ISO 15189 2022 Package

The ISO 15189 document package is designed to help laboratories improve the quality of results and meet the requirements for accreditation. It includes a set of documents that define the minimum characteristics that the laboratory must meet to achieve ISO 15189 accreditation.

These documents can be used by laboratory personnel to enhance their understanding of quality systems, to ensure effective and consistent implementation of procedures, and to assist personnel in complying with accredited requirements.

The documents proposed by the ISO 15189 package include guidelines on results management, laboratory procedures and practices, internal and external controls, and quality assurance in medical laboratories.

It also provides a detailed description of laboratory policies and procedures to be implemented to ensure that all tests performed meet the standards required by the accreditation system.

👉 What is the ISO 15189 standard?

ISO 15189 is an international standard that defines the criteria that a medical laboratory must meet for quality control and accuracy of results.

It defines the minimum quality and safety requirements for the accreditation of medical laboratories and for their acceptance by national health systems. It includes requirements for personnel management, analytical procedures, validation of results, and appropriate equipment and controls.

ISO 15189 is globally recognized as a quality standard for medical laboratories and ensures that a certified laboratory provides services that meet the highest levels of quality and accuracy.

Certified laboratories are regularly monitored to ensure that they meet the required quality standard.

ISO 15189 certification is recognized as an international mark of quality and allows national accreditation bodies (NABs) to grant accreditations to medical laboratories meeting this standard.

👉 ISO 15189 requirements:

The requirements of ISO 15189 include specific quality and safety requirements that must be met by accredited medical laboratories. The standard contains elements such as quality assurance principles, internal control, and the accreditation system. It also specifies requirements for personnel management, appropriate use of data and information, and the technical characteristics required to ensure adequate support of analytical activities.

ISO 15189 also contains requirements for documentation and identification of procedures in place to ensure proper operation and effective quality control. Medical laboratories must provide complete documentation of their analytical techniques, the quality controls they perform, and their results validation process. They must also have a comprehensive and up-to-date documentation system that covers all regulations applicable to the laboratory’s work.

In addition, to ensure the highest quality of testing performed by the medical laboratory, it is necessary for the medical laboratory to ensure that it implements appropriate measures to maintain an ongoing focus on continuous improvement of service to patients.

Medical laboratories must therefore demonstrate that they can properly consider all relevant information related to clinical needs or applicable laws in order to ensure public health and protect the well-being of each patient whose analysis the process.

In addition, to ensure good compliance with ISO 15189, a medical laboratory must be able to thoroughly monitor the results obtained against existing international and national standards. For this, a rigorous system must be put in place that can constantly monitor the lab’s performance to ensure ad-hoc support if necessary in case of non-compliance or if you observe a decrease in the overall performance of the lab.

👉 This package will help you to:

• Assess and improve your lab’s compliance with ISO 15189 standard requirements.
• Provide comprehensive information on analytical procedures, quality controls and result validation process.
• Implement comprehensive and up-to-date documentation systems to ensure proper operation and effective quality control.
• Provide specific guidance regarding personnel management, appropriate use of data and information, and technical specifications required to ensure adequate support of analytical activities.
• Provide tools to continuously monitor laboratory performance to ensure optimal quality of analyses performed and to properly address relevant information related to clinical needs or applicable laws.
• Enable your laboratory to benefit from strict compliance with ISO 15189.
• Provide a detailed guide on how to apply the good practices identified by the standard within the laboratory and how to integrate them into the daily process to achieve greater efficiency.
• Finally, the package will provide a detailed analysis of how your organization can maintain the constant focus on continuous improvement of the service offered to patients, as well as a complete list of regulations applicable to the work of the laboratory to ensure the public health and protect the well-being of every patient treated by the laboratory.

👉Who this package is for:

This package is intended for medical laboratory professionals who want to ensure compliance with ISO 15189 standard requirements ;

• It is specifically designed for laboratory managers, as well as staff members involved in the analytical process and quality ;
• The package provides a comprehensive view of the integrated procedures necessary to continuously improve the quality of medical testing performed by the laboratory;
• The package provides a complete view of the integrated procedures necessary to continuously improve the quality of the medical tests performed by the laboratory; it can therefore be useful for all those who are looking for a practical and efficient solution to ensure strict quality control and ad-hoc management if necessary or if the overall performance of the lab is diminished;
• The package will also be very useful for experts in charge of training and informing staff on the application and adaptation of good practices at all stages of analysis in the context of optimal compliance with ISO 15189 standards.

👉What are the expected results?

– A complete and accurate assessment of the laboratory’s compliance with ISO 15189 standard requirements

– Detailed information on analytical procedures, quality controls and results validation process

– Establishment of an organized documentation system to ensure proper and efficient operation

– Specific guidance on personnel management, appropriate use of data and information, and required technical specifications

– Tools to constantly monitor the performance of the laboratory to ensure optimal quality of the analyses performed by the laboratory

– A comprehensive guide on how to apply the good practices identified in the standard in the laboratory

– A detailed analysis of how your organization can maintain a focus on continuous improvement of service to patients