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ISO 19011:2026 Internal Auditor: Auditing ISO 9001:2026 Quality Management Systems

Rated 4.8 out of 5
(47 reviews)
ISO19011 2026 internal auditor

Duration :

2

2 hour(s)

Skill level:

Regulatory

Language:

English

Final exam:

Yes

Certificate of Completion:

Yes

CEU / CPD Accreditation:

Yes

Certification:

Successful completion provides learners with a dated, traceable and downloadable certificate for the course : 

Each certificate is CPD/CEU accredited and 21 CFR PART 11 compliant. Certificates validity can be checked online through our certificate online checker. They can also be shared on Linkedin.

Description:

Both standards behind every internal audit changed in 2026. ISO 19011:2026 brought remote audits and virtual locations into the main text in May. ISO 9001:2026 followed in September with quality culture, ethics and opportunities. Certified organizations have until 30 September 2029 to transition, and the certification auditor will ask for your 2026 internal audit first. Your next certification visit starts with your internal audit. This two-hour online training makes your internal auditors 2026-ready: plan, audit, report.

Across ten hands-on lessons, this certified course covers the whole audit cycle with seven real cases, from clause 9.2 to verified corrective action, for teams working under ISO 9001:2026, ISO 13485 and GMP self-inspection. Its traceable certificate gives you audit-ready proof that you, or your team, are ready to apply ISO 19011:2026 in practice.

  

Why teams choose this course

  • Built with management system auditors and life sciences practitioners
  • Written on the published 2026 editions of ISO 19011 and ISO 9001
  • Real cases: Brumadinho, Daihatsu, Rana Plaza, Boeing 737, GVK Biosciences, Able Laboratories, Peanut Corporation of America
  • Remote, hybrid and virtual-location audits as everyday methods
  • One-year access per learner and a CPD/CEU certificate your QA can verify online

  

What you’ll learn

  • Build a risk-based audit program around the processes that matter
  • Turn objectives, scope and criteria into a workable audit plan
  • Run opening meetings, interviews and observations that get to the facts
  • Sample and verify evidence, including electronic records and audit trails
  • Audit the 2026 expectations on culture, ethics, risks, opportunities and climate
  • Write nonconformities that cite the requirement, the evidence and the gap
  • Follow corrective actions to verified closure before the certification body does

  

Who should enroll

  • Internal auditors and audit program managers
  • Quality assurance and QMS teams
  • Process owners preparing for the ISO 9001:2026 transition
  • Suppliers and laboratories audited by life sciences customers

  

Upon successful completion, each learner receives a validated certificate accredited with CPD/CEU credits, suitable for audit and compliance documentation.

  

Curriculum

Lesson: A Brief History of Management System Auditing

Lesson 1: Internal Audit in ISO 9001:2026: Clause 9.2 and the 2026 Changes

Lesson 2: The Seven Principles of Auditing and the Conduct of the Auditor

Lesson 3: Managing a Risk-Based Audit Program

Lesson 4: Planning the Audit: Objectives, Scope, Criteria and Methods

Lesson 5: Conducting the Audit: Meetings, Interviews and Observation

Lesson 6: Audit Evidence, Sampling and Verification

Lesson 7: Remote Audits, Virtual Locations and Digital Evidence

Lesson 8: Auditing the ISO 9001:2026 Requirements, Clause by Clause

Lesson 9: Audit Findings, Grading and the Audit Report

Lesson 10: Follow-Up, Corrective Action and Auditor Competence

Conclusion

Glossary

Final Assessment

Author:

Dr. Helena Vorster
Dr. Helena Vorster is a quality management system lead auditor with over 20 years of experience in life sciences. She has planned and led internal, supplier and certification-readiness audits against ISO 9001, ISO 13485 and ISO 19011 for pharmaceutical, biotechnology, medical device and laboratory organisations, on site and remotely. Her work covers risk-based audit programmes, GMP self-inspection, nonconformity grading and the verification of corrective actions, and she trains internal audit teams to produce findings that stand up to certification bodies and regulators.

Reviews:

Rated 4.8 out of 5
(47 reviews)

$95

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This course includes:
One-year access
Updated content every month
Certificate of completion

Join 20,000+ Professionals Certified Worldwide

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$95.00 / year

$95.00 / year

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