本欧洲标准规定了医疗机构对质量管理体系的要求: a）需要证明其能够持续提供满足客户和适用的法定和监管要求的医疗保健产品或服务 b）旨在通过系统的有效应用来提高客户满意度，包括改进系统的流程和符合客户要求的保证，适用的法定和法规要求以及与质量特征有关的要求;适当，正确的护理;可用性;护理连续性有效性效率;公平;证据/知识为基础的护理;以患者为中心的护理，包括身体，心理和社会完整性;患者参与患者安全和时间安排/可及性。 注1法定和法规要求可以表示为法律规定。 与组织，血液制品，药品，细胞培养产品和医疗器械等物质输出有关的要求并没有集中在本标准的范围内，因为它们在其他地方被监管。 本标准着重于临床过程的要求。组织也包括研究或教育过程，或两者都在thei

This European Standard specifies 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. NOTE 1 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 have not been focused in the scope of this standard as they are regulated elsewhere. This 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 standard where applicable. This standard aims to adjust and specify the requirements, as well as the “product and service” concept and customer perspectives in EN ISO 9001:2015 to the specific conditions for healthcare providing mainly services and where customers are mainly patients.