ISO 9001 Requirements for Practitioners and Auditors

395.00
4.6 ★★★★★ 220 Reviews
CQI-IRCA Cretified Course

ISO 9001 Requirements Training is for Practitioners and Auditors looking to gain a comprehensive understanding of the core requirements of ISO 9001 and this highly interactive course can be completed anytime, anywhere (24/7).

From 5th October 2026, this credential will be based on ISO 9001:2026.

What makes Comply Guru’s eLearning different from competitors is we instructionally design modules based on engaging, applied learning with real-world examples and case studies. Our online training is a highly interactive way to learn at a time & pace that works best for you, making it easier to get the training you need while balancing a busy home or work life.

This course is an internationally accredited credential. CQI and IRCA certify this course (No. 2148) offering global recognition for successful participants.

ISO 9001 Requirements for Practitioners and Auditors

Overview of our ISO 9001 Requirements Training

Approved By
CQI & IRCA (No. 2148)
Duration
7hrs
eLearning Access
365 Days
Teaching Format
eLearning
Course Entry Requirements
Prior knowledge is recommended
Certification on Completion
Issued in 1 business day
Course Content Based on
ISO 9001
Course Last Updated
November 2024
Language (s)
English
395.00 / Seat
Sample Certificate of ISO 9001 Requirements for Practitioners and Auditors
Trusted By Notified Bodies & Global Brands
Trusted By Notified Bodies & Global Brands
Trusted By Notified Bodies & Global Brands
Trusted By Notified Bodies & Global Brands
Trusted By Notified Bodies & Global Brands
Trusted By Notified Bodies & Global Brands

What's covered on our ISO 9001 Requirements Training

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

eLearning
  • What is a Quality Management System (QMS)
  • Purpose, Benefits and Structure of ISO 9001
  • Terms and Definitions
  • Risk Based Thinking (RBT)
  • Plan-Do-Check-Act (PDCA)
  • Process Approach
  • PDCA and ISO 9001
  • Customer Focus
  • Leadership
  • Engagement of People
  • Process Approach
  • Improvement
  • Evidence-based Decision Making
  • Relationship Management
  • 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
  • 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
  • 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
  • Operational Planning and Control
  • Requirements for Products and Services
  • Design and Development
  • External Providers
  • Production and Service Provision
  • Operation
  • Control of Non-Conformity Outputs
  • Monitoring, Measurement, Analysis and Improvement
  • Internal Audit Requirements
  • Management Review
  • Improvement
  • Non-Conformity and Corrective Actions
  • Continual Improvement
About our eLearning
 
Michelle Keane

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.
Eoin Philip Kelly

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.

On completion of this course, successful Learners will have the practical knowledge and be able to:

  • Explain the purpose of a quality management system, 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
  • Any individual requiring a working knowledge and understanding of the ISO 9000 series of standards
  • Quality professionals/consultants
  • Presidents/Vice Presidents/CEOs
  • ISO Coordinators/management representatives
  • Engineers
  • Supervisors

CQI IRCA

CQI & IRCA certify this course (No. 2148).

Upon successful completion, each Learner shall receive two digital Certificates of Completion.

The course name on the CQI & IRCA Approved Certificate states: FD116: QMS ISO 9001:2015 Foundation Training (No. 2148)

Before completing this course, it is recommended that each Learner should have an understanding of the following:

  • 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.
  • The fundamental concepts and the seven quality management principles (see ISO 9000)
  • The relationship between quality management and customer satisfaction
  • The commonly used quality management terms and definitions (see ISO 9000).

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 very challenging to complete successfully.

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

  • Complete all eLearning modules and obtain 70% or higher in the final assessment (MCQ-based)

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.

Need Corporate, In-House or Customized Training?

Comply Guru offers corporate, in-house and customized training solutions for your organization’s specific needs.

Speak with an experienced member of our team today to learn how we can help.

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.

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.

NEW GENERATION
of eLearning

Upskill Anytime,
Anywhere

Flexible learning with courses that can be completed at your own pace and schedule

Explorative and
Interactive

Learners are required to explore and interact, not just sit and listen to videos or PowerPoint presentations

Clear and
Engaging Design

Modules crafted by experienced graphical & instructional designers that are easy to follow, will keep your attention and are well structured

Experiential
Learning

A method that involves actively engaging through experience and reflection, helping Learners connect theory to real-world situations

Diversity for Various
Learning Styles

Not everyone learns the same. Our approach incorporates a multi-tier approach to ensure inclusivity for a variety of different learning styles

Checkpoint Activities
and Knowledge Checks

Regular, in-module quizzes, exercises, and case studies to reinforce learning and verify understanding

NEW GENERATION
of eLearning

Upskill Anytime,
Anywhere

Flexible learning with courses that can be completed at your own pace and schedule

Explorative and
Interactive

Learners are required to explore and interact, not just sit and listen to videos or PowerPoint presentations

Clear and
Engaging Design

Modules crafted by experienced graphical & instructional designers that are easy to follow, will keep your attention and are well structured

Experiential
Learning

A method that involves actively engaging through experience and reflection, helping Learners connect theory to real-world situations

Diversity for Various
Learning Styles

Not everyone learns the same. Our approach incorporates a multi-tier approach to ensure inclusivity for a variety of different learning styles

Checkpoint Activities
and Knowledge Checks

Regular, in-module quizzes, exercises, and case studies to reinforce learning and verify understanding

Training Transformed with Comply Guru

Comply Guru has helped organizations reduce training costs by up to 50%, accelerate workforce development, and create sustainable business value through innovative learning solutions.

What Our Learners Are Saying

Read verified reviews from Learners who have completed this course.