Quality Management System for Medical Devices or ISO 13485 Certification

What is Quality Management System for Medical Devices or ISO 13485 Certification?

Quality Management System for Medical Devices or ISO 13485 Certification requires an organization to demonstrate the ability of medical equipment and related services.

Standards of ISO 13485 Certification

GQS provides all assistance towards ISO 13485:2012 Certification which includes

  • Writing ISO 13485 Manual
  • Writing 13485 Procedures
  • Designing Forms required by the ISO 13485 standard
  • ISO 13485 Internal audit
  • ISO 13485 Certification.

The following ISO standards are referred depending upon the suitability of the organization, while building a QMS for medical equipments.

  • ISO 14971:2000, Medical devices — Application of risk management to medical devices
  • ISO 14937:2000, Sterilization of health care products — General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilizing agent
  • ISO 14160:1998, Sterilization of medical devices — Validation and routine control of sterilization of single-use medical devices incorporating materials of animal origin by liquid chemical sterilants
  • ISO 14155-2:2003, Clinical investigation of medical devices for human subjects — Part 2: Clinical investigation plans
  • ISO 14155-1:2003, Clinical investigation of medical devices for human subjects — Part 1: General Requirements
  • ISO 13683:1997, Sterilization of health care products — Requirement for validation and routine control of moist heat sterilization in health care facilities
  • ISO 13641:2002, Elimination or reduction of risk of infection related to in vitro diagnostic medical Devices
  • ISO 11137:1995, Sterilization of health care products — Requirements for validation and routine control — Radiation sterilization (Corrigendum 1 published 1995; Amendment 1 published 2001)
  • ISO 11135:1994, Medical devices — Validation and routine control of ethylene oxide sterilization
  • ISO 11134:1994, Sterilization of health care products — Requirements for validation and routine control — Industrial moist heat sterilization re cool