What is ISO 15189 and why is it important?

Aaron Hoare Date published: Feb 14, 23

ISO 15189:2022 – Medical Laboratories is an international standard that specifies the requirements for quality and competence in medical lab environments. Essentially, it is a standard that requires labs to develop a robust, reliable quality management system (QMS) to establish their competence.

A revised version of ISO 15189 was published in December 2022, bringing with it an array of refinements, clarifications, and changes to the 2012 version. If you are already familiar with ISO 15189 and want more information about the 2022 revision, we put together a free, comprehensive white paper about transitioning to the new standard. However, if you are looking for information about the standard more generally – perhaps you are looking into becoming ISO 15189 certified for the first time or researching if it is applicable to your organization – then read on.

The key detail of ISO 15189 is that is applies specifically to medical laboratories. It is, therefore, differentiated from ISO 9001, which sets out the criteria for a quality management system in any type of organisation, and from ISO/IEC 17025, which sets out the general requirements for the competence of testing and calibration laboratories (not necessarily medical labs).

These are likely to be the other ISOs you have come across if you have just started the process of getting your lab ISO accredited. But keep in mind that it is ISO 15189 you should be looking to attain if you operate a medical laboratory specifically.

ISO 15189 is so important for medical laboratories because it is a globally recognised accreditation that will allow you to ensure the reliability, competence, integrity, and overall quality of your lab’s practices. It is crucial to the perception of your entire organisation as trustworthy, credible, and competent to your customers or business partners.

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Is ISO 15189 a requirement for medical laboratories?

ISO 15189 certification is not mandatory, but it is not an overstatement to say it is highly recommended. Especially when you are dealing with the health of the public, a better question might be ‘can you afford to not be ISO 15189 accredited?’

As a globally recognised standard of quality, laboratories who do not hold ISO 15189 will soon find they lose out on preferred supplier status. Even worse, you might simply fail to meet the standards of rigorous tender application processes altogether. Additionally, as laboratories all over the world seek to standardise their practices as far as possible to enable better data sharing, many see an ISO accreditation as a vital step towards globally consistent data.

But these are not the only benefits of ISO 15189 that make accreditation so essential, even if it is not a strict requirement. Below, we have listed more of the benefits of getting ISO 15189 certified if you are not yet convinced of its importance.

What are the benefits of ISO 15189 accreditation?

There are many key benefits of meeting ISO 15189 accreditation standards. Some of those important benefits include:

• By meeting ISO 15189 standards, you will be compliant with the relevant legal requirements to your sector
• It is internationally recognised, meaning institutions around the world will be reassured of the quality of your practices – see for example the International Laboratory Accreditation Cooperation (ILAC) endorsement of ISO accreditation
• You ensure you meet this common, strict prerequisite for many tender application processes
• You will meet the increasing demand for producing data that is globally consistent
• Boosting your reputation in the global community
• Increasing your chances of achieving preferred supplier/partner status with new or existing customers
• You can gain an advantage over competitors who do not hold ISO 15189 certification
• Elevating your lab(s) to the same reputation level as competitors who already hold ISO 15189
• Saving money by implementing more efficient practices and avoiding costly mistakes
• Time will be saved by automating many tedious, time-consuming tasks
• Proactively managing the risks inherent in medical testing laboratories, heading off any potential impact on equipment, services, and of course public health
• Centrally holding documents and key information to provide a single source of truth across your lab(s)
• You can demonstrate a commitment to protecting data
• You will be set up to work towards continual improvement, driving positive results for a range of KPIs
• You can show your commitment to continuous improvement, utilising a plan-do-check-act (PDCA) model

A reliable, effective quality management software solution is the best way to reap the benefits of ISO 15189 certification and go beyond compliance into continual improvement. From managing training and professional development, to centrally managing audits in an efficient manner, an effective QMS reduces the administration time required for crucial quality management tasks in medical labs. This means you can focus on the quality of the service you provide while also using the software’s insights to work towards improvements.

Ultimately, your goals should be to ensure effective diagnoses through accurate analytical work, to improve patient care outcomes by running the most efficient laboratory possible, and to reduce your lab’s exposure to risk through strong due diligence practices. Ideagen Quality Management can make achieving these goals straightforward.

How to attain ISO 15189 accreditation

If you were wanting to know “what is ISO 15189 accreditation”, then you probably also want to know how to achieve it. If you are confident in your quality management systems, you apply to a relevant accreditation body in your country. The application process is generally online.

In the UK, the United Kingdom Accreditation Service (UKAS) grants ISO 15189 accreditation. Other bodies exist globally, such as the International Accreditation Service (IAS), or the College of American Pathology, (CAP) who provide ISO 15189 certification in the USA.

After applying, there is a pre-assessment, where the accrediting body will identify any substantial issues you may need to address before your assessment. This may be referred to as an “audit gap analysis.” This is the stage at which you might realise you need to significantly overhaul or modernise your quality management system, for example by using powerful QMS software.

You will then be audited against the criteria detailed in ISO 15189. Unlike similar accreditation assessments, for example for ISO 9001 certification, your assessment will be carried out by experts in your field. As such, auditors will have a significant degree of technical knowledge and insight into the tests you carry out in your lab.

You can usually expect it to take 3 to 6 months to attain certification. This can of course vary based on what quality management systems you already have in place and the amount of issues identified during your pre-assessment or assessment. But 3 to 6 months is a realistic timeframe for most labs.

Maintaining ISO 15189 accreditation

Once you have accreditation, in the UK you will enter a “surveillance” period. This means that UKAS will check up on your processes every year, checking for obvious breaches of ISO 15189 compliance. Every 4 years, you will have a full re-assessment carried out by UKAS.

Internationally, this surveillance and re-assessment process varies depending on the accreditation body. However, the process will still follow a cycle of periodic surveillance check-ups followed by less frequent, full re-assessments. The CAP for example run a 3-year assessment cycle, but the pattern it follows is very similar to UKAS.

By far the easiest way to maintain compliance with all the requirements of ISO 15189 is to use powerful, tried and tested quality management software. This is especially important if you are still using a paper-based system or numerous spreadsheets requiring substantial manual oversight.

A trusted QMS software will allow your entire organisation to operate using a single source of truth, track emerging risks, ensure the competency of staff, and generally foster a culture of quality from top to bottom that is essential to your lab thriving.

Discover how Spire healthcare achieved ISO 15189 accreditation with Ideagen Quality Management

Spire Healthcare use [Ideagen Quality Management] in its 22 labs across the UK to achieve and maintain ISO 15189 certification. It has allowed them to overcome many of the operational challenges they face, which proved particularly valuable during the Covid-19 pandemic. They are now reaping the benefits, pursuing a process of continual improvement. Watch this case study to learn more about how Spire are thriving now they have the systems in place to maintain their ISO 15189 accreditation with ease.  

View the Spire Healthcare case study

Watch this case study to learn more about how Spire are thriving now they have the systems in place to maintain their ISO 15189 accreditation with ease.

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