Quality Control of medical equipment
Quality Management System (QMS) has been implemented in our company in 1994. It absorbed everything best taken from MCS of aerospace manufacturing practices and allows to fabricate complex medical purpose technical devices with traditionally high degree of performance, reliability and longevity.
Quality Management System (QMS) of medical equipment that includes the company executives’ responsibility, materials and resources management, control of all the processes of life cycle of products, quantification, analysis and improvement has been functioning efficiently ever since. That is confirmed by internal, external and certification audits.
In 2003 QMS of the company has been certified according to The American Society of Mechanical Engineers (ASME) Code. The company was granted a right to fabricate high-pressure vessels.
Our company was granted a Permission of Gosgortechnadzor of Russian Federation, which is an authorized State Agency responsible for control and enforcement of fire and explosion protection measures, to design, fabricate, commission and maintain high-pressure vessels used for medical purposes.
Company employs specialists with highest degree of expertise and certified professionals in industrial safety control system field. It has spectroscopy and mechanical laboratories, X-Ray, ultrasound and visually-instrumental check laboratories accredited by ASME and Gosgortechnadzor of Russian Federation. An acoustic emission method and method of penetrating liquids are applied as well for testing purposes.
All aforementioned allowed our company to obtain the license to conduct an independent industrial safety expertise of medical high-pressure vessels of all existing types.
We are presently at the final stage of preparation for certification of our manufacturing processes according to ISO 9001 standard and Directives 9342, 9723 and 13485.
- All products of our plant have positive result of sanitary-hygienic norms conformance examination.
- All products of our plant have Certificate of Conformance issued by Russian Federation Gosstandard (State Standardization Committee) upon positive results of certification tests and audit.
- All designers, technologists, specialists and workers are trained and certified by accredited and authorized organizations.
- All parts, assemblies and systems of products are subject to three-stage intermediate operational and final check with mandatory documenting.
- All products undergo acceptance tests with mandatory issuing of acceptance tests protocol.
- All internal documentation is stored during the entire product lifetime while it is operated by the customer.
- All requirements and requests of our customers would be implemented given full and unconditional conformance to ISO 9000 and 10000 standards, ASME Code and Russian Federation standards.