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ISO 9001 Internal Auditor Training for Quality Management Systems (QMS)

4 ★★★★★ 3 Reviews 97% Recommended from 5K+ Learners

ISO 9001 Internal Auditor Training is for anyone that wants to be part of the team conducting internal QMS audits of part of their Quality Management System based on ISO 9001 2015.

Our eLearning courses are a highly interactive way to learn at a time & a pace that works best for you, making it easier to get the training you need while balancing a busy home or work life.

Exemplar Global certify this course offering global recognition for successful participants.

Exemplar Global Cretified Course
ISO 9001 Internal Auditor Training for Quality Management Systems (QMS)
 
Course Snapshot
Approved By
Exemplar Global
Duration
16hrs
Teaching Format
eLearning
Delivery Options
Blended Learning Also Available
Certification of Completion
Yes
Language (s)
English
Individual Price
$595.00
Team of 4 Price Register 4 + Get 1 Free
$2380.00 $2380.00
Learner Rating
4 ★★★★★ 3 Reviews

Have 6 or more that need training?

We offer group discounts and are available for in-house (live or virtual) or tailored training in multiple formats.

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“Over the years, I have used many well-known U.S training providers, but I found Comply Guru had truly mastered ‘online’ training which has saved Skeletal Dynamics over 50% in training fees, associated expenses as well as 100% of the time lost spent travelling to training with other providers.”
Mario Arbesu

Mario Arbesu

VP of Quality Assurance & Regulatory Affairs

How TÜV SÜD utilized eLearning & saved 40% on Lead Auditor Training

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How TÜV SÜD utilized eLearning & saved 40% on Lead Auditor Training

"Comply Guru’s trainers are not only experienced in their specific fields but are also experts in the art of training. By using a provider who integrates modern self-study e-learning methods with traditional in-person sessions, we can be confident that our learning outcomes are maximized."
Zoran Klaric

Zoran Klaric

Manager Regional Training & Onboarding

Our Methodology

Not all eLearning is the same

Most other providers offer online training that is one-dimensional utilizing either Videos or PowerPoint Presentations. That is not effective training. We deploy a multi-layered methodology that offers you a New Generation of eLearning.

Not all eLearning is the same
Not all eLearning is the same
 

Course Structure Explained

Detailed Breakdown & Agenda

An interactive, engaging eLearning experience that you can complete Anytime, Anywhere.

Time Topic
35mins eLearning

Module 1: Overview of ISO 9001 

  • What is a Quality Management System (QMS)
  • Purpose, Benefits and Structure of ISO 9001
  • Terms and Definitions
40mins eLearning

Module 2: Key Concepts of ISO 9001 

  • Risk Based Thinking (RBT)
  • Plan-Do-Check-Act (PDCA)
  • Process Approach
  • PDCA and ISO 9001
55mins eLearning

Module 3: Principles of Quality Management

  • Customer Focus
  • Leadership
  • Engagement of People
  • Process Approach
  • Improvement
  • Evidence-based Decision Making
  • Relationship Management
55mins eLearning

Module 4: Context of the Organization

  • Clause 4.1 Context of the Organization
  • Idea of Currency
  • External and Internal Context
  • Interested Party Requirements
  • Scope of the QMS
  • QMS and its Processes
40mins eLearning

Module 5: Leadership and Planning

  • Leadership and Commitment
  • Customer Focus
  • Establishing the Quality Policy
  • Communicating the Quality Policy
  • Organizational Roles, Responsibilities and Authorities
  • Actions to address Risks and Opportunities
  • Quality Objectives
  • Planning of Changes
55mins eLearning

Module 6: Support

  • Resources
  • People Requirements
  • Infrastructure Requirements
  • Environment for the Operation of Process Requirements
  • Monitoring and Measuring Resource Requirements
  • Operational Knowledge
  • Competence
  • Awareness
  • Communications
  • Documented Information Requirements
85mins eLearning

Module 7: Operation

  • Operational Planning and Control
  • Requirements for Products and Services
  • Design and Development
  • External Providers
  • Production and Service Provision
  • Operation
  • Control of Non-Conformity Outputs
45mins eLearning

