ISO 13485 Medical Devices - Maintain regulatory compliance by being ISO 13485 certified

The ISO 13485 standard is an effective solution to meet the comprehensive requirements for a quality management system (QMS). Adopting ISO 13485 provides a practical foundation for manufacturers to address the regulations and responsibilities as well as demonstrating a commitment to the safety and quality of medical devices.

The medical device manufacturing sector is one of the most regulated sectors in which significant quality systems and product requirements must be satisfied. The regulatory requirements are intended to ensure that manufacturers consistently design, produce, and place onto the market, medical devices that are safe and fit for their intended purpose.

With over 150 BSI QMS assessors globally supported by BSI product experts, our ISO 13485 certificates are known and trusted in the medical device industry by authorities, suppliers and manufacturers around the world.



What is ISO 13485 Medical Devices?

ISO 13485 is a stand-alone Quality Management Systems (QMS) standard, derived from the internationally recognized and accepted ISO 9000 quality management standard series.

ISO 13485 adapts the ISO 9000 process-based model for a regulated medical device manufacturing environment. While ISO 13485 is based on the ISO 9001 process model concepts of Plan, Do, Check, Act, it is designed for regulatory compliance. Thus it is more prescriptive in nature and requires a more thoroughly documented quality management system.

ISO 13485 was written to support medical device manufacturers in designing quality management systems that establish and maintain the effectiveness of their processes. It ensures the consistent design, development, production, installation, and delivery of medical devices that are safe for their intended purpose.


What are the benefits of ISO 13485 Medical Devices?

Whether you are looking to operate internationally or expand locally, ISO 13485 Certification can help you improve overall performance, eliminate uncertainty, and widen market opportunities. Companies with this certification communicate a commitment to quality to both customers and regulators.

  • Increase access to more markets worldwide with certification
  • Outline how to review and improve processes across your organisation
  • Increase efficiency, cut costs and monitor supply chain performance
  • Demonstrate that you produce safer and more effective medical devices
  • Meet regulatory requirements and customer expectations





Popular training courses for ISO 13485

Our ISO 13485 quality management training will help you to demonstrate your ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements.

Internal Auditor: ISO 13485:2016

$1995

2 days classroom based training course (exc GST)

    This intensive two day course is intended for medical device quality professionals aiming to build on their knowledge of ISO 13485:2016 and evaluate the effectiveness of the quality management system in their organization. 

    Learn the principles and practices of effective quality management systems process audits in accordance with the ISO 13485:2016 and ISO 19011:2011.

View details for Internal Auditor: ISO 13485:2016

Why choose us?

BSI (British Standards Institution) is the business standards company that equips businesses with the necessary solutions to turn standards of best practice into habits of excellence. Formed in 1901, BSI was the world’s first National Standards Body and a founding member of the International Organization for Standardization (ISO). Over a century later it continues to facilitate business improvement across the globe by helping its clients drive performance, manage risk and grow sustainably through the adoption of international management systems standards, many of which BSI originated. Renowned for its marks of excellence including the consumer recognized BSI Kitemark, BSI’s influence spans multiple sectors including aerospace, automotive, built environment, food, healthcare and ICT. With over 80,000 clients in 172 countries, BSI is an organization whose standards inspire excellence across the globe.

Our clients choose us:

  • For our unique client management structure
  • For our expertise
  • For our integrity
  • Because we are performance minded
  • For our expert assessors