Certification of ISO 7101:2023 for management systems of healthcare organisations
About the programme
UKAS is establishing a project to develop accreditation for the certification of management systems in healthcare services for ISO 1701 to ISO/IEC 17021-1:2015.
ISO 7101:2023 is a international standard for Healthcare quality management. Healthcare organisations around the world have faced issues such as workforce shortages, financial resource, increased numbers of patients and an absence of defined system governance.
The benefits of ISO 7101 certification are increased cost efficiencies, improved quality delivery, increased operational effectiveness, improved patient safety and strengthened reputation.
Accreditation of certification to ISO 7101 provides confidence that organisations have met rigorous internationally recognised standards in respect to the delivery of healthcare and care outcomes.
Associated Standards
ISO/IEC 17021-1:2015 Conformity assessment — Requirements for bodies providing audit and certification of management systems — Part 1: Requirements
ISO 7101:2023, Healthcare organization management – Management systems for quality in healthcare organizations – Requirements.
Current status
UKAS is conducting a pilot accreditation programme for ISO 7101. This project involves the following certification bodies from our existing customer base, all of whom are collaborating with the UKAS Development Team to explore and refine the accreditation process for this emerging standard.
BSI Assurance UK Ltd
CHKS
The pilot aims to identify the optimal approach for assessing certification bodies against ISO 7101 and related requirements. Through rigorous evaluation and stakeholder engagement, UKAS is working to establish an effective methodology that ensures accreditation is reliable, consistent, and provides trust and confidence to users.
Once the pilot programme is complete and the assessment approach is finalised, UKAS will begin granting initial accreditations. This milestone will mark the start of a new era in the certification of Healthcare Quality Management.
