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

4.8/5

6280 Enrolled

Overview

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

Learning Objectives

Upon course completion, you will master:

Develop knowledge of the ISO 13485 standard and its requirements for Medical Device Quality Management Systems (MD QMS)

Plan, conduct and report on audits of MD QMS, following ISO 19011 guidelines

Assess the compliance of MD QMS with ISO 13485 and relevant regulatory standards

Recommend appropriate corrective actions and improvement measures to address identified non-conformities

Contribute to the continuous improvement of MD QMS by providing valuable insights

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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

Overall ratings by our students

Upcoming sessions

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.

Our Trainers

Related courses

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

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.