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ISO 15189:2022 Medical laboratories

ISO 15189:2012 Medical laboratories

What is ISO 15189:2022 – Medical laboratories-Requirements for quality and competence?

ISO 15189:2022 Medical laboratories specifies requirements for quality and competence in medical laboratories. It covers both the management aspects of the laboratory (e.g., quality management systems, document control, continual improvement) and the technical aspects (e.g., personnel competence, equipment calibration, pre-examination processes, examination procedures, post-examination processes, and reporting of results).

Moreover, the standard is designed to ensure that medical laboratories produce accurate and reliable results, which are crucial for patient diagnosis and treatment. Compliance with ISO 15189 helps ensure that laboratories operate efficiently and consistently, maintaining the highest standards in their testing processes and also the quality management systems.

Some key areas covered by the standard include:
  1. Quality Management System: Establishing and maintaining a robust quality management system that complies with ISO 15189-Medical laboratories requirements and continually improves its effectiveness.
  2. Personnel Competence: To ensure that laboratory personnel possess the necessary qualifications, experience, and training to perform their roles competently is equally important
  3. Equipment and Facilities: Ensuring that the laboratory is equipped with appropriate tools and facilities to conduct tests accurately as well as reliably
  4. Pre-examination Processes: Defining and controlling processes related to sample handling, transportation, and identification before testing.
  5. Examination Procedures: Implementing standardized with validated testing methods to ensure accurate and consistent results.
  6. Post-examination Processes: Handling and storing specimens after testing, as well as ensuring proper disposal and recording of data.
  7. Reporting of Results: Establishing clear and accurate reporting processes to deliver results to healthcare providers and patients.

Requirements of ISO 15189:2022 Medical laboratories

  1. Quality Management System (QMS):
    • Establishing and implementing a comprehensive quality management system specific to the medical laboratory
    • Defining the laboratory’s scope of activities, including the types of tests and examinations performed
    • Identifying and documenting responsibilities, authorities, and inter-relationships among laboratory personnel
  2. Personnel Competence:
    • Ensuring that all laboratory staff members possess the necessary qualifications, training, and experience to perform their assigned tasks competently.
    • Providing ongoing training and professional development opportunities for laboratory personnel.
    • Documenting the competency assessment of laboratory staff.
  3. Equipment and Facilities:
    • Ensuring that the laboratory is equipped with appropriate instruments, tools, and facilities to perform the required tests accurately.
    • Establishing procedures for the calibration, maintenance, and verification of laboratory equipment.
  4. Pre-examination Processes:
    • Defining and implementing procedures for the proper handling, transportation, and identification of patient samples before testing.
    • Ensuring that the request and acceptance of patient samples are properly documented.
  5. Examination Procedures:
    • Developing and following standardized and validated examination procedures for each type of test performed by the laboratory.
    • Establishing criteria for result interpretation and ensuring the accuracy of results.
  6. Post-examination Processes:
    • Establishing procedures for the safe handling, storage, and disposal of samples after testing.
    • Ensuring the proper recording and retention of examination data and results.
  7. Reporting of Results:
    • Establishing a clear and accurate reporting process for communicating results to healthcare providers and patients.
    • Ensuring the confidentiality and security of patient information.
  8. Internal Quality Control and External Quality Assessment:
    • Implementing internal quality control measures to monitor the accuracy and precision of test results.
    • Participating in external quality assessment programs to compare the laboratory’s performance with other laboratories.
  9. Continual Improvement:
    • Monitoring and measuring the effectiveness of the laboratory’s quality management system.
    • Implementing corrective and preventive actions to address any identified nonconformities or areas for improvement.

Benefits of ISO 15189:2022

  1. Improved Quality and Accuracy: ISO 15189:2022 Medical laboratories sets rigorous requirements for quality management and technical competence, leading to improved accuracy and reliability of test results. As a result, it helps healthcare providers make more informed and precise decisions for patient diagnosis and treatment.
  2. Enhanced Patient Safety: The standard’s emphasis on quality control and proper procedures reduces the likelihood of errors and mishandling of patient samples, thereby enhancing patient safety and reducing the risk of adverse outcomes.
  3. International Recognition: Compliance with ISO 15189 demonstrates a laboratory’s commitment to quality and competence on an international level. It also leads to increased recognition and acceptance of the laboratory’s test results by other healthcare institutions and organizations worldwide.
  4. Efficient Processes: Implementing ISO 15189 encourages laboratories to optimize their processes, leading to improved efficiency and reduced turnaround times for test results.
  5. Greater Customer Confidence: Healthcare providers and patients gain confidence in the laboratory’s abilities when it meets ISO 15189 standards, knowing that they are receiving reliable and accurate test results.
  6. Continuous Improvement: The standard emphasizes continual improvement through regular internal audits and corrective actions, which fosters a culture of ongoing quality enhancement within the laboratory
  1. Standardization: ISO 15189 promotes the use of standardized procedures and methods, which makes it easier to compare results across different laboratories and ensuring consistency in healthcare practices.
  2. Interlaboratory Comparisons: Participation in external quality assessment programs, as required by ISO 15189, allows laboratories to benchmark their performance against other laboratories, identify areas for improvement, and learn from best practices.
  3. Compliance with Regulatory Requirements: In some regions or countries, compliance with ISO 15189 may be a regulatory requirement for medical laboratories, ensuring legal adherence and facilitating market access.
  4. Accreditation and Recognition: Laboratories that meet ISO 15189 standards may pursue accreditation from accreditation bodies, adding further credibility to their operations and facilitating partnerships with other healthcare providers.
  5. Risk Management: ISO 15189 also promotes a systematic approach to risk management, ensuring that potential risks to patient safety and the accuracy of test results are identified, evaluated, and addressed.

