ISO 15189 – What is it All About?

ISO 15189

ISO standards now number in their thousands and with so many certifications to choose from, it can be tough knowing which standard is best for your business. We’re are introducing a new ISO to the family of standards we offer – ISO 15189. But what does it measure and why is it important?

What is ISO 15189?

ISO 15189 Medical laboratories – Requirements for quality and competence is an international standard that is specific to medical laboratories and their quality management systems. It draws on details in ISO 17025 as well as other ISO families, such as 9001 and in doing so, a specific and defined standard has been created. It is a unique standard aimed at a unique set of businesses and organisations.

The first version of the standard was published in 2003, with updates in 2007 and most recently in 2012. It is this third edition that we are currently offering to organisations keen to cement their laboratory information management processes. In fact, ISO 15189:2012 is currently under review meaning that there could be modifications and additions in the coming 12 months. 

Effectively, this standard will see labs develop their own quality management systems as a demonstration of their competence. 

What’s the difference between ISO 15189 and other quality assurance and competency-based standards?

The ISO 9001 family of standards relate to quality management systems and whilst these standards are excellent in the many environments they are applied to, ISO 15189 is specific to medical laboratories. 

The framework to the standard provides a quality management system close to that of ISO 9001, with added specification relating to technical competence within a medical laboratory setting.

It is a standard based on a recognised quality assurance approach, known as Deming TQM and like other standards, ISO 15189 places a growing emphasis on leadership and the critical role it places throughout the cyclical phase of quality assurance.

What’s involved in ISO 15189?

The technical requirements of the standards are applied to personnel, accommodation and environmental conditions, as well as laboratory equipment, reagents and consumables. Also included are pre-examination processes and examination process, as well as ensuring the quality of testing processes results, post-examination process, reporting results, the release of results and laboratory information management.

Is this standard worth the effort?

Every ISO is worth the effort and input from every member of your team! The benefits are many and varied. For laboratories, this standard specific to quality assurance systems within the medical laboratory sector, afford a platform by which you can showcase the reliability of your organisation and the services that it offers.

How long does ISO 15189 certification take?

The amount of time varies, depending on the systems you currently have in place, how these align with the standard and any work involved in bringing what you do in line with the benchmarks set down by ISO 15189. A timeline of three to six months is not unrealistic.

Working with an expert team will help your organisation optimise the process of acquiring this important standard. Why not get in touch to find out more?

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Steve Kilburn
Steve Kilburn
I initially trained as an industrial chemist working in a variety of manufacturing environments eventually moving into quality management which grew to encompass environmental and occupational health and safety management systems. I hold a Masters Degree in Health and Safety law and Environmental Law and a Post Graduate Certificate in Sustainable Waste Management and I am a Graduate Level Member of the Institution of Occupational Safety and Health (IOSH). In my spare time I enjoy reading, my favourite author is Stephen King, and listening to music, generally from the late 70’s, 80’s and 90’s.
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