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QUALITY MANAGEMENT SYSTEMS - EN ISO 9001:2015 FOR HEALTHCARE
German Institute for Standardisation (Deutsches Institut für Normung)
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National foreword<br>National Annex NA (informative) - Bibliography<br>European foreword <br>Introduction <br>1 Scope <br>2 Normative references <br>3 Terms and definitions <br>4 Context of the organization <br>5 Leadership<br>6 Planning<br>7 Support<br>8 Operation<br>9 Performance evaluation<br>10 Improvement<br>Annex A (informative) - Clarification of new <br> structure, terminology and concepts<br>Annex B (informative) - Other International<br> Standards on quality management and<br> quality management systems developed<br> by ISO/TC 176<br>Annex C (informative) - Correlation matrix<br> EN 15224:2012 to EN ISO 9001:2015 to<br> EN 15224:2016<br>Annex D (informative) - Quality requirements<br> and quality characteristics in healthcare<br>Annex E (informative) - Guidance for process<br> approach in healthcare<br>Bibliography
Defines 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.
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