ISO 13485:2016 is the internationally recognised standard for quality management systems (QMS) specific to the medical device industry. It outlines the requirements for organisations involved in the design, production, installation, and servicing of medical devices, ensuring consistent quality and regulatory compliance. The LICQual ISO 13485:2016 Lead Auditor course provides professionals with the knowledge and competencies needed to assess and audit medical device QMS against this critical standard.
ISO 13485:2016 serves as a foundation for meeting European CE marking requirements, FDA regulations, and other global regulatory frameworks. It places a strong focus on risk management, documentation, process control, and regulatory alignment, all of which are vital in the production and lifecycle of safe and effective medical devices.
Achieving certification as a lead auditor for ISO 13485:2016 through LICQual is a strategic investment for professionals and organisations committed to medical device quality and regulatory success. It not only enhances individual skill sets but also reinforces trust in the systems that ensure patient safety and product efficacy.
All About LICQual ISO 13485:2016 Medical Devices Quality Management Systems Lead Auditor
Course Overview
The LICQual ISO 13485:2016 Lead Auditor course is designed to deliver a comprehensive understanding of audit principles, ISO 13485 requirements, and the specific auditing techniques relevant to the medical device sector. Through case studies, real-world audit scenarios, and hands-on exercises, participants will develop the practical skills to plan, execute, and report audits in accordance with ISO 19011 and ISO/IEC 17021 standards.
The course also covers the integration of regulatory expectations into QMS auditing and the management of nonconformities and corrective actions. It prepares participants not only to perform audits but to contribute meaningfully to quality system improvements that support business and compliance goals.
Study 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
To ensure participants gain maximum value from the LICQual ISO 13485:2016 Lead Auditor course, candidates are expected to meet the following entry requirements:
Minimum Age
Applicants must be at least 18 years old at the time of course registration.
Educational Background
A minimum of secondary education (such as GCSEs or equivalent) is required. A background in health sciences, engineering, quality management, or a related field is highly recommended to support understanding of technical and regulatory aspects.
Work Experience
While not mandatory, prior experience in quality management, medical device manufacturing, regulatory affairs, or auditing is advantageous. This course is particularly suitable for professionals working within quality assurance, compliance, or medical device production environments.
Language Proficiency
Since the course is delivered in English, participants must possess strong reading, writing, and verbal communication skills in English. This ensures clear comprehension of course content, active participation in discussions, and effective completion of written assessments and audit documentation.
Meeting these criteria enables participants to engage confidently with the course materials and successfully develop the competencies required of a lead auditor in the medical devices sector.
This course is tailored for professionals involved in the quality management and regulatory compliance of medical devices. It is ideal for those seeking to develop or validate their auditing competencies within the framework of ISO 13485:2016.
The course is suitable for:
- Quality assurance and quality control managers in medical device organisations
- Internal auditors responsible for medical device quality systems
- Regulatory affairs professionals overseeing ISO compliance
- Quality engineers and compliance officers in healthcare manufacturing
- Consultants offering advisory services in ISO 13485 implementation
- Third-party auditors and lead auditors aiming to expand their certification portfolio
- Project managers overseeing medical device development and compliance
- Professionals preparing for Notified Body or regulatory audits
- Technical personnel aspiring to transition into quality management roles
- Individuals seeking a globally recognised qualification in medical device auditing
Participants from both manufacturing and service environments related to medical devices will benefit from the practical, standards-based knowledge this course provides.
Learning Outcomes
Introduction to ISO 13485:2016
- Understand the purpose, scope, and structure of ISO 13485:2016
- Identify the key objectives and regulatory significance of the standard in the medical device industry
- Recognise the relationship between ISO 13485 and other global quality and regulatory standards
Quality Management Principles and Requirements
- Gain an in-depth understanding of the fundamental quality management principles in ISO 13485
- Learn how to interpret and apply the standard’s requirements across medical device operations
- Develop the ability to assess conformity to QMS requirements during audits
Management Responsibility and Leadership
- Understand the roles and responsibilities of top management in maintaining an effective QMS
- Learn how leadership commitment influences quality outcomes and regulatory compliance
- Evaluate how quality policies and objectives align with business strategies
Resource Management
- Identify the types of resources required for QMS effectiveness, including human, infrastructure, and environment
- Understand the importance of personnel competence, training, and awareness in medical device quality
- Assess the adequacy and management of resources during an audit
Product Realization and Design Control
- Understand the processes involved in planning and developing medical devices
- Learn how to assess design and development controls for regulatory and safety compliance
- Evaluate production and process controls, validation, and traceability measures
Measurement, Analysis, and Improvement
- Understand the methodologies for monitoring, measurement, and data analysis in a QMS
- Learn how to identify and evaluate nonconformities and implement effective corrective actions
- Gain the ability to assess continual improvement mechanisms within the QMS framework
FAQs LICQual ISO 13485:2016 Medical Devices Quality Management Systems Lead Auditor
