Program Overview
This intensive ISO 13485:2016 Lead Auditor training develops the competence required to plan, conduct, lead, and report first-, second-, and third-party audits in accordance with ISO 13485 requirements and ISO 19011 auditing guidelines. The course focuses on regulatory expectations within the medical devices sector, enabling participants to understand quality system requirements specific to medical device design, production, installation, and servicing. Participants gain both technical knowledge and practical auditing skills necessary for certification audits in the medical device industry.
Key Learning Outcomes
- • Interpretation and application of ISO 13485:2016 clauses
- • Understanding regulatory requirements for medical devices QMS
- • Risk management concepts aligned with ISO 14971 principles
- • Process approach in medical device quality management
- • Audit principles in accordance with ISO 19011
- • Audit program management
Target Participants
- • Quality Managers in medical device organizations
- • Regulatory Affairs Professionals
- • QMS and Compliance Officers
- • Internal and Supplier Auditors
- • Consultants and Trainers in medical devices
- • Professionals seeking Lead Auditor certification
- • Individuals pursuing careers in medical device quality and auditing
Duration & Format
5 Days (40 hours) - Specialized training for medical device sector
Certification
Upon successful completion, participants receive: ISO 13485:2016 Lead Auditor Certificate
Prerequisites
Background in quality management or medical device industry experience strongly recommended.
Fee
PKR 70,000
