ISO 13485:2016 Quality Management System for Medical Devices

Auditing & System Certification | Training & Personal Certification


Considered as one of the most highly regulated sector in the world, the medical devices industry must demonstrate compliance with regulatory and product requirements to ensure safety and performance of medical devices produced. ISO 13485 is the international standard that sets out the requirements for Quality Management System standard specifically for the medical devices industry.

To support you in strengthening your quality management systems and processes for medical devices, TÜV SÜD offers a wide range of ISO 13485 certifications, instructor-led and live virtual training courses.



ISO 13485:2016 Management System Certification

ISO 13485, Medical devices – Quality management systems – Requirements for regulatory purposes, addresses the development, implementation, and maintenance of a quality management system intended for use by medical device manufacturers, suppliers, distributors, and other services that correspond to medical services. ISO 13485 is originally derived from ISO 9001 and has the same basic principles. But It requires greater documentation and attaches additional emphasis on such areas as like work environment (ex. ISO 14644 – cleanroom), risk management (ISO 14971), design control, and regulatory requirements (ex. CPAKB in Indonesia).

TÜV SÜD, as a certification body that has received accreditation by applying ISO 17021 to be carried out compliance audits according to ISO 13485 standards. The accreditation bodies are DAkkS (Germany) and KAN (Indonesia). In addition, we are a leading global management certification body for quality management systems. It includes management systems applicable in the medical devices industries. Each audit team consists of experts with the skills and expertise needed to accurately assess the compliance of your management system. We will conduct in the local language, which will ease you to understand any requirement and change notices.

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ISO 13485 Awareness Live Virtual Training

ISO 13485:2016 addresses the quality management system for medical device manufacturers, suppliers, distributors or other services correspond to the medical devices industry. Awareness training is the first step of the ISO 13485 certification audit. It helps participants to understand ISO 13485 requirements, understand ISO 13485 interpretation and documentation principle. Our delivery method in the local language, interactive discussion, and understanding the relation with other related standards will be the most added value you need.

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ISO 13485 Internal Auditor Live Virtual Training

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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ISO 13485 QMS for Medical Devices

Efficient medical device quality management and testing

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