Overall, ISO 15189:2022 helps medical laboratories operate at a high level of quality and competence, fostering trust and reliability in their services and contributing to improved patient care and outcomes.

Audit checklist for ISO 15189:2022-Medical laboratories

  1. Quality Management System (QMS):
    • Is there a documented quality policy and quality manual?
    • Are roles, responsibilities, and authorities defined and communicated?
    • Are processes and procedures documented and accessible to all relevant personnel?
    • Is there evidence of management commitment to ensure continual improvement?
  2. Personnel Competence:
    • Are personnel qualifications, training, and competency assessments well-documented?
    • Are personnel trained on new procedures and updates as needed?
    • Is there a training record for each staff member?
  3. Equipment and Facilities:
    • Is all equipment properly calibrated, maintained, and equally documented?
    • Are there procedures for handling, maintenance, and calibration of equipment?
    • Are facilities suitable for the intended purposes of the laboratory?
  4. Pre-examination Processes:
    • Are sample handling and transportation procedures defined as well as followed?
    • Is sample identification and labeling accurate and consistent?
    • Are procedures in place for sample rejection and handling of inadequate samples?
  5. Examination Procedures:
    • Are testing procedures standardized, validated, and documented?
    • Is the accuracy and precision of testing methods verified through quality control measures?
    • Are critical reagents and materials properly managed as well as documented?
  1. Post-examination Processes:
    • Are procedures for proper specimen storage and disposal followed?
    • Are results verified and reviewed before release?
    • Is there a system for result reporting and documentation?
  2. Internal Quality Control and External Quality Assessment:
    • Are internal quality control measures performed, documented, and reviewed regularly?
    • Is the laboratory participating in external proficiency testing or interlaboratory comparisons?
    • Are corrective actions taken when quality control or proficiency testing results are unsatisfactory?
  3. Continual Improvement:
    • Are audit findings, nonconformities, and corrective actions documented and addressed?
    • Is there evidence of continuous improvement initiatives within the laboratory?
  4. Risk Management:
    • Is there a risk management process in place to identify, assess, and mitigate risks to patient safety and test accuracy?
    • Are preventive actions taken to avoid potential problems?
  5. Document Control:
    • Are all relevant documents (e.g., policies, procedures, manuals) controlled and regularly reviewed?
    • Is there evidence of document distribution and version control?
  6. Records Management:
    • Are records of training, calibration, quality control, and corrective actions well-maintained and easily accessible also?

Also, Pacific Certifications are accredited by ABIS to issue ISO 15189-Medical laboratories certification

Lastly, who needs ISO 15189:2022?

ISO 15189-Medical laboratories is relevant and beneficial for a wide range of medical laboratories, regardless of their size or the scope of their testing services.

Therefore, standard is applicable to various types of medical laboratories, including :
  1. Hospital Laboratories: Laboratories which operate within hospitals and healthcare institutions and providing diagnostic testing services to support patient care.
  2. Clinical Laboratories: Independent laboratories that offer clinical testing services, such as pathology, hematology, microbiology, chemistry, and immunology.
  3. Reference Laboratories: Laboratories that specialize in providing specialized tests and services, acting as a reference point for other laboratories
  4. Public Health Laboratories: Laboratories that are associated with public health departments, responsible for monitoring and investigating disease outbreaks and also conducting health-related research
  5. Veterinary Laboratories: Laboratories that conduct testing on samples from animals for diagnostic or research purposes.
  6. Research Laboratories: Laboratories involved in medical research that can also conduct testing to support their scientific studies.

Overall, Medical laboratories that choose to implement ISO 15189:2022 benefit from its emphasis on quality management, technical competence, and continual improvement, which can lead to enhanced patient safety, improved accuracy of test results, and greater confidence among healthcare providers and patients in the laboratory’s services.

At last, If you need more support with ISO 15189, please contact us at +91-8595603096 or support@pacificcert.com

Also read about related certifications –

  1. ISO 9001:2015
  2. ISO 14001:2015
  3. ISO 45001:2018
  4. ISO 22000:2018
  5. ISO 27001:2013

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