LICQual Awarding Body

Average Completion Time:
5 days

Course Category: ISO Internal Auditor

Study Method: Online

Study Units: 6 Units

Assessment Based

The LICQual ISO 13485:2016 Medical Devices Quality Management Systems Internal Auditor course could be the next step in your professional journey. This specialized training is designed to equip professionals with the essential knowledge and skills to become effective internal auditors, ensuring compliance with ISO 13485:2016—the international standard for quality management systems in medical devices.

ISO 13485:2016 is the internationally recognized standard for quality management systems (QMS) specifically tailored to the medical devices sector. It outlines the requirements for an organization’s QMS, focusing on maintaining product quality, safety, and effectiveness throughout the lifecycle of medical devices.

The LICQual ISO 13485:2016 Medical Devices Quality Management Systems Internal Auditor course is a valuable investment in your career. It offers essential knowledge, hands-on experience, and a globally recognized certification, ensuring you are equipped to meet the stringent quality management requirements of the medical devices industry.

Entry Requirements

Age Requirement: Applicants must be at least 16 years old.
Educational Requirements: A minimum of a bachelor’s degree in a relevant scientific, engineering, or technical field. A higher qualification, such as a master’s degree, may be required for specialized roles depending on the organization’s scope.
Experience: At least 2-3 years of experience in quality management, regulatory affairs, or laboratory management within the medical devices industry is recommended. Prior experience with ISO 13485:2016 or internal auditing is beneficial but not mandatory.
English Language Proficiency: Applicants must have a good command of English, both written and spoken. Non-native speakers must demonstrate proficiency through tests such as IELTS or TOEFL, or by undergoing an assessment during the interview process to ensure effective communication in the workplace.

Qualification Structure

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

Mandatory Units

Introduction to ISO 13485:2016 and Medical Devices Quality Management Systems
Quality Management System (QMS) Requirements in ISO 13485:2016
Risk Management and Compliance in Medical Device Manufacturing
Internal Auditing in Medical Device Quality Management Systems
Document and Record Control in Compliance with ISO 13485:2016
Maintaining Regulatory Compliance and Continuous Improvement in Medical Devices

Who is this Course For

Quality Managers and Quality Assurance Professionals in the medical device industry seeking to enhance their auditing skills.
Compliance Managers responsible for ensuring that organizations adhere to regulatory standards and want to gain a deeper understanding of ISO 13485:2016.
Internal Auditors and Audit Professionals looking to specialize in the medical device sector and improve their auditing knowledge of quality management systems.
Regulatory Affairs Professionals involved in certification, inspection, and regulatory compliance of medical devices.
Medical Device Engineers and Technicians who want to understand the internal audit process and its role in maintaining compliance with ISO 13485:2016.
Laboratory Managers and Operations Managers in the medical devices industry aiming to strengthen their knowledge of quality management systems and internal auditing.
Career Changers with a background in science or engineering interested in transitioning into quality assurance and auditing roles within medical device manufacturing.

Register Now

To Register in LICQual ISO 13485:2016 Medical Devices Quality Management Systems Internal 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 Internal Auditor course is a specialized training designed to provide professionals with the skills and knowledge required to perform internal audits in compliance with the ISO 13485:2016 standard. The course focuses on auditing processes related to quality management systems in the medical device industry.

This course is ideal for quality managers, compliance officers, internal auditors, regulatory affairs professionals, medical device engineers, and laboratory managers looking to specialize in quality management systems auditing for medical devices. It’s also suitable for career changers with a technical or scientific background interested in the medical device sector.

To enroll in this course, applicants must meet the following criteria:

Proficiency in English (written and spoken) is required, and non-native speakers may need to demonstrate their language skills.

Be at least 16 years old.

Hold a bachelor’s degree in a relevant field such as science, engineering, or technology.

Have at least 2-3 years of experience in quality management, regulatory affairs, or laboratory management in the medical device industry (experience with ISO 13485:2016 is an advantage).

The course covers key topics such as:

The ISO 13485:2016 standard and its requirements for medical device quality management systems.
Internal audit planning, execution, and reporting.
How to identify non-conformities and recommend corrective actions.
Best practices for maintaining compliance and ensuring continuous improvement in medical device manufacturing processes.

Upon completion, you’ll gain a globally recognized certification, making you highly qualified to work as an internal auditor in the medical devices sector. The certification boosts your career prospects, enhances your earning potential, and positions you for senior roles in quality management, regulatory compliance, and auditing within medical device organizations.

Yes, LICQual offers flexible learning options, including both online and in-person courses. This allows you to choose the mode of training that best suits your schedule and preferences.

The duration of the course depends on the delivery format. On average, the course takes around 3-5 days to complete. For online courses, the duration may vary depending on the pace of study.

The cost of the course can vary based on the location and training format. For specific pricing information, please visit the LICQual website or contact their training department for details on any available discounts or offers.

Yes, the certification you receive upon completing the LICQual ISO 13485:2016 course is globally recognized, making it highly valuable for advancing your career in the medical devices industry and quality management field.

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