Module 8: Performance and Improvement

  • Monitoring, Measurement, Analysis and Improvement
  • Internal Audit Requirements
  • Management Review
  • Improvement
  • Non-Conformity and Corrective Actions
  • Continual Improvement
45mins

Requirements Exam

  • 50 MCQ-based eAssessment with 70% or higher required to pass
120mins eLearning

Module 9: Introduction to Auditing 

  • Management System Audits
  • Audit Terminology
  • Principles of Auditing
  • Audit Program Management
  • Audit Lifecycle
40mins eLearning

Module 10: Audit Initiation and Preparation

  • Audit Planning
  • Audit Objective, Scope and Criteria
  • Selection of Audit Team and Leader
  • Audit Initiation
  • Audit Checklist Tools
  • Document Review
  • Audit Preparation Activities
  • Internal Audit Plan
  • Audit Checklist
80mins eLearning

Module 11: Conducting Audit Activities

  • Opening Meeting
  • Communication during the Audit
  • Collecting & Verifying Information
  • Audit Findings
  • Non-Conformity Grading
  • Document Review
25mins eLearning

Module 12: Audit Report, Close and Follow Up

  • Non-Conformity Reporting
  • Closing Meeting
  • Audit Report
  • Audit Follow Up Activities
40mins

Internal Auditor Exam

  • 30 MCQ-based eAssessment with 70% or higher required to achieve certification
Time Topic
09:00 - 10:00am

Course Introduction
Practical Workshop Documentation Review – Audit Plan
10:00 - 10:05am

Break
10:05 - 11:05am

Practical Workshop Audit Checklist
11:05 - 11:15am

Break
11:15am - 12:15pm

Practical Workshop Opening Meeting
Practical Workshop Simulated Case Study
12:15 - 12:20pm

Break
12:20 -1:00pm

Practical Workshop Generating Audit Findings
1:00 - 1:45pm

Lunch
1:45 – 2:45pm

Practical Workshop Generating Audit Findings (Continued)
2:45 - 2.50pm

Break
2:50 – 3:50pm

Practical Workshop Closing Meeting, Audit Report & Follow-Up
3:50 - 4:00pm

Break
4:00 - 5.00pm
  • Q&A
  • Course Wrap-Up

Our Experts

Meet The Instructors

Our experts possess a wealth of industry experience acquired over years of practical application, and in addition, they demonstrate a combination of unwavering passion and a proven aptitude for training.

Michelle Keane

Our Instructor

Michelle Keane

Michelle has a proven track record with over 20 years of experience working across both the Medical Device and Biotechnology sectors. Currently, she is a Lead Auditor for an INAB Accredited Certification Body, and an MDR Assessor for a Notified Body in Europe. In addition, she is the Team PRRC Representative for Ireland.
Leon Donnellan

Our Graphical & Instructional Designer

Leon Donnellan

Leon has over 20 years of experience in eLearning. During his illustrious career, he has spent 10+ years designing programs within highly regulated industries. He brings vast experience to Comply Guru in both graphical and instructional design.
Eoin Philip Kelly

Our Training Specialist

Eoin Philip Kelly

Eoin has almost 20yrs of experience in internationally accredited training design & delivery. He founded Comply Guru to pursue his vision to bridge the major gap in the market for learning solutions that were more accessible, convenient & flexible in a fast-changing world of International Standards & Medical Device Regulations.

Course Overview

ISO 9001 Internal Auditor Training

Key Benefits of Choosing Comply Guru Covered
Globally Recognized Qualification with Exemplar Global
More Flexibility & More Savings vs Other Providers
Industry-leading eLearning Methodology
Up-to-date Technical Content & Examples
Practical Case Studies based on Real-World Scenarios
Course Access for 6 Months
Ask The Instructor
Quick Enrolment within 1hr
Scalable Learning for Teams
Manager Accounts for Groups of 10+
Learning Objectives Covered

Explain the purpose of a quality management system (QMS), of quality management systems standards, and the business benefits of improved performance of the quality management system

Outline the structure and content of ISO 9001 and its relationship with ISO 9000

Explain the specific quality management-related requirements of ISO 9001

With reference to the PDCA cycle, explain the process based QMS Model for ISO 9001 2015 and the role of an internal auditor in the maintenance and improvement of Quality Management Systems

Explain the role and responsibilities of an auditor to plan, conduct, report, and follow-up an internal audit in accordance with ISO 19011

Course Certification

CQI IRCA

CQI & IRCA certify this course (No. 2149). Upon successful completion, each Learner shall receive a digital Certificate of Achievement within 1 business day.

