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ISO 13485

Quality management systems for the producers of medical devices

This standard establishes requirements to the quality management system, if the organization should demonstrate its capability to provide medical goods systematically and render services connected with them, that will meet requirements of the customer and regulating requirements to the medical goods and services connected with them.

Standard ISO 13485:2003 contains requirements to the quality management system of medical goods’ producers. It was published by the International Standard Organization ISO on 15th of July, 2003, and set aside the old standards ISO 13485:1996 and ISO 13488:1996.

Why is ISO 13485:2003 necessary?

  • To implement the quality management system, focused on processes of development, designing, production and use of medical goods and related services;
  • To demonstrate to all the concerned parties your capability to produce medical goods and render related services that meet the customers’ expectations and set requirements;
  • To evaluate capability of your organization to meet the customers’ requirements and compliance of the production with the set requirements;
  • To certify the quality management system for compliance with the requirements of the standard.

The standard can be applied together with ISO 9001:2008, and also with the principles of the Good Manufacturing Practice (GMP) that is widely used all over the world.

Medical devices refer to the group of products that have big nomenclature and big dispersion of requirements.

The intended use of the standard is evaluation of the supplier’s quality system. In case of the third party’s evaluation for the compliance with obligatory requirements, it may need the access to the confidential data. However the supplier is not obliged to provide the copies of these data for forming of his file.

In some countries the obligatory certification for this standard is or will be implemented.

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