Quality Systems in Medical Laboratory


Many medical laboratory technicians think of quality management and ways of making their laboratories become state-of-art that offers better and improved services. The world is advancing technologically at a fast rate, and everything is almost becoming digital. Engineers and scientists have come up with advanced equipment and techniques to solve diagnostic issues that have existed for centuries.

The advancement in medical knowledge accompanied by astute medical research projects has called for the improvement of medical laboratories to meet demands in the market. This paper discusses the quality of medical laboratories, and in particular, it discusses the meaning of “quality” and its relevance to the laboratory. The paper will also discuss the importance of a quality system, quality control, quality assurance, and quality management and their relevancies to the medical laboratory.


Medical laboratory testing services are fundamental in the stipulation of health care services to the people. They also play an important role in the utilization and reimbursement of medical services to clients. However, for these to happen, we must have quality laboratory services. Among the characteristics of a judicious medical laboratory include quality assurance, quality control, and quality management systems. However, laboratories that lack these indicators end up offering poor services.

In Australia, for example, the National Pathology Accreditation Advisory Council (NPAAC) is the body that has the sole responsibility of ensuring that all medical laboratories within the country comply with the set standards of laboratory practice. In other words, medical laboratories must meet the requirements in ISO 15189:2007 for them to start offering services. This ensures that there is no compromise in the provision of diagnostics and other health care services.

Nevertheless, depending on the type of testing, medical laboratories can interpret the requirements differently. The document also provides detailed information on pathology testing and accreditation procedures. It is important to note that for a medical laboratory to receive accreditation, it must comply with all quality requirements. In fact, accreditation ensures that the laboratory offers quality services in line with the set provisions.

Various countries have bodies that set out rules on the management of laboratories. These bodies ensure that all medical laboratories have quality management systems in place, procedures, accreditation programs, and offer quality services to the citizenry. On the other hand, those involved in setting up and running laboratory affairs are aware of quality management systems and the role they play in the provision of quality and reliable services.

The public demands quality and laboratories have no otherwise. Evidently, we have seen quality management systems perform a commendable job in industries, government institutions, and the military. Similarly, this is what medical laboratories require. Every medical laboratory in Australia must ensure that it complies with the set rules and regulations to offer quality services.

Planning Quality

To start with, quality is the measure of fineness or the condition exhibiting a lack of deficiencies, momentous disparities or defects. To achieve quality, one has to comply with certain provisions and always show commitment towards keeping them. The International Organisation of Standardization (ISO) sets the standards of uniformity, and firms or organizations that comply with the provisions receive accreditation. This means that they have efficient quality systems to offer quality services or manufacture quality products.

Quality Systems

A quality system is a requirement for a quality medical laboratory. To begin with, a quality system comprises structure, processes and procedures whose architect is the manufacturer. A quality system acts as an engine and runs all activities happening within the medical laboratory. The roles of a quality system include

  • Ensuring diagnostic and pathology testing produces conventional results, with minimal variations
  • Ensuring that all products from suppliers such as surgical pieces of equipment are of high standards
  • Ensuring that all activities in the laboratory follow all quality system regulation


The illustration above is an example of a quality system that is common in many medical laboratories. Normally, within a quality system, some subsystems have regulations too. However, these subsystems work in an integrated manner to complement the quality system. In fact, a quality system that has subsystems is more effective, as it starts with the ground-up part.

In other words, an effective quality system begins with ordinary headway of medical device design and production to the provision of quality medical services. Quality systems should also be flexible so that the users can implement supplementary regulations within the lifecycle and make the system even more efficient.

The quality system harbours standards and procedures, which not only ensure that the medical devices are standard, but also, they meet the performance metrics set out by regulating bodies. In case the laboratory is not sure about a certain quality system, it is important to countercheck with the International Organisation for Standards (ISO). This body has numerous offers to pick and they can help medical laboratories come up with astute quality systems.

For instance, the ISO 9001:1994 is accreditation for quality systems—design and implementation, while the ISO/CD 13485 is accreditation for quality systems-surgical equipment and other medical devices. Just like in Australia, medical regulation bodies allow laboratories to come up with and implement their quality systems. This is because of the varying nature of products, and each laboratory has varying outcomes. The rules and regulations from regulating bodies such as FDA and NPAAC are benchmarks of establishing a quality system.

It is also important to note that a quality system helps medical laboratories to meet regulatory requirements and offer quality services. Additionally, a quality system is also paramount in value addition and helps in the reduction of the costs of medical devices thus promoting the safety and effectiveness of the device. With an efficient quality system, laboratories will offer judicious medical services.

Quality Control

Undoubtedly, for a medical laboratory to attain the “quality” status, it must own and use several tools such as calibrations, instruction manuals, continuance schedules, and quality assurance programs. Quality control is vital to the operations of the medical laboratory. It involves a series of systematic and premeditated activities that not only promise confidentiality but also propel the laboratory towards meeting and fulfilling the requirements.

It also has a huge influence on the quality of services that the laboratory offers. One of the common activities happening in medical laboratories is testing. The quality of this activity largely depends on the exactness, consistency, and aptness of the outcomes or results. In a medical laboratory, quality control is a process of monitoring and evaluating activities and summing up the outcomes. It is statistical.

