ISO 13485:2016 Internal Auditor Course

This course aims to provide learning opportunities to acquire the knowledge of the requirements behind the ISO 13485:2016 standard to facilitate establishing a Quality Management System for medical devices to meet this standard, customer, and applicable regulatory requirements.

Objective:

• Understand ISO 13485:2016 QMS regulatory requirements
• Understand how to plan and conduct an internal audit based on the ISO 13485:2016 requirements

Who should attend:

• Implementers of ISO 13485:2016
• Management Representatives
• Quality Managers

Course Structure:

✓ Introduction to ISO 13485:2016
✓ Understanding the new high-level structure (HLS) system requirements of ISO 13485:2016
✓ Understanding the concept and scope of the general Quality Management System and its relation to the standard
✓ Understand the concept and process of internal audit, management review, and improvement

Course Details:

• Time: 9:30 am - 5:30 pm
• Venue: CIS Training Room
• Fee*: S$1,100 (excl 8% GST)
  • Day 1: $700 (excl 8% GST)
  • Day 2: $400 (excl 8% GST)

(Note: A discount of 10% awaits if you signed up for more than 3 participants)
*Inclusive of Summarized Notes & Certificate of Attendance

For more information:

• Contact Person: Reena Rai/ Qeisha Isabella
• Contact Email: training@cert-ints.com.sg/ qeisha.isabella@cert-ints.com.sg
• Address: 60 Albert Street #13-05 OG Albert Complex, Singapore 189969
• Phone: 6499 4710 / 6499 4712