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BS EN 15224 : 2016
M00015811
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BS EN 15224 : 2016
QUALITY MANAGEMENT SYSTEMS - EN ISO 9001:2015 FOR HEALTHCARE
British Standards Institution
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Table of Contents
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 structure,<br> terminology and concepts<br>Annex B (informative) - Other International Standards on<br> quality management and quality management systems<br> developed by ISO/TC 176<br>Annex C (informative) - Correlation matrix EN 15224:2012<br> to EN ISO 9001:2015 to EN 15224:2016<br>Annex D (informative) - Quality requirements and quality<br> characteristics in healthcare<br>Annex E (informative) - Guidance for process approach in<br> healthcare<br>Bibliography
Abstract
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 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.
General Product Information
| Document Type | Standard |
| Status | Current |
| Publisher | British Standards Institution |
| Committee | CH/100/-/2 |
| Supersedes |
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