Certified Professional in ISO 13485:2016 Lead Auditor Training
-- viewing nowISO 13485:2016 Lead Auditor Training Develop the skills to successfully audit medical device organizations with ISO 13485:2016, the international standard for medical device quality management systems. This training is designed for individuals who want to become certified lead auditors, ensuring medical device organizations meet the required standards.
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About this course
Learn how to conduct effective audits, identify nonconformities, and provide recommendations for improvement.
Understand the medical device industry's unique requirements and how to apply the standard to real-world scenarios.
Gain the knowledge and expertise to pass the ISO 13485:2016 audit certification exam.
Take the first step towards a successful medical device audit career. Explore our ISO 13485:2016 Lead Auditor Training program today and discover how to make a meaningful impact in the medical device industry.
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Course details
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Quality Management System (QMS) Overview: This unit covers the fundamentals of ISO 13485:2016, including its history, principles, and scope. It also introduces the concept of a quality management system and its importance in the medical device industry. •
Medical Device Regulation (MDR) and ISO 13485:2016: This unit delves into the regulatory requirements for medical devices in the European Union and the role of ISO 13485:2016 in ensuring compliance. It also covers the key differences between MDR and ISO 13485:2016. •
Risk Management and Risk-Based Thinking: This unit focuses on the risk management process in ISO 13485:2016, including risk identification, risk assessment, and risk treatment. It also introduces the concept of risk-based thinking and its application in the medical device industry. •
Document Control and Change Management: This unit covers the document control process in ISO 13485:2016, including document approval, revision, and distribution. It also introduces the concept of change management and its importance in maintaining a valid QMS. •
Training and Awareness: This unit emphasizes the importance of training and awareness in maintaining a valid QMS. It covers the types of training required, including employee training, customer training, and supplier training. •
Internal Audits and Management Review: This unit covers the internal audit process in ISO 13485:2016, including audit planning, audit execution, and audit reporting. It also introduces the concept of management review and its importance in maintaining a valid QMS. •
Continuous Improvement and Corrective Action: This unit focuses on the continuous improvement process in ISO 13485:2016, including the identification of opportunities for improvement and the implementation of corrective actions. It also introduces the concept of preventive action and its importance in maintaining a valid QMS. •
Quality Management System Implementation: This unit covers the steps involved in implementing a QMS in ISO 13485:2016, including the development of a QMS manual, the establishment of processes, and the implementation of controls. •
Lead Auditor Competencies and Skills: This unit emphasizes the importance of lead auditor competencies and skills in conducting effective audits. It covers the key competencies and skills required, including auditing knowledge, communication skills, and leadership skills. •
Lead Auditor Training and Certification: This unit covers the requirements for lead auditor training and certification in ISO 13485:2016. It also introduces the concept of certification and its importance in maintaining a valid QMS.
Quality Management System (QMS) Overview: This unit covers the fundamentals of ISO 13485:2016, including its history, principles, and scope. It also introduces the concept of a quality management system and its importance in the medical device industry. •
Medical Device Regulation (MDR) and ISO 13485:2016: This unit delves into the regulatory requirements for medical devices in the European Union and the role of ISO 13485:2016 in ensuring compliance. It also covers the key differences between MDR and ISO 13485:2016. •
Risk Management and Risk-Based Thinking: This unit focuses on the risk management process in ISO 13485:2016, including risk identification, risk assessment, and risk treatment. It also introduces the concept of risk-based thinking and its application in the medical device industry. •
Document Control and Change Management: This unit covers the document control process in ISO 13485:2016, including document approval, revision, and distribution. It also introduces the concept of change management and its importance in maintaining a valid QMS. •
Training and Awareness: This unit emphasizes the importance of training and awareness in maintaining a valid QMS. It covers the types of training required, including employee training, customer training, and supplier training. •
Internal Audits and Management Review: This unit covers the internal audit process in ISO 13485:2016, including audit planning, audit execution, and audit reporting. It also introduces the concept of management review and its importance in maintaining a valid QMS. •
Continuous Improvement and Corrective Action: This unit focuses on the continuous improvement process in ISO 13485:2016, including the identification of opportunities for improvement and the implementation of corrective actions. It also introduces the concept of preventive action and its importance in maintaining a valid QMS. •
Quality Management System Implementation: This unit covers the steps involved in implementing a QMS in ISO 13485:2016, including the development of a QMS manual, the establishment of processes, and the implementation of controls. •
Lead Auditor Competencies and Skills: This unit emphasizes the importance of lead auditor competencies and skills in conducting effective audits. It covers the key competencies and skills required, including auditing knowledge, communication skills, and leadership skills. •
Lead Auditor Training and Certification: This unit covers the requirements for lead auditor training and certification in ISO 13485:2016. It also introduces the concept of certification and its importance in maintaining a valid QMS.
Career path
Certified Professional in ISO 13485:2016 Lead Auditor Training
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**Career Roles and Responsibilities**
* **Certified Professional in ISO 13485:2016**
* Responsible for ensuring the quality management system meets international standards.
* Conducts audits and assessments to identify areas for improvement.
* Develops and implements corrective actions to address non-conformities.
* Collaborates with cross-functional teams to implement quality management system.
* **Quality Engineer**
* Designs and develops quality management systems and processes.
* Conducts quality audits and assessments to ensure compliance with regulations.
* Develops and implements corrective actions to address non-conformities.
* Collaborates with cross-functional teams to implement quality management system.
* **Regulatory Affairs Specialist**
* Ensures compliance with regulatory requirements and standards.
* Conducts research and analysis to stay up-to-date on regulatory changes.
* Develops and implements regulatory strategies to minimize risk.
* Collaborates with cross-functional teams to implement regulatory compliance.
* **Medical Device Auditor**
* Conducts audits and assessments to ensure compliance with regulatory requirements.
* Identifies areas for improvement and develops corrective actions.
* Collaborates with cross-functional teams to implement corrective actions.
* Ensures quality management system meets international standards.
* **Quality Manager**
* Develops and implements quality management systems and processes.
* Conducts quality audits and assessments to ensure compliance with regulations.
* Develops and implements corrective actions to address non-conformities.
* Collaborates with cross-functional teams to implement quality management system.
Entry requirements
- Basic understanding of the subject matter
- Proficiency in English language
- Computer and internet access
- Basic computer skills
- Dedication to complete the course
No prior formal qualifications required. Course designed for accessibility.
Course status
This course provides practical knowledge and skills for professional development. It is:
- Not accredited by a recognized body
- Not regulated by an authorized institution
- Complementary to formal qualifications
You'll receive a certificate of completion upon successfully finishing the course.
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CERTIFIED PROFESSIONAL IN ISO 13485:2016 LEAD AUDITOR TRAINING
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who has completed a programme at
London School of Planning and Management (LSPM)
Awarded on
05 May 2025
Blockchain Id: s-1-a-2-m-3-p-4-l-5-e
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