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ISO 15189:
Medical Laboratories

ISO 15189 is an international standard for medical laboratories. Its criteria help labs develop quality management systems and appraise their competence.

 

An accredited laboratory is required to have a quality management system that consists of a quality manual, explaining how the laboratory will conform to each requirement of the ISO 15189 international standard. A collection of quality procedures that provide instructions for performing the tasks must be carried out to conform to the standards’ requirements.

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What is ISO 15189?

Laboratory testing is playing an increasingly important role in the delivery of information-based healthcare outcomes. As the ultimate recipients of such testing are patients whose systems are compromised by disease, it is critical that such testing is only carried out by competent personnel and those who work to the highest ethical standards. The results delivered by such testing must be both clinically relevant and conform to the highest quality standards.

Achieving certification to the ISO 15189 international standard demonstrates a laboratory’s commitment to delivering results that meet internationally recognised standards for quality and competence. Achieving this certification is a significant undertaking. It will often require skills not routinely used by the laboratory, and it may not be economical to retain such expertise on the permanent staff.

Any medical laboratory wanting to deliver clinically relevant results that meet the highest ethical standards should consider ISO 15189 certification. Medical laboratory services are crucial to patient care and require meeting the needs of all patients and the clinical personnel responsible for the support of those patients. Therefore, an increasing number of medical laboratories voluntarily undertake a pathway towards achieving ISO 15189 certification to ensure practice and professional competence according to good clinical laboratory practice principles and to increase confidence in laboratory testing by all stakeholders.

While ISO 15189 is intended for use throughout medical laboratory services, those working in other services and disciplines, such as clinical physiology, medical imaging, and medical physics, could also find ISO 15189 appropriate and valuable.

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The Benefits of ISO 15189

One of the main benefits of ISO 15189 certification is that it is globally recognised. A series of Multilateral Mutual Recognition Arrangements within the International Laboratory Accreditation Cooperation (ILAC) means that laboratories certified to ISO 15189 will have their certificates and test reports accepted in over 80 countries around the world.

Reduction in risk by using well structured best practices
Recognises and promotes the technical competence of staff
Assures client results are technically valid
Conveys trust & a level of recognition to stakeholders
Improves staff motivation and reduces staff mistakes
Ensures support in the event of a legal challenge
Assists in the development of additional programmes
Assures that services are safe, reliable, and of good value
Provides a tool for measuring quality improvements
Saves costs associated with retesting

Steps to getting

ISO 15189 certified

Woking towards ISO 15189 certification with IMSM is a trouble-free, step-by-step approach.

1. Initial consultation

We help you outline your goals, focusing on what your business wants to achieve and how it defines success, particularly in relation to your client’s requirements. You and your ISO consultants will agree on reasonable outcomes and delivery dates.

2. System Documentation

Our client portal IMSMLoop offers a comprehensive insight into the progress of your ISO implementation, along with copies of the relevant audit reports, certifications, and any necessary corrective actions. The portal serves as a central hub for tracking your ISO journey.

3. ISO 15189 Framework Adoption

Ensuring the framework is embedded throughout your organisation, we can also develop and deliver tailored training for staff to ensure that the understanding and implementation of ISO 15189 is watertight. Creating consistency across your organisation.

4. Submission to External Auditor

Your organisation applies to the third-party certifying body that you have selected to conduct your audit. This audit objectively determines whether your business conforms to ISO 15189, and the relevant accompanying documentation is accessible through our client portal, IMSMLoop.

Our Benefits

Why choose IMSM?

Simple: We make it simple. Since 1994, we've helped businesses achieve ISO certification, with over 150 experts worldwide and 15,000+ clients trusting us to implement their ISOs. We've proven to be experts at handling the logistical heavy lifting, saving your company valuable time.

With a transparent fixed fee, flexible approach, and real-time access to updates, documentation, and an array of other features through IMSMLoop, we collaborate with your organisation to make any ISO implementation as straightforward and beneficial as possible.

Your journey starts here

More information on the Road to ISO Certification

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Experienced ISO Consultants

How can ISO Specialists help your business?

Getting started with ISO certification might seem daunting; this is often the reason why businesses enlist the help of an ISO consultant. For 30 years, we've supported and guided organisations like yours through certification. Our experienced consultants take the lead on auditing your business, helping you use the results to enhance your quality management system. If necessary, there is also plenty of room for training.

Established ISO Certifiers since 1994
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ISO 15189: Frequently Asked Questions

Why is ISO 15189 important?
Competence in any field is crucial, but it’s even more pertinent in the medical sphere where the patient’s system is compromised by disease or injury. ISO 15189 is a mark of confidence awarded to medical laboratories – an accreditation that proves you are dedicated to delivering a proficient and quality service across all aspects of your operation. With 300,000 tests performed every working day of the year and around 95% of clinical pathways relying on patients having access to pathology services, it’s clear that medical laboratories sit at the heart of a fully functional modern society. Becoming ISO 15189 accredited will verify three key components of a laboratory: your integrity, impartiality, and capabilities. Here’s a little bit more about this crucial ISO standard.
How much does it cost to get ISO certified?
The cost of getting ISO 15189 certified varies from organisation to organisation, but it is priced using three major factors: the size of your business, your industry and the complexity of your processes.
What is the difference between ISO 17025 and ISO 15189?
The main difference between ISO 17025 and ISO 15189 is that ISO 15189 is intended for an environment that accepts testing requests from medical professionals. ISO 17025 is more suitable for environments where anyone can request testing.
Who needs ISO 15189 certification?
Laboratory testing is incredibly important in the delivery of information-based healthcare outcomes – this is incredibly important in a world where decisions need to be driven by facts, science, and data. Any medical laboratory that wants to deliver clinically relevant results that meet the highest ethical standards should become ISO 15189 accredited.
Is ISO 15189 mandatory?
ISO 15189 accreditation is not mandatory in every jurisdiction, but it’s worth checking your local regulations. Nevertheless, the importance of laboratory accreditation should never be overlooked, especially when you are dealing with public health. As part of your accreditation process, you will get your organisation up to date with all the complex legal requirements that a medical laboratory must adhere to. With the ISO’s culture of continuous improvement, any changes to law or regulation will be implemented as part of your ongoing commitment to best practice.
This standard contributes to the following Sustainable Development Goals:
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"Our IMSM Assessor put in a lot of time and effort; they did a really good job for us, helping to organise what we had here. We had a lot of the pieces in place, they just weren’t put together, which IMSM helped us to do. We have a system in place now and we continually follow up on everything. “

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