MSI Internal Auditor Training
ISO 9001:2026 & ISO 13485:2016
One audit program, two standards, and one of them just changed.
Learn to audit a quality system to ISO 9001:2026 and ISO 13485:2016 together, and prove you can do it with an audit report MSI grades.
Pay now, first in when it opens November 11ISO 9001:2026 was published September 16, 2026. It adds requirements an auditor now has to look for and judge: quality culture and ethical behavior, climate change in the organization's context, and more from top management than the 2015 edition asked. An internal auditor still working from the old checklist will pass things a registrar won't.
If your organization is certified to both ISO 9001 and ISO 13485, your auditors have to cover both without running two audits. We're rebuilding this course around ISO 9001:2026 alongside ISO 13485:2016, so you learn what changed in 9001, where 13485 asks for more, and how to write findings your organization can act on.
Built by someone who has sat through 200+ registrar audits and knows what auditors actually ask for.
Where ISO 13485 goes further than ISO 9001, from design controls and risk management to regulatory requirements and records, and how to cover both in one pass.
You write a real internal audit report. MSI grades it, and your certificate issues only when it's accepted.
How to write a nonconformity with a requirement, evidence and a clear statement, so corrective action has somewhere to start.
Interviewing, sampling and following the trail from a policy to what really happens on the floor.
The ISO 9001 content is rebuilt for the 2026 edition, including the new leadership, culture and ethics expectations.
"See your corrective action program as your friend."Diana Lynn, Founder, Management Systems International
Narrated video lessons, self-paced, with a knowledge check at the end of each module.
What changed in ISO 9001:2026, where ISO 13485:2016 adds requirements, and what each means for the evidence you look for.
The audit program, scope and one checklist that covers both standards without doubling the work.
Opening meetings, interviews, sampling and gathering objective evidence.
Writing findings against the right standard and clause, the audit report, the closing meeting and following CAPA to closure.
Completion is not competence. Your certificate is earned in three steps.
Step 1
Pass a knowledge check at the end of each module.
Step 2
Write an internal audit report. MSI reviews it against a published rubric.
Step 3
Your certificate is issued when MSI accepts your report.
Diana Lynn, founder of Management Systems International, has worked in ISO management systems for 28 years and has sat through more than 200 registrar audits. She teaches auditing the way she practices it: direct, practical and focused on evidence.
MSI is veteran-owned and female-owned.
The course opens November 11. If you pay before then, you're first in, and you'll receive an email with your first step the day it opens.
Internal auditors, quality managers and audit program leaders at medical device manufacturers and suppliers certified, or working toward certification, to both ISO 9001 and ISO 13485.
No. The course covers audit planning, conducting and reporting from the start, and experienced auditors get the 2026 changes they need to update their approach.
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.
Yes. MSI's Corporate License brings the course to every auditor in your organization. Call 888-914-9141 or book a call to talk it through.
Pay today and you're first in the moment the course opens.
ISO is a trademark of the International Organization for Standardization. MSI is not affiliated with or endorsed by ISO or any certification or accreditation body.
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