The healthcare sector faces many complex challenges, from ageing populations and workforce shortages to the aftermath of global pandemics, and there is a growing need for a robust, sector-specific quality management framework. Introducing ISO 7101:2023, the new international standard designed specifically for healthcare organisations.

What is ISO 7101?

ISO 7101:2023 is a management system standard tailored for healthcare. Unlike the general quality management system ISO 9001:2015, which applies to any organisation regardless of sector, ISO 7101 focuses on the unique needs of healthcare providers, with a strong emphasis on:

• People-centred care
• Patient safety and equity
• Workforce wellbeing
• Ethical governance
• Resilience and learning from incidents

How Does ISO 7101 Fit into the UK Health Landscape?

The UK’s NHS and private healthcare providers already operate under a complex web of regulatory and quality frameworks, including CQC standards, NICE guidelines, and clinical governance models. 

ISO 7101 offers a unifying international framework that can:

• Complement existing UK regulations
• Provide a structured, auditable system for quality and safety
• Enhance global credibility for UK healthcare providers
• Support integrated care systems (ICSs) by aligning diverse providers under a common standard

Given the NHS’s increasing focus on patient experience, equity, and digital transformation, ISO 7101 could serve as a valuable tool for driving consistent, measurable improvement across the sector.  

The standard could be particularly useful to healthcare businesses managing multiple practices, as a way to manage their regulatory compliance while also measuring performance of every part of the organisation.

Built on Annex SL: Familiar Structure, New Focus

Like ISO 9001, ISO 7101 follows the Annex SL high-level structure, which means it shares a common framework with other ISO management system standards. This includes:

• 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

This structure makes it easier for organizations already certified to ISO 9001 to integrate ISO 7101 into their existing systems.

Expanding an ISO 9001 System to Include ISO 7101

For healthcare organisations already certified to ISO 9001, transitioning to or integrating ISO 7101 is relatively easy.

• Broadening the scope to include healthcare-specific terms like “service user,” “co-production,” and “intelligent kindness”
• Enhancing leadership and planning to address ethics, equity, and workforce wellbeing
• Strengthening operational controls around clinical care, patient safety, and environmental responsibility
• Upgrading performance evaluation to include clinical outcomes, health indicators, and service user feedback

However, the transition is not a simple “bolt-on”, it requires a cultural shift toward people-centred care and a deeper engagement with healthcare-specific risks and opportunities.

Certification to ISO 7101

ISO 7101 is certifiable, and organisations can seek third-party certification to demonstrate their commitment to high-quality, equitable, and safe healthcare delivery. 

Certification can:

• Build trust with patients and stakeholders
• Support contractual and regulatory compliance
• Provide a competitive edge in both public and private healthcare markets
• Enable international benchmarking and collaboration

As certification bodies begin to offer audits against ISO 7101, early adopters will be well-positioned to lead the way in healthcare quality innovation.

A Note on ISO 7101 Certification: As of October 2025, the UK’s Accreditation Body, UKAS does not offer accredited certification.  However, there are certification bodies, including BSI, who may provide unaccredited certification. 
Read more: ISO 7101 Certification: A New Standard for Quality in Healthcare Management 

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Conclusion

ISO 7101 represents a significant step forward in aligning healthcare quality management with the realities of modern care delivery. For UK healthcare providers, whether NHS trusts, private clinics, or integrated care systems, it offers a powerful framework to enhance safety, equity, and patient experience.

If you’re already working with ISO 9001, ISO 7101 is a natural evolution. And if you’re new to ISO standards, this is a timely opportunity to build a resilient, people-centred management system from the ground up.

ISO 7101 Pilot Scheme

Assent Risk Management champions international standards. We have worked with many clients in the healthcare industry and we would like to run a pilot scheme for any organisations interested in implementing ISO 7101 and/or achieving ISO 7101 Certification. Please contact us to discuss this opportunity further.