Hivatkozási szám

MSZ EN 15224:2017

Dokumentumazonosító

665366

Cím

Minőségirányítási rendszerek. Az EN ISO 9001:2015 az egészségügyben

Angol cím

Quality management systems. EN ISO 9001:2015 for healthcare

Alkalmazási terület

This international standard specifies requirements for a quality management system when a healthcare organization: a) needs to demonstrate its ability to consistently provide healthcare product or service 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 improvement of the system and the assurance of conformity to customer requirements, applicable statutory and regulatory requirements and requirements related to the quality aspects; appropriate, correct care; availability; continuity of care; effectiveness; efficiency; equity; evidence/knowledge based care; patient centred care including physical, psychological and social integrity; patient involvement; patient safety and timelines/accessibility. All the requirements of this International Standard are generic and are intended to be applicable to any health care organization, regardless of its type or size, or the products and services it provides. NOTE 1 In this standard the terms “product” or “service” only apply to products and services intended for, or required by, a customer. NOTE 2 Statutory and regulatory requirements can be expressed as legal requirements. Requirements related to material outputs such as tissue, blood products, pharmaceuticals, cell culture products and medical devices are not the focus of the scope of this standard as they are regulated elsewhere. This standard is focused on requirements for management of clinical processes. Organizations that also include research or education processes in their quality management system could use the requirements in this standard where applicable. This standard aims to specify and complement the requirements in EN ISO 9001:2015 to the specific conditions for healthcare providing mainly services and where customers are mainly patients.

ICS

03.100.70 Irányítási rendszerek

03.120.10 Minőségirányítás és minőségbiztosítás

11.020.01 Minőség- és környezetközpontú irányítás az egészségügyben

A szabvány nyelve

angol

Az érvényesség kezdete

2017-06-01

Forrás

idt EN 15224:2016

Előd

MSZ EN 15224:2013

Utód

Módosítás

SZK-közlemények

Kapcsolódó európai jogszabály

A szabvány

kapható formátuma

Papír ,
PDF (letöltés) (a fájl mérete: 3720063) ,

oldalszáma

84 oldal; XB kategória

ára

Nettó: 25750 Ft
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