FDA can read your audit reports now. Write ones that hold up.
See what changed when Part 820 started pointing at ISO 13485, then audit an audit plan before it runs.
Since February 2, 2026, FDA inspects device makers against ISO 13485, and investigators can ask for your internal audit reports. Learn to plan, run and write up audits that stand up when they do.
Training + AI coaching + reusable workflows. Learn ISO 13485 auditing in the QMSR context and use Coach Q to prepare audit and follow-up workflows for qualified human review.
Created by a quality auditor with 20 years in the industry, from ISO 13485:2016, clauses 4 through 8, and the QMSR in 21 CFR Part 820.
100+ years of combined audit experience, boiled down to one thing: spotting what everyone else walks past.
See how it works ↓For comparison, TÜV SÜD's live online ISO 13485 Internal Auditor with FDA QMSR class lists at $1,630 (tuvsud.com, October 2026).
Try lesson 1 before you pay. 3-day refund after you buy.
One-time course purchase. Lifetime lessons and your AI coach included.
Coach Q, your private AI coach, comes with your course. No subscription or renewal fee. Your purchased lessons remain available for life.
Training your audit team? Qualify them together, and show FDA and your registrar an impartial program where nobody audits their own work.
10% off for 5 or more people.
- Write internal audit reports that hold up now that FDA can ask for them, practiced on realistic device records
- A final exam (3 versions, 80% to pass) and a certificate anyone can verify
- Coach Q, your specialist coach, included with your course
- 30 hands-on lessons and a full mock audit of a contract manufacturer
- Audit templates you can save as your own
- A study plan, a focus timer and an application tracker
- Every lesson, yours for life
3-day refund window. Refund policy
More than 50 people, or need an invoice instead? Email will@qmslearning.com for a quote.
Learn it. Practice it. Bring it to work.
Build subject knowledge, earn your course certificate and prepare work you can check and use.
Pass the final exam and your certificate shows your name, the course, the date and what was tested. Anyone can confirm it at academy.qmslearning.com/verify, and you can add it to your LinkedIn profile in one click. It records your course achievement; your workplace results come from applying and checking the work.
Work through the lessons at your own pace. Ask Coach Q to explain a concept, try another example or question your reasoning. Use the course study plan and focus timer to fit learning around your week.
Use Course Hub to create workflow materials, save revisions and keep reusable templates. Download your work for review by the people who will use it. Your lessons remain available for life, and AI coaching comes with your course.
Learn the skill. Put your AI coach to work.
When a complaint file looks thin and you need to know what the record should hold, return to the method with Coach Q. Your AI quality and compliance colleague helps you think through the problem and build a workflow you can review.
Know what good work needs
Learn ISO 13485 and QMSR auditing, work through the course scenarios and ask your AI coach to explain what is unclear. Bring your own reasoning and ask it to challenge the gaps.
Build a reusable workflow
Use the Course Hub document tools to prepare an internal audit program, a finding statement, a complaint record check sheet and a CAPA follow-up log, using the facts you supply.
FDA can read your audit reports now. You'll check that every conclusion rests on records you actually sampled, and that the AI never paraphrased a requirement into something the standard doesn't say.
Start the next job with a method
Edit your workflow materials, save revisions, download your work, or save the structure as a reusable template. For the next case, replace the old facts and check the new evidence before drawing conclusions.
Your saved work is in Course Hub when you return to the same account.
An expert in your pocket means an AI coach within reach. Learn in your browser, then return when you need help applying the subject. AI output can be wrong; you and your organization own the review and the decision.
Coach Q, your private AI coach, comes with your course. No subscription or renewal fee. Your purchased lessons remain available for life.
Walk into your next audit knowing what an FDA investigator will look for.
Short lessons, a plan that fits your week, and a coach who knows the job. These are real screens from the course, and the label says when one comes from another course. Click through at your own pace.
Practice on real device records before FDA reads yours.
Short lessons built on real shop-floor scenes, then hands-on exercises. Make your call, then see how an experienced auditor would handle it.
- Built on findings auditors actually write up
- See how a pro would handle it
- Pick up right where you left off
Ready when you are.
$495 per person, one-time. Lifetime access to the lessons · AI coach included · No subscription · 3-day refund window.
10% off for 5 or more people.
The audit got done. Would the report hold up if FDA read it?
“Nobody outside the company reads our audit reports.”
That was the old rule. Under the QMSR, an investigator can ask for your internal audit reports, supplier audit reports and management review records. You'll learn to write reports that make sense to someone reading them cold.
“Customer error. Closed.”
A complaint file with no investigation results and no reply to the complainant. You'll learn what 820.35 asks a complaint record to hold, and how to write it up when it's missing.
“We audited it against our ISO 9001 checklist.”
ISO 13485 keeps a management representative, preventive action and many documented procedures, and asks you to maintain effectiveness. You'll learn where a copied checklist misses them.
“The supplier handles sterilization. It's their problem.”
An outsourced process stays your responsibility, controlled in proportion to risk with a written quality agreement. You'll learn to audit what your company still owns.
“Regulatory decided it wasn't reportable.”
The file shows no date for the decision and no reason. You'll learn to audit the MDR and correction or removal trail, and write the finding without making the legal call yourself.
“Our quality engineer audited her own process.”
Internal auditors have to be objective and impartial and can't audit their own work. You'll learn to build an audit program where that holds, and to spot it when it doesn't.
