BS EN ISO 13485:2016

What is this standard about?

This is the internationally recognised quality management system (QMS) standard for the medical device industry. It has more than 27,000 accreditations worldwide. It specifies requirements for a QMS for organizations involved in one or more stages of the lifecycle of a medical device. It provides the basis for ensuring consistent design, development, production, installation and delivery of products that are safe for their intended purpose. 

Who is this standard for?

It can be used by any organization involved in one or more stages of the lifecycle of a medical device, including:

• Design and development
• Production
• Storage and distribution
• Installation or servicing
• Final decommissioning
• Design, development or provision of associated activities (such as technical support)

In addition, the standard can be used by other internal and external parties, such as certification bodies, to help them with their certification processes, or by supply chain organizations that are required by contract to conform.

Why should you use this standard?

ISO 13485:2016 can be used to test an organization's ability to meet both customer and regulatory requirements. Certification is not a requirement and organizations can reap the benefits of the standard without being certified.

Its use shows a commitment to quality, however, and users will be able to:

• Demonstrate compliance with regulatory and legal requirements
• Ensure the establishment of quality management system practices that consistently yield safe and effective medical devices
• Manage risk effectively
• Improve processes and efficiencies
• Gain a competitive advantage

What's changed since the last update?

This revision ensures that the standard provides a quality management system that's kept up with the evolving directives and other international regulatory changes that have occurred since 2003. Some of the key changes include:

• Harmonization of regulatory requirements
• Inclusion of risk management throughout the quality management system
• Additional clarity with regard to validation, verification and design activities
• Strengthening of supplier control processes
• Increased focus regarding feedback mechanisms
• Harmonization of the requirements for software validation for different software applications