ISO 13485 QMS – Medical Devices

ISO 13485 QMS – Medical Devices

About ISO 13485 Quality Management System for Medical Devices

ISO 13485 Medical Devices – Quality Management Systems is an international standard that provides a quality management system model for medical device manufacturers to meet regulatory requirements. It includes particular requirements for medical devices and excludes some of the requirements of ISO 9001 that are not appropriate as regulatory requirements. ISO 13485 is intended originally for organizations that design, develop, and produce medical devices. However, the new standard has also expanded its applicability to include organizations that carry out activities related storage and distribution, installation, servicing and final decommissioning and disposal of medical devices, and design and development, or provision of associated activities (e.g. technical support). The requirements of this International Standard can also be used by suppliers or other external parties providing the products (e.g. raw materials, devices, sterilization services, calibration maintenance services) to such organisations.

This standard has been adopted by regulators internationally, including the Medical Devices Authority (MDA), Ministry of Health Malaysia with the aim to harmonize the quality system requirements, to reduce conflicts on different demands and most importantly it will facilitate license application for manufacturers of medical devices. ISO 13485 is being referred to Medical Devices Authority (MDA) in implementing Medical Device Act 2012 (Act 737). 

What are the benefits of ISO 13485 Medical Devices?

  • Facilitate the export of medical devices to markets where regulatory requirements apply to the Medical Device Act 737.
  • Increase the probability of manufacturing safe and effective medical devices.
  • Provide assurance to the authorities that a manufacturer of medical devices has developed and implemented a quality management system based on a widely accepted international standard.

Why SIRIM QAS International?

  • SIRIM QAS is an internationally recognised conformity assessment body with decades of experience in providing testing, inspection and certification services to both local and international customers.
  • We are accredited by the Department of Standards Malaysia (STANDARDS MALAYSIA).
  • Our collaboration with the International Certification Network, IQNet and networking with foreign Certification Bodies and associated international certification organisations leads to worldwide market access.
  • Our highly experienced and professional auditors are competent in a wide range of sectors.

How to apply ISO 13485 Medical Devices?

  1. Submission of Request for Information (RFI)
  2. Issuance of Quotation
  3. Submission of Application
  4. Stage 1 Audit
  5. Stage 2 Audit
  6. Recommendation and Approval
  7. Issuance of Certificate
  8. Surveillance and Recertification Audit

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