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CQI & IRCA Certified ISO 13485:2016 Medical Device Quality Management System Lead Auditor Training

  • Mode Icon
    Mode
    Virtual Class
  • Duration Icon
    Duration
    40 hrs [5 days]
  • Fees Icon
    Fees
    S$1500
ISO 13485:2016 Medical Device Quality Management System Lead Auditor Training

ISO 13485 lead auditor training:

ISO 13485:2016 is a quality system management standard. It’s similar to ISO 9001 but has a few more stipulations to help companies meet the more specialized demands that come with making medical components and healthcare related products.

UTAP grant supported, able to claim up to 50% of course fee.

ISO 13485 lead auditor training

  • Explain the purpose of a medical device quality management system (MD-QMS), interaction with appropriate medical device regulatory authority requirements, quality management systems standards, third-party certification, and the business benefits of the quality management system.
  • Explain the role and responsibilities of an auditor to plan, conduct, report, and follow- up a quality management system audit in accordance with ISO 19011 and ISO/IEC 17021.
  • Plan, conduct, report, and follow-up an audit of a medical device quality management system to establish conformity (or otherwise) with ISO 13485 and applicable medical device regulatory requirement documents in accordance with ISO 19011, ISO/IEC 17021.

This course is specially designed for:

  • A Third-Party Assessor or Lead Assessor of ISO 13485:2016
  • Responsible for undertaking audits of suppliers/subcontractors as per ISO 13485:2016
  • Responsible for implementing internal audits and audit programs as per ISO 13485:2016
  • Responsible for implementing the ISO 13485 series of standards

ISO 13485 lead auditor training:

ISO 13485:2016 is a quality system management standard. It’s similar to ISO 9001 but has a few more stipulations to help companies meet the more specialized demands that come with making medical components and healthcare related products.

UTAP grant supported, able to claim up to 50% of course fee.

Next Schedule:
Month Date Duration
August 2026 8, 9, 15, 16 and 22 August 40 hrs [5 days]
September 2026 12, 13, 19, 20 and 26 September
October 2026 15, 16, 17, 18 and 19 October
November 2026 16, 17, 18, 19 and 20 November

ISO 13485 lead auditor training

  • Explain the purpose of a medical device quality management system (MD-QMS), interaction with appropriate medical device regulatory authority requirements, quality management systems standards, third-party certification, and the business benefits of the quality management system.
  • Explain the role and responsibilities of an auditor to plan, conduct, report, and follow- up a quality management system audit in accordance with ISO 19011 and ISO/IEC 17021.
  • Plan, conduct, report, and follow-up an audit of a medical device quality management system to establish conformity (or otherwise) with ISO 13485 and applicable medical device regulatory requirement documents in accordance with ISO 19011, ISO/IEC 17021.

This course is specially designed for:

  • A Third-Party Assessor or Lead Assessor of ISO 13485:2016
  • Responsible for undertaking audits of suppliers/subcontractors as per ISO 13485:2016
  • Responsible for implementing internal audits and audit programs as per ISO 13485:2016
  • Responsible for implementing the ISO 13485 series of standards

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    Frequently Asked Questions

    Find Quick Answers To Help You Get Started With Confidence.

    The ISO 13485 Lead Auditor training program posts your certification to plan, lead, and report on Quality Management System (QMS) audits against the ISO 13485:2016 standard to demonstrate medical device manufacturing compliance.

    • Quality Managers and QMS consultants.
    • Employees hoping to become Lead Auditors for certification bodies.
    • Anyone responsible for regulatory compliance (e.g. EU MDR, FDA).
    • QMS Auditors moving to ISO 13485:2016 standard.

    There are no requirements to take the ISO 13485 training course. However, we highly recommend prior knowledge of the ISO 13485:2016 standard and basic QMS concepts/principles (e.g. PDCA), for your success in the course.

    The course fee for ISO Lead Auditor training is SGD 1500 and it typically covers intensive training for 5 days, training materials, and the final examination.

    Yes, there is often some financial support available. For eligible apprentices in Singapore, you are able to use the SkillsFuture Credit. NTUC members may also be eligible for UTAP funding. You may contact our team for eligibility.

    The training consists as follows:

    • Introduction to ISO 13485:2016 and its purpose
    • Clause-by-clause interpretation of the standard
    • Key documentation and implementation strategies
    • Risk management principles in medical device production
    • Audit preparation and continuous improvement

    The training is generally a 5-day course. See the Course Schedule page located at [https://qesacademy.com/iso-13485-lead-auditor-training/] for all upcoming dates, times, and locations (Virtual or In-Person).

    Yes, it will be equally effective. The accredited virtual course (VILT) adheres to the same rigorous standards, and employs the same interactive delivery (role-play, case studies) and will still result in the same internationally recognized certification as in-person training.

    Our training helps you:

    • Understand the structure and requirements of ISO 13485:2016
    • Align your processes with international regulatory expectations
    • Strengthen your internal quality systems for medical devices
    • Prepare for third-party audits and certification
    • Stay updated on the latest risk-based approaches and compliance changes

    Yes, the certification is recognized internationally. If the course is accredited to a large body (i.e. CQI & IRCA or Exemplar Global), the certificate will provide evidence of competence against the international standard for ISO 13485 and will be valid for work in the international medical device sector.