Accreditation for the ISO 13485 "Quality
management system for the for the manufacturers of
the medical equipment and devices"
ISO 13485 - is an international standard that was developed for the
introduction of the quality management systems for the manufacturers
of the of the medical devices and medical equipment. The basic model
of the ISO 13485 standard was based on the ISO 9001 family.
ISO 13485 contains information and specific requirements to the
control stages and planning of the manufacturing process including
control of the manufacturing conditions, processes control, process
and equipment validation, sterilization, tracking and documented
evidence of the manufacturing process of the medical equipment and