ISO 13485 is obtained by taking ISO 9001:2000 as a base and is the management system that includes special terms for medical equipments.

This standard covers the requirements of the management system for producers working on providing medical equipments, distributors, importers and exporters, the organizations who has to prove their ability for meeting the legislation requirements applicable to the services related with the medical equipments.

ISO 13485 BENEFITS

 
 
 
 
Provides national and international competitive advantage.
 
 
 
 
Increases economization, efficiency and profitability.
 
 
 
 
Provides product/sevice reliability.
 
 
 
 
Decreases costs.
 
 
 
 
Provides company acceptability by customer easily in export and internal market.
 
 
 
 
Provides facility for traceability.
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