What Are The Entry Requirements

Before completing this course, each Learner should have the following prior knowledge:

  • It is recommended that anyone wishing to attend this course has some work-based experience in Quality Management (based on ISO 9001)
  • The Plan, Do Check, Act (PDCA) Cycle
  • The core elements of a management system and the interrelationship between top management responsibility, policy, objectives, planning, implementation, measurement, review, and continual improvement.

Fluency in written and spoken English

  • For participants whose first language is not English, we recommend a minimum English language competency of IELTS 5.5 (or equivalent) for successful completion of the program. This is not assessed by Comply Guru in advance & each participant must self-assess their competency.

Copy of ISO 9001 (International Standard)

  • Each participant should have a copy of the standard to reference while completing this course. This is not provided by Comply Guru and without it, this course will be challenging to complete successfully.
How Will You Be Assessed

In order to successfully complete this course, each Learner will need to:

  • Complete the eLearning modules and obtain 70% or higher in the final assessments (MCQ-based) by the required deadline set in advance of the given workshop dates you are registered for (applies to blended format only)
  • Fully attend the Live Instructor Workshop as 100% attendance is required
  • Obtain 70% or higher in the graded assessments during the Live Instructor Workshop
What Are The Technology Requirements

For the live workshops during a virtual delivery, we utilise both Zoom and Microsoft Teams.

Learners need to individually have:

  • PC or MAC Computer
  • Reliable Internet
  • Video Webcam
  • Headset or Earbuds
  • Quiet Setting

In relation to the eLearning Modules, in our experience, Workplace IT environments’ internal configurations and available software can vary (new or old), and there may be various limitations or other restrictions in place, and as such, the functionality of any Learning Management System (LMS) may be impacted, restricted and may not perform well. Read the full technology requirements here.

Customer Reviews

What Our Learners Are Saying

Read verified reviews from Learners who have completed this course.

Frequently Asked Questions

Yes, we permit substitutions provided the license has not been activated and this is requested within 30-days of the purchase date. There is no fee for substitutions.
Yes, we offer discounts. The first discount will apply for an order of 5 licenses (Team of 5). If you need more licenses, complete the request quote form as the discount will be applied based on the exact number of licenses required.
This course duration provided is an estimate based on a standard formula for the time it will take an average Learner. The precise amount of time it takes to complete the course will vary depending on your prior experience & learning style.
The standard license is for 90 days (3 months). Access is available 24/7 for the full 90-days even if you complete the course, you can still go back in and view the course content, but you cannot retake the assessments.
Each Learner is provided with 3 attempts at each final assessment. We strongly encourage all Learners to review the course content again before each attempt (if unsuccessful on an attempt). If unsuccessful after a 3rd attempt, a new course license is required (fee applies).
The fastest and easiest way to pay would be to use your credit card. If you cannot do that, and you require a PO, please email our team at training@complyguru.com
There are recommended requirements for each Learner in wishing to complete any of our eLearning modules. In our experience, Workplace IT environments’ internal configurations and available software can vary (new or old), and there may be various limitations or other restrictions in place, and as such, the functionality of any Learning Management System (LMS) may be impacted, restricted and may not perform well. Read the full technology requirements here.
Once you have completed the final assessments, your certificate will be available within 1 business day via your Dashboard. To access your certificate, you must first submit a short course survey and then the certificate will be available for download/print.

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Globally Recognized Qualifications
Training credentials that you can trust.
CQI-IRCA Cretified Course
Exemplar Global Cretified Course
RAPS Cretified Course