ISO 13485 Lead Auditor Training
PECB-accredited program
10 modules covering the latest ISO standards
Immersive 40-hour learning experience
Be knowledgeable on medical device quality management systems
Systematic doubt-clearing sessions available
Virtual and classroom learning choices
4.8/54.8/5Overview
What we will teach you through our course
- Learn about ISO 13485 standards and principles
- Planning and organizing MD QMS audits
- Develop and utilise audit checklists and plans
- Collect and analyse audit evidence systematically
- Report audit findings and identify non-conformities
- Prepare for the ISO 13485 Lead Auditor certification exam
Upcoming sessions
Curriculum
- •
Knowledge of the following quality management principles and concepts:
<ul> <li> <p>The Plan, Do, Check, Act (PDCA) cycle.</p> </li> <li> <p>The relationship between quality management and customer satisfaction</p> </li> <li> <p>Commonly used quality management terms and definitions and the 8 Quality Principles as given in ISO 9000.</p> </li> <li> <p>The process approach is used in quality management.</p> </li> <li> <p>The Model of a Process Based Quality Management System, the structure and content of ISO 13485.</p> </li> <li> <p>Knowledge of the requirements of ISO 13485.</p> </li> </ul> </li>
- •Purpose and benefits of MD-QMS-Requirements for Regulatory Purposes including an understanding of the basic MD-QMS principles
- •Terms, Fundamentals, and Principles
- •Process Approach with PDCA
- •Mandatory Documents for Regulatory Purposes
- •Difference between Compliance and Conformance
- •Relationship between IMDRF and GHTF
- •Principles of IMDRF
- •MDR European Union Regulations
- •MD-QMS Requirements (Clause 1 to 8)
- •Auditing Objectives
- •Types of Audits
- •Audit Life Cycle
- •Terms and Definition
- •Principle of Auditing
- •Annex A – Guidance of Auditors
- •Audit Programme Objectives
- •The Auditees Responsibilities
- •The Lead Auditors’ Responsibilities
- •Auditors' Qualifications and Certifications
- •Pre-Audit Planning
- •Reviewing Documentation
- •Developing an Audit Plan
- •Preparing Checklists or Working Documents
- •Communication Factors
- •Opening Meeting
- •Collecting Objective/Audit Evidence
- •Effective Interviewing Techniques
- •Identifying and Recording Nonconformities
- •Preparing for the Closing Meeting
- •Conducting the Closing Meeting
- •Preparing the Audit Report
- •Distributing the Audit Report
- •Corrective Action Responsibilities
- •Follow up Scheduling
- •Monitoring Corrective Action
- •The Registration Processes
- •Surveillance Audits
Meet your Trainer
Our Trainers
We, at Learners Point, take immense pride in our teaching methods and instructors. Our instructors are some of the best experts in their fields and employ a practical approach to learning. Many of them are globally recognised and have a diverse set of experience in their field of expertise. You are always sure to have the best in the industry as your teachers who are ready to guide you at every step and make the experience informative yet enjoyable. Apart from the focus on learning your chosen course, our instructors also encourage students to develop communication skills and interpersonal skills necessary to excel in the practical world.
Our cutting edge teaching methods make every program an immersive and productive experience for the learners. Our learning methods are research-driven and are continuously updated to stay relevant to present times as well as the future. You will enjoy practical applications of everything learned through theory and regular mock examinations to help monitor your progress. Our courses are led by an instructor in a classroom setup and we do offer online high-quality sessions as well for individuals. We also monitor the training sessions with a progress tracker to maintain high standards of instruction & ethics.
Meet your Trainer
Our Trainers
We, at Learners Point, take immense pride in our teaching methods and instructors. Our instructors are some of the best experts in their fields and employ a practical approach to learning. Many of them are globally recognised and have a diverse set of experience in their field of expertise. You are always sure to have the best in the industry as your teachers who are ready to guide you at every step and make the experience informative yet enjoyable. Apart from the focus on learning your chosen course, our instructors also encourage students to develop communication skills and interpersonal skills necessary to excel in the practical world.
Our cutting edge teaching methods make every program an immersive and productive experience for the learners. Our learning methods are research-driven and are continuously updated to stay relevant to present times as well as the future. You will enjoy practical applications of everything learned through theory and regular mock examinations to help monitor your progress. Our courses are led by an instructor in a classroom setup and we do offer online high-quality sessions as well for individuals. We also monitor the training sessions with a progress tracker to maintain high standards of instruction and ethics.
Learning Outcomes
Upon course completion, you will master:
1
Develop knowledge of the ISO 13485 standard and its requirements for Medical Device Quality Management Systems (MD QMS)
2
Plan, conduct and report on audits of MD QMS, following ISO 19011 guidelines
3
Assess the compliance of MD QMS with ISO 13485 and relevant regulatory standards
4
Recommend appropriate corrective actions and improvement measures to address identified non-conformities
5
Contribute to the continuous improvement of MD QMS by providing valuable insights
Prerequisites
To enrol for the ISO 13485 Lead Auditor Training, some knowledge of the following quality management principles and concepts is required:
- The Plan, Do, Check, Act (PDCA) cycle
- The relationship between quality management and customer satisfaction
- Commonly used quality management terms and definitions and the 8 Quality Principles as given in ISO 9000
- The process approach is used in quality management
- The Model of a Process Based Quality Management System, the structure and content of ISO 13485
- Knowledge of the requirements of ISO 13485
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Frequently asked questions
An ISO 13485 Lead Auditor is responsible for conducting audits of medical device quality management systems against ISO 13485 standards, ensuring compliance, and identifying areas for improvement.
ISO 13485 Lead Auditor training is essential to develop the necessary knowledge and skills to effectively audit medical device quality management systems, contributing to regulatory compliance and continuous improvement.
Yes, ISO 13485 Lead Auditor training is globally recognized and provides individuals with the necessary skills to conduct audits in compliance with international standards.
Yes, many training providers offer ISO 13485 Lead Auditor courses online, allowing participants to complete the training remotely at their own pace.
The training sessions at Learners Point are an interactive, immersive, and intensive hands-on program. We offer three modes of delivery and participants can choose from instructor-led classroom-based group coaching, one-to-one training session, or high-quality live and interactive online sessions as per convenience.
At Learners Point Academy, if a participant doesn’t wish to proceed with the training after the registration due to any reason, he or she is entitled to a 100% refund. However, the refund will be issued only if we are notified in writing within two days from the date of registration. The refund will be processed within four weeks from the day of exit.
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