ISO 9001:2026 & 13485:2016 Internal Auditor Training

Need to Train a Team or Audit Program?

This training is available for corporate teams, multi‑site organizations, and consulting firms and can be delivered online, privately, or on‑site with auditor qualification documentation aligned to expectations. 
See our developing Learning Paths
This course goes well with the Overview Training

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Master the Skills That Keep Certified Companies Compliant—and Competitive

Internal Auditor Training for ISO 9001:2026 and ISO 13485:2016, With a Graded Sample Audit

ISO 9001 has more than a million certificates worldwide, and every certified organization needs internal auditors who can actually audit. Most have people who were handed the job. If your organization is certified to both ISO 9001 and ISO 13485, those auditors have to cover both standards in one program, and ISO 9001:2026, published September 16, 2026, has just changed half of it.

This course gives you hands-on practice planning, conducting and reporting internal audits to both standards. You finish by conducting a sample audit and submitting it for evaluation, and your certificate issues when that work is satisfactory. Self-paced online, equivalent to two days of classroom training. Pay now and you’re first in when the course opens November 11.

What You'll Learn

Internal Audit Fundamentals

ISO 9001 & 13485 Requirements Overview

Planning Professional Audits 

Conducting Effective Audit Interviews 

Documenting and Reporting Audit Findings 

The Internal Audit Program

Why This Training is Different

The course runs the audit process in phases — planning, interviewing, records review, reporting, certification readiness — with the templates, checksheets and forms you use on a real audit rather than a worked example you throw away. Every phase is built for ISO 9001:2026 alongside ISO 13485:2016, so you practice on the requirements your registrar will audit against.

Taught and assessed by Diana Lynn, President of Management Systems International, implementing ISO systems and auditing quality since 1998. Not theory — hundreds of internal audits across manufacturing, medical device, semiconductor, technology and service industries.

And your sample audit is read by her. That is the part no seat-time course offers, and it is why the certificate means something when a registrar checks auditor competence.

Nine Levels, Nine Badges

The course is built in nine levels that follow the order of a real audit, from audit foundations through context, leadership, planning, support, operation and performance evaluation, to running the audit program. Each level closes with a short knowledge check covering both ISO 9001:2026 and ISO 13485:2016. Pass it and you earn that level’s badge:

  • Foundation Auditor: audit purpose, the process approach and how the two standards are structured
  • Context Navigator: scope, exclusions and regulatory roles
  • Leadership Lens: top management, the quality policy and the management representative
  • Risk and Change Planner: risk management, objectives and planned changes
  • Support Systems Checker: competence, training effectiveness, records and software validation
  • Operations Tracer: suppliers, process validation, traceability and nonconforming output
  • Performance Evaluator: complaints, regulatory reporting, management review and corrective action
  • Principled Auditor: objectivity, classifying findings and writing them well
  • Audit Program Lead: earned when you pass the final knowledge check

You can retake any knowledge check, and your badges collect on your My Badges page so you can see how far you have come. Each badge names the standards it covers, for example Foundation Auditor (ISO 9001 & 13485). The badges track your progress. Your certificate still depends on the sample audit you submit.

Our Track Record 

What Makes This Training Valuable 

Most online audit training ends when the last video does. This one ends when you have conducted an audit and someone has read it. You practice on real audit scenarios for both standards, role-play document control and CAPA interviews, and get feedback on your technique — then you do it for real and submit it.

Who Should Take This Training

Designed for anyone who will conduct or participate in internal audits: 

  • Quality Managers and Quality Engineers responsible for leading the internal audit program 
  • Process Owners and Department Managers who will audit other departments 
  • Operations and Manufacturing Personnel being trained as internal auditors 
  • Regulatory and Compliance Staff who need to understand audit requirements 
  • New Auditors with no prior ISO audit experience 
  • Experienced Auditors who need a formal qualification on record
  • Auditors Trained on ISO 9001:2015 who need to audit to the 2026 edition before their next registrar visit
  • Cross-functional Team Members participating in audit teams 

No prior ISO knowledge required. We cover everything from the ground up, including what ISO is, why audits matter, and how to conduct them professionally. 

Course Details

Opens: November 11. Pay now and you’re first in.
Duration: About 16 hours total — video instruction, plus assignments and a full internal audit you conduct and submit for evaluation. Equivalent to two days of classroom training.
Sample Audit: Audit a real process in your own organization, or use an MSI case study if you would rather not. Either way it is submitted, evaluated, and returned with feedback.
Format: Self-paced online. Lectures, exercises, role-play scenarios and practice audits.
Available: Online, self-paced. To train your whole team on your own procedures and records, ask about MSI’s Corporate License.
Levels and Badges: Nine levels, each closing with a short knowledge check. Pass it and you earn that level’s badge, from Foundation Auditor to Audit Program Lead, and see your progress on your My Badges page.
Standards Covered: ISO 9001:2026 and ISO 13485:2016
Level: Suitable for new auditors and for experienced auditors who need a formal qualification on record.
Instructor: Diana Lynn, President, Management Systems International
Certificate: ISO 9001:2026 & ISO 13485:2016 Internal Auditor Certificate of Completion, issued once your submitted audit is evaluated as satisfactory. This is the document a registrar reads when checking auditor competence.

Investment: $1,137 paid in full, or three monthly payments of $379 ($1,137 total). Both options give you the same course. The payment plan ends after the third payment. It is not a subscription.

What Effective Internal Audits Deliver

Organizations with well-trained internal auditors see:

All of this comes from the same place: auditors who were trained for the job, not simply handed it.

Frequently Asked Questions

When do I get access? The course opens November 11. If you pay before then, you’re first in, and you’ll get an email with your first step the day it opens.

