ISO 13485-2016 Medical Devices & IA

ISO 13485-2016 Medical Devices & IA 2018-10-04T13:01:38+00:00

OBJECTIVES
ISO 13485:2016 specifies requirements for a quality management system where an organisation needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.
1. The functions & requirements of the ISO 13485:2016 Medical Devices Standard
2. The understanding & implementing of the ISO 13485 Medical Devices standard effectively as to work instructions / standard operation procedure manuals requirements
3. Using ISO 13485 Medical Devices standard to drive towards becoming a quality class organization

WHO SHOULD ATTEND
Managers, executives, supervisors and management staff who want to gain knowledge on ISO 13485:2016 Medical Devices and staff who are likely or currently involved in implementing and maintaining ISO 13485:2003 and key personnel assigned for internal audits, management representatives (MR), etc

COURSE OUTLINE
The course includes a high level of interactivity during training on:

• Interpret all clauses of ISO 13485:2003
• Understand differences between ISO 13485:2003 and ISO 13485:2016
• Understand the Quality Management Principles
• Apply principles of the ISO 19011 to the auditing process
• Plan, conduct and report effective internal audits to the ISO 13485:2016

Please fax or email your completed form to:
Fax: (65) 6467 4226
E-mail: enquiries@sqi.org.sg

BENEFIT TO YOUR BUSINESS
A trained-combined system Internal Auditor with the skill set to:
• Conduct an internal audit of the ISO 13485 management system
• Enable your business to remain compliant with the requirements of the ISO 134845
• Follow through complex audit trails and identify any possible management systems discrepancies
• Identify any gaps that threaten the effectiveness of your management systems

COURSE FEES
Member: $415, Non Member: $435 (GST is not Applicable)
Course fees include training material & certificate of completion and light refreshments
Registration Fee of $16 per participant will be added to all Executive Courses. (GST not applicable)

DURATION
2-Day (9.00am – 5.00pm)

TRAINING VENUE
SQI, No 1 Sophia Road #05-06/07, Peace Centre, Singapore 228149

FOR RESERVATION
Contact: Jonathan Koh
Email: jonathan@sqi.org.sg
DID: 6467 4225
Fax: 6467 4226