What is ISO 15189?​

What is ISO 15189?

ISO 15189 is an international standard that specifies requirements for quality and competence in medical laboratories, including point-of-care testing (POCT), risk management, laboratory safety and sample collection and transport.

The standard is based on the principles of ISO/IEC 17025:2017, which is a general standard for the competence of testing and calibration laboratories. However, ISO 15189:2022 also takes into account the specific needs and characteristics of medical laboratories, such as the involvement of patients and health professionals, the ethical aspects of medical testing, and the clinical relevance of results.

The standard is intended to be used by medical laboratories for developing their management systems and assessing their competence. It can also be used by laboratory users, regulatory authorities, and accreditation bodies for confirming or recognizing the competence of medical laboratories. Accreditation is a voluntary process that involves an independent evaluation of a laboratory’s compliance with ISO 15189:2022 by an authorized body. Accreditation can provide assurance to laboratory users and stakeholders that a laboratory meets the requirements of the standard and delivers quality services.

ISO 15189 is applicable to all types of medical laboratories, regardless of their size, scope or location. It is also applicable to point-of-care testing (POCT), which is the performance of laboratory tests outside the conventional laboratory setting, such as at the bedside, in the field or in the home.

ISO 15189 was first published in 2003 and has been revised four times since then. The latest edition, ISO 15189:2022, was published in January 2022 and incorporates several changes and improvements from the previous edition

ISO 15189 is widely recognized and adopted by medical laboratories around the world. It is also used as a basis for accreditation by many national and regional accreditation bodies. Accreditation is a voluntary process that involves an independent evaluation of a laboratory’s compliance with ISO 15189 by a competent authority. Accreditation provides a formal recognition of a laboratory’s quality and competence and enhances its reputation and trustworthiness.

ISO 15189 is an important tool for ensuring quality and competence in medical laboratories. It benefits patients, users, laboratories, authorities and society at large. By following ISO 15189, medical laboratories can provide high-quality services that contribute to health care improvement and patient safety.

Why is ISO 15189 Consultancy & Training important?

ISO 15189 is important because it helps medical laboratories to develop their management systems and assess their competence. It also helps laboratory users, regulatory authorities and accreditation bodies to confirm or recognize the competence of medical laboratories. By following ISO 15189, medical laboratories can ensure that they provide accurate, reliable and timely results that meet the needs of patients and health care providers .

What are the benefits of ISO 15189?

ISO 15189 has many benefits for medical laboratories and their stakeholders. Some of the benefits are:

– Improved quality and consistency of laboratory results

– Enhanced customer satisfaction and trust

– Reduced errors and risks

– Increased efficiency and effectiveness

– Facilitated international recognition and cooperation

– Supported innovation and continuous improvement

– It helps medical laboratories to provide accurate, reliable and timely results for patients, clinicians and other users.

– It helps medical laboratories to comply with regulatory and legal obligations, as well as ethical and professional standards.

– It helps medical laboratories to implement a quality management system that covers all aspects of their activities, from pre-examination to post-examination processes.

– It helps medical laboratories to identify and manage risks, ensure safety and prevent errors.

– It helps medical laboratories to demonstrate their competence and credibility to users, authorities and accreditation bodies.

– It helps medical laboratories to improve their performance and efficiency, as well as their customer satisfaction.

Why is ISO 15189 Consultancy & Training important?

Our Service Offerings and Approach

ISO CERT can help you in the following areas:

  • Developing and implementing ISO 15189 Standard.
  • Detailed analysis of medical laboratory procedures in a bid to make sure that all weaknesses have been identified.
  • Detailed evaluation reports of the existing quality management system as well as other monitoring and evaluation reports.
  • Developing and implementing authentic work process for each of the test.
  • Identifying and implementing appropriate global method statements for each test.
  • Developing technically competent employees.
  • Producing records demonstrating conformance with ISO 15189 requirements.

What are the main features of ISO 15189?

