What is ISO 13485:2016?

ISO 13485:2016 is recognized throughout the world as a quality management system standard designed specifically for medical device manufacturers. Based on the same basic principles and clause structure as ISO 9001:2015, ISO 13485:2016 is a crucial first step in ensuring manufacturing and design processes consistently produce quality products that meet regulatory requirements.   

ISO 13485:2016 is used to assist in the synchronization of quality management systems and medical device regulatory requirements in organizations involved in one or more stages of the life-cycle of a medical device.

Who Should Seek ISO 13485 Certification? 

• Companies who manufacture private label medical devices and hope to eventually place them in the EU market 

• Organizations that design and assemble medical devices 

• Medical component manufacturers 

• Manufacturers that want to prepare for future IVD regulatory obligations to enter the EU 

• Companies who store and/or distribute medical products 

• Companies who install and/or service medical devices 

• Companies that design, develop, or provision associated services (e.g. technical support) 

Benefits of ISO 13485 Certification

With ISO 13485:2016 certification, manufacturers are provided with a process-based model and approach to developing and improving the effectiveness of a quality management system. ISO 13485:2016 certification also assists in meeting customer and global regulatory requirements by: 

• Maintaining global recognition as the best quality practices from companies within the medical device industry 

• Enabling companies to work within various countries and organizations, meeting necessary regulations and obligations 

• Helping to create an organized framework in which companies can maintain and evaluate their processes and customer response 

• Providing a framework to ensure maintenance and improvement of the effectiveness of those processes with applicable requirements 

• Enabling improved performance, such as increased sales, increased timeliness in getting products to the global marketplace, reduced costs, fewer errors, less waste, better use of time and resources and a lower product failure rate 

• Demonstrating compliance with European Union Directives through establishment and independent assessment of the quality management system