ISO 13485

ISO 13485 Medical Devices


BTS Consulting provides guidance for the implementation of ISO 13485 Medical Devices Quality Management System with an effective approach that combines implementation experience, availability of templates and the use of proprietary support software. 

“ISO 13485:2003 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services. 

The primary objective of ISO 13485:2003 is to facilitate harmonized medical device regulatory requirements for quality management systems. As a result, it includes some particular requirements for medical devices and excludes some of the requirements of ISO 9001 that are not appropriate as regulatory requirements. Because of these exclusions, organizations whose quality management systems conform to this International Standard cannot claim conformity to ISO 9001 unless their quality management systems conform to all the requirements of ISO 9001. 

All requirements of ISO 13485:2003 are specific to organizations providing medical devices, regardless of the type or size of the organization. 
 

Our Approach

For any organization the degree of change necessary will be dependent upon the maturity and effectiveness of the existing management systems, organizational structure and practices, therefore an impact analysis/gap assessment is strongly recommended in order to identify realistic resource and time implications. 

Organizations pursuing the certification of Medical Devices Quality Management System are recommended to take the following actions: 
a) Identify organizational gaps which need to be addressed to meet new requirements.
b) Develop an integration plan.
c) Provide appropriate training and awareness for all parties that have an impact on the effectiveness of the organization. 
d) Update the existing management systems to meet the common requirements of the integration strategy. 
e) Where applicable, liaise with their Certification Body for integration arrangements.