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Medical Devices Lead Auditor EN · KO Coaching FR

ISO 13485 Lead Auditor

Master the audit of a quality management system for medical devices based on ISO 13485, using widely recognised audit principles, procedures and techniques.

5 daysof training
Leadadvanced level
EN · KOlanguages
OfficialPECB exam incl.

Who is this course for?

  • Auditors who audit medical devices QMS
  • Quality and regulatory consultants and managers
  • Professionals responsible for conformity of a medical devices QMS
  • Professionals seeking an audit specialisation

What you'll gain

  • The PECB Certified ISO 13485 Lead Auditor credential, recognised internationally
  • The ability to lead audits of an ISO 13485 QMS
  • Command of the audit process based on ISO 19011
  • A specialised medical devices quality audit profile

Course programme

Day 1 · Introduction to ISO 13485 and audit principles
  • Management system concepts
  • Audit principles and fundamental concepts
  • The certification process
Day 2 · Audit preparation
  • Initiating the audit
  • Preparing the audit activities
  • Documentation and audit plan
Day 3 · Conducting the audit
  • On-site audit activities
  • Communication and evidence collection
  • Audit findings and non-conformities
Day 4 · Closing the audit and managing an audit programme
  • Audit conclusions and reporting
  • Follow-up and audit programme management
  • Auditor competence and evaluation
Day 5 · Certification exam
  • Review and mock exam
  • Official "PECB Certified ISO 13485 Lead Auditor" exam (3 hours)

Exam, credits & certification

3 h
Duration of the official PECB exam
31 CPD
Continuing Professional Development credits granted by the course
Included
Exam, marking and first issue of the certification, included in the price

Once you pass the exam, you can apply for the "PECB Certified ISO 13485 Lead Auditor" credential. The exam includes 2 attempts: the first plus a free retake, usable within the following 12 months. Passing first time is no longer a source of pressure. CPD credits correspond to the course level according to PECB. The exam duration is indicative; ask me for the exact details when you enrol.

Your trainer

Ricardo Coronel Lemus, PECB trainer

Ricardo Coronel Lemus

Practising GRC / vCISO consultant · PECB Certified Trainer (CT6496)

More than 20 years in cybersecurity and compliance, today a vCISO and GRC consultant with real clients in France, Spain and Mexico. I don't approach these standards theoretically: I apply them day to day with real clients: that's what I bring to the coaching and exam preparation I offer.

ISO 27001 Lead Auditor / Lead Implementer CISSPCISMCRISCCCISODORA Lead ManagerPCI DSS - PCIP

Frequently asked questions

Do I need any prerequisites?
There are no formal prerequisites. A basic familiarity with ISO 27001 (for example the Foundation level) is recommended, but not required.
What language is the exam in?
The official PECB material and exam for this course are available in the languages shown on this page. Coaching is delivered in English to prepare you thoroughly. If you need a specific language, contact us and we will confirm it.
What is the difference between Self-Study and Self-Study + Coaching?
Self-Study gives you the official material, the exam and the certification to progress at your own pace. The coaching option adds one-to-one sessions with me, real-world case studies and guided exam preparation: I support you until you feel ready to get certified.
What if I don't pass the exam?
The PECB exam includes 2 attempts: the first plus a free retake usable within the following 12 months. So a failure doesn't leave you stranded. What's more, with the coaching option we prepare for the exam together with mock exams so that you arrive with confidence.
How does ISO 13485 relate to medical device regulations?
ISO 13485 is the internationally recognised quality management system standard for medical devices. A compliant QMS supports conformity with regulations such as the EU MDR/IVDR and expectations of authorities worldwide.

Ready to advance your medical devices quality career?

Choose your option above and enrol online. A question or need some advice? Write to me or book a call.

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