ISO 13485

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

medical devices.

Medical project audit

Medical projects and
health care facilities audit