDR and correction or removal trail. Then a full mock audit of a fictional contract manufacturer.
You walk out with a risk-based audit program, an audit plan and a clause checklist with the QMSR add-ons, finding statements an investigator can follow, and a complaint record check sheet.
- About 11 hours
- Final exam
- Certificate anyone can verify
- Lesson 1 free
See what you get →The course page shows everything included, then the price.
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Step 2 · Prove the cause and the fix
Root Cause Analysis & CAPA (AS13000)
Work the 8D: contain the problem, define it with data, find and test candidate causes with fishbone, Is/Is-Not and 5-Why, and set the effectiveness check before the fix. Most cases are aerospace, but the tools work in any plant.
You walk out with a 5-Why with evidence at every step, an Is/Is-Not that bounds the problem, an effectiveness check set before the change, and a 90-day plan for your CAPA system.
- About 21 hours
- Certificate anyone can verify
- Lesson 1 free
See what you get →The course page shows everything included, then the price.
On the way in this path
Risk management, design controls, complaint handling and FMEA courses are on the way, each with a waitlist you can join now.
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On the way
Risk Management for Medical Devices (ISO 14971)
The risk standard ISO 13485 relies on.
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On the way
Design Controls
ISO 13485 clause 7.3, now enforced through the QMSR.
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On the way
Complaint Handling and MDR Reporting
Where complaints meet FDA's reporting rules.
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On the way
FMEA and Control Plans
Find failure modes before they reach the customer.
Not like training used to be
Short, hands-on, built around you. And the coach stays.
Training used to mean days in a classroom or hours of video. Here are real screens from this path: short sessions where you make the call, a plan that fits your week, and an expert in your pocket in every course.
Coach Q · from ISO 13485 Internal Auditor with FDA QMSR
It can be, once you tie it to a requirement. Start with the company's own complaint procedure, then 820.35: a complaint record includes the dates and results of the investigation, any corrective action taken and any reply to the complainant.
Write it as requirement, evidence, gap: the complaint number, what the record is missing, and what the procedure or 820.35 asks for. Before you move on, check whether anyone looked at it as a possible MDR.
Want me to prepare the finding statement from your notes so you can check it?
Coaching, not decisions. You make the call. Comes with every course, no renewal fee.
Study plan · Your personal trainer
Tell it your goal date. It builds sessions around your week and shows each day whether you're on plan, so the course actually gets finished.
Focus timer · 25 minutes, no tab-hopping
One click starts a focused session, and it follows you from lesson to lesson. Short sessions are how busy people finish.
Apply at work · Proof your boss can see
Log what you tried, what happened and how you know. Record your manager's sign-off with their name and date, and export the log for your performance review.
Built around you
Give the study plan your goal date and it sizes each session to your week. Coach Q works on the facts you bring from your own job, so the examples are yours, not a textbook's.
Hands-on, not hours of video
Lessons are built around calls you make: read the record, sort the evidence, catch the mistake. Checks and labs score you on the spot, and your first win comes in the first few minutes of lesson 1.
Stays with you. Stays current.
Coach Q doesn't leave when you finish. It comes with your course, no subscription and no renewal fee, so it's there for the next CAPA, and the next FDA inspection. When the rules behind this course change, we update the lessons and the coach's setup, and we move the coach to newer AI models as we test them.
What you walk out with
Working documents for your own company, not notes.
In Course Hub you pick a template and give Coach Q your facts. It drafts a first version. You edit it, and it's yours to keep and use.
ISO 13485 Internal Auditor with FDA QMSR
- Internal audit programDraft with Coach Q
- Clause checklist with QMSR add-onsDraft with Coach Q
- Finding statementDraft with Coach Q
- Internal audit reportDraft with Coach Q
- Complaint record check sheetDraft with Coach Q
- Outsourced process and supplier registerDraft with Coach Q
Root Cause Analysis & CAPA (AS13000)
- 5-Why Worksheet (Audit-Defensible Format)Draft with Coach Q
- Is/Is-Not Analysis WorksheetDraft with Coach Q
- CAPA Effectiveness Verification FormDraft with Coach Q
Who built it
Built by an auditor, from both sides of the table.
