ISO 13485:2003

Medical Devices - Quality Management Systems 

This is an industry specific management standard specially developed for medial devices manufacturing industry. The primary objective of ISO 13485:2003 is to facilitate harmonized medical device regulatory requirements for quality management systems.

ISO 13485:2003 - Medical devices -- Quality management systems -- Requirements for regulatory purposes 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.

If regulatory requirements permit exclusions of design and development controls, this can be used as a justification for their exclusion from the quality management system. These regulations can provide alternative arrangements that are to be addressed in the quality management system. It is the responsibility of the organization to ensure that claims of conformity with ISO 13485:2003 reflect exclusion of design and development controls.

Systemic Requirement
- Establish a quality  system for medical devices
- Document your medical device quality system

Management Requirements
- Support quality
- Focus on customers
- Establish a quality policy
- Perform quality planning
- Control  your quality management system
- Carry out management reviews

Resource Requirements

- Provide quality resources
- Provide quality personnel
- Provide quality infrastructure
- Provide quality environment

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

OUR SERVICEs

Testimonials

Amar D R Singhani Managing Director Temasme Vesselex India Pvt. Ltd.Vital gave us the perfect guidance for our ISO 9001 Certification process, Mr. Rakesh Dwivedi was very helpful to our entire team and he gave us the proper suggestions and solutions for our problems relating to ISO and because of their systematic approach we were able to achieve our certification on time."

   View All