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ISO 13485:2016 Standard - Transition, Certification & Auditor Training


ISO 13485:2016 Standard - Transition, Certification & Auditor Training

About ISO 13485:2016 Standard - Transition, Certification & Auditor Training

The ISO 13485 standard, currently ISO 13485:2016 Medical Devices – Quality Management Systems – Requirements for Regulatory Purposes, sets the basis for a quality management system for organizations involved in the life-cycle of a medical device. Certification demonstrates your commitment to meeting your customers’ requirements and supports regulatory compliance in many jurisdictions.

Our wide range of regulatory approvals, our United Kingdom Accreditation Service (UKAS) accreditation and close links with medical authorities enable us to meet your certification requirements effectively. For many markets, ISO 13485 certification is not sufficient on its own and the appropriate local regulatory certification is also required to legally manufacture and sell medical devices. With a strong reputation for certification, we have the expert knowledge and global networks of auditors to help you achieve your objectives.

Why Choose ISO 13485 Certification from SGS?

We offer a global service for UKAS accredited ISO 13485 certification. Our worldwide presence means your audit will normally be carried out by local-language auditors.

We can help you:

  • Gain UKAS accredited ISO 13485 certification 
  • Demonstrate your commitment to meeting your customer requirements 
  • Comply with regulations and gain the additional local regulatory certification you need to manufacture and sell medical devices

ISO 13485:2016 is applicable to all manufacturers and providers of medical devices, component manufacturers, contract service providers and distributors of medical devices.

We can also help you build strong foundations for your medical devices certification strategy with our UKAS accredited ISO 13485:2016 audit, supporting regulatory approvals globally.

How Can SGS Help?

We provide a wide range of solutions to help you to stay on top of the latest developments and ensure a smooth and transparent transition from your current ISO 13485:2003 certification. We also offer awareness, lead auditor and internal auditor training courses to help you to understand the requirements of ISO 13485:2016 and risk-based thinking.

To discuss your ISO 13485 certification requirements, contact us today.

Strengths & benefits

Global Coverage 
We are SGS – the world’s leading testing, inspection and certification company. We are recognized as the global benchmark for quality and integrity. Our 96,000 employees operate a network of 2,600 offices and laboratories, working together to enable a better, safer and more interconnected world.

Local Expertise 
Our auditors are experienced and regularly trained to ensure up to date technical knowledge on standards and international regulations.

Order flow

1. Request A Quote

Complete the form to get an initial quote online

2. Confirm Quote

Confirm requirement, scope and schedule to finalize the quote

3. Arrange Payment

Arrange bank transfer payment and send record to us

4. Onsite Service

Conduct service based on committed schedule

5. Receive Report

Receive our audit report and certificate

Need a quote?

During this training, we will provide you with an introduction to the updated standard, including an overview of the purpose and requirements of ISO 13485:2016. Our trainers will help you to understand the intent behind the new, revised management system standards and to learn how to successfully apply the principles of quality management to your organization.

This training course is taught by qualified experts and is aimed at anyone who is involved with medical devices and who has responsibility for developing or working with a quality management system (QMS).

The course is comprised of presentations and workshop exercises.

Contact SGS now for further information on our ISO 13485:2016 training courses.

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