QMS Implementation in Vet Labs: Key Considerations & the Role of Veterinary Laboratory Management Software

Veterinary Laboratory Management Software for Implementing a Quality Management System (QMS) in VET Labs
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Quality management is a fundamental aspect of ensuring that veterinary laboratories deliver accurate, reliable, and consistent results. Implementing a Quality Management System (QMS) is therefore essential for maintaining high standards of quality and compliance in veterinary labs. In this blog, we will explore the key considerations and benefits of implementing a QMS in veterinary laboratories.

Why a QMS Matters in Veterinary Labs

Veterinary laboratories, also known as animal health laboratories, play a critical role in diagnosing and monitoring the health of animals. Whether they are conducting routine blood tests or investigating complex diseases, the accuracy of their results directly impacts the treatment and care of animals. This underscores the importance of quality management in veterinary labs.

Here are some reasons why a QMS is indispensable in veterinary labs:

  • Quality Assurance: A QMS’s basic job is to ensure that all processes and procedures are standardized and followed consistently. This minimizes the likelihood of errors and ensures that the quality of results remains high.
  • Compliance: Veterinary statutory bodies and associations impose strict standards on veterinary services, which trickle down to veterinary laboratories. A well-implemented QMS helps labs meet these regulatory guidelines, minimizing legal issues and penalties.
  • Enhanced Credibility: Veterinary labs that adhere to a QMS demonstrate their commitment to providing accurate and reliable results. This enhances their reputation and credibility among clients, veterinarians, and the wider community.

Key Considerations for Implementing a QMS

Several factors must be taken into consideration when implementing a QMS in a laboratory setting. They include the following:

  1. The Goals of the Laboratory: The goals of the veterinary laboratory must be kept in mind when implementing a QMS. They often include the type of tests that are usually conducted, the purpose of test results (e.g., import/export, quarantine), risk tolerance (e.g., vaccination versus culling), customer demands (e.g., sensitivity, specificity, cost, turnaround time), the laboratory’s involvement in legal or regulatory programs (e.g., disease eradication), as well as the overall business objectives. These factors underline the diverse considerations and customization that are needed for a robust QMS.
  2. Industry Standards and Guides: Laboratories should select reputable and widely accepted standards and guidelines when designing their quality management systems. For laboratories seeking testing accreditation, as well as all World Organization for Animal Health (WOAH) reference laboratories, adherence to ISO/IEC 17025:2017 or its equivalent is imperative. This comprehensive standard covers general, resource, process, and management system requirements for establishing compliant veterinary laboratories. Additional information on relevant standards can be obtained from each country’s national standards body, the International Laboratory Accreditation Cooperation (ILAC), and accreditation bodies such as the National Association of Testing Authorities (NATA) in Australia, the United Kingdom Accreditation Service (UKAS), the American Association for Laboratory Accreditation (A2LA), among others.
  3. QMS Accreditation: Should the laboratory opt to pursue formal recognition of its quality management system and testing processes, it will require third-party verification. ILAC has issued specific mandates and guidance documents for both laboratories and accreditation bodies. Within the ILAC framework, ISO/IEC 17025 serves as the designated standard for accrediting laboratories engaged in testing or calibration activities, and ISO 15189 for medical testing laboratories, including veterinary laboratories. Definitions related to laboratory accreditation can be located in ISO/IEC International Standard 17000: Conformity Assessment – Vocabulary and Principles (ISO/IEC, 2020).
  4. Choosing an Accreditation Body: To ensure the international acceptance of the laboratory’s test results, it is essential that the accreditation standard used is globally recognized and the accreditation body itself is acknowledged as competent for accrediting laboratories. The procedures for accrediting accreditation bodies, as outlined in the ILAC scheme, are based on the stipulations of ISO/IEC International Standard 17011:2017. Details regarding accreditation bodies that enjoy recognition can be acquired from the entities that grant such recognition. This includes organizations like the Asia-Pacific Laboratory Accreditation Cooperation (APLAC), the Inter-American Accreditation Cooperation (IAAC), and the European Co-operation for Accreditation (EA). Moreover, accreditation bodies may also be parties to mutual recognition arrangements (MRAs), such as those under ILAC, and regional bodies like APLAC.
  5. The Scope of the QMS: The quality management system should encompass all aspects of laboratory operations that impact all testing conducted within the laboratory. While accredited laboratories are mandated to adhere to the stipulated standards, these principles may apply to all testing laboratories. Laboratories accredited according to ISO/IEC 17025 or ISO 15189 maintain a specific catalog of accredited tests, referred to as the scope of accreditation. It remains at the discretion of the laboratory to determine which tests will receive accreditation and feature in the scope. Should an accredited laboratory offer non-accredited tests, it must transparently distinguish these in any reports that claim or reference accreditation status.
  6. Quality Assurance and Quality Control: Quality assurance (QA) is primarily concerned with instilling confidence in the attainment of quality requirements, whether they are internal or specified in accreditation or certification standards. QA is process-centric, ensuring that the correct procedures that meet quality requirements are executed in the appropriate manner. On the other hand, quality control (QC) involves systematic and preplanned monitoring of output to ensure that minimum quality standards have been achieved. In the context of a veterinary testing laboratory, this pertains to validating the accuracy of test processes and confirming that results fall within predetermined parameters and limits.
  7. Test Methods to be Used: ISO/IEC 17025 and ISO 15189 outline requirements for the selection, development, and validation of testing methods to establish their fitness for the intended purpose. In the veterinary field, standard methods from recognized standards or fully validated methods published by authoritative bodies like AOAC International may be preferred but not always accessible. Many veterinary labs develop, adapt, or combine standard and non-standard methods. Even when using standard methods, in-house evaluation, optimization, or validation is often necessary to ensure result validity. Therefore, veterinary testing labs must demonstrate proficiency in developing, adapting, and validating test methods.

How Does Veterinary Laboratory Management Software Support QMS Implementation in Vet Labs?

Laboratory Information Management Systems (LIMS) play a pivotal role in supporting the implementation of a Quality Management System (QMS) in various industries, including veterinary laboratories. A Veterinary LIMS, also known as veterinary laboratory management software, acts as a central hub for managing and streamlining laboratory processes, data, documentation, staff training, QC sample processing, lab equipment, and inventory, which are essential components of an effective QMS. Veterinary laboratory management software enhances data integrity, traceability, staff accountability, and transparency, all of which are critical elements of a robust QMS, making it an invaluable tool for veterinary laboratories striving to uphold quality standards and compliance.

Conclusion

Implementing a QMS in veterinary labs is a strategic decision that enhances the quality of care animals receive and ensures the reliability of diagnostic results. By following the key considerations outlined in this blog, veterinary laboratories can not only meet regulatory requirements but also improve efficiency, accuracy, and client trust. A well-implemented QMS is an investment in the health and well-being of animals and the long-term success of the lab itself.

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