Addressing the Need for High-Quality Healthcare Globally with ISO 7101

ISO 7101 outlines requirements for organizations that strive to deliver safe, timely, efficient, effective, equitable and people-centered care.

The Healthcare Quality Management Systems Standard is a new global standard designed to elevate the quality of healthcare around the world. It is focused on helping organizations to enhance patient experience, improve operational efficiency and foster a culture of quality and safety.

Join us as we explore how ISO 7101 can make high-quality care accessible for everyone.

The global healthcare challenge and the opportunity to address it

Global healthcare has been weathering a ‘triple threat’ for some time, meaning there is significant impetus for solutions to address these challenges and benefit patients and professionals alike.

Healthcare systems are facing growing demands, limited funding, and major workforce shortages. And this has all been exacerbated by the pandemic, with care being delayed for many people around the world.

While health outcomes have improved over the last decade, the care that people receive is often inadequate, For example, research by The LANCET and WHO has shown that in low and middle-income countries (LMICs):

• More than 8 million people die from conditions that should be treatable every year
• 60% of deaths from conditions amenable to health care are due to poor-quality care
• One in three people cited negative experiences with their health system in the areas of attention, respect, communication, and length of visit
• Nearly 40% of health care facilities lack improved water
• Under one in 10 people diagnosed with major depressive disorder receive minimally adequate treatment
• Less than 50% of suspected tuberculosis cases are managed correctly
• Adherence to clinical practice guidelines in several countries falls below 50%

And in high income countries:

• One in 10 patients are adversely affected during treatment
• Around 15% of hospital expenditure is used to correct preventable complications of care and patient harm

In order to drive progress towards healthcare systems that work for all, and address these issues, there are clear benefits to come from finding ways to improve quality of delivery in all countries.

Seizing the high-quality healthcare opportunity

High-quality health systems could save over 8 million lives each year in LMICs, prevent 2·5 million deaths from cardiovascular disease, 1 million newborn deaths, 900,000 deaths from tuberculosis, and half of all maternal deaths each year. WHO defines quality as; effectiveness, accessibility and timeliness, efficiency, and equity.

But how do we achieve this?

The Lancet Global Health Commission recommends measuring and reporting on what matters most to people, system-wide action and establishing a national quality guarantee for health services, specifying the level of competence and user experience that people can expect. Likewise, Professor Adam Layland, Convenor for ISO 7101 and NHS Director, has called for ‘a structured system with key quality metrics to achieve higher and better quality overall’.

Birthing a global quality standard in healthcare

At the same time as these leading organizations advocated for high-quality healthcare systems, technical experts identified the need for a healthcare industry framework grounded in the proven International Organization for Standardization (ISO) management systems approach.

A dedicated expert working group was formed; Technical Committee 304 for Healthcare Organization Management. Its mission? To enhance global health systems, improve health outcomes, and ensure patient safety worldwide. This initiative committed to making a positive impact and bringing high-quality healthcare within reach for all.

A collaborative global effort

“We took all the documents, mapped them out and came up with the high-quality healthcare framework” – Angela McCaskill, Project Lead, ISO 7101, BSI.

Doctors, nurses, risk managers, academics, and consultants came together in the working group to create a standard that transcends national agendas. The group included experts from all continents and all World Bank income categories, adding to the diversity of knowledge and experience.

Professor Adam Layland, the former 304 Technical Committee Chair and work group Convenor, played a key role in guiding complex discussions and building consensus.

The standard that was developed from this collaboration reflects a shared dedication to improving global healthcare. Professor Layland emphasized the international consensus approach, saying;

“Our philosophy throughout the development of the standard has been, For the world, by the world.”

Introducing ISO 7101

“This is more than a standard.. it’s a movement” 

The Healthcare Organization Standard (ISO 7101) has been created to provide a clear, systematic approach to improve patient care, patient quality and support workforce wellbeing. It’s applicable to healthcare organizations of all sizes and types. This standard focuses on continual quality improvement, effective leadership, risk management, and comprehensive information management.

The key benefits

The standard is designed to help transform operations and performance across healthcare organizations. It focuses on:

• Better service user experience: Enhances patient safety and care outcomes, focusing on creating positive experiences for individual patients, families and caregivers. The standard encourages co-design of patient care delivery.
• Stronger organizational reputation: Boosts reputation, helps workforce recruitment, and demonstrates a public commitment to the highest quality standards.
• Greater employee engagement: Prioritizes people and their professional development, aiding in workforce retention, continuity of care, and loyalty to the organization.
• Improved regulatory alignment: Aligns with standards like the Care Quality Commission’s metrics, making compliance easier.
• Increased operational efficiency: Reduces bureaucracy, optimizes resource use, and streamlines service delivery, positioning organizations for additional funding and research opportunities.

Tailored for every stage of your quality journey

The standard is applicable to organizations of any size or maturity.

• Emerging: Offers a clear starting point for setting up quality management systems.
• Developing: Designed to help you spot improvement opportunities through gap analysis and feedback.
• Mature: Structured to allow established organizations to refine systems and identify new areas for improvement.

Embracing continual improvement with the PDSA cycle

The Plan-Do-Study-Act (PDSA) cycle is at the heart of ISO 7101, driving ongoing quality improvement in healthcare.

• Plan: Develop detailed processes and identify your resource needs.
• Do: Put your plans into action.
• Study: Evaluate effectiveness and learn from the results.
• Act: Make any necessary adjustments and continue the cycle.

ISO 7101 Implementation tips

Find our tips for effective implementation of the standard and long term success.

• Understand the standard: Get to know the ten clauses of ISO 7101
• Engage leadership: Make sure leaders champion the quality agenda
• Communicate clearly: Share quality goals and indicators across the organization
• Document processes: Keep detailed records to track your progress
• Focus on people: Prioritize inclusivity, diversity, co-production, and wellbeing

Setting the standard for quality healthcare

The Healthcare Quality Management Systems Standard sets clear requirements for organizations dedicated to delivering safe, effective, timely, efficient, equitable and patient-centered care.

By focusing on leadership, organizations will be well placed to enhance service user experiences, boost operational efficiency, and foster a culture of quality and safety.

Successful implementation can come from education and collaboration, ensuring everyone understands and applies the standard effectively.

With support from GlobalStandards and global organizations like the World Health Organization (WHO), this effort aims to elevate patient care and drive better organizational performance through resilient systems.