I need to audit to ISO 9001:2015 right now. Can you help? Yes. ISO 9001:2015 certificates stay valid during the transition period, and your ISO 13485 audits don’t change. Call 888-914-9141 or book a call and we’ll talk through your options.

Prior ISO knowledge needed? No. We cover ISO fundamentals before diving into auditing techniques.

Do I need to be certified to ISO 9001 or 13485 to attend? No. This training works whether you’re already certified, implementing, or just learning.

Can I audit both ISO 9001 and ISO 13485 after this course? Yes. We cover both standards, where ISO 13485 asks for more than ISO 9001, and how to audit both in one program.

Will I be qualified to conduct audits after this course? Yes. You conduct a full internal audit, submit it, and receive your Internal Auditor Certificate of Completion once it is evaluated as satisfactory. That certificate goes into your auditor qualification records.

Is this course recognized by registrars? Registrars do not accredit training courses — they check that your organization qualified its auditors and can evidence it. Your certificate, issued after a graded audit, is that evidence. It is what MSI presents on client audits, and we have attended 200+ of them.

Is this a personal auditor certification? No. It’s a certificate of completion, issued only after your audit is graded, and it goes into your organization’s auditor qualification records, which is what a registrar checks for internal auditors. Personal certification through a body such as Exemplar Global is a separate credential, mostly relevant to people auditing as a career.

How is this different from a cheaper online auditor course? Most issue a certificate when the last video ends — nothing you produce is reviewed, because you were never asked to produce anything. Here you conduct an audit and it is read and evaluated before your certificate issues.

Can we bring this training on-site? Yes, as a separate service. This course is self-paced online. For teams, MSI offers a Corporate License that gives every auditor access to the course, and we also teach internal auditor training in person at client facilities. Call 888-914-9141 or book a call to talk through which fits.

What are the badges? The course is built in nine levels, and each one ends with a short knowledge check covering both standards. Pass it and you earn that level’s badge: Foundation Auditor, Context Navigator, Leadership Lens, Risk and Change Planner, Support Systems Checker, Operations Tracer, Performance Evaluator, Principled Auditor, and Audit Program Lead when you pass the final knowledge check. You can retake any check. The badges show your progress. Your certificate still issues only after your sample audit is evaluated.

Ready to Get Started?

This course gives you the practice and the graded sample audit to run internal audits that hold up to a registrar, across both ISO 9001:2026 and ISO 13485:2016.

Two ways to enroll: pay $1,137 in full, or make three monthly payments of $379.

10-Business-Day Money-Back Guarantee: Work through the course. If within 10 business days of your access starting it is not right for you, we refund you in full.

Still Have Questions?
Email: info@msi-international.com
Phone: (888) 914-9141
We typically respond within 2 hours during business hours.

Register Before November 11 and Start Today With a Free QuickStart ($49 Value)

Register for this course before it opens on November 11 and you get immediate access to an MSI QuickStart, waiting in your course downloads the moment you register. It is a working guide you can put to use right away, before the first lesson opens.

Every QuickStart gives you:

  • What the standard actually asks for, in plain language.
  • What changed from the 2015 edition, and where it affects your system.
  • The decisions, in order, each mapped to where it lives in your procedure.
  • A “you are done when” checklist, so you know when you have finished.

The QuickStart is a companion guide, not a replacement for the course. It gives you a head start while you wait for launch day.

REGISTER NOW AND GET YOUR $49 QUICKSTART TODAY. COURSE OPENS NOVEMBER 11.

Learning Objectives

  • Audit Planning
  • ISO requirements
  • Audit Checksheet development
  • Interviewing Strategies
  • Opening and closing meetings
  • Report Writing
  • Audit Program

Course Curriculum

Internal Audit Training
Internal Audit preparation, Requirements, Audit strategies for requirements, Auditing Interviews, Reporting and Audit Program

  • 19:00
  • Video 2
    33:00
  • Video 3
    18:00
  • Video 4
    20:00
  • Video 5
    30:40
  • Video 6
    29:25
  • Video 7
    12:21
  • Video 8
    28:38
  • Video 9
    40:00
  • Video 10
    47:33
  • Video 11
    45:23
  • Video 12
    23:43
  • Video 13
    01:13:00
  • Lesson14
    57:06

Module 1: Audit Foundations
Start here. See how the nine levels, badges and certificate work, what changed in ISO 9001:2026, how ISO 13485:2016 differs, and why internal audits keep a medical device quality management system working between registrar visits. Level 1 ends with your first knowledge check.

Module 2: Strategic Direction of the QMS
Audit context, interested parties, scope, regulatory roles and leadership across ISO 9001 and ISO 13485, including quality culture, ethical behavior, the management representative and the quality policy. Levels 2 and 3.

Module 3: Planning Performance
Audit risks and opportunities, quality objectives, risk management in product realization, and planned changes under ISO 9001:2026 clause 6.3. Level 4.

Module 4: Implementing and Operating the QMS
Audit competence and training effectiveness, documented information and records retention, software validation, externally provided processes, process validation, traceability and nonconforming outputs. Levels 5 and 6.

Module 5: Measuring Performance
Audit monitoring and measurement, customer feedback and complaint handling, reporting to regulatory authorities, management review, nonconformity and corrective action. Level 7.

Module 6: Becoming an Internal Auditor
Put it all together: the principles of auditing, conducting combined ISO 9001 and ISO 13485 audits and running one audit program for both standards, the final knowledge check, and your graded sample audit. Levels 8 and 9.

Earn a certificate

Add this certificate to your resume to demonstrate your skills & increase your chances of getting noticed.

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Requirements

  • Must satisfactorily complete all assignments in order to receive the Certificate.

Tags

Target Audience

  • Current internal auditors
  • Managers of Audit Program
  • Newly assigned Internal Auditors
  • Those pursuing consulting in ISO industry

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