ISO 13485:2003 Certification

ISO 13485:2003 defines the Quality Management System for Medical Devices. It is specifically introduced for the medical device manufactures. Its helps to improve the quality management system of medical devices which ensures the safety of medical devices and also helps to improve the services of organization.

Benefits Of ISO 13485:2003

• Improves the manufacturing procedure that ensures for safety of medical devices.
• Improves Risk Management
• Achievement of goals
• Improves the business
• Customer satisfaction
• Mutual understanding between customers and manufactures
• Improves quality of medical devices
• Improves market value and brand value of the organization

Indicum Consultancy Road Map Of ISO 13485:2003

• Assessment of Existing Resources including infrastructures
• Assessment of existing System & Identification of processes
• Identification of Task Group & Management Representative
• ISO 13485:2003 Awareness Training Program in batches
• Development of  Process Flow Charts, Policy, Objectives, Formats & other supporting documents (Work Instructions etc)
• Finalization of above documents & release for implementation
• Preliminary Audit (Gap Analysis) & revisions to documents
• Design & Development of Quality Manual & issue draft for review
• Finalization of Manual  & issue documents for implementation
• Implementation of Quality Management System
• Provision of Identified Resources
• Qualification of processes & personnel for special processes
• Calibration of Monitoring & Measuring Instruments
• Selection & Finalization of Certification Body
• Training of Internal auditors in two batches if > 20
• Audit by ICPL Auditor and Management Review Meeting – I
• Implementation of Corrective & Preventive Actions
• Submission of Quality Manual to Certification Body for review
• Corrective & Preventive Action on review comments
• Audit by ICPL  and Management Review–II
• Corrective Action on Internal Audit
• Preparation for Certification Audit
• Final Audit by Certification Body
• Implementation of Corrective & Preventive Actions
• Award of certificate by certification body