ISO/IEC 17025:2017 Clause 6.3 (6.3.1 to 6.3.5)

 6.3 Facilities and environmental conditions

6.3.1

Creating the Perfect Environment for Reliable Lab Results:

Laboratory activities require a precise and controlled environment to ensure the accuracy and reliability of results. The facilities and environmental conditions play a essential role in influencing the outcomes of experiments and tests.

To obtain reliable results, laboratories must provide a space that is favourable to scientific endeavors. This means maintaining optimal conditions that won't compromise the integrity of experiments. Factors such as temperature, humidity, and sound levels need to be carefully controlled to create the ideal working environment.

Several external influences can negatively impact the validity of laboratory results. These include microbial contamination, dust, electromagnetic disturbances, radiation, and variations in electrical supply. Each of these factors has the potential to introduce errors or irregularities into experimental outcomes. Microbial contamination and dust particles can alter the composition of samples, leading to inaccurate results. Electromagnetic disturbances and radiation can interfere with sensitive equipment, affecting the precision of measurements. Fluctuations in humidity, temperature, and electrical supply may also introduce variability, impacting the reliability of findings.

6.3.2

Documenting the specific needs regarding the facilities and environmental conditions essential for laboratory activities is essential. it involves recording in how the laboratory space should be set up and the conditions it must uphold during different tests and experiments. This documentation serves as a comprehensive guide, ensuring that everyone involved in the laboratory's work is aware of and follows the necessary specifications for conducting experiments accurately and reliably. In essence, it's about creating a written reference that acts as a blueprint for maintaining the optimal environment required for precise and consistent laboratory outcomes.

Facilities: This refers to the physical space, equipment, and infrastructure within the laboratory. It includes everything from the layout of the rooms to the types of instruments and tools needed for experiments.

Environmental Conditions: This encompasses factors like temperature, humidity, lighting, and cleanliness within the laboratory. Different experiments may require specific environmental conditions to ensure accurate and reliable results.

6.3.3

It is necessary for laboratories to actively oversee, manage, and document the environmental conditions in their workspace. The monitoring and control processes should align with specified standards, methods, or procedures. The focus is on ensuring that the conditions are not only compliant with established criteria but also that they do not adversely affect the accuracy and reliability of the results obtained from laboratory activities.

Monitor, Control, and Record Environmental Conditions:  Laboratories are required to continuously observe, regulate, and document the environmental factors within their premises. This includes aspects like temperature, humidity, cleanliness, and other conditions that might impact the outcomes of experiments.

Adherence to Relevant Specifications, Methods, or Procedures:  The monitoring and control activities should follow established specifications, methods, or procedures. These guidelines ensure that the environmental conditions are maintained at levels deemed appropriate for the specific laboratory activities being conducted.

Influence on the Validity of Results: The emphasis is on recognizing the significance of environmental conditions in relation to the validity of results. If certain conditions are not adequately managed, they may introduce errors or uncertainties into the results, potentially compromising their accuracy.

Documentation: Keeping records of the monitored environmental conditions is essential. This documentation serves as evidence that the laboratory has adhered to the prescribed standards and provides a basis for reviewing and ensuring the quality of the results.

6.3.4

This section emphasizes the need for implementing, monitoring, and regularly reviewing measures to control facilities within a laboratory. The objective is to ensure a controlled and suitable environment for conducting laboratory activities. The specified measures include, but are not limited to:

 a)  Access to and Use of Areas Affecting Laboratory Activities:  Controlling who can enter specific areas within the laboratory is crucial. This involves managing access to rooms or zones where important activities, experiments, or tests take place. Limiting access helps maintain the integrity of these areas and ensures that only authorized personnel are present.

b)  Prevention of Contamination, Interference, or Adverse Influences: The measures should focus on preventing any form of contamination, interference, or negative influences on laboratory activities. This could include implementing protocols to avoid the introduction of foreign substances, ensuring equipment doesn't disrupt experiments, and shielding against external factors that could affect the accuracy of results.

c)  Effective Separation Between Areas with Incompatible Activities: It is essential to establish distinct and efficient boundaries between various sections within the laboratory that conduct activities that could adversely interact. For instance, areas dedicated to working with delicate biological samples must be clearly segregated from those involved in handling chemicals. This segregation aims to prevent any potential cross-contamination or interference. Additionally, separation should also be maintained within the instrumentation section, ensuring a clear divide, especially in the preparation of samples for pesticides, antibiotics, and heavy metals.

 6.3.5

When a laboratory conducts its operations at external locations not under its permanent control, there is a crucial responsibility to ensure that the stipulated requirements for facilities and environmental conditions are upheld. In essence, even when working in places not owned or directly managed by the laboratory, it must guarantee that the necessary conditions for its testing and experiments remain optimal.

This obligation extends to multiple facets. Firstly, the laboratory needs to ascertain that the physical facilities, encompassing the laboratory space and equipment, adhere to the standards delineated in the document. Whether it's a temporary site or another facility, the laboratory must confirm that the infrastructure meets the specified criteria to maintain the quality and reliability of its work.

Secondly, the laboratory is tasked with verifying that environmental conditions, such as temperature, humidity, and cleanliness, align with the requirements outlined in the document. This ensures that the external location provides a suitable setting for conducting precise and dependable laboratory activities.

 In simpler terms, irrespective of where the laboratory operates, be it in its own facility or at an external site, the commitment remains unwavering—to uphold consistent standards and create an environment conducive to accurate and reliable scientific work. This not only safeguards the integrity of the laboratory's activities but also reinforces a commitment to quality across diverse operational settings.

 

 

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