  • The standard covers various aspects of medical laboratory activities, such as:

    • General requirements, such as impartiality, confidentiality, and patient rights;
    • Structural and governance requirements, such as legal entity, laboratory director, and objectives and policies;
    • Resource requirements, such as personnel, facilities, equipment, and reagents;
    • Process requirements, such as pre-examination, examination, and post-examination processes;
    • Information management requirements, such as validation, verification, reporting, and communication of results;
    • Quality management system requirements, such as quality policy, quality objectives, quality manual, document control, and internal audit;
    • Risk management requirements, such as identification, analysis, evaluation, and treatment of risks;
    • Laboratory safety requirements, such as biosafety, chemical safety, radiation safety, and waste management.
What are the main features of ISO 15189?
How can organizations implement and get certified in ISO 15189?

How can organizations implement and get certified in ISO 15189?

To implement ISO 15189, organizations need to establish, document, implement, maintain and continually improve a management system that meets the requirements of the standard. The management system should address the following aspects:


  • Impartiality: The laboratory should act impartially and avoid conflicts of interest in its activities.
  • Confidentiality: The laboratory should protect the confidentiality of patient information and test results.
  • Requirements regarding patients: The laboratory should respect the rights and needs of patients, obtain informed consent when necessary, provide clear instructions for sample collection and transport, ensure patient identification and traceability, and communicate results effectively.
  • Legal entity: The laboratory should be a legal entity or a defined part of a legal entity that can be held legally responsible for its activities.
  • Laboratory director: The laboratory should have a designated director who has the authority and responsibility for its operation, performance and compliance.
  • Laboratory activities: The laboratory should define the scope of its activities, including the types of tests, examinations or calibrations it performs, the methods it uses, the reference materials it employs, the equipment it operates, the personnel it employs, the subcontractors it engages, and the customers it serves.
  • Structure and authority: The laboratory should have a defined organizational structure that specifies the roles, responsibilities and authorities of its personnel, committees and management.
  • Objectives and policies: The laboratory should establish quality objectives and policies that are consistent with its vision, mission and values, and communicate them to its personnel, customers and stakeholders.
  • Risk management: The laboratory should identify, analyze, evaluate, treat, monitor and review the risks associated with its activities, processes and resources, and take actions to prevent or mitigate their impact on quality.
  • Personnel: The laboratory should ensure that its personnel are competent, qualified, trained, supervised and authorized to perform their duties, and that they are aware of their roles and responsibilities in relation to quality.
  • Facilities and environment: The laboratory should provide suitable facilities

Using the ISO CERT approach to ISO 15189 Accreditation in a Laboratory covers:

  • Professional support for accreditation process.
  • Define the scope of accreditation.
  • Undertake measurement uncertainty analysis.
  • Undertake inter-laboratory comparison for your test.
  • Guide on Equipment Calibration Program.
  • Prepare your staff to face the accreditation board.
  • Prepare your lab for accreditation.
  • Undertake relevant training for your employees.
  • Undertake schedule of internal audits.
  • Undertake your annual surveillance audits.
  • Act as your third-party professional laboratory/quality advisory board or quality management department.
Using the ISO CERT approach to ISO 15189 Accreditation in a Laboratory covers:


It improves testing results and efficiency;

  • National and international recognition and reputable image of your organization through quality assurance and Management system;
  • Public and industry acceptance globally.
  • Assurance to clients of good laboratory practice.
  • It promotes modern laboratory practices that include professionalism and expertise in conduction of medical activities in the labs.
  • The insurer provides lower premiums to accredited organizations.
  • Provides comparability in measurements.
  • Decision-makers can rely on test results.
  • Ensures better support in the event of legal challenges.
  • Saves money by getting it right at first time.

ISO CERT is the preferred consulting company for ISO 15189 Medical Test laboratory accreditation across the Middle East. We will get your laboratory accredited quickly. We can provide you with a complete system including a Quality Manual, Procedures, Forms and other documentation along with the training for your staff and support through the accreditation process to get you to the point you need to be – ISO 15189 ACCREDITED. Our consultants have extensive knowledge of working with various accreditation bodies for Medical Test Laboratory

If you are interested in implementing ISO 15189 in your organization, you can contact us for more information. We are a certified ISO 15189 consultant that can help you design, develop, implement, audit, and improve your information security management systems. We have the expertise, experience, and tools to help you achieve your goals.