ISO 15189:2022 Quality Assurance For Medical Laboratories!

Quality control and assurance in a laboratory are essential and strictly regulated in many industries, such as food and health. Quality in laboratories generally refers to the accuracy and reliability of analysis and results. In addition, laboratories that have international standards gain more credibility and international recognition. Among these standards, we can find ISO 17025 and ISO 15189 for medical laboratories.

What is ISO 15189 about? How to implement the ISO 15189 standard’s requirements?

The following article will look into these questions and more.

What is the ISO 15189 standard about?

A few definitions

The ISO 15189 standard is an international quality standard for medical and clinical laboratories. Since 2007 and until its latest version update in 2022, this standard sets the requirements for quality management, technical processes, and competence in medical laboratories. Therefore, the ISO15189:2022 standard promotes confidence and high quality in medical laboratories' analysis and results generation.

The ISO 15189 standard is based on both ISO 9001 and 17025 standards for quality and process requirements. The ISO 9001 standard refers to quality management requirements and ISO 17025 standard provides requirements for testing and calibration laboratories. However, the ISO 15189:2022 standard is destined for medical laboratories, detailing the examination processes and equipment requirements to comply with the standard and to provide high-quality and reliable results. 

The ISO 15189 standard like the ISO 17025 has 5 main requirements. However, there are 5 additional criteria dedicated to medical laboratories:

• Collecting and sharing data on the procedures, sample volumes, and sample containers;
• Implementing ethical practice;
• Cooperating between clinical staff and the medical laboratory which is responsible for providing a quality service to clinicians providing patient samples for testing;
• Giving council on the different ways of testing and various samples that may be needed in laboratories;
• Adding notes and remarques on the analysis results related to the diagnosis and patient care.

The benefits of the ISO 15189 standard certification

It is well known that when a laboratory is ISO certified, it gains not only local recognition but international too. And ISO 15189 standard for medical laboratories provides this privilege too. However, there are many other benefits than brand image and marketing goals of the ISO 15189 certification, here are some:

• Risk reduction and mitigation;
• Improved team morale and well-being;
• Better efficiency;
• Cost-saving thanks to increased quality, testing, and validating procedures;
• Customer satisfaction;
• Continuous improvement.

How to implement and get the ISO 15189 certification?

The ISO 15189 standard indicates the importance of the management committee's involvement when implementing a new quality management system. And of course, before getting any changes or adaptations done, one must check all the requirements for implementing the right procedures and processes to comply with the standard.

The medical laboratory’s management committee has an important responsibility and a key role when it comes to planning, implementing, and continuous improvement of processes, by providing:

• The appropriate policy and managerial support;
• The distribution roles and responsibilities in the company;
• All the necessary resources needed to comply with the standard;
• Adequate training is consistent with the implementation of a QMS.

The implementation of a QMS based on ISO 15189 relies on several requirements. Here are some of them:

Organisational requirements:

• The definition and adoption of a general policy along with its objectives and indicators;
• Communication system with all stakeholders (especially in the context of interlaboratory comparisons);
• Training of personnel.

Risk management requirements:

• The implementation of quality assurance principles via the documentation’s general control;
• The list of procedures and analytical methods;
• Risk prevention;
• Quality controls;
• Internal audits;
• The global action plan.

Technical requirements:

• Management of materials, equipment, and premises;
• Consideration of environmental aspects (consumables, waste, etc.);
• The laboratory computer system.

The implementation of the ISO 15189 standard is a complete and engaging process, that necessitates the involvement of all operators and procedures throughout the life cycle of laboratory analysis whether in the three examination processes: the pre-examination process (prescription and sample analysis), the examination process and the post-examination process (reporting on the analysis). Each step is crucial for good patient care.

Accreditation bodies for ISO 15189

Every country has specialised organisations that can help companies and laboratories get certified. In addition, these third-party bodies are the ones that conduct the audit for certification purposes.

Among these organisations we can mention, in the United Kingdom, there is UKAS the National Accreditation Body. Medical laboratories can submit their certification requests to UKAS. In addition, with the newest version of the ISO 15189 published in December 2022, UKAS gave a transition period of 3 years for all the certified laboratories and published the transition requirements that all customers must meet.

In North America, there is ANAB (The ANSI National Accreditation Board) that certifies medical laboratories.

When an audit is scheduled for the ISO 15189 certification for a medical laboratory, the latter can rely on digital technology to be fully prepared, without missing out on any requirement.

Medical laboratories have every interest in digitising their document system when preparing for accreditation and enhancing their quality management system over the years. An electronic document management system can greatly improve the preparations and quality management system of medical laboratories. It will allow the centralisation and pooling of all the necessary information, general, environmental, staff, equipment, and many others on a single platform. 

Digital technology will bring excellent support and innovation to medical laboratories, and it is a guarantee of internal quality and simplification of administrative procedures. Nowadays, many tools can be used to digitally check all the requirements for the standard making sure to remember all. In addition, digital technology can help with the self-assessment and evaluate the implemented actions before the certification audit.

The ISO 15189 standard is an international certification for medical laboratories that brings high-quality services and competencies. Like all the other ISO standards, ISO 15189 commits the laboratory to a technically, managerially, and administratively demanding approach. To successfully achieve these tasks, organisations can rely on digital tools to save time, innovate and self-assessment before a certification audit. This technology along with the ISO certification will guarantee a successful and efficient implementation of an effective quality management system.

Take the first step towards success by starting your certification preparation now, thanks to the QMS app.