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ISO 13485:2003 Medical Devices

ISO 13485:2003 specifies needs for a quality management system where an organization requirements to demonstrate its capability to present medical devices and connected services that constantly meet client needs and regulatory needs applicable to medical devices and related services.

The Medical Devices Regulations need class II, III and IV medical devices to be manufactured (class II) or designed and manufactured (class III & IV) under CAN/CSA ISO 13485:2003. There are no regulatory quality system needs for Class I medical devices. These quality system necessities came into power on January 1, 2003.

All needs of ISO 13485:2003 are exact to organizations given those medical devices, regardless of the type or size of the organization.

ISO 13485: 2003 represents the needs that medical device manufacturers must incorporate into their management systems. The present document supersedes its 1996 incarnation as well as EN 46001, EN 46002 and ISO 13488.

Our wide range of regulatory approvals, close links with medical authorities make us a natural partner to meeting your certification necessities. For many markets ISO 13485 certification is not enough on its own and the suitable local regulatory certification is also necessary to officially manufacture and sell medical devices. With a strong status for technically correct advice and certification, we have the specialist knowledge and worldwide network of auditors to support you achieve your objectives.

Benefits of ISO 13485:2003

  • ISO 13485 is a quality system standard for organizations that design, develop, produce or service medical devices. All necessities of ISO 13485 are exact to organizations manufacturing medical devices, regardless of the type or size of the organization.
  • Promotes harmonization of regulatory necessities for the manufacturers of medical devices on an worldwide scale.
  • ISO 13485 certification is advantageous to medical device companies which export their products to worldwide markets. Some of the additional necessities relate to design controls, procedure controls (including environmental controls), special processes, traceability, record retention, and regulatory events, which are more critical for the medical device industry.
  • Companies that get ISO 13485 certification enjoy the benefits of an enlarged amount of clients who have more reason to trust and purchase products of constant high quality.
  • ISO 13485 compliant management systems adopt a risk management approach which includes assessment to recognize & estimate risk, uses risk controls and techniques with a view to eliminate hazardous situations throughout product realization.
  • ISO 13485 will benefit clients, suppliers, management, and mainly workers