ISO 15189 Examination | Things to Look Out For

ISO 15189 Examination

Ensuring Quality of ISO 15189 Examination Results

Medical laboratories are essential for proper patient care and accurate results must be obtained in order to to take the right course of action to treat any patient. To ensure that medical laboratories are ready to meet all the needs that patients might have, medical laboratories must pass ISO 15189 Examinations.

Quality control materials, along with patient samples, should be examined at appropriate intervals based on the procedure’s stability. The laboratory should select control material concentrations, particularly those at or near clinical decision values, to ensure the validity of decisions made. The use of independent third-party control materials, either instead of or in addition to any control materials supplied by the reagent or instrument manufacturer, should be considered. The basic idea behind the control sample system is that quality control materials are processed in the same way that patient samples are. The quality control materials’ results should not exceed tolerance limits (permissible deviations of measurements).

The laboratory management is in charge of defining the tolerance limits. These limits, as well as the reasoning behind their establishment, should be documented. When quality control rules are broken, examination results should be rejected, and relevant patient samples should be re-examined after the error condition has been corrected and within-specification performance has been verified. The laboratory should also evaluate the results of patient samples examined following the most recent successful quality control event.

Quality control data should be reviewed and monitored on a regular basis in order to detect trends in examination performance that could indicate problems with the examination system. When such trends are identified, preventive measures should be implemented and documented. Wherever possible, established statistical techniques and process control rules should be used to continuously monitor examination system performance. Qualitative tests necessitate specific internal quality control procedures.

Qualitative examinations are those that assess cellular characteristics such as morphology or measure the presence or absence of a substance. The outcomes are not expressed numerically, but rather descriptively or qualitatively as positive, negative, reactive, nonreactive, normal, or abnormal. Many of these tests do not lend themselves as easily to quality control as quantitative tests do. As a result, in addition to traditional quality control methods, it is critical to carefully monitor other processes within the quality system.

The following are some key quality concepts that apply to both qualitative and semi-quantitative tests in ISO 15189 Examination.:

  • In all laboratory testing, sample management is critical.
  • Examinations requiring a viable organism in the sample may necessitate close monitoring and effective communication with non-laboratory personnel/departments.
  • Incubators, refrigerators, microscopes, autoclaves, and other equipment must be kept in good working order and closely monitored.
  • To monitor the effectiveness of test procedures that use special stains or reagents, as well as tests with endpoints such as agglutination, colour change, or other non-numerical results, positive and negative controls must be used.
  • Reagents should be stored according to manufacturer’s instructions, labelled with the date opened and used, and discarded when they reach their expiration date.

Qualitative examinations necessitate a wide range of control materials. Built-in (onboard or procedural) controls, traditional controls that mimic patient samples, or stock cultures for use with microbiological examinations are examples of these.

External Quality Assessment Schemes in ISO 15189 Examination

The laboratory should take part in external quality assurance (EQA) programmes (or proficiency testing programmes) that are relevant to the examinations and interpretations offered. The laboratory should develop a documented procedure outlining the responsibilities and instructions for participating in external quality assurance schemes. The basic idea behind the control sample system is that quality control materials are processed in the same way that patient samples are.

External quality assessment schemes should be run on both primary and backup analyzers, if available. When control criteria are not met, the laboratory director should monitor the results of the external quality assessment schemes and participate in the implementation of corrective actions. Laboratories should formalize which actions are taken and who is responsible for the outcomes by signing them (e.g., responsible technicians, quality manager, and laboratory or unit head).

Laboratories should share the results of external quality assessment reports with all affected personnel to inform them of gaps and corrective actions taken. It is recommended that samples obtained from external quality assessment scheme providers be measured at two different levels for each parameter at least four times per year. Laboratories that do not check bias in each cycle within their internal controls should participate in external quality assessment schemes six times per year.


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Examination processes of ISO 15189 Examination

The laboratory should choose testing methods suitable for the examination being conducted and meeting user needs. Only testing methods that have been approved for their intended purpose should be used in the laboratory. Before being used regularly, examination techniques from method developers employed unchanged should be subjected to verification. The laboratory should get data from the provider to check the performance characteristics of examination techniques once the manufacturer has validated them. The laboratory staff should be able to understand the examination processes, which should be written down and made available in the right places.

Validation or Verification

The decision between validation and verification could be more precise. This depends on the availability of trustworthy and accurate information regarding the performance traits of the expected examination technique.

The laboratory gathers valid and trustworthy data on the performance parameters to determine whether the acceptance requirements have been met. If so, it is sufficient to verify the pertinent performance characteristics. However, the laboratory must gather data if the performance parameters are unavailable or match the acceptance standards (validation). As a result, verification may be sufficient for procedures validated elsewhere for processes involving accuracy, trueness, and decision limits, but additional confirmation of the sample’s stability may be required.

