ISO 13485:2003 STANDARD FOR MEDICAL DEVICES MANAGEMENT SYSTEM
BrandISO GLOBAL CERTIFICATION
SKUISG006
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ISO 13485 certification is a specific certificate for medical device industry. ISO 13485:2003 is a QMS standard for Medical device industry.
All requirements of ISO 13485:2003 are specific to organizations providing medical devices, regardless of the type or size of the organization:-
Systemic Requirements 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.
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