Roles and Responsibilities

1. *Conduct ISO 9001 Quality Management System audits as per applicable standards and audit guidelines.
*Conduct ISO 13485 Medical Device Quality Management System audits for medical device manufacturers, importers and healthcare organizations.
*Perform Stage 1, Stage 2, Surveillance and Recertification audits (as applicable).
*Evaluate effectiveness of implemented processes beyond documentation review.---

2. Audit Planning & Execution
- Review client scope, processes, applicable regulations and previous audit records before audits. Prepare audit plans, checklists and audit schedules.
Conduct opening and closing meetings with client management.
Collect objective evidence through interviews, document review and process evaluation.
Identify non-conformities, observations and improvement opportunities.---

3.



Audit Reporting
- Prepare detailed audit reports within defined timelines. Document findings with explicit evidence and applicable clause references.
Review corrective action plans submitted by clients.
Verify effectiveness of corrective actions and closure of non-conformities.---

4. ISO 13485 Specific Responsibilities (Medical Devices)
- Audit medical device Quality Management Systems as per ISO 13485 requirements. Evaluate areas including: Design & Development Controls
Risk Management
Production & Process Controls
Validation Activities
Supplier Controls
Complaint Handling
CAPA System
Regulatory Compliance Controls

📌 ISO Auditor Lead (New Delhi)
🏢 Assuretica
📍 New Delhi