Standard

NEN-EN 15224:2017 nl

Quality management systems - EN ISO 9001:2015 for healthcare

125,00 136,25 Incl BTW

About norm

Status Current
Number of pages 87
Committee ISO 9001 voor de zorg
Published on 01-01-2017
Language Dutch
NEN-EN 15224 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. 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.

Details

ICS-code 03.100.70
03.120.10
11.020
11.020.01
11.020.10
Dutch title Kwaliteitsmanagementsystemen - EN ISO 9001:2015 voor zorg en welzijn 
English title Quality management systems - EN ISO 9001:2015 for healthcare
Replaces

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