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ISO 9001 : 2008 QMS
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ISO 13485 :2003
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ISO 20000 : ISO/IEC 20000-

Integrates the process based approach of ISO's management system standard

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ISO 27000 : ISO/IEC 27001-

2005, Information Technology Security Techniques Information Security

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ISO 26000 -
26000 standard giving guidance on social responsibility has taken a significant step forward with

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Introduction to ISO 13485


ISO 13485:2003 an international standard designed to orient quality management systems toward the design, development, production, and installation of medical devices and related services. Medical Devices are products designed to cope with disease, treat injuries, investigate and augment human functions and they also are made up of a host of other apparatuses and appliances.

ISO 13485 is a Quality Management Standard for Medical Devices. Many medical device companies are utilizing ISO 13485:2003 as a platform to build their business management systems because of its benefits or because it is a necessary step to market their products and services in certain regions. For many companies, registration to ISO 13485 is a key to securing and maintaining global business.

The introduction of ISO 9001:2000 has affected the standards used in the medical device sector. ISO 13485 will now replace EN 46001 as the European Harmonized Quality Management Standard. Notified Bodies will use this standard when assessing whether companies have a QMS, which meets European Directive requirements. Such an assessment is required where a manufacturer seeks to apply the CE mark. This means that companies must be conversant with:
 

  • ISO 13485
     
  • The significant aspects of the directives
     
  • The documentation requirements of ISO 13485 & the directives
     
  • The role of relevant guidance standards

     

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