• EN ISO 13485:2012 Quality Systems for Medical Device Producers and Distributors

Manufacturers of Medical devices may intend to gain Certification for their products in order to meet current legal requirements, increase efficiency, and gain assurance against potential lawsuits within harmonization processes of European Union and acquis communautaire               

ISO 13485 requires to use CE Certification logo within European Union and Turkey by the date of September 13th 2013. Even though resemblances had been demonstrated in between ISO 9001:2008 Quality Management Systems and ISO 13485 Quality management systems for Medical Devices, additional requirements may be demanded.

Although ISO 13485:2012 had been generated for the purpose of Medical Devices, it requires to harmonize with infrastructure of ISO 9001: 2008. In some points, it differentiates from ISO 9001: 2008. ISO 13485 standard aims to establish a direct connection in between main purposes and efficiency of organization by making transition from classical control mechanism to process based approach.

It is possible to give prominence for compliance with legal requirements, maintenance of current efficiency, process approach by applying the cycle of ‘’Plan-Do-Check-Act’’


 

Benefits of ISO 13485:

  •     enables to monitor systematically organization’s activities
  •     enables to detect and correct disruptions
  •     enables to increase customer satisfaction
  •     enables to maintain current system’s efficiency and continuity

ISO 13485-certified client organization:

  •     demonstrates to comply with current legal requirements
  •     obtains efficiency to label products with CE certification logo
  •     expands customer portfolio by documenting its compliance with an international standard
  •     decreases potential failures on products by its efficient appliance

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