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SGS will be holding a half-day seminar to explain on the structure, terminology and key changes to ISO 13485:2016.


Oct 24, 2016, 09:00


Oct 24, 2016, 13:00


Kuala Lumpur, Malaysia

Transition to ISO 13485:2016 Medical Devices - Quality Management Systems Seminar

ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and regulatory requirements. The standard can be used by organizations that are involved in one or more stages of the life-cycle of a medical device, including design and development, production, storage and distribution, installation, servicing and final decommissioning and disposal of medical devices, and design and development, or provision of associated activities (eg. technical support).

The new version of ISO 13485, published on 1 March 2016, has evolved. To streamline and improve the quality management of medical device design and manufacture, the standard now encompasses all stakeholder roles within the medical device life cycle. Furthermore, it also requires organisations to adopt a risk-based approach to their quality management systems. In a market subject to increasing levels of regulation, ISO 13485:2016 also places increased emphasis on meeting regulatory requirements.

The seminar will look at structure, terminology and key changes to ISO 13485.

Duration:   ½ day
Time: 9 am to 1 pm
Fee: RM 250 (price is not inclusive 6% GST)


At the end of the seminar, participants will:

  • Gain an understanding of the NEW requirements / changes from the ISO 13485:2003 / EN ISO 13485:2012 version to ISO 13485:2016
  • Recognise the structure and terminology used in the new ISO 13485
  • Identify actions needed to prepare for the transition plan with timescales.

Who Should Attend

  • Managing Directors, Chief Executive Officers, General Managers
  • Management Representatives
  • Factory Managers, Departmental Managers (Sales, Administration R&D, etc.)
  • Lead Auditors, Internal Auditors
  • Practitioners, Control Personnel


For more information on the seminar, please contact SGS Academy at +603 2095 9200 (Mr. Hasbi) or email