When a patient goes for testing, the laboratory technicians will take samples and measure them before giving results. These results are in the form of quality control results—either qualitative or quantitative. In terms of quality control, the laboratory expert will analyze whether the measuring instrument gives reliable results according to the specifications.

It is only after the validation of the results using the pre-defined specifications that one can take them for diagnosis, and later on, prognosis and treatment. Consider a case of testing the serum of a patient and the results indicate that potassium. Through the results, it is possible to determine the level of potassium in the patient’s blood. In some cases, the results can be contrary to the expectations and only quality control instruments and statistical tendencies will validate the results.

In most laboratories, internal quality control plays a significant role in ensuring that the results are not only exact but also reliable. Among the characteristics of internal quality control, include (6):

  • Periodic quality control checks of all reagents including serogrouping and serotyping ones. Medics can choose to perform this exercise after every three months.
  • The reference strains play a big role in tests and it is better to characterize them. In case characterization fails, then one can use the susceptibility testing reference from the World Health Organization.
  • In performing internal quality control, one should not follow those from the manufacturer as the mean, standard deviation, and ranges of devices differ depending on the manufacturer.
  • It is important to use appropriate materials for the calibration of essays for accurate results.
  • Internal quality control procedures establish monitoring systems that report performance.
  • Results from internal control testing mechanisms should not vary by large margins from the standard ones (usually not more than 2SD).
  • It is also important to present numerical internal quality control results graphically to observe the trends. Below is a graphical representation of quality control.

Levey-jennings graph

Quality Assurance

Although there is a connection between quality control and quality assurance, quality assurance goes further to explain the methods of arriving at the results. In fact, quality assurance begins from the initial stage of testing (pre-analytic) and proceeds to the final stage where we have patient results of quality control results.

Personnel: To attain quality assurance, the laboratory should have competent personnel who are always committed to working hard. Additionally, to promote quality assurance, the laboratory personnel should undergo major training, especially on new ways of doing tests. In some laboratories, there are assessment and proficiency tests aimed at keeping the personnel vigil at work. Record monitoring, quality control analysis, and other measures can guarantee quality assurance in a medical laboratory.

Equipment: in a medical laboratory, the most common activities include the identification and characterization of the sample. This may require both simple and complicated equipment such as electron microscopes, refrigerators, freezers, antibiotic susceptibility tanks, incubators and digital systems. The choice of these equipment depends on the type of test to perform, and therefore, the staff must have enough knowledge on these equipment and their uses. It is also important they go through equipment manuals to familiarize themselves with the operations of the equipment. Moreover, regular servicing and maintenance of the equipment are paramount in the realization of reliable results.

Quality Assurance

Quality management

Quality management looks at all quality activities in a medical laboratory. Any laboratory aims to be accurate and reliable to maintain the confidence of the clients. Very many laboratories have come up with a quality management system whose role is to monitor all activities within the laboratory.

Consequently, these laboratories have not only received ISO accreditation, but also their optimal laboratory performance is above board. Three major processes happen in a medical laboratory. The first one of course is pre-examination where technicians examine the patients orally. Secondly, we have an examination, and finally, post-examination.

Quality management

To have an effective quality management system, the above measures are necessary. The biggest outcome of a quality management system is the test results. If they are reliable, then the quality management system is perfect. It is also important to note that quality management systems not only monitor quality assurance and quality control programs but also take into consideration the managerial part of the laboratory. Managerial considerations can influence the quality and effectiveness of medical laboratory operations.

Quality management systems ensure that laboratories comply with the regulations set by authorities, thus, offering quality services. For instance, through quality management systems, laboratories can manage recordkeeping, conduct safe and exact tests, solve complaints, and perform audits easily.

Quality management systems also help laboratories to reduce operating costs by switching into an integrated system that requires no paper hence, creating an automated enterprise solution. It also makes monitoring easier and reduces consultancy fees. Additionally, a quality management system improves the efficiency of laboratories and enhances productivity.


Quality is a paramount component in the daily running of affairs of medical laboratories. It enhances service delivery and leads the laboratory into destined performance.


  1. Australian Commission on Safety and Quality in Health Care, 2013. Australian Safety and Quality Goals for Health Care. Web.
  2. Clancy, C. M., 2013. One Step Forward on Quality Improvement, One Step Back on Access. Agency for Healthcare Research and Quality. Web.
  3. Donabedian, A., 1996. Evaluating the quality of medical care. Supplementary Journal, 44(3), pp. 166-206.
  4. Agency for Healthcare Research and Quality, 2003. The National Healthcare Disparities Report. Web.
  5. Westgard, J.O., 2012. Six Sigma – Quality Design and Control. Web.
  6. Westgard, J.O., 2010. Managing quality vs. measuring uncertainty in the medical laboratory. Clinical Chemistry Laboratory Medicine, 48, pp. 31-40.
  7. RCPA Quality Assurance Programs Pty Limited, 2013. Quality Assurance. Web.
  8. National Association of Testing Authorities, Australia (NATA), 2012. Interpretation of NPAAC Requirements and ISO 15189. Web.
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