Verification of examination procedures

The intended use of the examination results must consider the performance characteristics of the examination technique assessed during the verification process. The examination technique can be validated rather than verified if all the necessary performance parameters are available and valid for one’s laboratory. In this context, “valid” denotes that the data were gathered under explicitly stated circumstances similar to those for the intended application.

To confirm the known performance characteristics of the examination technique, the laboratory must have information accessible from the manufacturer/developer of the examination procedure or examination findings from trustworthy independent research. Each instrument’s proper operation must be when more than one instrument is used to measure the measurand.

Establishing a validation or a verification plan

The performance parameters must be evaluated concerning the acceptance criteria for both validation and verification. The validation and verification programmes have already defined and justified these acceptance requirements. In addition to the acceptance criteria, the measurand, intended use, and examination procedure must all be determined.

It is crucial to precisely specify the measurand, particularly for validating an examination technique. Understanding the component or chemical entity (analyte), the matrix, the state of the analyte, and the features of the examination process employed is necessary for describing the measurand.

Performance characteristics

The staff member with the relevant authority will decide whether or not to evaluate these performance factors; the examination should also be statistically sound. The choice of the performance characteristics to be considered includes a professional appraisal of the characteristic’s intended use as a critical component. Results of preliminary research into the anticipated procedure or standards, as well as opinions from the medical community. The laboratory must consider each of these performance criteria during validation and verification. Accuracy can be left out of the performance traits list because it results from bias and imprecision. Satisfactory bias and imprecision will naturally result in acceptable measurement uncertainty because a lack of accuracy is described as measurement uncertainty.

The need for local analytical confirmation is unavoidable, at least for some performance aspects. Imprecision must be evaluated through analysis because it depends on regional factors. Additionally, a comparison to the preceding approach, if applicable, must be assessed under local circumstances, as this data is necessary to alert test requesters to impending changes.


The documentation for validation or verification includes a validation/verification strategy, the results, including raw data, and a validation/verification report that provides information on the implementation and an analysis of the acceptance criteria. When relevant to the inspection process, the following information should be included in the documentation:

  • purpose of the examination;
  • principle and method of the procedure used for examination;
  • performance characteristics;
  • type of sample (e.g. plasma, serum, urine);
  • patient preparation;
  • type of container and additives;
  • sample rejection criteria;
  • required equipment and reagents;

Referral by Examination Laboratories

Laboratories must have a documented procedure for the selection and evaluation of referral laboratories and consultants. These laboratories or consultants may provide analysis, opinions, or interpretations. In such instances the laboratories would be responsible for selecting referral laboratories and referring consultants, monitoring the quality of performance, and ensuring that the referral bodies are competent to perform the requested tasks. This may entail audits and periodic reviews to ensure that the relevant parts of this standard are adhered to. Such records are to be maintained. The laboratory will also require keeping a master list register of all referral laboratories and consultants for a defined period of time.

The referring laboratory would be responsible for the issue of examination results of the referral laboratory. These results could be a copy of the referral laboratory, or else the referring laboratory is to report it in its own template. Thus, even though the referral lab, may have its own reporting and turnaround times, it is the referring laboratories’ responsibility to ensure that the turnaround time and the reporting are as that stipulated in the service agreement.

If in cases that the referring laboratory prepares its own reports, it shall include all essential elements of the results reported by the referral laboratory or consultant, without any changes that may affect clinical interpretations. The report shall include which examinations were performed by the referral laboratory and if it holds any accreditation or certification. This implies that the referring laboratory is responsible for the final report and that any amendments are traceable, any remarks are identifiable, and that if any extra results are included, they are clearly marked.

Finally, laboratories shall also assess referral laboratories by considering several factors, to ensure compliancy with the internal requirements. Such factors that may be considered include the turnaround times, measurement accuracy, transcription processes and interpretive skill.


Luke Desira is an ISO management system consultant whose main goal is to put your company on a class of its own! Learn more on the laboratory medical management system that can be achieved through ISO 15189 accreditation! If you are seeking to further enhance your knowledge on ISO 15189, then look no further! Find out how you can secure success with ISO 15189 accreditation for medical laboratories.

All management systems based on ISO Standards that are implemented should pertain directly to the organization’s objectives. The same mindset applies to ISO 15189 – Medical Laboratories Management System. Have a look at the ISO Certification specialised by Industry to understand which ISO certifications and accreditations your laboratory can benefit from.

Luke offers a variety of ISO certification services that puts him as the leading ISO Certification consultant in Malta. He can help you achieve ISO accreditation efficiently. When ready, just call Luke Desira – he’ll be happy to lend a helping hand.

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