ISO 15189: QMS For Medical Laboratories

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ISO 15189 is an international standard to be followed for the implementation and maintenance of quality management system of medical laboratory. ISO 15189 may be consider the analogue of ISO 13485, with the differences being that the former one is specifically focused on medical laboratories. In fact, in the section related to the scope of ISO 15189, the following statements are reported:

This document can be used by medical laboratories in developing their management system. This document can be used by medical laboratories in developing their management systems and assessing their competence. It can also be used for confirming or recognizing the competence of medical laboratories by laboratory users, regulatory authorities and accreditation bodies.

ISO 15189 provides a framework for the implementation of QMS processes for medical laboratories, to make sure of their competency, process controlling, examinations and ensure that test results meet the adequate level of accuracy is needed. The ISO 15189 certification is applicable to any medical or clinical laboratories that provide services to patients or any public medical services that verify and validate medical samples. This ISO standard is divided into different sections, following the general structure of QMS-related ISO Standards. Specifically, the main sections are:

Clause 5 – Structure and Governance Requirements
Clause 6 – Resource Requirements
Clause 7 – Process Requirements
Clause 8 – Management System Requirement

In this article we will go trough the main requirements and related documentation for ISO 15189. Considering the broad range of requirements, we will focus specifically on few important aspects of ISO 15189.

Before moving forward, it is also very important to define exactly what a medical laboratory is, in order to make sure that the applicability of this ISO standard is properly understood. The definition provided by the ISO 15189 is the following:

an entity for the examination of materials for the purpose of providing information for the diagnosis, management, prevention and treatment of disease, or assessment of health; the laboratory can also provide advice covering all aspects of examinations including the interpretation of results and advice on further examinations.

Metrological Traceability according to ISO 15189

The requirements for metrological traceability are reported within section 6 of ISO 15189. In this section, it is first clearly mention the necessity for the laboratory to establish and maintain metrological traceability of its measurement results. This should be achieved through a “documented unbroken chain of calibrations, each contributing to the measurement uncertainty, linking them to an appropriate reference”.

The measurements performed by the laboratory shall be traceable to the highest order of traceability and shall be as close as possible to the International Systems of Units. This can be achieved in different ways:

Calibration of instruments performed by a competent laboratory;
Certified values of certified reference materials with a clear stated metrological traceability;
Realization of the SI units ensured by comparison with national or international standards.

Process Requirements according to ISO 15189

The process for ISO 15189 can be divided into three categories:

Pre-examination process
Examination process
Post-Examination process

A risk-based approach shall always be used. In fact, the laboratory shall identify potential risks to the patient care in all the aforementioned categories. Risk shall be assessed, evaluated and appropriate risk control measure shall be implemented, following a standard risk management approach.

Focusing specifically to the pre-examination processes, the laboratory shall have adequate procedure to address all the processes related to sample collection, patient preparation, sample transportation, sample receipt procedure and exceptions. Handling, preparation and storage of samples for analysis shall be handled though specific written procedures that may take in full consideration the type of samples under evaluation and their stability.

Specific QMS Requirements according to ISO 15189

As mentioned before, also medical laboratories need to have a quality management system implemented. There are obviously specific processes that always need to be implemented in whatever type of quality management system, such as:

Management Review
Internal Audits
CAPA and non-conformities.
KPI monitoring
etc

We will not enter into the details of these processes, however will just focus on management review by analyzing the specific inputs and outputs that need to be taken in consideration according to ISO 15189.

The inputs of the management review shall be:

status of actions from previous management reviews, internal and external changes to the management system, changes in the volume and type of laboratory activities and adequacy of resources;
fulfilment of objectives and suitability of policies and procedures;
outcomes of recent evaluations, internal audits, analysis of non-conformities, corrective actions and assessments by external bodies;
user and personnel feedback and complaints;
quality assurance of result validity, effectiveness of any implemented improvements and actions taken to address risks and opportunities, and performance of external providers
results of participation in inter-laboratory comparison programmes;
evaluation of POCT activities, and
other relevant factors, such as monitoring activities and training.

Regarding the outputs of the management review, these should be the following:

the effectiveness of the management system and the related processes;
improvement of the laboratory activities related to the fulfilment of the requirements of this document;
provision of required resources;
improvement of services to users;
any need for change.

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