ISO 9001 Lead Auditor Training is for anyone that 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 Comply Guru?
- CQI, IRCA & Exemplar Global Certified
- Industry-leading Blended Methodology
- Delivered by Experts with Proven Expertise
- Less Fixed Classroom Time
- Learn Online from Home or Work
Key Course Information
What you need to know?
Our industry-leading Blended Learning Methodology is a hybrid of 16hrs of highly interactive eLearning modules that are completed first before attending 4-days (virtual) of skills-based Live Instructor Workshops that focus on practical application in a real life context.
On successful completion of this course, 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
A summary of learning topics within this course include:
- 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
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.
- 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.
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.
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).
CQI & IRCA certify this course (No. 2192). Upon successful completion, each Learner shall receive a digital Certificate of Achievement.
Exemplar Global also certify this course under the Recognized Training Provider scheme. Learners will receive dual accreditation where both logos will appear on their digital Certificate of Achievement.
For the live workshops during a virtual delivery, we utilize 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.
Pricing & Schedule
Gain an Internationally Accredited ISO Lead Auditor Certification
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Frequently Asked Questions
Reviews & Ratings
67 global ratings
I enjoyed the experience to better understand 9001 and 19011 standards. John provided a great background of the requirements and related them to the departments in the company. Through the training I gained the knowledge needed to improve the audit process in my organization.
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.