Norm

NEN-EN-ISO 15378:2017 en

Primaire verpakkingsmaterialen voor medicinale producten - Speciale eisen voor de toepassing van de ISO 9001:2015, met referentie naar Good Manufacturing Practice (GMP)

161,21 195,06 Incl BTW

Over deze norm

Status Definitief
Aantal pagina's 79
Commissie Transfusie, infusie en injectieapparatuur voor medische toepassingen
Gepubliceerd op 01-11-2017
Taal Engels
NEN-EN-ISO 15378 specifies requirements for a quality management system when an organization: a) needs to demonstrate its ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements, and b) aims to enhance customer satisfaction through the effective application of the system, including processes for improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements. All the requirements of this International Standard are generic and are intended to be applicable to any organization, regardless of its type or size, or the products and services it provides.

Details

ICS-code 03.100.70
03.120.10
11.040.01
11.120.10
55.040
Nederlandse titel Primaire verpakkingsmaterialen voor medicinale producten - Speciale eisen voor de toepassing van de ISO 9001:2015, met referentie naar Good Manufacturing Practice (GMP)
Engelse titel Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP)

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