ISO 13485 – Why should suppliers have a certified Quality Management System (QMS)?

ISO 13485 is an international standard that specifies requirements for a quality management system (QMS) for the design, development, production, installation, and servicing of medical devices. It is published by the International Organization for Standardization (ISO).

The purpose of ISO 13485 is to provide a framework for organizations to ensure that they are able to consistently provide medical devices that meet customer and regulatory requirements. The standard covers all aspects of the QMS, from design and development to production and servicing.

Here are some of the key benefits of working with suppliers who have a certified QMS:

· Improved quality of products and services: A certified QMS helps to ensure that suppliers have the processes and procedures in place to produce high-quality products and services. This can help to reduce the risk of defects and recalls, and it can also improve customer satisfaction.

· Reduced risk of defects and recalls: A certified QMS helps to identify and mitigate risks of defects and recalls. This can help to protect your company from the financial and reputational damage that can result from a product recall.

· Increased customer satisfaction: Customers are more likely to be satisfied with products and services that meet their expectations. A certified QMS can help to ensure that your suppliers are meeting the quality and regulatory requirements of your customers.

· Improved compliance with regulations: A certified QMS can help your suppliers to comply with the regulations that govern the manufacture and supply of medical devices. This can help to protect your company from regulatory fines and penalties.

· Reduced costs: A certified QMS can help to reduce costs by improving efficiency and reducing waste. This can lead to lower production costs and lower costs for customer support.

· Increased efficiency: A certified QMS can help your suppliers to operate more efficiently by streamlining processes and improving communication. This can lead to faster production times and shorter lead times.

· Improved reputation: A certified QMS can help to improve your company’s reputation by demonstrating your commitment to quality and compliance. This can make it easier to win new customers and retain existing customers.


If you are a manufacturer of medical devices, it is important to work with suppliers who have a certified QMS. This will help you to ensure that the products you receive meet your quality and regulatory requirements.