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Quality management system

TÜV TÜVIn the field of quality management system we linked up to the successful history of our firm. In 1998 the quality management system according to EN ISO 9001:1994 and EN 46001 was introduced and certified. Due to this system and its development, BMT Medical Technology s.r.o., as the first producer in the Czech republic, fulfilled requirements of the international directive for medical means MDD 93/42/EEC already in 2000. With respect to the increasing requirements and needs of customers and employees and the varying conditions in society, our top-priority objective is to introduce and enforce the TQM philosophy in all spheres of the company management. The continual growth of value of our products and services is ensured by the high professional level of our employees, the top-quality technical equipment and the functional quality system. BMT a.s. is one of few companies in the Czech republic, who obtained the accreditation of the Czech Accreditation Institute (Český institut pro akreditaci ČIA) in the field of validation and proof of sterilization safety for steam and hot air sterilizers. Our accredited test laboratory was allocated the No.1325.

  • Quality management system
  • Accredited test laboratory No. 1325

In 1998 in the company there was established and certified the system of quality management in accordance with the standards EN ISO 9001:1994 and EN 46001 and in 2004 there was implemented a re-certification in accordance with the standards EN ISO 9001:2000 and EN ISO 13485:2003. In 2018 there was performed the certification of quality systems management according to new standards EN ISO 9001:2015 and EN ISO 13485:2016.

The principal part of our products is a pressure vessel. Therefore apart from a series of obtained national certifications for pressure vessel production (Switzerland, Italy, Poland...) in 2001 there was certified a process of production of pressure vessels as well as for the U.S.A. in accordance with the ASME-Code. In 2002 there was certified the process of pressure appliances manufacture according to EU Directive No. 97/23/EC and in 2017 it was updated according to the requirements of the new European Directive 2014/68/EU. Our company has also certified the process of pressure vessels and steam boilers (steam generators) manufacture according to AQSIQ for export to China.

Regarding to the fact that we spare  no effort  to develop further services to our customers, we have built and have a testing laboratory accredited by the Český institut pro akreditaci (Czech institute for accreditation) for testing

– documentation of sterilization efficiency of big steam sterilizers in accordance with the standard EN 285,
– performed upon validation of the sterilization by means of wet heat in accordance with the standard EN ISO 17665-2
– hot air sterilizers and apparatuses of heat technique in accordance with the standard DIN 12880.

System of quality management

The quality system is built on a principle of processing approach anchored in the standards EN ISO 9001:2008 and EN ISO 13485:2003 in accordance with the Policy of corporate quality. Testing of effectiveness of the quality system is performed on the basis of the internal audit evaluation.

All our products undergo the 100 % output control and we perform a random interstage control. In the company we apply, among the respective centres and operations  the principle customer-supplier i.e. including the self-inspections. We try to eliminate the arisen disagreement within the shortest possible terms and by adopting the proper measures. We are sincere and helpful to our customers.

Accredited tests

Accreditation of the test laboratory No. 1325

EN 285:

  • air leakage test
  • thermometric test
  • dynamic chamber pressure test

  • load dryness test

QPP 19-06, 19-14 a 19-15:

  • measurement of temperature profile in the empty chamber
  • measurement of temperature distribution in the chamber with load

DIN 12880:

  • measurement of homogeneity and time stability of temperature in the empty chamber