ISO 13485 2016

ISO 13485 2016

ISO 13485 2016 states the requirements for a Quality Management System (QMS), in which organizations will demonstrate their ability to provide devices needed in the medical industry and related services that needs to comply regulatory requirement and customer needs.

This standard can also be used by external parties and suppliers who supply such products and services to those organizations.

Contact us to attain ISO 13485:2016 standard certification to your Organization. Get in touch with us.

How would we help you attain this 13485:2016 QMS for Medical devices?


ISO 13485 Development

Understanding the company processes and developing procedures according to the ISO 13485 requirement.


Train key personnel for awareness training courses and internal audit training courses.


Assist the team in the implementation of the procedures

Internal Audit

Conduct an internal audit to ensure compliance of the requirement and recommend further improvement

Certification Audit

Arrange and assist during the certification audit to ensure a smooth audit process.

With the 5 steps approach, the organization can attain the certification in the fastest and most effective way.


  • Gain certification to enable your company to increase access to a wider market worldwide
  • Plan efficient methods to review and streamline processes in your organization
  • Enhance supply chain performance, minimise costs and increase business efficiency
  • Able to produce safe and effective medical equipment and devices
  • Meet regulatory requirements and customer expectations

QE Safety Consultancy providing the following training courses for ISO Standards:
– Lead Auditor Training Courses
– Internal Auditor Training Courses

Contact our consultants

to discuss more about your requirement and get competitive quote

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