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 pertaining to metrological traceability are outlined in section 6 of ISO 15189. This section emphasizes the crucial need for laboratories to establish and maintain traceability of their measurement results. To achieve this, laboratories must maintain a well-documented unbroken chain of calibrations, with each calibration contributing to the overall measurement uncertainty and linking them to an appropriate reference.
Metrological traceability ensures that the measurements conducted by the laboratory can be traced back to the highest level of traceability, aligning as closely as possible with the International System of Units (SI units). Several methods can be employed to achieve this level of traceability:
- Calibration of Instruments: Laboratories can ensure traceability by having their instruments calibrated by a competent laboratory. This involves comparing the measurements obtained by the laboratory’s instruments against a known standard, verifying their accuracy and establishing traceability to recognized references.
- Certified Reference Materials: Another avenue for achieving traceability is through the use of certified reference materials. These materials have certified values with explicitly stated metrological traceability. By employing these materials during measurements, laboratories can validate their results and maintain traceability to recognized standards.
- Comparison with National or International Standards: Laboratories can also achieve traceability by comparing their measurements against national or international standards. This process involves aligning the laboratory’s measurements with the reference values established by these standards, thereby ensuring traceability to the highest level of accuracy.
Adhering to these metrological traceability requirements is fundamental to maintaining the reliability and accuracy of measurement results in laboratories. It facilitates comparability, consistency, and credibility of measurements across different laboratories, ensuring harmonization and quality assurance within the field.
By establishing and maintaining metrological traceability, laboratories demonstrate their commitment to providing accurate and reliable measurement results, instilling confidence in the validity of their analyses and enhancing the overall quality of their services.
Process Requirements according to ISO 15189
The process for ISO 15189 accreditation can be categorized into three main stages: the pre-examination process, the examination process, and the post-examination process. It is important to note that a risk-based approach should be applied throughout these stages. The laboratory must identify potential risks associated with patient care in each category, assess and evaluate these risks, and implement appropriate risk control measures in accordance with standard risk management practices.
In terms of the pre-examination processes, the laboratory should have well-defined procedures to address all aspects related to sample collection, patient preparation, sample transportation, sample receipt procedures, and any exceptional situations that may arise. The handling, preparation, and storage of samples for analysis should be carried out in accordance with specific written procedures that carefully consider the type of samples being evaluated and their stability.
During the pre-examination process, it is essential for the laboratory to ensure proper sample collection techniques, taking into account factors such as patient comfort, sample integrity, and the avoidance of contamination. Adequate patient preparation protocols should be established, ensuring that patients are appropriately prepared for sample collection procedures, which may include fasting or specific dietary restrictions, medication cessation, or other necessary preparations.
Additionally, the laboratory should have a well-defined sample transportation system in place to maintain the integrity and stability of samples during transit. This includes ensuring proper packaging, labeling, and documentation to prevent sample mix-ups, loss, or degradation.
Upon receipt of samples, the laboratory should follow established procedures for sample registration, verification, and accessioning. Exceptions or deviations from normal processes should be carefully documented and managed according to predefined protocols to ensure accurate and traceable sample handling.
The laboratory should also establish suitable procedures for the handling, preparation, and storage of samples prior to analysis. This may involve specific protocols for sample aliquoting, preservation, and storage conditions, considering the requirements of different sample types and their stability profiles.
By adhering to these comprehensive pre-examination processes, laboratories can enhance the reliability and accuracy of their diagnostic testing, reduce the likelihood of errors, and ensure the quality of patient care. The implementation of standardized procedures, coupled with a risk-based approach, enables laboratories to mitigate potential risks, maintain sample integrity, and uphold the highest standards of quality and patient safety.
Specific QMS Requirements according to ISO 15189
As mentioned earlier, medical laboratories are also required to implement a quality management system. While there are common processes that are implemented in any type of quality management system, such as management review, internal audits, CAPA (Corrective and Preventive Actions), and KPI (Key Performance Indicator) monitoring, we will focus specifically on the management review process and its inputs and outputs as outlined in ISO 15189.
The management review process serves as a critical component of the quality management system and involves analyzing specific inputs and generating relevant outputs. The inputs for the management review include:
- Status of actions from previous management reviews: This involves assessing the progress and effectiveness of actions taken based on previous management review outcomes.
- Internal and external changes to the management system: Any changes within the laboratory’s internal environment or external factors that impact the management system should be considered.
- Changes in the volume and type of laboratory activities and adequacy of resources: Any changes in the workload, scope, or types of activities performed by the laboratory, as well as the availability and sufficiency of resources required to support those activities, should be evaluated.
- Fulfillment of objectives and suitability of policies and procedures: The extent to which the laboratory has achieved its defined objectives and the suitability and effectiveness of its policies and procedures should be assessed.
- Outcomes of recent evaluations, internal audits, analysis of non-conformities, corrective actions, and assessments by external bodies: The results and findings from evaluations, audits, analysis of non-conformities, and corrective actions should be reviewed to identify areas for improvement.
- User and personnel feedback and complaints: Feedback, complaints, and suggestions received from users of laboratory services and laboratory personnel should be considered to identify opportunities for improvement.
- Quality assurance of result validity, effectiveness of improvements, and actions taken to address risks and opportunities, and performance of external providers: The quality assurance of test results, effectiveness of implemented improvements, actions taken to address identified risks and opportunities, and performance of external providers should be evaluated.
- Results of participation in inter-laboratory comparison programs: The results obtained from participating in inter-laboratory comparison programs should be reviewed to assess the laboratory’s performance and identify areas that require attention.
- Evaluation of point-of-care testing (POCT) activities: If applicable, the evaluation of POCT activities, including their effectiveness and compliance with relevant standards and guidelines, should be considered.
- Other relevant factors, such as monitoring activities and training: Any other factors that are deemed relevant to the management system, such as ongoing monitoring activities and training initiatives, should be taken into account.
On the other hand, the outputs of the management review process should include:
- Assessment of the effectiveness of the management system and related processes: The management review should provide an evaluation of the effectiveness of the implemented management system and its associated processes.
- Improvement of laboratory activities related to fulfilling the requirements of ISO 15189: The management review process should lead to the identification of opportunities for improvement in laboratory activities to ensure compliance with the requirements outlined in ISO 15189.
- Provision of required resources: Based on the management review outcomes, decisions regarding the provision of necessary resources, such as personnel, equipment, facilities, and materials, should be made.
- Improvement of services to users: The management review process should facilitate the identification of areas where services provided to laboratory users can be enhanced and improved.
- Identification of the need for change: The management review should result in the recognition of any required changes, such as updates to policies, procedures, or processes, to enhance the effectiveness and efficiency of the laboratory’s operations.
By conducting thorough management reviews and considering the inputs and outputs as specified in ISO 15189, medical laboratories can continuously monitor and improve their quality management systems
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