The healthcare industry is currently experiencing a mix of exciting opportunities and challenging times. It’s embracing innovative technologies such as the use of artificial intelligence, wearable medical devices, telemedicine, cutting-edge gene technologies, and the growth of distance or “hospital at home” care. Alongside these innovations and opportunities, the healthcare sector is also facing challenges on an unprecedented scale.
The COVID-19 pandemic exposed major vulnerabilities within existing healthcare systems. Many systems that were already struggling financially before the pandemic have been left with tremendous debt. Globally, we’re facing healthcare workforce shortages, with the World Health Organization (WHO) predicting a “shortfall of 18 million health workers by 2030, mostly in low- and lower-middle income countries.” The WHO also highlights that countries across all socioeconomic levels are facing difficulties related to education, retention and healthcare workforce performance. Since the pandemic, we’ve observed a decline in healthcare worker reports of wellbeing, and seen a significant increase in reports of violence against healthcare staff.
Humans are living longer than ever before. While this can be praised as scientific success, longevity of life expectancy poses challenges to already strained social systems. As patients age they commonly have a higher prevalence of chronic conditions, resulting in greater demands on healthcare services. Additionally, climate change further strains the healthcare sector through the need to respond in natural disasters and extreme weather events, illness caused by lack of access to food and water, and the destruction of existing healthcare facilities.
While the challenges can feel overwhelming, the opportunities before us are even more significant. Over the past three years, a group of healthcare experts, including those from BSI, have been creating a new healthcare quality management systems standard that equips healthcare organizations to manage and mitigate many of these challenges. ISO 7101: 2023 is the first international consensus standard for healthcare quality management. The standard is a result of exemplary collaboration of experts representing all WHO regions and World Bank income categories. Although, standards for certification and accreditation exist in the healthcare sector, one major differentiating factor for ISO 7101 is that it was created and approved through the rigorous ISO process. This process ensures impartiality, safeguards against conflicts of interest, upholds transparency, and ensures equality through the one country, one vote approval method.
ISO 7101 establishes a comprehensive set of requirements for organizations who aim to demonstrate their ability to consistently meet service user, stakeholder, and applicable statutory and regulatory requirements; enhance service user experience during the continuum of care, continually improve healthcare quality; and create and maintain processes that ensure timely, safe, effective, efficient, equitable, and people-centered care. Crucially, ISO 7101 follows the ISO Harmonized Structure (HS) for management systems, simplifying implementation and complying with multiple ISO management systems standards at the same time. For instance, a hospital that is ISO 9001 certified would already meet many of the requirements of ISO 7101, but the journey towards compliance with ISO 7101 would encompass additional requirements directly related to healthcare organizations. A notable advantage of this quality standard is that it’s been written by individuals who work in the healthcare industry, so terminology and concepts used in the standard are familiar and understandable.
With ISO 7101, an organization is assured that all the basics of tried-and-true quality management are covered, while embracing a more holistic view of healthcare delivery. Over time, we’ve understood that health systems, hospital networks, individual clinics, and agencies providing auxiliary services operate in an ecosystem that includes patients, families, caregivers and even communities. This standard addresses the diverse needs of numerous stakeholders, leading to improved quality of care, better use of resources, increased user safety, improved workforce wellbeing, and health equity. If these benefits weren’t enough, the standard also outlines requirements for sustainability achieved through risk management, contingency planning, management of waste, and environmental responsibility.
In an evolving landscape where healthcare options are rapidly diversifying, with more patients choosing private healthcare options, and even opting for medical tourism, ISO 7101 certified organizations give service users confidence that they will receive high-quality, safe, person-centered care. As our world gets further connected through the use of technology, it’s necessary to speak the same language when referring to high quality healthcare. ISO 7101 provides a common voice and directional compass for a new era of healthcare quality management.
For more information on ISO 7101, visit: https://www.bsigroup.com/en-GB/standards/bs-iso-7101/
 World Health Organizations. (n.d.). Violence and harassment. https://www.who.int/tools/occupational-hazards-in-health-sector/violence-harassment