ISO 15189:2012

ISO 15189 Medical laboratories - Requirements for quality and competence is an international standard that specifies the quality management system requirements particular to medical laboratories.

ISO 15189:2012 can be used by medical laboratories in developing their quality management systems and assessing their own competence. It can also be used for confirming or recognizing the competence of medical laboratories by laboratory customers, regulating authorities and accreditation bodies.

ISO 15189 standard, was first published in 2003 and revised in 2007 and again in 2012. ISO 15189 is not a tool merely to meet accreditation requirements or provide quick fixes for individual mistakes. Instead, laboratories implementing ISO 15189 strive to:

  1. Create systems that are as failure resistant as possible, will catch mistakes before they become a problem, and reduce errors by getting things right the first time.
  2. Identify opportunities for improvement at all times.
  3. Involve and empower their staff by involving them in the solving of problems and the implementation of solutions.
ISO 15189:2012

ISO 15189 encourages full involvement and utilization of the abilities of all employees at all levels to improve the organization. In a laboratory accredited to ISO 15189, the goal is continual improvement, and for staff members to know exactly what to do, how to do it, who is in charge of a process, and where to find all information necessary to perform their jobs.

ISO 15189 is a comprehensive standard, offering an overarching structure to laboratory operations. It applies to all divisions of a medical laboratory, regardless of the services it provides or the way it is organized; the standard is as relevant in a full-service medical laboratory as it is in a laboratory providing services exclusively for either clinical or anatomic pathology. It is not prescriptive in the sense that it does not specify how to address a particular requirement or clause. Its focus and importance lies in encouraging users to maintain an effective quality management system integrated across all parts of their operation, with a goal of continual improvement.

By 2015, about 60 countries had made ISO 15189 part of their mandatory medical laboratory accreditation requirements. In the United States, accreditation to ISO 15189 is voluntary, as no governmental or regulatory agency requires laboratories or health care providers to conform to ISO 15189.

Internal Audits

ISO 15189 is a systems- and process-oriented QMS. It encourages systematic identification of processes and their interrelatedness. Proper documentation of core processes helps reveal the structure of the operation. The understanding of the interactions of processes enhances effectiveness and efficiency because it uncovers gaps and unnecessary activities. Assessing implementation and effectiveness of process is a major, if not the most important, element of a thorough ISO 15189 accreditation assessment.

ISO 15189-accredited laboratories have to perform internal audits of their QMS on a regular basis. Such audits need to include the managerial and technical components, as well as preexamination, examination, and postexamination processes. These serve to:

  • Ascertain that all activities of the QMS are covered ("Are we adhering to our own quality system?");
  • Assure that processes are effective ("Does every consultation report requested by a pathologist always end up being reported in an addendum?");
  • Identify opportunities for improvement ("Can we establish criteria with our oncologists when to perform reflex molecular testing rather than having to wait for a request to initiate testing?").
  • ISO 15189-accredited laboratories usually perform internal audits by section, with an entire cycle completed within one year. Increased frequency of audits may be required depending on risk and occurrence management outcomes.

    Internal audit results are one of several inputs for the regular, high-level management review required of ISO 15189-accredited laboratories. Management review meetings offer the opportunity to review issues that impact the laboratory's processes, including, but not limited to, internal audit results, quality metrics, ongoing quality improvement projects, opportunities for improvement, complaints, and forthcoming new technologies or regulatory changes.

    Quality management decisions in an ISO 15189 system are based on facts and data. This prevents personal preferences or a top-down management style from inhibiting process and quality improvement.

    Continual improvement is a permanent objective of ISO 15189 quality management. This does not mean, for example in anatomic pathology that every conceivable effort should be made to reduce the frozen section turnaround time by 1 min. The laboratory should find meaningful metrics that are aligned with the laboratory's mission. Improvements may affect any aspect of the quality management system and its processes. They may involve issues such as saving control tissue for immunohistochemical stains, making the work instructions for lymphoma workups more succinct and accessible, or automating frozen section versus final diagnosis correlations using the laboratory information system.

    Similarly, in clinical chemistry, continual improvement does not mean making every conceivable effort to reduce hemoglobin turnaround time by 10 sec. However, it may mean making efforts to drive down variation and risk, which can help a core laboratory avoid repeating testing, incorrect results, physician complaints, or even possibly having to add a satellite lab with its associated overhead costs.

    More importantly, continual improvement also refers to the improvement of the quality management system, for example (1) performing better, more thorough internal audits; (2) increasing the use of personal protective equipment (and thus better implementation of safety procedures) in the gross room to prevent eye splashes or scalpel injuries; or (3) sending staff members to training courses for performing root cause analysis, an integral part of the standard for occurrence management.

    Risk Management

    ISO 15189 states, "The laboratory shall evaluate the impact of work processes and potential failures on examination results as they affect patient safety, and shall modify processes to reduce or eliminate the identified risks and document decisions and actions taken"

    Insights into existing or potential risks come from several sources.

    • When a new process is developed, the laboratory will identify the process owner, map the process, and identify its risk points.
    • In most cases, risks will be identified during internal or external audits (eg, inspections or PT events).
    • Review of the occurrence management data will allow identification of future risks based on past errors.
    • If the environment and culture of the organization support it, staff at all levels will feel comfortable and find it worthwhile to bring up potential risks identified during routine events and everyday observation (eg, near-misses that may otherwise get no follow-up, or unofficial "water-cooler talk" about an upcoming change in another department that may affect the laboratory).