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Audit, Governance & Compliance

ISO 13485 Medical Devices Lead Auditor

CQI and IRCA certified lead auditor training for medical device quality management systems.

Advanced5 daysEnglish or ArabicISO Systems

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Course overview

This 5-day CQI and IRCA certified ISO 13485:2016 Lead Auditor course (KELMAC Group® course ID 17584) gives medical device quality management system auditors the confidence, audit tools and techniques to audit an MD QMS effectively.

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Audits are planned and conducted in accordance with the ISO 19011:2018 audit protocol, using medical device case studies covering design control, risk management, sterilisation and regulatory requirements.

Key takeaways

  1. 01Interpret ISO 13485:2016 requirements for medical devices
  2. 02Audit risk management, design and development controls
  3. 03Assess regulatory requirements, traceability and post-market surveillance
  4. 04Plan and lead audits in line with ISO 19011:2018
  5. 05Report findings and follow up corrective and preventive action

Course outline

  1. Day 1
    Medical device QMS
    • Purpose and structure of ISO 13485:2016
    • Regulatory context for medical devices
    • Risk-based approach
  2. Day 2
    ISO 13485 requirements
    • Management responsibility and resources
    • Design and development controls
    • Purchasing, production and traceability
  3. Day 3
    Audit principles and planning
    • ISO 19011 audit principles
    • Audit programme and plan
    • Checklists and audit preparation
  4. Day 4
    Conducting the audit
    • Opening meeting and interviews
    • Sampling and objective evidence
    • Writing nonconformities
  5. Day 5
    Reporting and examination
    • Closing meeting and audit report
    • CAPA follow-up and surveillance
    • CQI and IRCA examination

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Frequently asked questions

Do I need medical device experience?

Knowledge of quality management systems is expected. Medical device experience helps but is not essential.

Is the course IRCA certified?

Yes. It is a CQI and IRCA certified course delivered with KELMAC Group®.

How do I choose the right course?

Compare your professional goals, experience and preferred format, or ask an adviser to help.

Are courses available online?

Yes. Live virtual and in-house options are available depending on the programme.

Will I receive a certificate?

Certificate requirements depend on the programme and awarding organisation.

Reviews

“Thank you for the excellent service again as always. BEMCON provide a friendly and professional service every time we carried out training for our food outlets. BEMCON trainers are friendly, very professional mentors and deliver quality training. The whole process is a breeze and everyone is helpful, courteous and knowledgeable. I would definitely recommend BEMCON to anyone.”
King Abdullah University of Science and Technology (KAUST), Thuwal, Saudi Arabia

Where this course runs

RiyadhJeddahLive Online

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