Could ISO 7101 transform healthcare?

The healthcare sector is facing existential pressures from all sides – an ageing population, rising rates of chronic disease, budgetary strains and workforce shortages. Alongside these challenges, the pandemic has stretched our healthcare services to the limit – highlighting the urgent need for greater resilience within the sector. It’s all contributing to a perfect storm of challenges for healthcare providers around the world.

Healthcare organisations are seeking new ways to drive quality improvements – ensuring that they’re delivering high-quality care and sustainable healthcare services.

Launched in 2023, ISO 7101 is a new healthcare quality management standard designed to help healthcare organisations take bold action to meet these challenges head-on and deliver better healthcare services. In this blog, I’ll be sharing my thoughts on ISO 7101 – the key principles, why it’s been developed and how it could benefit your healthcare organisation and the patients you serve.

ISO 7101 – the lowdown

You might be surprised to learn that ISO 7101 is the first international standard specifically dedicated to healthcare quality management. Until now, many healthcare providers have sought ISO 9001 certification. Of course, ISO 9001 is the world’s most popular standard. However, the framework is inevitably generic as it’s designed for use across different sectors. The complexities of healthcare, and the unique challenges facing the sector at this time, have prompted healthcare leaders to create a more tailored solution.

ISO 7101 has been developed over four years with input from healthcare experts from over 40 countries – including healthcare leaders in the UK, Canada, Japan, India, Africa and many other parts of the world.

The standard is applicable to healthcare organisations of any size and in any location – from GP practices to hospitals, private healthcare providers and healthcare agencies.

Specifically, ISO 7101 provides a structured approach to healthcare management by:

• Creating a culture driven by high-quality standards – overseen by strong leadership and effective healthcare policies
• A focus on patient-centered care – ensuring service users are treated with respect, dignity, compassion and equity
• Good communication – both internally and externally
• Effective planning and risk management to ensure patient safety
• High-quality education and training
• High standards of service delivery through well-documented processes and audits (to monitor effectiveness)
• Improved management of facilities, waste and technology
• Continuous monitoring and improvements

The new standard is based on the Plan-Do-Study-Act (PDSA) model used by organisations to deliver continual improvements through cycles of ongoing evaluation and an assessment of changes.

The benefits of ISO 7101

ISO certification requires some investment in terms of time, and money. So, what is the payback for your healthcare organisation?

First and foremost, ISO 7101 will help you drive improvements in patient care and safety – and ultimately increase patient satisfaction. Being certified to an international standard shows your commitment to enhancing the quality of healthcare provision. So, it can also have a huge reputational impact. This has a knock-on effect on staff recruitment, retention, morale and motivation – which ultimately enhances performance and productivity.

ISO 7101 certification can also demonstrate to regulators that you’re committed to delivering quality improvements – providing confidence from third-party auditors representing an accredited certification body. An enhanced reputation can also open up access to new funding or other opportunities – helping you to deliver greater impact and enhanced services, as well as improved health outcomes.

The wider impact of ISO 7101

Of course, ISO 7101 certification is not an endpoint. Healthcare organisations need to monitor compliance continuously to drive improvements. However, the significance of the new ISO 7101 standard shouldn’t be underestimated.

Professor Adam Layland, NHS director and clinician and international convenor of the ISO working group which developed ISO 7101, said in a 2023 podcast: “There are huge benefits to adopting ISO 7101 and utilising this as part of your regulatory compliance. It all adds to the confidence and evidence base on how you are as an organisation.

“I’d like to see ISO 7101 as part of the standard contract for all healthcare organisations…and part of that compliance to be an NHS organisation because that is what is going to deliver better care to the public.”[1]

“I truly believe that this will have such an impact on the delivery of healthcare services around the world.”

My view is that the impact of ISO 7101 is likely to be felt far and wide. I expect many healthcare organisations to transition from ISO 9001 to ISO 7101 in the long term – but it will take time to embed across the sector. You can demonstrate your credentials as a proactive organisation by becoming an early adopter.

To learn more about the steps involved in implementing ISO 7101 in your healthcare organisation, please take a look at my website and get in touch.

[1] The Standards Show, Episode 126, ISO 7101, Interview with Professor Adam Layland, 09/11/23