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04 December 2017

The ISAS standard has been revised - are you familiar with the changes?

By Andrew O'Hara

In the NHS, the Imaging Services Accreditation Scheme (ISAS) is increasingly seen as the gold standard for imaging services, with accreditation providing assurance to patients, the public and staff that services are safe and of high quality.

In a September 2016 survey by the NHS’s Benchmarking Network, 14 per cent of imaging services in England were already accredited to the standard, with 59 per cent either preparing for or already going through accreditation.

In January, the standard was revised to bring it into line with national and international accreditation standards. The revision reduces the 242 criteria of the previous version to 143, taking into account developments in several key areas since version 2.1 was published in 2013.

The biggest change to the standard is the addition of a new domain, Leadership and Management. This combines all the requirements to define roles and responsibilities from version 2.1 into three criteria that cover leadership and management at every level and in every area of the Service.

It also takes criteria from throughout the other domains to give greater direction in the overall leadership and management of the service.

The new domain also introduces the requirement for a formal quality management system, including the concepts of document control, audit, corrective and preventive action (CA/PA) and continual improvement and management review.

This is further reinforced by changes to the Facilities, Resources and Workforce domain. This now separates equipment procurement and maintenance into two statements, while keeping the statements to make sure staff are competent and to review their competence.

The revision also takes out the statement on authorising, managing and supporting staff in delivering the service, but adds its criteria to other statements. Together with patient feedback, this covers all the elements of a quality management system specified in ISO 9001 and other standards.

The changes bring ISAS more into line with similar standards in other disciplines, in particular ISO 15189:2012 for medical laboratories, which could be seen as positioning the standard for development into an international standard in the future.

It also combines all the risk management requirements into a single requirement to maintain a risk register. This is a forward-looking move that aligns it with the risk-based thinking introduced in the most recent revisions of ISO standards, such as ISO 9001:2015 and ISO 13485:2016.

Imaging services across the NHS use Q-Pulse to achieve and maintain ISAS accreditation, including Royal Devon and Exeter NHS Foundation Trust.With the publication of the new revision, we’re continuing to support imaging services seeking accreditation to the standard.

The latest version of our ISAS quick reference guide lists all 143 criteria, organised by domain and statement and identifies the modules of Q-Pulse that are appropriate to each.

The quick reference guide is available on request either as a downloadable PDF or as a print brochure that folds out into an A2 poster. Both let you see at a glance how Q-Pulse can help meet the standard’s criteria to help your service gain and maintain ISAS accreditation.

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