6.3 Facilities and Environmental Conditions

6.3.1 Suitability of Facilities and Environmental Conditions

The facilities and environmental conditions shall be suitable for the laboratory activities and shall not adversely affect the validity of results.

Note:
Influences that can adversely affect the validity of results can include, but are not limited to, microbial contamination, dust, electromagnetic disturbances, radiation, humidity, electrical supply, temperature, sound, and vibration.

6.3.2 Documentation of Requirements

The requirements for facilities and environmental conditions necessary for the performance of the laboratory activities shall be documented.

6.3.3 Monitoring and Control of Environmental Conditions

The laboratory shall monitor, control, and record environmental conditions in accordance with relevant specifications, methods, or procedures or where they influence the validity of the results.

6.3.4 Measures to Control Facilities

Measures to control facilities shall be implemented, monitored, and periodically reviewed and shall include, but not be limited to:

  • Access to and use of areas affecting laboratory activities;
  • Prevention of contamination, interference, or adverse influences on laboratory activities;
  • Effective separation between areas with incompatible laboratory activities.

6.3.5 External Laboratory Activities

When the laboratory performs laboratory activities at sites or facilities outside its permanent control, it shall ensure that the requirements related to facilities and environmental conditions of this document are met.