QUALITY CONTROL OF MEDICAL AND PHARMACEUTICAL GOODS AND STANDARDIZATION
Keywords:
medical field, medical device, standard, compliance, certificate, quality management, ISO 13485:2016, GMP.Abstract
One common source of misunderstanding in the medical device industry is the method the various national regulatory systems use to identify standards. This article explains the method, starting with standards from the International Organization for Standardization (ISO) adopted and recognized in various regulatory systems. ThearticleusesISO 13485:2016 andISO 9001:2015 asillustrations.
References
Ziyayeva M.N., Tillaeva G.U., Tulaganov A.A. “Modern trends in standardization and quality control of medical devices”. 208-223, 2015.
O`zbekiston Respublikasining standartlashtirish davlat tizimi. Tarmoq standartlarini ishlab chiqish, kelishib olish, tasdiqlash va ro`yxatga olish tartibi. Rasmiy nashr. RTs Uz 1.9-95, 2017.
UzDst 1.0-92. O’zbekiston Respublikasi standarti. O’zbekiston Respublikasi Standartlashtirish davlat tizimi. Asosiy qoidalar 2018.
O`zbekiston Respublikasi Vazirlar Maxkamasining 1995y.25.05 dagi 181-sonli Qarori-Dori vositalar, tibbiy buyumlar va davolash-profilaktika, oziq-ovqatlar sifati ustidan nazoratini tashkil etish to`g`risida. O`zbekiston Respublikasida farmatsevtika faoliyati. 1-tom. Toshkent. 2001y.
www.Flamenco.ru
