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HEALTH CARE SERVICES - QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS BASED ON EN ISO 9001:2015
Comite Europeen de Normalisation
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European forewordIntroduction1 Scope2 Normative references3 Terms and definitions4 Context of the organization5 Leadership6 Planning7 Support8 Operation9 Performance evaluation10 ImprovementAnnex A (informative) - Clarification of new structure, terminology and conceptsAnnex B (informative) - Correlation matrix EN 15224:2012 to EN ISO 9001:2015 to EN 15224:2016Annex C (informative) - Quality characteristics and quality requirements in healthcareAnnex D (informative) - Guidance for clinical process approachBibliography
Describes 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.
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