Published in 2023, ISO 7101 the new standard for healthcare organisations, is gaining interest across the world, particularly in India, Japan, South Africa, Italy and the UK. As of 7th July 2025, the UK’s accreditation body UKAS is in the pilot stage developing the necessary scheme to accredit UK Bodies to deliver the certification.
Here’s more about the standard and the ISO 7101 Certification Landscape.
What Is ISO 7101?
ISO 7101:2023, titled “Healthcare organization management – Management systems for quality in healthcare organizations – Requirements”, provides a framework for healthcare providers to implement a structured approach to quality management. It aligns with the principles of ISO 9001 but is tailored specifically to the healthcare sector, addressing unique challenges such as patient safety, clinical governance, and regulatory compliance.
The standard is intended for use by all types of healthcare organisations—from hospitals and clinics to long-term care facilities and community health services. It encourages a culture of quality, accountability, and evidence-based decision-making.
The standard has particular benefits in private/public healthcare systems where private organisations are operating facilities and delivering services. Even in the UK ISO 7101 has a place in managing the quality expectations of various stakeholders.
UKAS Pilot Programme: Laying the Groundwork for Accreditation
The United Kingdom Accreditation Service (UKAS) is currently in the early stages of developing an accreditation programme for certification bodies that wish to certify organisations against ISO 7101. As of 7th July 2025, UKAS has issued a call for expressions of interest from certification bodies and technical experts who may wish to participate in the pilot phase of this initiative.
BSI who have been active in the development and promotion of the standard, will certainly be included, but [hopefully] so will other certification bodies with an interest to create a competitive certification market.
The pilot programme will be based on ISO/IEC 17021-1, which outlines the requirements for bodies providing audit and certification of management systems. UKAS is using this initial phase to gauge interest and determine the demand for accreditation in this area. Certification bodies that express interest will be invited to a stakeholder meeting where the terms of the pilot, key milestones, and phased implementation will be discussed.
In addition, the specific competencies required to audit the management system have been defined in ISO 17021-15, competence requirements for auditing and certification of management systems for quality in healthcare organizations, also published in 2023. This will form the basis of auditor’s competency requirements.
Participation in the pilot will involve a development fee in addition to standard assessment costs. Importantly, submitting an expression of interest does not commit an organisation to participate, nor does it guarantee acceptance into the pilot.
How to Get Started with ISO 7101?
Although UKAS accredited certification is not yet available, you can still begin preparing for ISO 7101 by performing a gap analysis, implementing the requirements and conducting internal audits.
Our certification management team can direct you to experienced ISO 7101 consultants and help you choose the right certification body. Contact us.
For Healthcare professionals with a quality management background, you might consider a career in third-party auditing for certification bodies. Check ISO 17021-15 for the competence requirement or reach out to participating certification bodies.