Online ISO 13485 Lead Auditor Training | CQI, IRCA & Exemplar Global Certified

This ISO 13485 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.

Learning Objectives

On successful completion of this Online ISO 13485 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 13485 in accordance with ISO 19011 and ISO IEC 17021, as applicable

Entry Requirements

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 13485)

Management Systems

• 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 13485 Requirements

• Knowledge of the requirements of ISO 13485 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 13485 (International Standard)

• It is recommended that each Learner should have a printed copy of ISO 13485:2016 (International 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.

Note: The Learner’s understanding of the prior knowledge requirements will be tested as part of the course’s continuous assessment & final examination.

Assessment & Certification

Assessment Methodology

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

1. 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
2. Fully attend the Live Instructor Workshops as 100% attendance is required
3. Obtain 70% or higher in the graded assessments during the Live Instructor Workshops
4. Complete a 2hr Final Examination* that is remotely invigilated (Live Proctored). Each Learner must obtain 70% or higher in the Final Examination which is completed securely online (under strict examination conditions).

*Note: the final examination is closed book and will assess each Learner on the full course program – including knowledge of the ISO 13485 Requirements.

Certification

CQI & IRCA have certified our Blended ISO 13485 Lead Auditor Training Course (No. 2244). Successful completion will entitle each Learner to receive a digital Certificate of Achievement.