Value Process
This course is accredited by Exemplar Global, ensuring international recognition and alignment with globally accepted competency frameworks.
Course Overview
The Lead Auditor Training for Medical Device Quality Management Systems (MD-QMS), accredited by Exemplar Global, is an intensive program designed to equip professionals with the essential knowledge and skills required to effectively audit medical device organizations.
The course begins with a comprehensive introduction to the ISO 13485:2016 standard, which outlines the requirements for a quality management system (QMS) specifically tailored to the medical device industry. Participants will develop a clear understanding of the key clauses of the standard and learn how to apply them within their organization’s QMS.
A major focus is placed on risk management, a critical element in the medical device sector. Participants will be trained to identify, assess, and evaluate risks related to patient safety, regulatory compliance, and reputational impact.
The training also covers the design and development of a compliant QMS, teaching participants how to structure efficient systems, including the creation of relevant processes, policies, and work instructions that align with ISO 13485:2016.
Participants will gain hands-on experience in conducting internal audits, including planning, execution, reporting findings, and recommending improvements.
Supplier management is another important component, emphasizing how to ensure the reliability of the supply chain and assess supplier performance based on organizational requirements.
Course Objectives
By the end of the course, participants will be able to:
- Understand the core principles and requirements of ISO 13485:2016, along with relevant medical device regulations.
- Acquire practical auditing techniques applicable to real-world scenarios.
- Plan, perform, report, and follow up on audits in line with ISO 13485:2016 standards.
- Analyze QMS documentation and assess audit evidence effectively.
- Communicate efficiently with auditees and key stakeholders during the audit process.
- Prepare for the Exemplar Global Lead Auditor certification examination.
How This Course Benefits Your Career
Looking to master the quality management requirements in the medical device industry? Our ISO 13485:2016 MD-QMS Lead Auditor training provides you with:
- Up-to-date insights on medical device QMS standards and regulatory expectations
- Practical knowledge to design, implement, and sustain a compliant ISO 13485 system
- Skills to conduct effective audits and address non-conformities
- Qualification to become a certified Exemplar Global Lead Auditor
- Access to valuable materials such as templates, case studies, sample documentation, and audit checklists
Course Content Includes
- Detailed review of ISO 13485:2016 requirements
- Auditing principles based on ISO 19011 and the PDCA approach
- QMS documentation review and compliance assessments
- Roles and responsibilities of auditors
- Audit planning tools: Checklists, NCRs, and audit schedules
- Case studies, group activities, exercises, and verification techniques
- Auditor registration, certification, and accreditation process
Course Duration & Format
- Total Duration: 40 hours + 2 hours 15 minutes examination (for non-native English speakers)
- Course Schedule: 5-day program (9:30 AM to 6:30 PM IST), includes presentations, group activities, brainstorming sessions, practical exercises, and daily knowledge sharing
- Break: 45-minute lunch break each day
- Delivery Modes: Offered both online and in-person to suit participant preferences
Recommended Pre-Course Knowledge
While not mandatory, participants are encouraged to have:
- A basic understanding of management system concepts and the PDCA cycle
- Familiarity with ISO standards and terminology
- Awareness of process-based auditing approaches
- Prior experience with internal or external audits (preferred)
- A bachelor’s degree and 1–2 years of relevant work experience (recommended)
- Completion of a Foundation Course or equivalent self-study
Get in Touch with BSCIC to Learn More & Enrol
Equip yourself with the expertise to audit and improve medical device quality systems.
📞 Call: +971545308270
📧 Email: training.uae@bsc-icc.co
🌐 Website: https://www.uae.bsc-icc.com/
📍 LinkedIn: https://www.linkedin.com/company/bscic-management-systems-certification/
Enrol in BSCIC’s ISO 13485:2016 Lead Auditor Course – Become a Certified Medical Device QMS Expert Today!
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