LICQual ISO 13485:2016 Medical Devices Quality Management Systems Internal Auditor

Medical Devices Quality Management Systems

The LICQual ISO 13485:2016 Medical Devices Quality Management Systems Internal Auditor course is designed to provide learners with knowledge and practical skills for conducting internal audits based on ISO 13485:2016. The course focuses on Quality Management Systems (QMS) applicable to organisations involved in medical devices and related services.

Learners explore the key principles and requirements of ISO 13485:2016, with particular attention to internal auditing, QMS evaluation, compliance assessment, identification of non-conformities, and corrective actions. The course develops an understanding of how internal audits can be used to review the effectiveness of quality management processes and identify opportunities for improvement.

Through structured lessons, case studies, and practical audit activities, learners develop knowledge of how to plan, conduct, document, and report internal audits. On completion, learners gain LICQual certification demonstrating their knowledge and understanding of ISO 13485:2016, medical devices quality management systems, internal auditing, audit findings, and corrective action processes.

Course Overview

Qualification Title

LICQual ISO 13485:2016 Medical Devices Quality Management Systems

Total Units

Total Credits

GLH

120

Qualification #

LICQ2200120

Qualification Specification

Download Qualification Specification

Entry Requirements
Study Units
Learning Outcomes
Who Should Enroll?

To enroll in the LICQual ISO 13485:2016 Medical Devices Quality Management Systems Internal Auditor, applicants must meet the following criteria:

Age Requirement: Applicants must be at least 16 years old.
Educational Requirements: Applicants should possess a minimum of a high school diploma or equivalent.
Experience: While prior experience in quality management or the medical device industry is advantageous, it is not a strict requirement.
English Language Proficiency: Applicants should have a reasonable proficiency in the English language.

Qualification#	Unit Title	Credits	GLH
LICQ2200120-1	Introduction to ISO 13485:2016 and Medical Devices Quality Management Systems	8	24
LICQ2200120-2	Quality Management System (QMS) Requirements in ISO 13485:2016	8	24
LICQ2200120-3	Risk Management and Compliance in Medical Device Manufacturing	6	18
LICQ2200120-4	Internal Auditing in Medical Device Quality Management Systems	6	18
LICQ2200120-5	Document and Record Control in Compliance with ISO 13485:2016	6	18
LICQ2200120-6	Maintaining Regulatory Compliance and Continuous Improvement in Medical Devices	6	18

By the end of this course, learners will be able to:

Introduction to ISO 13485:2016 and Medical Devices Quality Management Systems

Understand the fundamental principles and objectives of ISO 13485:2016 and its significance in the medical device industry.
Identify the structure and scope of the standard and its key requirements.
Explain the relationship between ISO 13485:2016 and other quality management standards in the context of medical device manufacturing and regulatory compliance.
Recognize the importance of maintaining a robust Quality Management System (QMS) to ensure product safety, efficacy, and compliance with global regulations.

Quality Management System (QMS) Requirements in ISO 13485:2016

Demonstrate knowledge of the key requirements for establishing, implementing, and maintaining a QMS according to ISO 13485:2016.
Understand the roles and responsibilities of management in ensuring QMS effectiveness.
Implement processes for document control, resource management, and product realization in compliance with ISO 13485:2016.
Develop and align organizational processes to the ISO 13485 standard to ensure consistent product quality and regulatory compliance.

Risk Management and Compliance in Medical Device Manufacturing

Apply risk management principles and techniques to the medical device lifecycle, from design to post-market activities.
Understand the process of identifying, assessing, and mitigating risks in accordance with ISO 13485:2016.
Integrate risk management practices into the overall QMS to ensure compliance and patient safety.
Demonstrate the ability to manage risk throughout product development and manufacturing processes to meet regulatory requirements.

Internal Auditing in Medical Device Quality Management Systems

Conduct effective internal audits based on ISO 13485:2016, ensuring compliance with QMS standards.
Plan, execute, and report on audits to assess system performance and identify areas for improvement.
Identify non-conformities and recommend corrective actions to ensure continuous quality improvement.
Understand the role of internal audits in maintaining a robust and compliant QMS and fostering a culture of continual improvement.

Document and Record Control in Compliance with ISO 13485:2016

Implement document and record control procedures to ensure accuracy, traceability, and compliance with ISO 13485:2016.
Understand the lifecycle of documents and records within the QMS, including creation, approval, distribution, and retention.
Ensure all medical device documentation meets regulatory standards and can be easily accessed and tracked for audits and compliance purposes.
Maintain effective document control to support quality assurance and product traceability throughout the medical device lifecycle.

Maintaining Regulatory Compliance and Continuous Improvement in Medical Devices

Understand the importance of maintaining ongoing regulatory compliance in the medical device industry.
Apply continuous improvement practices to enhance the performance of QMS and product quality.
Utilize performance metrics and audit findings to drive corrective and preventive actions (CAPA) and ensure sustained compliance.
Implement strategies for monitoring and evaluating QMS performance, ensuring continual alignment with regulatory requirements and industry best practices.

This diploma is ideal for:

Professionals working in the medical device industry who want to enhance their knowledge and skills in quality management systems.
Individuals aspiring to become internal auditors for ISO 13485:2016 or looking to formalize their auditing expertise in the medical device sector.
Quality managers, compliance officers, and regulatory affairs professionals seeking to improve their understanding of ISO 13485:2016 and its application in medical device manufacturing.
Those interested in gaining a deeper understanding of risk management practices, regulatory compliance, and continuous improvement in the context of medical device quality management.
Professionals who are responsible for ensuring compliance with international standards and maintaining quality assurance processes within medical device organizations.
EIndividuals with a background in quality control, engineering, or healthcare who wish to transition into roles related to medical device quality management systems.
Those looking to enhance their career prospects and gain recognized certification in ISO 13485:2016 internal auditing and quality management for medical devices.

Assessment and Verification

All units within this qualification are subject to internal assessment by the approved centre and external verification by LICQual. The qualification follows a criterion-referenced assessment approach, ensuring that learners meet all specified learning outcomes.

To achieve a ‘Pass’ in any unit, learners must provide valid, sufficient, and authentic evidence demonstrating their attainment of all learning outcomes and compliance with the prescribed assessment criteria. The Assessor is responsible for evaluating the evidence and determining whether the learner has successfully met the required standards.

Assessors must maintain a clear and comprehensive audit trail, documenting the basis for their assessment decisions to ensure transparency, consistency, and compliance with quality assurance requirements.