Online ISO 9001 Lead Auditor Training | CQI & IRCA Certified
Online ISO 9001 Lead Auditor Training (CQI & IRCA Certified) for anyone that has a good understanding of Quality Management Systems (QMS) and the requirements of ISO 9001 training and wants to gain the knowledge and skills required to perform full system first, second and third-party audits of quality management systems against ISO 9001, in accordance with ISO 19011 and ISO IEC 17021-1.
Why Choose Blended ISO 9001 Lead Auditor Training?
Learners start by completing eLearning modules on the underlying principles & theory of Quality Management and ISO 9001 Lead Auditing that provides better preparation in advance of shorter, more focused instructor workshops on the practical skills for 1st, 2nd, and 3rd party auditing.
Course Format & Content Breakdown
This ISO 9001 Lead Auditor Training Course is split into a blend of 16hrs of eLearning that is completed first before attending 3-days (in-person) or 4-days (virtual) of skills-based Live Instructor Workshops. It is important to note that the exact time it takes to complete the eLearning modules will vary based on current knowledge, experience, and learning style.
During the eLearning modules, each Learner will cover the following theory & knowledge:
- Purpose, Benefits & Structure of ISO 9001
- Quality Management Principles
- Terms & Definitions
- Documentation Requirements
- Plan-Do-Check-Act (PDCA)
- Process-based Quality Management Systems
- Risk Based Thinking (RBT)
- Management Commitment
- Management System Audits
- Audit Terminology
- Principles of Auditing
- Audit Program Management
- Certification Audit Program
- Audit Life Cycle
- Audit Scope, Objectives & Criteria
- Selection of Audit Location
- Selection of Audit Team
- Auditee, Observer & Guides
- Audit Initiation & Preparation
- The Audit Plan
- Audit Documentation
- Overview of Audit Activities
- Opening Meeting
- Collecting & Verifying Information
- Audit Findings
- Final Audit Team Meeting
- Audit Conclusion
- Closing Meeting
- Audit Report
- Audit Completion
- Audit Follow-Up
Instructor Workshop Modules
During the instructor workshops, the focus is on skills & application of the theory for:
- QMS Document Review
- Development of the Audit Plan & Checklist
- Opening Meeting
- Simulated Audit Exercises
- Audit Findings
- Audit Conclusion
- Closing Meeting
- Audit Report
- Audit Follow Up
- CQI & IRCA Exam Preparation
On successful completion of this Online ISO 9001 Lead Auditor Training, Learners will have gained the knowledge & skills required to:
- Plan, conduct, report and follow up an audit of a quality management system to establish conformity (or otherwise) with ISO 9001 in accordance with ISO 19011 and ISO IEC 17021, as applicable
Before completing this course, each Learner should have the following prior knowledge: Work Experience
- It is recommended that anyone wishing to attend this course has some work-based experience in Quality Management (based on ISO 9001 standard)
- 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.
ISO 9001 Requirements
- Knowledge of the requirements of ISO 9001 and the commonly used quality management terms and definitions
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 & ISO 19011 (International Standards)
- Each participant should have a copy of both ISO 9001:2015 and ISO 19011:2018 to reference while completing this course, including final CQI & IRCA Exam. This is not provided by Comply Guru and without it, this course will be very challenging to complete successfully.
Note: The Learner’s understanding of the prior knowledge requirements will be tested as part of the course’s continuous assessment and final examination.
Assessment & Certification
ISO 9001 Lead Auditor Training Assessment Methodology
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
- Fully attend the Live Instructor Workshops as 100% attendance is required
- Obtain 70% or higher in the graded assessments during the Live Instructor Workshops
- Complete a CQI & IRCA 1hr 45min Online Assessment within 30-days of the final workshop date. See the next section below for more information.
ISO 9001 Lead Auditor Training Certification
CQI & IRCA certifies this course (No. 2192). Successful completion will entitle each Learner to receive a digital Certificate of Achievement.
CQI & IRCA Lead Auditor Exam
As of November 2022, CQI & IRCA have introduced a new form of online examination that is being standardized globally for lead auditor exams. This is managed by CQI & IRCA but facilitated by training providers. At the end of the training, each Learner will have 30-days to complete an online assessment consisting of 40 questions (80 marks with 1hr45mins permitted) on SARAS (CQI & IRCA’s online assessment system). To pass, each Learner must obtain 50% or higher in this assessment. During the workshop portion of the training, access details will be provided to Learners with instructions on how to access practice assessments and how to schedule their exam. Online assessment results are validated within 10 business days and once available, the Learner will be notified and if successful, a certificate of achievement will then be available via their Dashboard. The cost of this assessment is included in the course fee (1 attempt included). Important Note: the online assessment is open book and the exam will assess each Learner on the full course program including course pre-requisites (i.e. knowledge of the ISO 9001 Requirements).
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 full technology requirements
Terms & Conditions
In registering for this course, each Learner and/or Customer expressly acknowledges that they have read, fully understood and agreed to be bound by all of Comply Guru’s terms & conditions, including additional licensing agreement. The terms & conditions & licensing agreement can be read here.
- Subject Area
- 40 Hours
- € 995.00 per person
- Team Pricing
- € 1,990.00
(Book 2, Get 3rd Free)
- Blended Learning A hybrid of eLearning & Instructor Workshops
- CQI & IRCA (No. 2192)
- Delivery Mode
- Available Classroom, Virtual, Public or In-Company
- Explainer Video
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Reviews & Ratings
60 global ratings
I think the relationship between ISO19011 & ISO17021 could have been explored more.
Very good training experience.
It was very useful training course.
Course was excellent
Comply Guru has made it possible to pursue this course in the comfort of your home / area of your choice while still making it seem as though you are attending a classroom by facilitating live virtual sessions with an expert instructor and other course participants.
Excellent course. Brilliant guidance by the organisation and tutor.
I found Kristian to be an excellent instructor, very knowledgeable and he was able to anticipate and invited questions when I unmuted my mike. Excellent course content and the preparation for the exam was very well structured.
This was an excellent course. By completing the online theory in advance of the classroom workshops ensures that we focused on practical skills which was brilliant. Kris was proficient in teaching the modules and was a fountain of knowledge in auditing and brought out the best of all the attendees experiences. It is clear from the training that a lot of thought and effort was put into the modules as the information was concise and straight to the point. I would highly recommend anyone in the Pharmaceutical industry to complete this course.
Comply Guru were extremely helpful to deal with. Due to unforeseeable circumstances, I was unable to complete my initial LEAD Auditor course having attended the first day. Eoin was very understanding and offered me a place on the next course available. In addition, Kristian is a very helpful instructor. He builds a good rapport with participants, providing a nice atmosphere and his own personal experiences from auditing are helpful. Overall, the course follows a logical flow, starting with the audit initiation, followed by preparation, opening meeting, conducting the audit etc.
The blended ISO9001 course was great. The online classes were very well structured and the provided example material was beneficial in taking the content and aplying it to a hypothetical situation. The team exercises in the blended section were very engaging and really improved understanding of the content. Kristian, our course instructor, was very knowledgeable and very able to pass on what he knew