What Is ISO 13485?

Jessica Clifton

by Jessica Clifton

14th August 2019

In the medical devices industry, safety and quality are of the utmost importance. There are many strict regulations in place which cover the whole of a medical device product life cycle, right from concept through to delivery. Increasingly, businesses which are part of this life cycle must be able to clearly demonstrate their quality management processes and ensure best practice across the board. 

ISO 13485 accreditation ensures that businesses meet safety and quality standards for medical devices. 

Companies manufacturing medical devices and related products must meet stringent ISO 13485 standards

What is ISO 13485?

ISO 13485, officially called ISO 13485 Medical devices – Quality management systems – Requirements is an effectual solution for meeting the rigorous requirements of a quality management system specific to the medical devices industry. Businesses can use it as a practical foundation to meet Medical Device Directives, regulations, and responsibilities, while also showing that they are committed to the safety and quality of medical devices.

Under ISO 13485, businesses must be able to demonstrate their ability to provide medical devices and related services that constantly meet customer and relevant regulatory requirements. 

What is a Quality Management System?

A quality management system (QMS), is a documentation of policies, processes, procedures, and records. These documents define the internal rules that a business uses to create and deliver a product or service. For that reason, a QMS is bespoke to the needs of individual businesses and their product or service. ISO 13485 delivers guidelines that ensure a QMS contains all the elements needed to be successful.

What Types of Businesses Need ISO 13485?

Businesses that need ISO 13485 are involved in one or more stages of a medical device’s life-cycle. This includes:

  • Design and development
  • Production, such as the manufacture of in vitro diagnostic reagents
  • Storage 
  • Distribution
  • Installation
  • Servicing
ISO 13485 accreditation shows high quality in manufacturing in vitro diagnostic reagents for medical devices

ISO 13485 accreditation shows high quality standards in manufacturing in vitro diagnostic reagents for medical devices

The ISO 13485 standard applies to all businesses regardless of their size or type (with some very specific exceptions). The standard very explicitly applies to both medical devices as products and also any related services.

Benefits of Holding ISO 13485

Holding ISO 13485 certification has many benefits, including:

  • Global recognition – ISO 13485 is recognised in major markets around the world
  • Meeting legal, regulatory, contractual and marketing requirements
  • Improved product safety
  • Improved credibility, building customer trust
  • Higher rates of customer satisfaction – the ISO 13485 QMS focuses on improving customer satisfaction by identifying and meeting customer needs
  • Integrated processes – looking at individual processes and how processes interact means businesses can identify areas for improvement and resource savings
  • Making data-driven decisions to target resources to correct problems and improve efficiency
  • Creating a culture of continual improvement – save time, costs, and resources.
  • More effective risk management

We are delighted that ReAgent has just received ISO 13485 certification, meeting the stringent quality management system requirements and high international standards. We are also accredited to ISO 9001 and ISO 14001 for Environmental Management.


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