Subject
Healthcare systems and organizations of all sizes and structures embrace a culture of quality and continual improvement with the objective of providing timely, safe, effective, efficient, equitable and people-centred care. Given the current and future challenges in healthcare, more than ever it is vital to improve service user experience, quality of care, and provide sustainable solutions.
Healthcare organizations around the world have been facing significant threats such as decreasing financial resources, workforce shortages, increase in the number of people needing care as a result of ageing populations, increasing rates of chronic disease, lack of shared data for decision making, scarcity or inadequacy of medical equipment and medications, and an absence of clear healthcare system governance. Many countries have embarked on universal health coverage, while others struggle with rising healthcare costs. To compound this, a global pandemic has highlighted the importance of virtual healthcare, new technologies, and the need to create and adapt approaches to healthcare management and delivery. These health and organizational challenges require bold and innovative steps to improve healthcare quality around the world.
Applied standards
ISO 7101 provides requirements for management systems for quality in healthcare organizations. As such, its target audience is broad, including any healthcare system, organization, or entity that aims to increase the quality of its healthcare delivery and care outcomes. This includes ministries of health, public and private healthcare systems, hospitals, clinics, non-governmental organizations and agencies that provide healthcare services, and more.
The aims of a management system for quality in healthcare organizations include the following:
- create a culture of quality starting with strong top management;
- embrace a healthcare system based on people-centred care, respect, compassion, co-production, equity and dignity;
- identify and address risks;
- ensure patient and workforce safety and wellbeing;
- control service delivery through documented processes and documented information;
- monitor and evaluate clinical and non-clinical performance;
- continually improve its processes and results
The success of a management system for quality in a healthcare organization depends on the commitment from all levels and functions of the organization, led by top management. The top management structure of the organization can create a culture of quality by including quality principles in the organization’s strategic direction, decision making, and aligning them with other operational priorities. Successful implementation of this document can demonstrate to stakeholders that an effective management system for quality in the healthcare organization is in place.
The level of detail and complexity of a management system for quality in the healthcare organization varies depending on the context of the organization, the scope of its work, its regional, national, and international conformity obligations, the nature of its activities, services provided, and resources available.
Our services
The SSA provides high quality services of Certification of management system for quality in healthcare organizations based on ISO 7101. The service includes a complex of onsite and off-site assessment of how organisation established, implemented, maintained and continually improved a healthcare quality management system.
Links
- ISO 7101:2023 - Healthcare organization management — Management systems for quality in healthcare organizations — Requirements
- ISO 22886:2020 - Healthcare organization management — Vocabulary
- ISO 22956:2021 - Healthcare organization management — Requirements for patient-centred staffing
- ISO 22525:2020 - Tourism and related services — Medical tourism — Service requirements
- IWA 35:2020 - Quality of learning environments for students in healthcare professions — Requirements for healthcare education providers in care settings
- ISO 81001-1:2021 - Health software and health IT systems safety, effectiveness and security — Part 1: Principles and concepts
- ISO 22600-1:2014 - Health informatics — Privilege management and access control — Part 1: Overview and policy management
- ISO/TS 17975:2022 - Health informatics — Principles and data requirements for consent in the collection, use or disclosure of personal health information
- ISO 15189:2022 - Medical laboratories — Requirements for quality and competence
- ISO 35001:2019 - Biorisk management for laboratories and other related organisations
- ISO 15378:2017 - Primary packaging materials for medicinal products — Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP)
- ISO 13485:2016 - Medical devices — Quality management systems — Requirements for regulatory purposes