Myth or fact?
Four things people say about ISO 13485 audits since the QMSR took effect. Make your call on each one.
“FDA still can't look at our internal audit reports.”
“Our ISO 13485 certificate means FDA will treat us as compliant.”
“Internal auditors can't audit their own work.”
“ISO 13485 tells you what counts as a major or a minor nonconformity.”
0 of 4 checked. Tap Myth or Fact on each one.
Practice on the records you'll actually audit.
Counted from the live course lessons and final exam.
You don't just learn the clauses. You practice every step of an audit FDA could read.
Every lesson puts a realistic record in front of you and ends with a checkpoint you work through with your coach. Modules 7 to 9 take you through a full internal audit, from the program to the report, then a mock audit of a fictional contract manufacturer.
A risk-based audit program
Score processes by status, importance and past results for a fictional contract packager, then audit the program for the gaps an investigator would notice.
8.2.4 · Module 7An audit plan and checklist
Scope, criteria, a plan and checklist questions that get evidence, not yes or no answers, for one audit of sterile kit release.
Module 7 · Prepare one auditA complaint file audit
Check a closed complaint against what 820.35 asks a complaint record to hold, and write up the early closure.
820.35 · Modules 2 and 6A reportability log review
Test a log against the MDR and correction or removal clocks, and write the finding without making the legal call.
Parts 803 and 806 · Module 6Findings an investigator can check
Requirement, evidence and gap, written so someone reading the report months later can follow every step.
Module 8 · ReportingA full mock audit
Plan and run an audit of a fictional contract manufacturer of surgical instruments and implantable screws: trace a lot, read a complaint, grade the findings and write the conclusion.
Module 9 · Mock auditLearn it, practice it, prove it, use it.
ISO 13485 and the QMSR, clause by clause
Lessons of 20 to 30 minutes on what each requirement means, what Part 820 adds, and what evidence shows it's working. What changed on February 2, 2026 comes first.
Realistic device records
Audit batch records, complaint files, label checks, NCRs and CAPAs, then work each lesson's checkpoint with your coach.
A final exam in 3 versions
Each attempt is 30 questions drawn from every module. Finish every lesson and score 80% or better to earn your certificate.
Your next internal audit
Build your program, plan your audit and write your report, with your coach on hand.
Ask the question you'd ask a lead auditor. Get a straight answer.
Coach Q comes with your course. It points you to the clause, the record to pull and the next step. Whether it's a finding stays your call.
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?
From your first lesson to an audit report you'd hand an FDA investigator.
9 modules. About 11 hours of self-paced lessons.
- Module 1
The New Rules (ISO 13485 and the FDA QMSR)
What became law on February 2, 2026, what FDA can now read, and how ISO 13485 is built. 3 lessons.
- Module 2
The System and Its Records (Clause 4 and FDA Add-ons)
QMS requirements, outsourced processes, software validation, documents, records, the medical device file and FDA's extra records. 3 lessons.
- Module 3
Management and Resources (Clauses 5 and 6)
Management responsibility, management review, competence and training effectiveness, infrastructure, work environment and contamination control. 3 lessons.
- Module 4
Planning, Risk and Design (7.1 to 7.3)
Planning product realization, risk management, customer and regulatory requirements, design and development from plan to transfer and change. 4 lessons.
- Module 5
Suppliers and Production (7.4 to 7.6)
Purchasing and supplier controls, production controls, process validation, sterilization, identification, traceability, labeling, preservation and measuring equipment. 5 lessons.
- Module 6
Feedback, Complaints and CAPA (Clause 8)
Feedback, complaint handling, reporting to FDA, nonconforming product, data analysis, corrective and preventive action. 4 lessons.
- Module 7
Plan the Audit
A risk-based audit program and the preparation for one audit. 2 lessons.
- Module 8
Run the Audit
Opening meeting, process tracing, interviews, sampling, findings that hold up, closing meeting, report and follow-up. 4 lessons.
- Module 9
Mock Audit
A full internal audit of a fictional contract manufacturer of surgical instruments and implantable screws. 2 lessons.
Built for the people who run internal audits at device makers, or are about to.
- Internal auditors at medical device makers now inspected under the QMSR
- Quality and regulatory staff who own the internal audit program
- Engineers and supervisors asked to audit another department
- Contract manufacturers and suppliers working to their customers' quality agreements
Written by a quality auditor with 20 years in the industry, from ISO 13485:2016, clauses 4 through 8, the QMSR in 21 CFR Part 820, and the real work of running internal audits.
The course paraphrases the standard and never reprints it. Every company, person and record in it is fictional. This course is $495, runs at your pace, and ends with a final exam and a certificate for your training record.
Straight answers.
What does an expert in my pocket mean?
Can I use what I learn on a real problem?
Can I reuse the work for the next job?
Is this an auditor certification?
Do I need a copy of ISO 13485?
Does it cover the FDA QMSR?
We're a contract manufacturer. Is this for us?
How do I earn the certificate?
Can I try it first?
How long do I keep access?
Can my company pay?
What if it isn't for me?
Training a team?
Audit what FDA will read. Write what holds up.
$495. About 11 hours. Every clause, the QMSR add-ons, a full mock audit, a final exam and a certificate anyone can verify.
10% off for 5 or more people.
3-day refund window · Lifetime access to the lessons · Certificate anyone can verify · AI coach included · No subscription