The QualCert ISO 13485:2016 – Quality Management Systems for Medical Devices Lead Auditor Course is designed to provide professionals with the knowledge and skills required to audit, assess, and certify quality management systems (QMS) specific to the medical device industry. The QualCert ISO 13485:2016 – Quality Management Systems for Medical Devices Lead Auditor Course follows internationally recognized auditing principles and best practices to ensure compliance with ISO 13485:2016, the globally accepted standard for medical device QMS. Participants will gain a deep understanding of the requirements of ISO 13485:2016, including risk-based approaches, regulatory frameworks, and the integration of quality and safety in medical device manufacturing.
The QualCert ISO 13485:2016 – Quality Management Systems for Medical Devices Lead Auditor Course covers audit planning, execution, non-conformity reporting, and corrective actions, preparing learners to lead internal and third-party audits effectively. With a focus on regulatory compliance, risk management, and continuous improvement, this course is ideal for quality professionals, auditors, and medical device manufacturers aiming for ISO 13485 certification. The training includes real-world case studies, practical exercises, and role-based audit scenarios to ensure participants acquire hands-on experience in conducting ISO 13485:2016 audits.
By completing this QualCert ISO 13485:2016 – Quality Management Systems for Medical Devices Lead Auditor Course, participants will be equipped to enhance product quality, patient safety, and regulatory compliance, ensuring the highest standards within the medical device industry. The QualCert ISO 13485:2016 – Quality Management Systems for Medical Devices Lead Auditor Course is a comprehensive training program designed to develop expertise in auditing and assessing medical device quality management systems (QMS) in accordance with ISO 13485:2016. This course equips professionals with the necessary knowledge and skills to conduct first-party (internal), second-party (supplier), and third-party (certification) audits, ensuring compliance with international regulatory requirements.
The course provides a detailed understanding of the ISO 13485:2016 standard, covering its principles, structure, and specific requirements for medical device QMS. Participants will learn the auditing process, including audit planning, execution, reporting, and follow-up actions. Additionally, emphasis is placed on risk management, regulatory compliance, and corrective and preventive actions (CAPA) within the medical device industry.
Course Contents of QualCert ISO 13485:2016 – Quality Management Systems for Medical Devices Lead Auditor Course:
The QualCert ISO 13485:2016 – Quality Management Systems for Medical Devices Lead Auditor Course offers 30 Credits, requiring a Total Qualification Time (TQT) of 150 hours, including 75 Guided Learning Hours (GLH).
| Unit Ref# | Unit Title | Credit | GLH | TQT |
| QC17004-1 | Introduction to ISO 13485:2016 and Medical Device QMS | 5 | 15 | 25 |
| QC17004-2 | Regulatory Requirements for Medical Devices | 5 | 15 | 25 |
| QC17004-3 | Audit Planning, Preparation, and Risk Management | 5 | 15 | 25 |
| QC17004-4 | Conducting QMS Audits for Medical Devices | 5 | 10 | 25 |
| QC17004-5 | Non-Conformity Identification, Reporting, and CAPA | 5 | 10 | 25 |
| QC17004-6 | Certification Process and Auditor Responsibilities | 5 | 10 | 25 |
Entry Requirements for QualCert ISO 13485:2016 – Quality Management Systems for Medical Devices Lead Auditor Course:
To enroll in the QualCert ISO 13485:2016 – Quality Management Systems for Medical Devices Lead Auditor Course, participants must meet the following requirements:
- A high school diploma or equivalent (such as a GED) is required.
- Basic knowledge of quality management systems (QMS), preferably ISO 9001 or ISO 13485.
- Familiarity with medical device regulations and industry practices (e.g., FDA, EU MDR, or other international regulatory frameworks) is recommended.
- Experience in quality assurance, regulatory affairs, or medical device manufacturing is preferred but not mandatory.
- Proficiency in the language of instruction (typically English) to effectively understand course materials and participate in assessments.
This course is ideal for individuals looking to advance their expertise in medical device QMS auditing and gain internationally recognized lead auditor certification.
Learning Outcomes of QualCert ISO 13485:2016 – Quality Management Systems for Medical Devices Lead Auditor Course:
Introduction to Quality Management Systems (QMS)
- Understand the fundamental principles of quality management and their importance in the medical device industry.
- Explain the purpose and benefits of an effective ISO 13485:2016 QMS.
2. ISO 13485:2016 Standard and Requirements
- Identify key ISO 13485:2016 clauses and their application in medical device manufacturing.
- Demonstrate knowledge of regulatory requirements related to medical devices (e.g., FDA, EU MDR).
3. Audit Fundamentals and Principles
- Explain the principles of auditing, including integrity, fair presentation, confidentiality, and due professional care.
- Recognize the role of an ISO 13485 lead auditor in ensuring compliance and continual improvement.
4. Audit Planning and Preparation
- Develop an audit plan, including defining objectives, scope, and criteria for an ISO 13485 audit.
- Apply risk-based thinking to prioritize critical audit areas in medical device QMS.
5. Conducting an ISO 13485:2016 Audit
- Perform on-site and remote audits using standard auditing techniques.
- Assess compliance with ISO 13485:2016 requirements and identify areas for improvement.
6. Non-Conformity Identification and Reporting
- Detect and document non-conformities using standardized methods and reporting structures.
- Provide corrective and preventive action (CAPA) recommendations to enhance QMS compliance and effectiveness.
The QualCert ISO 13485:2016 – Quality Management Systems for Medical Devices Lead Auditor Course is designed for professionals involved in medical device quality management, auditing, and regulatory compliance. This course is ideal for:
- Quality Assurance (QA) and Quality Control (QC) Professionals – Individuals responsible for maintaining and improving quality management systems in medical device manufacturing.
- Internal and Lead Auditors – Professionals conducting first-party (internal), second-party (supplier), or third-party (certification) audits within the medical device industry.
- Regulatory Affairs Specialists – Those working with global medical device regulations, ensuring compliance with FDA, EU MDR, and other international standards.
- Medical Device Manufacturers and Suppliers – Organizations seeking to achieve or maintain ISO 13485:2016 certification to ensure product quality and patient safety.
- Consultants and Compliance Officers – Experts advising medical device companies on ISO 13485 implementation, auditing, and regulatory requirements.
- Engineers and Production Managers – Individuals responsible for ensuring manufacturing processes comply with ISO 13485:2016 quality and safety requirements.
This course is suitable for professionals seeking to develop in-depth auditing skills, enhance regulatory compliance, and improve overall quality management in the medical device industry.