Quality Monitor Systems

The definition of medical devices, has defined the country depending on local laws and standards, is not unique. Japan, EU, USA, Canada and Australia are organized by the medical device regulatory harmonization of international conferences (Global Harmonization Task Force. 1993年inauguration), "all the enginery instrument, in-vitro diagnostics, materials, software, materials and It is similar to the intended use of human body and its intended use, injury and disease diagnosis, prevention, monitoring, treatment, mitigation, such as anatomy or biological inspection, maintenance and support of life, medical Sterilization equipment, etc. used in the adjustment of conception "is defined as, GHTF definition of the purpose of regulation of medical devices quality management system of ISO 13485 standards in Section 3, positioned as the definition of medical equipment Said.

The definition of quality control, JIS Z 8101, "meet the demands of the buyer-quality goods or services in an economical way to create a system of.." In addition, the "order (the order) to the requirements of product quality and the rational and economical means and methods for producing the study." Requirement Source] Both will be defined. Quality control, Shewhart Walter (Walter A. Shewhart), Edwards Deming (W. Edwards Deming), Kaoru Ishikawa (Tokyo University, former dean of Musashi Institute of Technology) and was built in the postwar period. For defective goods to zero as a quality control activities, since the 1960s to the scene of Japan's manufacturing industry is widespread. Japanese products in a marked improvement in the quality and contribution. QC circle activities in Japan, coupled with the closely related to KAIZEN. Not only in the manufacturing sector and services sector and company-wide management and other activities to spread QC activities, TQC (Total Quality Control) calls. TQC that this was the development of TQM (Total Quality Management). Widely used in America in the 1990s, a resurgence of the U.S. manufacturing sector has contributed greatly to be.