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ISO 13485:2012 Certification

The ISO 13485 standard, officially named EN ISO 13485:2012, can be used by organizations in the design, development and production procedure for medical devices but also connected services. It can also be used by announcement bodies to meet regulatory needs.

In Europe, ISO 13485 is view as the de facto standard for the medical device industry. Based on the broader ISO 9001 standard, ISO 13485 was first implemented in Europe in 1996. Although ISO 13485 certification is voluntary, obtaining certification allows you to meet the quality system needs of the European Medical Device Directive (93/42/EEC), In Vitro Medical Device Directive (98/79/EC) and Active Implantable Medical Device Directive (90/835/EEC) with less complexity.

ISO 13485 is suitable to all manufacturers and suppliers of medical devices, element, contract services and dealer of medical devices. For a number of markets ISO 13485 Certification is not enough on its own and the convenient local regulatory certification is also necessary to officially manufacture and sell medical devices.

The primary objective of ISO 13485 is to make possible harmonized medical device regulatory needs for quality management systems. ISO 13485 is a standalone standard. It is basically based on the configuration of ISO 9001, but includes some particular needs for medical devices such as risk explication, sterile manufacturing and traceability. Organizations certified to ISO 13485 cannot demand conformity to ISO 9001.

Key additional requirements of ISO 13485

  • Keep the continued suitability and efficiency of the quality management system, rather than trying for continuous development
  • Training and supervision of staff
  • Observing whether customer needs are met, rather than more subjective customer gratification measures
  • Contamination stopover
  • Risk management required at all stages of product understanding
  • Multiple documentation needs

Benefits of ISO 13485

  • Reduced operating costs – through continual development of procedures and resulting operational efficiencies
  • Legal compliance – by understanding how statutory and regulatory needs effect the organization and its clients
  • Enhanced stakeholder relationships – as well as staff, customers and suppliers
  • Enhanced risk management – through greater consistency and traceability of products and make use of risk management techniques
  • Ability to win more business – particularly where procurement identification need certification as a condition to supply in a highly regulated sector
  • Customer pleasure – through relief of products that consistently meet customer needs as well as quality, safety and legal needs
  • Proven business credentials – through independent verification against acknowledged standards

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