Become Familiar with The ISO 15189 Quality Manual for Medical Laboratories Accreditation

The achievement of accreditation by the International Standard Organization (ISO) 15189 in the world of laboratory medicine strengthens the hopes of laboratory professionals about the potential outcome of demonstrating the importance of their involvement in providing safe care and improved outcomes.

The International Standard ISO 15189 is the best for medical laboratory accreditation, comprising both administrative and technical standards for assessing employee competency. As a result, ISO 15189 accreditation ensures that the laboratory has been assessed against internationally recognized standards to demonstrate the existence of a quality system, and competence and that the personnel is capable of producing technically valid results and appropriate information for the intended use of each test. Each country has its national accreditation organization, which is in charge of issuing accreditation and follows ISO 17011, the International Standard for accreditation bodies.

An increasing number of medical laboratories are voluntarily pursuing certification, ensuring practice and professional competency by the Laboratory Best Practice principle, and enhancing confidence in laboratory testing among all stakeholders, including patients and doctors.

In the ISO 15189 documents, the ISO 15189 quality manual is the most crucial component. ISO 9000 defines it as a document that specifies an organization’s quality management system. The quality manual is a framework of the ISO 15189 documentation structure document. This documentary structure is frequently depicted in the form of a pyramid, with the quality manual at the top and the records at the bottom. Every organization is free to create its own tailored document structure, including document types, identification, and quality manual form. As a result, a small business may find it suitable to provide a thorough explanation of its quality system, including all recorded procedures needed by the standard, in the quality handbook. On the contrary, large organizations may require a greater number of documentary layers, such as national procedures, local procedures, sectorial methods of operation, and maybe several quality manuals such as group quality manuals, site quality manuals, and so on.

A quality manual, according to ISO 15189 clause 4.2.2, shall outline the quality management system and its documentation structure. Supporting processes, including technical procedures, should be included or referred to in the quality manual. It should illustrate the quality management system’s documentation structure. The quality manual should also cover the technical director’s and quality manager’s roles and responsibilities, including their responsibility for conformity with this international standard. The entire team should be trained in the use and application of the quality manual, the relevant documents, and all of the implementation requirements. Under the authority and responsibility of a quality manager selected by the laboratory’s director, the quality manual should be kept up to date.

The following are examples of the tables of contents of an ISO 15189 quality manual for medical laboratories, so every quality manual must have this listed content in the manual documents:

  • Overview
  • Laboratory description, its legal status, resources, and main activities.
  • Quality policy of ISO 15189.
  • Records, conservation, and archiving.
  • Facilities and environment.
  • Instruments control reagents and/or appropriate consumables.
  • Qualification and staff training.
  • Quality assurance.
  • Documents control.
  • Analytical procedures validation.
  • Environmental aspects for example conveyance, consumables, and waste disposal, in addition, and independently of bullets
  • Quality controls (including inter-laboratory comparison).
  • Laboratory’s information system.
  • Results review.
  • Remedial actions and processing of complaints.
  • Research and development.
  • Procedures and analytical methods list.
  • Prescription protocols, primary samples removal, sample collection, and processing.
  • Results validation.
  • Interactions and other communications with customers, medical experts, subcontracting labs, and suppliers.
  • ISO 15189 Internal audits.
  • Ethics
  • References

Recognize the Requirements and Benefits of ISO 15189 Accreditation

ISO 15189:2012 is a global standard for medical laboratories. Laboratory accreditation supports labs to develop quality management systems, assesses their competence, and guarantees that they are functioning properly with industry and legal standards. ISO 15189 standard is closely based on ISO/IEC 17025 and ISO 9001. ISO 15189 accreditation tries to create a system that is failure-resistant, catching mistakes before it becomes serious issue. Also, it aims to achieve precise results in one try by reducing the number of errors. Accreditation helps to identify the opportunities for continuous improvement in labs and empowers lab staff by involving them in serious problem-solving and implementation of solutions. The accreditation ensures that labs or organizations are fully up-to-date with all the complex legal requirements and it also shows that the customers and key stakeholders a commitment to best practices.

The benefits of ISO 15189 accreditation
Here are some of the several benefits of ISO 15189 accreditation.

  • Risk reduction: When an organization structures its operation around best practices, the systems will be more difficult. Also, planning for and identifying any potential risks will help massively decrease them, especially in laboratories that deal with delicate information, complex equipment, and matters about people’s wellbeing.
  • Cost-saving: By promising results that are technically valid, the laboratory will save costs associated with retesting. There will also be other cost-saving procedures implemented across the standard as the efficiency increases.
  • Improved team morale: The standard everything to reduce staff mistakes and other unnecessary errors. Organization staff motivation will not only be improved by their demonstration of better performance, but also by recognizing and promoting the staff’s technical competence.
  • Legally compliant: By implementing legislation and industry standards into the medical laboratory, ISO 15189 assures that the clinical services are safe, reliable and of good value. That carries trust to stakeholders and decision-makers who recognize and grow the commitment. Also, the legal challenges will be less likely and, if they do arise, the organization can ensure the framework will support them.
  • Continual improvement: Best practices will not start and end with the ISO 15189 certification. But also, by integrating the framework into the core of what organizations do, organizations will develop additional programs over time. The framework acts as a tool for measuring quality developments and continually supporting consistency.
  • Globally recognized: Being a universally recognized standard not only has reputational benefits. For ISO 15189, global acknowledgment is particularly pertinent. A sequence of Multilateral Mutual Recognition Arrangements within the International Laboratory Accreditation Cooperation (ILAC) means that laboratories accredited to ISO 15189 will have their certificates and test reports accepted in over 80 countries around the globe. That way, organizations can benefit medical health not just domestically, but all over the globe.

The List of ISO 15189 accreditation Requirements
To implement ISO 15189 accreditation there are two types of requirements that are mandatory one is management requirements and the second is technical requirements.

Management requirements

  • Organization and management responsibility
  • Quality management system
  • ISO 15189 documents control
  • Service agreements
  • Examination by referral laboratories
  • External services and supplies
  • Advisory services
  • Resolution of complaints
  • Identification and control of nonconformities
  • Corrective action
  • Preventive action
  • Continual improvement
  • Control of records
  • Evaluation and audits
  • Management review

Technical Requirements

  • Personnel
  • Accommodation and environmental conditions
  • Laboratory equipment, reagents, and consumables
  • Pre-examination processes
  • Examination processes
  • Ensuring quality of examination results
  • post-examination of processes
  • Reporting of results
  • Release of results