Avtor/Urednik		Kavčič-Marinko, Andreja; Krbavčič, Aleš
Naslov		Standard kakovosti ISO 9001
Prevedeni naslov		Standard of quality assurance ISO 9001
Tip		članek
Vir		Farm Vestn
Vol. in št.		Letnik 50, št. 2
Leto izdaje		1999
Obseg		str. 169-72
Jezik		slo
Abstrakt		Quality standards ISO 9000 are published by International Organisation for Standardisation. In last few years they are frequently present in Slovenia too, because of the oppening of Slovene management to the European market. There are given some basis about ISO standards in the article. ISO 9001, which represent the highest level for quality assurance or model for quality assurance in design, development, production, instalation and servicing, more detailed is described. Quality sistem requirements of ISO standard are generic and independant of any specific industry or economic sector and have many requriments in common with GMP, which is the legal binding set of quality requirements for the pharmaceutical industry.
Izvleček		Standarde kakovosti ISO 9000 izdaja Mednarodna organizacija za standardizacijo. Ti standardi so tudi pri nas, zaradi odpiranja slovenske industrije v Evropo, v zadnjih letih vse bolj aktualni. Članek podaja nekaj osnov o družini ISO standardov, podrobneje pa je opisan standard ISO 9001, ki predstavlja najvišji nivo zagotavljanja kakovosti oz. model za vzpostavitev sistema kakovosti v proizvodnji, vgradnji in servisiranju. Zahteve ISO standarda, ki so splošne in neodvisne od industrijske panoge, imajo veliko skupnega tudi s smernicami DPP, ki predstavljajo v farmacevtski industriji obveznost in hkrati osnovo za kakršen koli nastop na trgu.
Deskriptorji		DRUG INDUSTRY QUALITY CONTROL TOTAL QUALITY MANAGEMENT WORLD HEALTH ORGANIZATION EUROPE