During World War II, to promote cooperation and standardize production among wartime allies, the United States, Canada, and Great Britain formed the United Nations Standards Coordinating Committee (UNSCC).1 When the war ended, 65 delegates representing 25 countries from the UNSCC and the International Federation of the National Standardizing Associations (ISA) met at the Institute of Civil Engineers in London, England.2 After days of intense deliberations, the UNSCC/ISA delegation of global experts established a new international standardizing body with a Central Secretariat (i.e., headquarters) located in Geneva, Switzerland. Since its inception in 1947, 169 member countries have joined the International Organization for Standardization (ISO) to collectively publish over 25,000 expert consensus International Standards and related documents in technology, management, and manufacturing.3
ISO 7101:2023
ISO International Standards provide requirements, recommendations, and guidance for industry sectors such as health, information technology, and transportation. Sector-specific health standards specify requirements to enhance patient safety and encourage innovation in healthcare services, medical devices, and health informatics. On October 3, 2023, ISO published a new International Standard with requirements applicable to any organization that delivers healthcare services.4 ISO 7101:2023 is the first management system standard (MSS) produced by ISO for healthcare organizations using quality management principles (QMPs) for process and performance improvements.
Quality management principles
To build a firm foundation of quality during standards development, ISO Technical Committees (TCs) apply seven basic quality management principles (QMPs). These QMPs are the “fundamental beliefs, norms, rules and values that are accepted as true and can be used as a basis for quality management.”5 ISO 9001:2015, the most popular quality management standard published by ISO, is based on the following QMPs:5
- QMP 1 – Customer focus
- QMP 2 – Leadership
- QMP 3 – Engagement of people
- QMP 4 – Process approach
- QMP 5 – Improvement
- QMP 6 – Evidence-based decision making
- QMP 7 – Relationship management
Management system standards
Healthcare organizations use management system standards (MSSs) to maintain business continuity and achieve strategic goals and objectives. Healthcare organizations often implement multiple MSSs simultaneously, thereby establishing an integrated management system of coordinated healthcare services. To facilitate this integration, ISO TCs develop MSSs with an identical or harmonized structure of clause numbers, clause titles, document text, common terms, and core definitions.6 For example, both ISO 9001:2015 and ISO 7101:2023 contain the following:7
- Clause 0 – Introduction
- Clause 1 – Scope
- Clause 2 – Normative references
- Clause 3 – Terms and definitions
- Clause 4 – Context of the organization
- Clause 5 – Leadership
- Clause 6 – Planning
- Clause 7 – Support
- Clause 8 – Operation
- Clause 9 – Performance evaluation
- Clause 10 – Improvement
The team of global health experts supplemented the harmonized structure of ISO 7101:2023, creating a framework of requirements for operations, quality, and risk management specifically for healthcare organizations.
Applicability of ISO 7101:2023 to diagnostic services
Diagnostic services are an integral part of healthcare organizations, playing a significant role in the provision of information contributing to patient diagnosis and treatment. Almost all the clauses in ISO 7101:2023 apply not only to direct patient services, but equally to medical laboratories, blood transfusion services, pathology, respiratory therapy, and diagnostic imaging services. Therefore, an organization choosing to demonstrate conformity to the requirements of ISO 7101:2023 needs to engage laboratory and diagnostic service managers in the process. Also, while it is important to read and understand an entire ISO standard, subclauses containing requirements of particular importance to medical laboratories can be found in Clause 7 and Clause 8 of ISO 7101:2023.
Clause 7: Support
The ten clauses of ISO 7101:2023 include subclauses of requirements and notes containing details to ensure consistent and effective implementation of the standard. While the heading of this clause may appear to simplify important requirements that apply to all areas of an organization, subclauses of Clause 7, the Support clause include topics such as personnel competence, orientation, and performance evaluation as well as the need for workforce awareness of the organization’s quality policy and objectives. Other requirements address communication, control of documented information, and the all-important information management systems.
Clause 8: Operation
Clause 8, the Operation clause, has subclauses for identifying and evaluating the characteristic and critical aspects of healthcare operations management, most of which are applicable to all areas of an organization, including diagnostic services. Some of the principles in the subclauses are not yet universally applied in medical laboratories and require additional clarification.
Subclause 8.10: People-centred care
People-centered care requires a culture of engagement and collaboration. Patients, families, and caregivers actively partner to improve the service experience and health outcomes. Diagnostic service managers are expected to undertake comprehensive assessments of a wide range of service-user experiences and include the results in a required management review. Workforce training is to be provided for the delivery of compassionate care, as well as to ensure a culture of inclusivity and diversity.
This subclause also provides requirements for health literacy in healthcare organizations. ISO defines health literacy as the “ability of individuals to gain access to, understand and use information in ways which promote and maintain good health for themselves, their families, and their communities.”4 Research shows low health literacy can delay life-saving healthcare services and contribute to health disparities among vulnerable patient populations.8 Subclause 8.10.5 Health literacy expects healthcare organizations to integrate health literacy into operations to ensure fair and impartial delivery of health services to all service users.
Subclause 8.11: Ethics
This is a small but especially important subclause requiring an organization to have processes and workforce training on how to address ethical dilemmas. In the laboratory setting, this may include such things as managing incidental findings unrelated to an original request or conducting human subject research.
