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ISO 13485Certified by the International Register of Certificated Auditors (IRCA)

ISO 13485 Lead Auditor

Globally Certified CQI / IRCA Registered Professional Qualification Framework Program

4 Days Professional Training Program
Immediate IRCA Examination Eligibility
Course Overview

Next Batch

We don't have a public batch open for this course right now. We run it on demand and as private group training at your premises or online.

Executive Focus & Programmatic Intent

The ISO 13485 Lead Auditor course prepares you to audit medical-device quality systems and meet regulatory expectations.

Target Operational Competencies

Medical-device quality managers.
Regulatory affairs staff.
Device auditors.

Course Syllabus

Module 1: Device QMS
•Understand ISO 13485 scope.
•Review regulatory links.

Mandatory Entry Gate Criteria

Accreditation matrices demand verified alignment with foundational high-level standards prior to parsing final examinations.

[!]ISO 9001 awareness helpful.

CQI / IRCA Certificate Issuance

Upon verified tracking configuration completion and passing the centralized module evaluation, candidate profiles register directly inside the CQI global directory database, confirming immutable auditing rights worldwide.

Authorized Issuing Agent:RSI Quality Assurance Group
Schedule

Available Batches

No public batches are scheduled yet. Request the next batch or a private group and we will propose dates.

No public batches scheduled yet — this course runs on demand and as private group training.
STATUS:Next batch on request