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ISO 13485:2003 - MANAGEMENT SYSTEM STANDARD FOR MANUFACTURE OF MEDICAL DEVICES

ISO 13485:2016 is an international standard that defines quality management systemrequirements for manufacturers of medical devices. The primary objective of thestandard is to facilitate harmonised quality management system requirements forregulatory purposes within the medical device sector. ISO 13485 containsrequirements that are essential for any organization operating at any tier inthe medical device and pharmaceutical supply chain. It is especially relevantto manufacturers that wish to demonstrate applicable regulatory requirements,and by organizations whose services support medical device manufacturers. 

Benefits of ISO 13485

ISO13485:2016 promotes harmonisationof regulatory requirements for manufacturers of medical devices on aninternational scale. It incorporates many of the quality management principlesand delivers the benefits of an ISO 9001 based quality management system.

  • It demonstrates the manufacturer’s ability to supply medical devices & related services that are compliant with all regulatory requirements
  • Assures the customers that the product complies with all relevant product & service-oriented technical standards & regulations
  • Reduced operating costs – through continual improvement of processes and resulting operational efficiencies
  • Emphasizes the cleanliness & sterility in the production area, which in turn increases efficiency & enhances safety at the workplace
  • Organization establishes for risk management throughout the product realization.

How We Can Help

Globus Certifications has rich experience in designing, developing and implementing ISO 13485 ready Management System from the bottom up to meet ISO certification requirement. Â If the organization already has an existing management system, we help you by integrating ISO 13485 system with your current system.
 Our trained and experienced management system consultants assist an organization in designing, developing, and implementing ISO 13485.

Our 5 Step Process – Consulting to Facilitating Certification

  1. Perform gap analysis
  2. Design & Implement System (documentation of policy, quality manual, procedures, and forms, implementation of processes and Training)
  3. Pre-Certification Audit
  4. Coordinate Certification
  5. Get Certified!