Subclause 8.12: Patient safety
Patient safety is paramount in the delivery of services in all settings. As a minimum, consideration must be given to workforce balance, workload and workflow, institutional capacity, assessing the patient experience, and critical incident reporting. Subclauses of 8.12 of particular relevance to diagnostic services providers are 8.12.6 Infection prevention and control (IPC), 8.12.8 Diagnostic safety, and 8.12.9 Blood transfusions. The applicability of IPC requirements depends on the extent of laboratory involvement in infection prevention and control. 8.12.8 Diagnostic safety encompasses laboratory testing, pathology, and imaging services, with requirements for accurate and timely services, result reporting, and record keeping. ISO15189 is cited as an international quality and competence document that can apply to not only medical laboratories but also diagnostic imaging, respiratory therapy, physiological sciences, blood banks, and transfusion services. 8.12.9 Blood transfusions speaks to blood transfusion safety, donor education, preparation and administration of blood products, as well as training and education, adverse events, and waste management.
Conformity assessment
To aid agencies auditing healthcare organizations using the ISO 7101:2023 International Standard, there is a conformity assessment document, ISO/IEC TS 17021–15: 2023. The intent is to ensure that only auditors demonstrating relevant competence are authorized to perform management system audits.9 This document supplements the requirements of ISO/IEC 17021-1:2015 and ISO/IEC 17021-3:2017.
Sustainable development goals
In addition to providing requirements, recommendations, and guidance, ISO International Standards promote economic, social, and environmental sustainability.10 In 2015, the United Nations (UN) adopted 17 sustainable development goals (SDGs) and 169 targets to promote global sustainable development.11 Through SDG 3 (Good Health and Well-being), the UN intends to “ensure healthy lives and promote well-being for all at all ages”11 and in Target 3.8 intends to “achieve universal health coverage, including financial risk protection, access to quality essential healthcare services and access to safe, effective, quality and affordable essential medicines and vaccines for all.”11 ISO 7101:2023 contributes to Target 3.8 in SDG 3 through Clause 5, the Leadership clause at subclause 5.5 Access to care. ISO 7101:2023 also contributes to SDG 8 (Decent Work and Economic Growth), SDG 9 (Industry, Innovation and Infrastructure), SDG 10 (Reduced Inequalities), and SDG 11 (Sustainable Cities and Communities).4
Conclusion
“ISO standards on healthcare enhance patient safety, help streamline supply chains, and foster innovation in digital health and sustainable healthcare solutions.”12
ISO 7101:2023 has already been adopted by several countries for use as the preferred standard to ensure quality in healthcare organizations. Conformity assessment to this standard will ensure the inclusion of laboratory and other diagnostic services in healthcare organization decision-making. Historically, these service areas have been subject to minimal scrutiny and their invaluable contributions to patient care have often been overlooked.
REFERENCES
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2. Latimer J, ed. Recollections from ISO’s First Fifty Years.; 1997. https://www.iso.org/files/live/sites/isoorg/files/about%20ISO/docs/en/Friendship_among_equals.pdf.
3. About us. ISO. Published 2023. Accessed January 22, 2024. https://www.iso.org/about-us.html.
4. ISO 7101:2023. ISO. Published 2023. Accessed January 22, 2024. https://www.iso.org/standard/81647.html.
5. ISO. Quality Management Principles. Published 2015. Accessed January 22, 2024. https://www.iso.org/files/live/sites/isoorg/files/store/en/PUB100080.pdf.
6. ISO/IEC Directives, Part 1. ISO. Published 2023. Accessed December 1, 2023. https://www.iso.org/resources/publicly-available-resources.html?t=712usHn2eATZXjtj0c3FIJ16gvWZXP-_fykOV8H1WAolmA84oAGBwILzOVFUEc46&view=documents#section-isodocuments-top.
7. ISO 9001:2015. ISO. Published 2023. Accessed January 22, 2024. https://www.iso.org/standard/62085.html.
8. Gillespie DM. REDUCING POTENTIAL BARRIERS TO CERVICAL CANCER SCREENING OF UNDERSERVED SOUTHEAST ASIAN WOMEN IN MILWAUKEE, WISCONSIN by. Hmonglibrary.org. Accessed January 22, 2024. https://www.hmonglibrary.org/uploads/4/5/8/7/4587788/v2_proquest_txu002240924_eco_gillespie_donna_m_amu_dissertation.pdf.
9. Iso/iec ts 17021-15:2023. ISO. Published 2023. Accessed January 22, 2024. https://www.iso.org/standard/85773.html.
10. Contributing to the UN Sustainable Development Goals with ISO Standards. Published 2018. Accessed January 22, 2024. https://www.iso.org/files/live/sites/isoorg/files/store/en/PUB100429.pdf.
11. United Nations. Transforming Our World: The 2030 Agenda for Sustainable Development United Nations. Published 2015. Accessed January 22, 2024. https://sdgs.un.org/sites/default/files/publications/21252030%20Agenda%20for%20Sustainable%20Development%20web.pdf.
12. Naden C. Health. ISO. Published 2023. Accessed January 22, 2024. https://www.iso.org/sectors/health.
