BS EN 15224:2016规定了医疗保健系统运行时的质量管理体系要求 组织:需要展示其持续提供符合以下要求的医疗保健产品或服务的能力: 客户和适用的法律法规要求，以及通过有效应用系统来提高客户满意度，包括 改进系统和确保符合客户要求的流程 要求、适用的法律法规要求以及与 质量方面；适当、正确的护理；可利用性护理的连续性；有效性效率 股本基于证据/知识的护理；以患者为中心的护理，包括身体、心理和心理护理 社会诚信；患者参与；患者安全和时间表/可访问性。本国际标准的所有要求均为通用要求，适用于任何 医疗保健组织，无论其类型或规模，或其提供的产品和服务。注1:在本标准中，术语“产品”或“服务”仅适用于拟用于或 顾客的要求。注2:法定和监管要求可以表示为法律要求。与组织、血液制品、药品、细胞培养等材料输出相关的要求 产品和医疗器械不在本标准范围内，因为它们受到监管 在别处本标准侧重于临床过程管理的要求。 还有 将研究或教育过程纳入其质量管理体系，可以使用 本标准适用时。本标准旨在规定并补充EN ISO 9001:2015中的要求 医疗保健主要提供服务，客户主要是患者的条件。交叉引用:EN ISO 9000:2015ISO 9000:2015EN ISO 9004ISO 10001ISO 10002ISO 10003ISO 10004ISO 10005ISO 10006ISO 10007ISO 10008EN ISO 10012:2003ISO/TR 10013ISO 10014ISO 10015ISO/TR 10017ISO 10018ISO 10019EN ISO 14001EN ISO 19011ISO 31000ISO 37500ISO/IEC 9000300-1IEC 60300-1EN 61160IEC 61160ISO 9001EN ISO 9001:2015ISO/IEC 27000:2009ISO/IEC 27001:2005EN ISO 13485: 2016ISO 13485:2016EN ISO 13940:2016ISO 13940:2015ISO/TR 20514:2005ISO指南73:2009ISO 704:2009ISO 860:2007EN ISO 9004:2009ISO 9004:2009购买本文件时提供的所有当前修订版均包含在购买本文件中。

BS EN 15224:2016 specifies requirements for a quality management system when a healthcare organization:needs to demonstrate its ability to consistently provide healthcare product or service that meets customer and applicable statutory and regulatory requirements, andaims 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.All the requirements of this International Standard are generic and are intended to be applicable to any health care organization, regardless of its type or size, or the products and services it provides.NOTE 1 In this standard the terms "product" or "service" only apply to products and services intended for, or required by, a customer.NOTE 2 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 are not the focus of the scope of this standard as they are regulated elsewhere.This standard is focused on requirements for management of clinical processes. Organizations that also include research or education processes in their quality management system could use the requirements in this standard where applicable.This standard aims to specify and complement the requirements in EN ISO 9001:2015 to the specific conditions for healthcare providing mainly services and where customers are mainly patients.Cross References:EN ISO 9000:2015ISO 9000:2015EN ISO 9004ISO 10001ISO 10002ISO 10003ISO 10004ISO 10005ISO 10006ISO 10007ISO 10008EN ISO 10012:2003ISO 10012:2003ISO/TR 10013ISO 10014ISO 10015ISO/TR 10017ISO 10018ISO 10019EN ISO 14001EN ISO 19011ISO 31000ISO 37500ISO/IEC 90003EN 60300-1IEC 60300-1EN 61160IEC 61160ISO 9001EN ISO 9001:2015ISO/IEC 27000:2009ISO/IEC 27001:2005EN ISO 13485:2016ISO 13485:2016EN ISO 13940:2016ISO 13940:2015ISO/TR 20514:2005ISO Guide 73:2009ISO 704:2009ISO 860:2007EN ISO 9004:2009ISO 9004:2009All current amendments available at time of purchase are included with the purchase of this document.