Health services. Quality management systems. Guide for the use of EN ISO 9004:2000 in health services for performance improvement

2015 ◽  
2010 ◽  
Vol 30 (02) ◽  
pp. 55-62
Author(s):  
M. Fritzer-Szekeres

SummaryDuring the 20th century understanding for quality has changed and international and national requirements for quality have been published. Therefore also medical branches started to establish quality management systems. Quality assurance has always been important for medical laboratories. Certification according to the standard ISO 9001 and accreditation according to the standard ISO 17025 have been the proof of fulfilling quality requirements. The relatively new standard ISO 15189 is the first standard for medical laboratories. This standard includes technical and management requirements for the medical laboratory. The main focus is the proof of competence within the personnel. As this standard is accepted throughout the European Union an increase in accreditations of medical laboratories is predictable.


2019 ◽  
Vol 6 (3) ◽  
pp. 54-60
Author(s):  
Mikhail Jurievich Rudiuk ◽  
Anastasiia Vladislavovna Gerasimova ◽  
Ekaterina Mikhailovna Pomozova

The authors' task was to analyze the development of quality management systems at the current stage in Russia, as well as at the previous stage in the USSR. As a result, we came to the conclusion that the factors stimulating the implementation of ISO 9000 standards are the need to promote products on the world market, as well as the possibility of receiving orders from the state. In the future, strict adherence to these standards will allow enterprises to significantly reduce the likelihood of lawsuits from consumers, which is important in the context of the development of the legislative framework and increased control over the business. The practical significance of the article is the possibility of familiarizing management and personnel with quality services, whose task is to prepare for certification for compliance with ISO 9000 standards in how this process took place in other companies. The originality of this work is to summarize the experience of implementation of ISO 9000 standards at enterprises and to analyze the factors contributing to or hindering this process.


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