ISO 13485:2003 | Medical Devices Certification

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 main purpose is to facilitate alignment of regulatory requirements regarding production of medical equipment. 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.

This standard contains specific requirements for manufacturers, installation and maintenance by asking:

1. 
   
   Application of Quality Management System with several factors increase


2. 
   
   Risk management-based approach to product development and realization processes of validation


3. 
   
   Compliance with the requirements of legislation and regulations


4. 
   
   Effectiveness ability to scan products and product recall system fails
   

What are the benefits gained from ISO 13485:2003 certification?

1. 
   
   Customer satisfaction - through delivery of products that consistently meet customer requirements as well as quality, safety and legal compliance


2. 
   
   Reduced operating costs - through continual improvement of processes which resulted in operational efficiencies


3. 
   
   Improving relations with the parties concerned - including employees, customers and partners


4. 
   
   Legal compliance requirements - with an understanding on how the requirements of regulations and legislation that affect an organization and your customers


5. 
   
   Increase in the risk management control - with the consistency, the product traceability and use of risk management techniques


6. 
   
   The achievement of public trust in business is run - as evidenced by the existence of an independent third party verification on recognized standards


7. 
   
   The ability to get more business - particularly procurement specifications require certification requirements to become a partner for the sector that has been set

Who can use ISO 13485?

ISO 13485 contains requirements essential for every organization in medical equipment operation and supply chain related to pharmaceuticals. It is especially associated with the medical equipments manufacturers who hope to comply with the regulatory requirements that may be used, and any organization that has support services for manufacturers of medical equipment.

How to get certified?

There are many Certification Body in the world can certified the organization. There are NQA Services or DEKRA Certification, Inc