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ISO 13485

 

ISO 13485:2003 (QMS-MEDICAL DEVICES)

ISO 13485:2003 SPECIFY THE REQUIREMENT FOR A QUALITY MANAGEMENT SYSTEM IN MEDICAL DEVICES MANUFACTURING AND SUPPLING INDUSTRY WHERE AN ORGANIZATION NEEDS TO DEMONSTRATE ITS ABILITY TO PROVIDE ITS SERVICES. WHICH FULFILL CUSTOMER AND REGULATORY REQUIREMENT APPLICABLE IN THIS STANDARD-13485 : 2003.

THE BASIC PURPOSE OF ISO 13485:2003 IS TO HELP HARMONIZED MEDICAL DEVICE REGULATORY REQUIREMENT FOR QUALITY MANAGEMENT SYSTEM.

ALL NECESSITIES IN MEDICAL DEVICES OF ISO 13485:2003 ARE SPECIFIC TO ORGANIZATION, REGARDSLESS OF THE STYLE AND DIMENSION OF ORGANIZATION.

MOST INTERNATIONAL MEDICAL DEVICES MARKET REGULATORIES REQUIRES MANUFACTURER TO IMPLEMENT A QUALITY MANAGEMENT SYSTEM (QMS) AS PART OF THEIR PRODUCT REGISTRATION ATTEMPT IN ITS ORGANIZATION. IN MOST COUNTRIES, ISO 13485 CERTIFICATION IS THE PREFERRED OR REQUIRED METHOD OF MEETING QMS REQUIREMENTS IN ANY OF THE ORGANIZATION.

ISO 13485:2003 IS BASED OFF INTERNATIONAL STANDARD ISO 9001 WITH SPECIFIC REQUIREMENTS TO MEED REGULATORY NEEDS

THE ISO 13485 STANDARD, OFFICIALLY NAMED EN ISO 13485:2003, CAN BE USED BY ORGANIZATIONS IN THE DESIGN, DEVELOPMENT AND PRODUCTION PROCESS FOR MEDICAL DEVICES BUT ALSO RELATED SERVICES. IT CAN ALSO BE USED BY NOTIFICATION BODIES TO MEET REGULATORY REQUIREMENTS.

ISO 13485:2003 REQUIREMENTS

  • DOCUMENT AND RECORD CONTROLS.
  • INTERNAL AUDITING PROCEDURES
  • CONTROLS FOR NON CONFORMANCE
  • CORRECTIVE AND PREVENTIVE ACTIONS
  • PROCESSES AND DESIGN CONTROLS
  • RECORD RETENSION
  • ACCOUNTABILITY AND TRACABILITY

ISO 13485:2003 BENEFITS?

HERE ARE SOME BENEFITS OF ISO 13485:2003 CERTIFICATION:

  • DECREASE OPERATIONAL COST BY HIGHLIGHT PROCESS DEFICIENCIES AND IMPROVING EFFICIENCIES.
  • ACCESS TO MARKETS THAT RECOGNIZE OR REQUIRE THE CERTIFICATION.
  • INCREASE CUSTOMER SATISFACTION BY CONSISTENTLY DELIVERING QUALITY PRODUCT AND STYSTEMATICALLY ADDRESSING COMPLAINTS.
  • ADD TRANSPARENCY TO THE WAY COMPLAINS, SERVEILLANCE OR PRODUCT RECALLS ARE HANDLED.