ISO 15189

Gain international compliance for medical laboratory competence and quality with this standard.

A person looking through a microscope

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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Why 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.

What are the benefits of ISO 15189?

  • Reduction in risk by using well structured best practices
  • Recognises and promotes the technical competence of staff
  • Assures client results are technically valid and saves costs associated with retesting
  • Conveys trust and a level of recognition to stakeholders and decision-makers
  • 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 clinical laboratory services are safe, reliable, and of good value
  • Provides a tool for measuring quality improvements and supporting consistency

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.

Steps to getting ISO 15189 certified

Working 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 consultant will agree on reasonable outcomes and delivery dates.
  2. Producing your organization’s ISO 15189 manual system documentation
    Next, the IMSM consultant will audit your existing procedures and help you document the new systems that will help deliver success – both existing and how you will improve these. The manual system documentation sets out how your business should operate going forward so that it can deliver ISO 15189.
    You will be able to view the manual system documentation, along with most other relevant documentation, on our client portal IMSMLoop. It 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. Training you to adopt the ISO 15189 framework
    While the manual system documentation is a vital document moving forward, it is even more important that it gets put to practical use. We work with the senior management team to ensure the framework is embedded throughout your organization. We can also develop and deliver tailored training for staff to ensure that the understanding and implementation of ISO 15189 is watertight. This will create consistency across your organization, transforming your business from day one so it is optimised for efficiency, continual improvement, and greater profitability.
  4. Submission to a third-party external auditor
    Before you can be awarded the ISO 15189 certification, your organization 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.

As we have provided excellent support and guidance to your business every step of the way, you can rest assured that your ISO 15189 certification will be successful.

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Simple: We make it simple. Since 1994, we’ve been helping businesses achieve ISO certification and have over 150 experts worldwide. With 15,000+ clients trusting us to implement their ISOs, we have proven to be experts capable of handling the logistical heavy lifting, saving your company precious time. With a transparent fixed fee, flexible approach, and real-time access to updates, documentation, and an array of other features through IMSMLoop, we work with your organization to make ISO 15189 implementation as straightforward and beneficial as possible.

We strive to do this with our:

– World-class gap analysis
– Experienced and diverse ISO consultants
– Regular updates, provided through IMSMLoop
– Flexible terms and contract
– Fixed fee
– Full implementation

How can ISO specialists help your business?

Getting started with ISO 15189 certification might seem daunting; this is often the reason why businesses enlist the help of an ISO consultant. For thirty years, we’ve supported and guided organizations 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.

Contact Us

For a free Quotation or On-Site presentation by an ISO Specialist, contact us today!

IMSM Inc USA Headquarters
515 S. Flower Street,
18th Floor,
Los Angeles, CA 90071

Tel: 833 237 4676

Contact Us

For a free Quotation or On-Site presentation by an ISO Specialist, contact us today!

IMSM Inc USA Headquarters
515 S. Flower Street,
18th Floor,
Los Angeles, CA 90071

Tel: 833 237 4676