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ISO 9001 & 13485 2 Day Internal Auditor Training

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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. 
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 This course goes well with the Overview Training

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Master the Skills That Keep Certified Companies Compliant—and Competitive

2-Day Comprehensive Training That Transforms You Into a Confident, Qualified ISO Internal Auditor 

Over 1 million companies worldwide hold ISO 9001 certification, and every one requires qualified internal auditors to maintain it—yet most struggle to find trained auditors who understand both standards and audit processes. This intensive 2-day course gives you hands-on practice to plan, conduct, and report professional internal audits for ISO 9001 and ISO 13485, earning you registrar-verified credentials that employers value, because audit quality directly impacts your ability to maintain certification and drive continuous improvement. 

What You'll Learn

Internal Audit Fundamentals

  • Why internal audits are the main trigger for continuous improvement in ISO systems
  • How qualified internal auditors contribute to financial savings by identifying bottlenecks and risks
  • Your role in verifying the company "says what it does, does what it says, and proves it"
  • The registrar's expectations: Why they verify auditor credentials during certification audits

ISO 9001 & 13485 Requirements Overview

  • The seven principles that guide all ISO standards: customer focus, leadership, engagement, process approach, improvement, evidence-based decisions, and relationship management
  • Key differences between ISO 9001 (any industry) and ISO 13485 (medical devices)
  • What the PDCA cycle (Plan-Do-Check-Act) means for auditors
  • Applicable regulatory requirements and how audits verify compliance

Planning Professional Audits 

  • How to develop comprehensive audit plans that cover all processes
  • Preparing effective audit checklists without becoming checklist-dependent
  • Time management: Allocating appropriate time per department and process
  • Risk-based audit planning: Focusing on high-risk areas while covering mandatory requirements

Conducting Effective Audit Interviews 

  • The art of asking open-ended questions that reveal process effectiveness
  • Sampling techniques: What records to review and how many
  • Recognizing when something is a minor nonconformity vs. major nonconformity vs. observation
  • Handling difficult auditees and maintaining professionalism under pressure

Documenting and Reporting Audit Findings 

  • How to write clear, factual nonconformity statements that lead to effective corrective actions
  • Distinguishing between major nonconformities, minor nonconformities, observations, and improvement opportunities
  • Preparing audit reports that are actionable, not just compliant
  • Following up on corrective actions: Verifying effectiveness, not just completion

The Internal Audit Program

  • Establishing audit schedules: How often to audit each process
  • Auditor qualification requirements: What you need to be a qualified auditor
  • How internal audits feed into management review
  • Using audit trends to identify systemic issues requiring organization-wide corrective action

Why This Training is Different

Taught by Diana Lynn, President of Management Systems Consulting with 25+ years of hands-on ISO implementation and auditing experience—not theoretical knowledge, but real-world expertise from conducting hundreds of internal audits across manufacturing, medical device, semiconductor, technology, and service industries. 

Our Track Record 

  • 70+ companies personally guided to certification across all ISO standards
  • 25+ years of implementation and auditing experience since 1998
  • Hundreds of internal audits conducted for clients on an ongoing basis
  • 100% certification success rate for clients who complete our programs
  • 85% of clients continue using us for annual internal audits and management review support
  • Practical, not academic: Every technique taught comes from real audit situations

What Makes This Training Valuable 

Most ISO audit training is either boring PowerPoint lectures or vague theory. This one isn’t. You get hands-on practice with real scenarios, audit role-playing, and feedback on your audit technique—preparing you to conduct confident, professional audits immediately after completing the course. 

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 seeking formal training and certification 
  • 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

Duration: 2 days (16 hours total) 
Format: Interactive training with lectures, exercises, role-playing, and practice audits 
Available: Public courses or on-site at your facility 
Standards Covered: ISO 9001 and ISO 13485 
Level: Comprehensive training for new and experienced auditors 
Instructor: Diana Lynn 
Certificate: Yes—certificate of completion that demonstrates qualification to registrars 

The Cost of Poor Internal Audits

Organizations with weak internal audit programs experience: 

  • Certification audit failures that could have been prevented by catching issues internally
  • Repeated findings from registrars on the same issues year after year
  • Missed improvement opportunities because audits are just "checkbox exercises"
  • Low credibility with employees who see audits as pointless bureaucracy
  • Wasted time conducting ineffective audits that don't drive improvement

Professional internal audits prevent these problems and turn compliance into competitive advantage. 

Frequently Asked Questions

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. 

Will I be qualified to conduct audits after this course? Yes. You’ll receive a certificate demonstrating completion of formal auditor training. 

Can I audit both ISO 9001 and ISO 13485 after this course? Yes. We cover both standards and their differences. 

Is this course recognized by registrars? Yes. Registrars verify auditor qualifications, and formal training is a key requirement. 

Certificate provided? Yes—formal certificate of completion for your auditor qualification records. 

Can we bring this training on-site? Yes. We conduct this training at client facilities for teams. 

Ready to Get Started?

This 2-day investment gives you the skills and credentials to conduct professional internal audits that maintain certification, drive improvement, and demonstrate value to your organization. 

30-Day Money-Back Guarantee: If you don’t find this training valuable, we’ll refund every penny. 

Still Have Questions? 

Email: info@msi-international.com 
Phone: (888) 914-9141 

We typically respond within 2 hours during business hours.

START YOUR 2 DAY INTERNAL TRAINING NOW  

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

  • Video 1
    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

Earn a certificate

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Purchase  $379   Purchase  $1,137  
  • Level
    Intermediate
  • Duration
    8 hours26 minutes
  • Last Updated
    August 2, 2026
  • Certificate
    Certificate of completion

A course by

Diana Lynn
M

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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