ISO 7101:2023 医疗机构管理 医疗机构质量管理体系 要求

标准编号:ISO 7101:2023

中文名称:医疗机构管理 医疗机构质量管理体系 要求

英文名称:Healthcare organization management — Management systems for quality in healthcare organizations — Requirements

发布日期:2023-10

标准范围

本文件的目的是为组织提供提供高质量医疗保健的要求,并规定当组织希望:A)?证明其有能力始终如一地满足服务用户、利益相关者以及适用的法律和监管要求;b)?在连续护理过程中增强服务用户体验,并不断提高医疗质量;和c)?创建和维护流程,确保及时、安全、有效、高效、公平和以人为本的护理。本文件的要求基于公认的最佳实践,旨在适用于任何提供医疗保健服务的组织,无论其类型、规模或提供的服务如何。

The purpose of this document is to provide organizations with requirements to deliver high-quality healthcare and specifies requirements for management systems for quality in healthcare organizations when an organization desires to:

a)       demonstrate its ability to consistently meet service user, stakeholder, and applicable statutory and regulatory requirements;

b)       enhance service user experience during the continuum of care and continually improve healthcare quality; and

c)        create and maintain processes that ensure timely, safe, effective, efficient, equitable, and people-centred care.

The requirements of this document are based on recognized best practices and are intended to be applicable to any organization providing healthcare services, regardless of its type, size, or the services it provides.

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