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ISO 13485

ISO 13485 Lead Auditor

Lead Auditor

Master the audit of a Medical Devices Quality Management System (MDQMS) based on ISO 13485.

Category Quality and Management
Level Lead Auditor
Language EN
Duration 5 days

The programme

ISO 13485 Lead Auditor training enables you to develop the necessary expertise to perform a Medical Devices Quality Management System (MDQMS) audit by applying widely recognized audit principles, procedures and techniques, and to plan and carry out internal and external audits in compliance with ISO 19011 and the ISO/IEC 17021-1 certification process. After passing the exam, you can apply for the “PECB Certified ISO 13485 Lead Auditor” credential.

Who should attend?

  • Auditors seeking to perform and lead MDQMS certification audits
  • Managers or consultants seeking to master the MDQMS audit process
  • Individuals responsible for maintaining conformity with MDQMS requirements
  • Technical experts seeking to prepare for an MDQMS audit

Course agenda

  • Day 1 — Introduction to the Medical Devices Quality Management System (MDQMS) and ISO 13485
  • Day 2 — Audit principles and the preparation for and initiation of an audit
  • Day 3 — On-site audit activities
  • Day 4 — Closing of the audit
  • Day 5 — Certification exam

Learning objectives

  • Understand the operations of an MDQMS based on ISO 13485
  • Understand an auditor’s role to plan, lead and follow up on a management system audit in accordance with ISO 19011
  • Interpret the requirements of ISO 13485 in the context of an MDQMS audit
  • Plan an audit, lead an audit team, draft reports, and follow up on an audit

Examination

Exam duration: 3 hours.

General information

  • More than 450 pages of training materials, including practical examples, exercises and quizzes.
  • An attestation of course completion worth 31 CPD (Continuing Professional Development) credits.

Language: available in English. For another language, send us a request and we will check availability.

Where each format is available

  • Self-paced study — available worldwide.
  • Classroom and live online sessions — Africa and the Middle East.

Tell us where you are and which format suits you; we confirm what is available.

The certification

The examination is set and marked by PECB, which issues the certificate on success. DataConfo Academy delivers the training and registers you.

Examination format, eligibility conditions and retake terms are confirmed with you before registration.

Level Lead Auditor
Duration 5 days
Language EN
Awarding body PECB

PECB is a proprietary mark of PECB Group Inc. and is used under licence.

Certification pathway

Where this programme sits in the Quality and Management progression.

FoundationISO 13485 Foundation$390FoundationISO 21001 Foundation$390FoundationISO 21502 Foundation$390FoundationISO 9001 Foundation Original price was: $390.Current price is: $330.FoundationISO/IEC 17025 Foundation$390AuditorCertified IPC Management Systems Auditor (CMSA)$790AuditorManagement Systems Internal Auditor$790SpecialistSix Sigma Green Belt$790Lead AuditorISO 13485 Lead Auditor$790Lead ImplementerISO 13485 Lead Implementer$790Lead AuditorISO 21001 Lead Auditor$790Lead ImplementerISO 21001 Lead Implementer$790Lead ManagerISO 21502 Lead Project Manager$790Lead AuditorISO 9001 Lead Auditor Original price was: $790.Current price is: $650.Lead ImplementerISO 9001 Lead Implementer Original price was: $790.Current price is: $650.Lead AuditorISO/IEC 17025 Lead Assessor$790Lead ImplementerISO/IEC 17025 Lead Implementer$790

Frequently asked questions

How do I register?
Add the course to your cart and complete the checkout. You can also write to us first using Request Information.
In which language will the session be delivered?
Choose your language on this page before adding the certification to your cart. Only the languages listed for this programme are available.
What happens after I pay?
You receive an order confirmation by email. We then contact you to agree the dates, open your access and register you with PECB. A person handles every registration.
Can you deliver this in-company?
Yes. Use Request Information and tell us the number of participants and your preferred dates.
Is the examination included?
Yes. The PECB examination and the certificate are included in the price shown.

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