LICQual Awarding Body

Average Completion Time:
5 days

Course Category: ISO Lead Auditor

Study Method: Online

Study Units: 6 Units

Assessment Based

The medical device industry is one of the most highly regulated sectors globally, requiring stringent quality management systems to ensure safety, reliability, and effectiveness. ISO 13485:2016 is the international standard for quality management systems (QMS) in the medical device industry, focusing on meeting regulatory requirements and maintaining high-quality manufacturing practices. To stay competitive and compliant, professionals in the medical device sector must stay updated with the latest industry standards.

The LICQual ISO 13485:2016 Medical Devices Quality Management Systems Lead Auditor course is designed to provide you with the skills to lead audits in this critical industry. Whether you’re an auditor, quality manager, or a consultant, obtaining this certification will significantly enhance your career prospects in the medical device field.

ISO 13485:2016 is a globally recognized standard for quality management systems in the medical device industry. It specifies the requirements for a comprehensive QMS that ensures medical devices consistently meet regulatory standards and quality expectations. By implementing ISO 13485:2016, organizations can demonstrate their commitment to regulatory compliance and product safety, which is crucial for maintaining a competitive edge in the market.

The LICQual ISO 13485:2016 Medical Devices Quality Management Systems Lead Auditor course is a critical certification for professionals looking to advance in the medical device industry. Whether you are a quality manager, auditor, or consultant, this course will equip you with the necessary skills and knowledge to perform audits and ensure regulatory compliance with ISO 13485:2016. By becoming a certified Lead Auditor, you can open the door to exciting career opportunities and contribute to the safety and efficacy of medical devices worldwide.

Entry Requirements

Age Requirement: Applicants must be at least 16 years old.
Educational Requirements: A minimum of a high school diploma or equivalent.
A background in healthcare, engineering, quality management, or related fields is highly recommended.
A degree in biomedical engineering, life sciences, or a similar discipline is beneficial for a deeper understanding of the course material.
Experience: While prior auditing experience is not required, at least 2 years of professional experience in medical device manufacturing or a related field is recommended.
Familiarity with quality management systems (QMS), particularly in a regulated environment, will enhance understanding of course concepts.
English Language Proficiency: Strong proficiency in technical English is essential.
Candidates must be able to read, write, and understand complex terminology related to medical device quality management and auditing.

Qualification Structure

The LICQual ISO 13485:2016 Medical Devices Quality Management Systems Lead Auditor
consist of 6 Mandatory Units , 40 credits and 120 GLH.

Mandatory Units

Introduction to ISO 13485:2016
Quality Management Principles and Requirements
Management Responsibility and Leadership
Resource Management
Product Realization and Design Control
Measurement, Analysis, and Improvement

Who is this Course For

Quality Managers and Auditors: Professionals responsible for ensuring compliance with ISO 13485:2016 and conducting audits in medical device manufacturing organizations.
Regulatory Affairs Professionals: Individuals involved in ensuring that medical devices meet the necessary regulatory standards for quality and safety.
Medical Device Managers and Supervisors: Managers overseeing operations, production, or quality control in the medical device industry, seeking a deeper understanding of quality management systems.
Consultants: Those providing consultancy services to medical device organizations on ISO 13485:2016 compliance and process improvements.
Aspiring Lead Auditors: Individuals aiming to specialize in auditing medical device quality management systems and gain expertise in the ISO 13485:2016 standard.
Healthcare and Medical Device Technicians: Professionals in medical device manufacturing or healthcare settings looking to develop their knowledge in quality management and auditing processes.

Register Now

To Register in LICQual ISO 13485:2016 Medical Devices Quality Management Systems Lead Auditor
Please fill the Registration form or contact us on WhatsApp

Have Queries? Find Solutions Here

The LICQual ISO 13485:2016 Medical Devices Quality Management Systems Lead Auditor course provides the essential knowledge and skills needed to audit medical device organizations for compliance with ISO 13485:2016. The course covers audit techniques, regulatory requirements, and quality management systems in the medical device sector.

This course is designed for quality managers, auditors, regulatory affairs professionals, medical device supervisors, consultants, and those aspiring to become lead auditors in the medical device industry.

Applicants must be at least 16 years old with a minimum of a high school diploma. A background in healthcare, engineering, or quality management is recommended. At least 2 years of professional experience in a medical device manufacturing or related field is advised.

The course duration varies depending on the learning format, typically ranging from a few days to two weeks. Flexible online and in-person options are available to suit your schedule.

You will learn about ISO 13485:2016 requirements, audit processes, medical device regulatory standards, risk management, and the implementation of quality management systems in the medical device sector.

Yes, upon successful completion, you will receive a globally recognized certification as an ISO 13485:2016 Lead Auditor, which will enhance your credibility and career opportunities in the medical device industry.

This certification enhances your qualifications as a Lead Auditor, making you a valuable asset in the medical device industry. It opens career opportunities in auditing, quality management, compliance, and regulatory affairs.

Yes, the course is available in both online and in-person formats, providing flexibility for professionals with different learning preferences and schedules.

To enroll, visit the LICQual website, review course details, and follow the enrollment steps. Ensure that you meet the entry requirements before applying.

The Global Training and Certification Service (TGTCS) Is Directly Approved Centre of LICQual