BS EN 15224:2012 - Health care services. Quality management systems. Requirements based on EN ISO 9001:2008

BS EN 15224:2012

Health care services. Quality management systems. Requirements based on EN ISO 9001:2008

Status : Revised, Superseded, Withdrawn   Published : November 2012 Replaced By : BS EN 15224:2016

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1.1 General This European standard specifies requirements for a quality management system where an organization: a) needs to demonstrate its ability to consistently provide health care services that meet requirements from customers as well as applicable statutory and regulatory requirements, and professional standards b) aims to enhance customer satisfaction through the effective application of the system, including continual improvement of the management system, the clinical processes and the assurance of conformity to 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 and psychological integrity; patient involvement; patient safety and timelines/accessibility. Material products such as tissue, blood products, pharmaceuticals, cell culture products and medical devices have not been focused in the scope of the standard as they are regulated elsewhere. This European 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 European Standard where applicable. This European Standard aims to adjust and specify the requirements, as well as the “product” concept and customer perspectives in EN ISO 9001:2008 to the specific conditions for health care where products are mainly services and customers are mainly patients. The focus of this European Standard is the clinical processes and their risk management in order to promote good quality health care. 1.2 Application This European Standard a) gives requirements for systematic approaches for the organization’s ability to produce good quality health care. b) can be used by management at all levels in the health care organization to implement and maintain a quality management system or by internal and external parties, including certification bodies, to assess the organization’s ability to meet patients’ needs and expectations as well those from other customers. c) is applicable to health care organizations, regardless of structure, organization, owner, size or type of health care services provided. d) is applicable to e.g. primary health care, pre-hospital and hospital care, tertiary care, nursing homes, hospices, preventive health care, mental health services, dental services, physiotherapy, occupational health services and pharmacies. e) is focused on requirements for clinical processes. Organizations that also include research or education processes, in the scope of their quality management system could use the requirements in this standard where applicable. Where any requirement(s) of this European Standard cannot be applied due to the nature of a health care organization and its product (including services), this can be considered for exclusion. Where exclusions are made, claims of conformity to this European Standard are not acceptable unless these exclusions are limited to requirements within Clause 7, and such exclusions do not affect the health care organization’s ability, or responsibility, to provide products (including services) that meets customer and applicable statutory and regulatory requirements.




Standard NumberBS EN 15224:2012
TitleHealth care services. Quality management systems. Requirements based on EN ISO 9001:2008
StatusRevised, Superseded, Withdrawn
Publication Date30 November 2012
Withdrawn Date28 February 2017
Normative References(Required to achieve compliance to this standard)EN ISO 9000:2005, ISO 9000:2005
Informative References(Provided for Information)ISO 9001:2008, ISO 9004:2009, ISO 10005:2005, ISO 10006:2003, ISO 10007:2003, ISO 19011:2002, ISO 14001:2004, ISO/IEC 27000:2009, ISO/IEC 27001:2005, ISO 13485:2003, EN ISO 10012:2003, ISO 10012:2003, EN 13940-1:2007, prEN 13940-2, ISO/TR 20514:2005, ISO Guide 73:2009, ISO 704:2009, ISO 860:2007, ISO 31000:2009, ISO/IEC Guide 2, ISO/IEC Guide 51, CEN/TR 15592:2009, ISO 9001:2000
Replaced ByBS EN 15224:2016
ReplacesDD CEN/TS 15224:2005
International RelationshipsEN 15224:2012
Draft Superseded By11/30236589 DC
DescriptorsHealth services, Quality management, Management, Quality assurance systems, Quality assurance, Environmental health, Process control, Planning, Quality control, Inspection, Health service personnel, Patients
ICS03.100.70
03.120.10
11.020.01
Title in FrenchServices de santé. Systèmes de management de la qualité. Exigences selon l'EN ISO 9001:2008
Title in GermanDienstleistungen in der Gesundheitsversorgung. Qualitätsmanagementsysteme. Anforderungen nach EN ISO 9001:2008
CommitteeCH/100
ISBN978 0 580 73262 1
PublisherBSI
FormatA4
DeliveryNo
Pages68
File Size1.358 MB
Price£254.00


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