Course Details
- Live - online Training
- Learning platform: Zoom
- Duration: 8 Hours
- Exemplar Global International Recognised
- Standards covered: ISO 13485 Internal Auditor Training Course
- Price on enquiry
Course Details
| Course Title | ISO 13485 Internal Auditor Training Course |
|---|---|
| Duration | 02 Days (16 Hours) |
| Delivery Mode | Live-Online: Tutor led |
| Language | English |
| Prerequisites | Graduation; ISO 9001 Auditor Training Preferred (not compulsory) |
| Certification | ISO 13485 Internal Auditor |
| Accreditation | Recognized by Exemplar Global, USA |
| Training Methods | Online through Zoom, led by subject experts in QMS implementation. |
| Assessment | MCQ based questionnaire |
| Fee | Contact +91 90567-42784 or write to info@sftrainings.org for Price and Discount |
Course Details
- Live - online Training
- Learning platform: Zoom
- Duration: 16 Hours
- Exemplar Global International Recognised
- Standards covered: ISO 13485, ISO 19011:2018
- Price on enquiry
Major Learning Objectives of this Course
This 16-hour training will equip you with the basics of ISO 13485:2016 focusing on:
- Master ISO 13485 and gain Audit confidence: Achieve in-depth knowledge of ISO 13485's structure, requirements, and implementation within your organization. Gain the confidence to navigate internal and external audits for a seamless certification journey.
- Document Management & Regulatory Compliance: Learn to manage medical device files and ensure your QMS aligns with legal requirements
- Risk Management & Quality Improvement: Sharpen your skills in analyzing risks, identifying inconsistencies in quality plans, and recommending improvements.
- Product Lifecycle Expertise: Ensure quality through customer communication, design validation and supply chain control for medical devices
- Traceability & Compliance Essentials: Understand UDI, software control, complaint handling and non-conforming product management
Who should attend this Course ?
This training is ideal for anyone who wants a basic understanding of ISO ISO 13485:2016 particularly:
- Internal Auditors, Product Managers, Compliance Officers, Quality Professionals, Healthcare Professionals, Manufacturing Managers
- Medical Device Consultants
- Regulatory affairs professionals
- Medical device manufacturers and distributors
- Design and development engineers and technicians
- Individuals interested in pursuing a career in medical device quality auditing.
- Medical device personnel, suppliers, managers, or anyone interested in conducting first-party, second-party, or third-party audits.
Credentials Earned (Certification)
Upon successful completion, participants will awarded:
- A Soft Training Completion Certificate from Sustainable Futures Trainings.
- An Exemplar Global Graduate Certificate, acknowledging proficiency in ISO 13485 essentials.
USER TESTIMONIALS
What our students say about us
Sriraag Avasarala
The training was well conducted. I would definitely recommend this to my peers.
Rohit Agarwal
A very insightful training to hone your social auditing skills.
Vishal Sharma
It was a great learning exeprience as all the real life examples taken.A friendly informative experience given by SF
Mayank
SF trainings help our employees to increase their knowldge of testing and calibration by giving custoized training in our organization.
Shivani Sharma
I did ISO 9001 Lead Auditor course from SF. It not only increased my knowledge of ISO 9001 but also given me add on advantage of using DMS. Thanks to SF
Nikhil Arora
ISO 9001 Lead Auditor Course
Jaiprakash Singh
I did ISO 9001 Lead Auditor course from SF. It not only increased my knowledge of ISO 9001 but also...
