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Hivatkozási szám, azonosító jelzet, vagy a szabványcímben előforduló kulcsszó szerinti keresés:


ICS (a szabványok nemzetközi osztályozási rendszere) szerinti keresés

Nettó ár: 19470 Ft
Kosárba tesz
Alapadatok
Hivatkozási szám
MSZ EN ISO 15378:2016
Dokumentumazonosító
162479
Cím
Gyógyszerek elsődleges csomagolóanyagai. Az ISO 9001:2008 alkalmazásának sajátos követelményei, tekintettel a helyes gyártási gyakorlatra (GMP) (ISO 15378:2015)
Angol cím
Primary packaging materials for medicinal products. Particular requirements for the application of ISO 9001:2008, with reference to Good Manufacturing Practice (GMP) (ISO 15378:2015)
Alkalmazási terület
1.1 General This International Standard specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide primary packaging materials for medicinal products, which consistently meet customer requirements, including regulatory requirements and International Standards applicable to primary packaging materials. In this International Standard, the term “if appropriate” is used several times. When a requirement is qualified by this phrase, it is deemed to be “appropriate” unless the organization can document a justification otherwise. ISO 9001:2008, Quality management systems — Requirements 1.1 General This International Standard specifies requirements for a quality management system where an organization a) needs to demonstrate its ability to consistently provide product that meets customer and applicable statutory and regulatory requirements, and b) aims to enhance customer satisfaction through the effective application of the system, including processes for continual improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements. NOTE 1 In this International Standard, the term “product” only applies to a) product intended for, or required by, a customer, b) any intended output resulting from the product realization processes. NOTE 2 Statutory and regulatory requirements can be expressed as legal requirements. 1.2 Application This International Standard is an application standard for the design, manufacture and supply of primary packaging materials for medicinal products. It is also applicable for certification purposes. ISO 9001:2008, Quality management systems — Requirements 1.2 Application All requirements of this International Standard are generic and are intended to be applicable to all organizations, regardless of type, size and product provided. Where any requirement(s) of this International Standard cannot be applied due to the nature of an organization and its product, this can be considered for exclusion. Where exclusions are made, claims of conformity to this International Standard are not acceptable unless these exclusions are limited to requirements within Clause 7, and such exclusions do not affect the organization’s ability, or responsibility, to provide product that meets customer and applicable statutory and regulatory requirements.
ICS
03.100.70 Irányítási rendszerek
11.040.01 Orvostechnikai berendezések általában
A szabvány nyelve
angol
Az érvényesség kezdete
2016-04-01
A visszavonás napja
2018-04-01
További adatok
Forrás
idt EN ISO 15378:2015; idt ISO 15378:2015
Módosítás
Kiegészítő információk
SZK-közlemények
Kapcsolódó európai jogszabály
Kereskedelmi adatok
A szabvány
kapható formátuma
Papír ,
PDF (letöltés) (a fájl mérete: 1119180) ,
oldalszáma
74 oldal; W kategória
ára
Nettó: 19470 Ft
Bruttó:
Papír formátum esetén (5% Áfával): 24532 Ft
PDF (letöltés) formátum esetén (27% Áfával): 24727 Ft
Szabvány életútja
Megtekintett szabvány

MSZ EN ISO 15378:2016

2016-04-01 - 2018-04-01