ISO 13485:2016 Training Courses

WHAT YOU’LL GAIN FROM THE ISO 13485 TRAINING COURSES?

By pursuing ISO 13485:2016 Awareness, Internal Auditor, or Lead Auditor training, professionals can prove their value for organisations committed to Medical Devices QMS and compliance. By completing the ISO 13485:2016 Awareness and Auditor courses, you will get the following:

• Global recognition with a TÜV SÜD certification and a CQI IRCA certification for the Lead Auditor course
• Comprehensive professional training for medical devices QMS auditing
• Competitive career advantage
• Auditing experience and expertise for a career as a consultant, lead auditor, or an internal auditor
• Interactive and flexible learning through different modes
• A chance to broaden your network and interact with other professionals

ABOUT THE ISO 13485 TRAINING COURSES

ISO 13485:2016, the globally recognised Quality Management System (QMS) standard for the medical device industry, has evolved to ensure continuous improvement. The revised ISO 13485:2016 standard, published in February 2016, brings essential changes that impact registrants within the scheme.

The comprehensive training courses offered by TÜV SÜD in Singapore provide awareness of these pivotal changes, equipping participants with the understanding of how these updates affect organisations, ensuring that the participants are well informed. The courses also prepare individuals for auditing against the updated standard. By combining these aspects, the courses support organisations in their journey towards enhancing their quality management systems, building customer loyalty and satisfaction, and enduring partnerships in the medical device industry.

TRAINING COURSES

ISO 13485:2016 AWARENESS TRAINING COURSE

This ISO 13485 awareness training will highlight the significant changes that affect registrants within the scheme, to help organisations understand some of the changes and how the changes may impact them.

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ISO 13485:2016 INTERNAL AUDITOR TRAINING COURSE

This two-day ISO 13485 internal auditor training will allow learners to understand the significant changes that affect registrants within the scheme, how the changes may impact them, and how to audit against the revised ISO 13485:2016 standard.

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LEAD AUDITOR TRAINING PROGRAM ON MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEM - REQUIREMENTS FOR REGULATORY PURPOSES BASED ON ISO 13485:2016

This training program aims to provide learners with the knowledge and skills required to perform first, second, and third-party audits of Medical Device Quality Management Systems (MD-QMS) against ISO 13485 and applicable international regulatory standards in accordance with ISO 19011, ISO/IEC 17021.

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TRAINING DURATION

• ISO 13485 Awareness Training: 1 day instructor-led training
• ISO 13485 Internal Auditor Training: 2 day instructor-led training
• ISO 13485 Lead Auditor Training Program: 5 day instructor-led training