Laboratories

In medical, biotechnical, chemical and pharmaceutical laboratories and cleanrooms, important climatic parameters have to be monitored. This is the only way to protect sensitive samples and maintain a high quality standard. Temperature in particular is a critical parameter that must be monitored. Humidity and pressure must also be included in standard-compliant environmental monitoring. 

"How to comply with ISO 15189 ?"

ISO 15189 is an international standard that specifies the requirements for quality and competence in medical laboratories. It ensures that laboratories provide accurate and reliable test results, which are critical for patient care. One of the key areas covered by this standard is temperature monitoring, which is vital for maintaining the integrity of medical samples and reagents.

To comply with ISO 15189, laboratories must implement a comprehensive temperature monitoring system. This includes:

  1. Continuous Monitoring: Laboratories should continuously monitor the temperature of critical areas, such as specimen storage, reagent storage, and equipment like refrigerators and freezers.

  2. Calibration: Temperature monitoring devices must be calibrated regularly to ensure accuracy. This involves using certified reference materials and adhering to established calibration protocols.

  3. Documentation: Comprehensive records of temperature monitoring activities must be maintained. This includes logging daily temperatures, documenting any deviations, and detailing the corrective actions taken.

  4. Alert Systems: Laboratories should have alert systems in place that notify personnel of temperature deviations in real-time. This can help mitigate risks quickly and effectively.

  5. Training: Staff must be trained on the importance of temperature control and monitoring protocols, ensuring that everyone understands their role in maintaining compliance with the standard.

By meeting these requirements, laboratories can ensure the preservation of sample integrity and the reliability of their testing processes, thus upholding the standards set forth by ISO 15189.

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