Will Trikha
Founder and CEO, QMS Learning · Third-party registrar auditor
Will Trikha is a third-party registrar auditor with more than 20 years in aerospace and quality. Auditors read records cold, after the fact, so the courses on this path teach the work the way it gets read: findings someone can follow, causes with evidence behind them, and fixes with data that shows they held.
He's COO of PTX Defense, an AS9100D-certified aerospace manufacturer, so he lives with customer quality requirements from the supplier side. Through QMS Leader, the consulting firm he founded, he implements quality management systems for manufacturers. He has trained Lanner Electronics USA, Luna Innovations and Velocity Electronics in root cause analysis.
Check us before you pay
- Take lesson 1 free. The real first lesson of any course on the path, with Coach Q. No card.
- Look Will up. His LinkedIn profile lists the work behind the courses.
- Check a certificate. Every certificate can be confirmed at academy.qmslearning.com/verify.
- Keep your exit. 3 days after you buy a course to ask for a refund.
Try before you buy
Try it before you pay. Change your mind after.
Before you pay
Lesson 1 is free.
Every live course on the path has a free first lesson, with the exercises and Coach Q. Start with step 1 and judge it yourself.
Try lesson 1 free ↑After you buy
3 days to change your mind.
Email will@qmslearning.com within 3 days of buying a course for a refund. A refund ends access to that course. Refund policy
Company pays
Send it to your manager.
We wrote the email for you, with each course on the path and a link to what it includes. Need a quote or a PO? Email will@qmslearning.com.
Send this to my manager →Questions
Straight answers.
Do I have to take them all?
No. Each course stands on its own, with its own certificate, and lesson 1 is free on every course that's live. The path is the order we'd take them in.
What changed on February 2, 2026?
The QMSR took effect, two years after FDA published the final rule on February 2, 2024. 21 CFR Part 820 now incorporates ISO 13485:2016 by reference, with FDA's own added requirements on top, and FDA stopped using QSIT for device inspections. FDA can now inspect management review, internal audit and supplier audit reports. It doesn't issue ISO 13485 certificates, and a certificate doesn't exempt you from inspection.
Is this an accredited certification?
No. Each course ends with a QMS Learning certificate anyone can check at academy.qmslearning.com/verify, and ISO 13485 Internal Auditor's comes after a final exam. It isn't a lead auditor qualification or a registrar credential, and it doesn't certify your company. Your employer decides who is qualified to audit.
Root Cause and CAPA uses aerospace cases. Will it fit a device CAPA?
For the method, yes. Most cases are aerospace and defense, and the 8D module teaches the aerospace version. The tools (fishbone, 5-Why, Is/Is-Not, fault tree, FMEA, SPC, Pareto and DMAIC) work in any plant. ISO 13485 Internal Auditor covers the step 8.5.2 adds for devices: checking that the action doesn't hurt safety, performance or regulatory compliance.
We're a contract manufacturer, not the device maker. Is this for us?
Yes. Your customers' requirements reach you through their purchasing controls and the quality agreements you sign, and ISO 13485 Internal Auditor shows you how to audit to them. Its mock audit is an internal audit of a fictional contract manufacturer of surgical instruments and implantable screws.
Training a team?
Open any course on the path and pick how many people before you check out. Five or more people get 10% off every seat, applied at checkout. Each person gets their own login, private coach, study plan and certificate. More than 50 people, or need an invoice instead? Email will@qmslearning.com for a quote.
How long do I keep access?
The lessons are yours for life, and Coach Q comes with your course and stays with you after you finish. There's no subscription or renewal fee.
Does the course keep up when the rules change?
Yes, for the edition it teaches. When the rules or guidance behind this course change, we update the lessons and the coach's setup, and you get the update at no extra charge. When a new edition replaces the standard, we point you to the transition training. Your conversations with Coach Q aren't used to train AI models.
The Medical Device Quality path
Start free with lesson 1: what became law on February 2, 2026.
- Step 1: ISO 13485 Internal Auditor with FDA QMSRAbout 11 hours
- Step 2: Root Cause Analysis & CAPA (AS13000)About 21 hours
Lessons for life. Coach Q comes with every course, no renewal fee.
Ready to buy? Pick a course from the path. Each course page shows everything included, then the price.