ISO 13485 Medical Devices Quality management systems (MQMS) Lead Auditor Course

Our internationally recognized ISO 13485:2016 Medical Device Quality Management System Lead Auditor course prepares you to gain the necessary knowledge to start your journey as an assessment professional.  ISO 13485:2016 Medical Device Quality Management System Lead Auditor Certified professionals are considered as a strong asset to any organization. Meeting future needs and expectations is a big challenge for organizations that operate in any industry, especially in today’s increasingly dynamic environment. Once you finish your Lead Auditor training with us, you will be ready to start your journey as a certified internal or external auditor. 

Exceptional Approach: 

We designed our courses to capture necessary knowledge while you are in the classroom environment. We shall not create any homework or take-home assessment. All our ISO standard Lead Auditor courses are certified by Exemplar Global and recognized internationally. Our trainers are experienced audit professionals and recognized internationally, we will provide you with all the learning materials. 

By the end of the course the participants shall be expected to get the knowledge of: 

• The purpose, content and interrelationship of ISO 13485.  

• Eight core principles: customer focus, people involvement, continual improvement, a decision-making process that is fact-based, a process approach, a system approach to management, supplier relationships that are mutually beneficial and leadership.  

• Responsibilities of a lead auditor and describe the role of auditors in the maintenance and improvement of management systems 

• Planning, conducting, reporting an audit of part of the quality management system in accordance with ISO 19011. 

• Apply what you learn across all industries around the world. 

We will prepare you: 

Our training courses are designed to meet and exceed today’s industry requirements. ISO 13485 Lead Auditor Course is for anyone intending to acquire the competence to audit ISO 13485:2016 Medical Device Quality management systems in organizations to confirm the organization’s conformity of the requirement, either as a first, second or third-party auditor. 

We deliver our knowledge to prepare you as a competent assessment professional. Our knowledge delivery professionals and evaluation methods we use are recognized internationally. Be trained with us and be confident in the professional world. 

Course Content 

• Course Introduction 

• Basic understanding of MDQMS 

• Normative References 

• Context of the organization 

• Leadership & Management Responsibility 

• Resource Management 

• Design and Development 

• Control 

• Measurement, Analysis and Evaluation 

• Audit Program 

• Audit Types 

• Principle of Auditing 

• Opening Meeting 

• Writing an NCR 

• Closing Meeting  

• Review  

• Final Exams of ISO 13485 Final Exam – Lead Auditor course 

Recognition: This training is certified by Exemplar Global and recognized globally.  

Duration: 5 Days  

Exam Requirement: Two Hours Exam 

Prerequisites: Prior knowledge of Quality Management System and the ISO 13485 Standard. 

Group booking – We offer Face to face/Virtual Instructor Led training sessions for a group of Five (5) Delegates and above. 

Public/Individual course booking – eLearning Option with opportunity for tutor support to clear doubts where necessary. 

If choosing the eLearning Learning option, Our ISO Lead Auditor course is delivered on the GRS Learning Portal. Upon confirmation of your registration/payment, we will provide you with a login access link within 24hrs. Once logged on using your account, you will be able to browse through the sections of the training course. 

A look inside how the eLearning training option will be conducted:
In addition to having the training course content in video format, you will also be able to access the regular training course materials format structured in different training course with the additional files available in an editable format (depending on the training course, the case study, exercises, and exercises correction key files will also be available) for you to study with access up to Eight (8) weeks. 

In addition to the lectures and the training course materials, quizzes have been incorporated into each section covering Sixteen Lessons of the training to ensure that our training is as interactive as possible. 

While taking the training course, access the materials on GRS Learning Portal, Enter the exam at your most convenient date, time, and location via GRS Exams. 

In response to COVID-19 and social distancing, we’ve developed an online digital classroom to deliver our courses virtually and keep the interaction and engagement between trainers and participants.  

Our virtual training platform incorporates: 

• Group exercises – facilitated by mini break out workshops amongst the team 

• Ability to ask questions in real-time 

• Built-in note-taking and tracking of course materials 

• You can interact with participants throughout the session through a chat functionality 

• Online assessments providing a streamlined marking process 

Our aim is to recreate the classroom experience in a safe, virtual environment, maintaining the fun and engaging experience our clients find useful and valuable.