BS EN 15224:2016 - Quality management systems. EN ISO 9001:2015 for healthcare
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BS EN 15224:2016

Quality management systems. EN ISO 9001:2015 for healthcare

Status : Current   Published : February 2017



This European 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 characteristics; 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. NOTE 1 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 have not been focused in the scope of this standard as they are regulated elsewhere. This standard is focused on requirements for clinical processes. Organizations that also include research or education processes, or both in their quality management system could use the requirements in this standard where applicable. This standard aims to adjust and specify the requirements, as well as the “product and service” concept and customer perspectives in EN ISO 9001:2015 to the specific conditions for healthcare providing mainly services and where customers are mainly patients.

Standard NumberBS EN 15224:2016
TitleQuality management systems. EN ISO 9001:2015 for healthcare
Publication Date28 February 2017
Normative References(Required to achieve compliance to this standard)ISO 9000:2015
Informative References(Provided for Information)ISO 10015, ISO 13485:2016, ISO 13940:2015, ISO/IEC 27001:2005, ISO 10018, ISO 10007:2017, ISO 31000
ReplacesBS EN 15224:2012
International RelationshipsEN 15224:2016
Draft Superseded By16/30334735 DC
DescriptorsProcess control, Patients, Quality assurance, Inspection, Health services, Quality assurance systems, Environmental health, Quality control, Health service personnel, Management, Quality management, Planning
Title in FrenchServices de santé. Systèmes de management de la qualité. Application de l'EN ISO 9001:2015 aux soins de santé
Title in GermanQualitätsmanagementsysteme. EN ISO 9001:2015 für die Gesundheitsversorgung
ISBN978 0 580 92703 4
File Size4.969 MB

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