What standards must laboratories that test N95 mask quality uphold?

The pandemic shakes the testing laboratories in testing the capacity of masks that can provide protection against the deadly covid-19 virus. One of these masks is the N95 mask. The N95 mask is a tight sealing mask that is known to protect the wearer from any form of harmful microorganisms.

The N95 mask is the most reliable mask according to medical specialists. This is due to the fact that the N95 mask is capable of filtering particles up to 95%. The N95 mask is not only popular in the medical field. But the N95 mask is also known to other fields like Construction, Engineering, and Mining.

Out of all the available types of masks, the N95 mask stands out due to its filtration and breathability. The N95 mask gives you protection against the virus and breathability that does not compromise the wearer.

The N95 mask is regulated and certified by the Food and Drug Administration (FDA) and the National Institute for Occupational Health and Safety (NIOSH) in the United States. These two authorities are responsible for the keeping quality of the N95 mask prior to its distribution. There are laboratories that test the quality of the N95 mask. These laboratories have specific standards that they uphold in order to ensure the quality of the N95 mask. Laboratories must be an accredited authority to make sure that the N95 mask qualifies the standards of the FDA and NIOSH.

Quality System

Making sure of the quality is always a priority. N95 mask testing laboratories must have a structured system to ensure quality testing capacity. Also, the quality organization has to uphold its ability to be consistent, reliable, traceable, and able to reproduce quality services and products like the N95 mask. 

According to the International Organization for Standardization (ISO), a structured system of quality must have the following elements:

  • Organizational Management and Structure

Management is the key to a successful laboratory. ISO stipulated that the members governing the laboratory must uphold the responsibility that they have towards their employees that test the N95 mask. Also, organizational management and structure focus on the structured procedure of designing, implementing, maintaining, and improving their system to produce quality results. 

  • Quality Standards

Laboratory standards are a part of an organization Thus, without this, a laboratory cannot be trusted. There are sets of prerequisites that have to be followed by a testing laboratory to ensure that the N95 mask is well tested. A part of these prerequisites is the monitoring of laboratory functions.

  • Documentation

Documentation is not only intended for formality. In testing the N95 mask, results must be documented well. A systemized quality of documentation includes the following:

  • Regulatory policies that employees must uphold in testing the N95 mask.
  • Manuals that the laboratory follows which stipulates the testing processes for the N95 mask.
  • Procedures that employees in testing the N95 mask.
  • Specifications as to how the procedures are carried out in testing the N95 mask.

These must be documented and stored in either an electronic copy or a hard physical copy.

  • Training

Along with the system of quality is a team that is responsible for the testing of the N95 mask. Proper execution and translation of theory into practice matter. Training is an integral part of the laboratory’s testing success. With the training, employees must know the importance of testing the quality of the N95 mask. All employees must be competent and have to be supported by the laboratory even after training.

  • Assessment

Not every laboratory testing assessment is successful. It will always have room for error and improvement. In such cases, the N95 mask testing laboratory must have the necessary steps in managing the error in the process of testing. This allows the N95 mask testing laboratory to improve its testing capacity. With the management of error, this makes the N95 mask testing laboratory to become aware of the opportunities wherein they can enhance their service.

Why must N95 mask testing laboratories be accredited?

The N95 mask is a delicate piece of Personal Protective Equipment or PPE that is responsible for protecting healthcare workers. Without the N95 mask, healthcare workers would have an increased chance of contracting the virus and it endangers their life as well.

The N95 mask must also be tested by accredited laboratories to ensure its quality that it offers to the wearer. This quality ensures the safety of the wearer. Thus, creating a protective barrier against harmful microorganisms.

Accreditation in N95 mask testing laboratories makes sure that the organization meets the standards set by an external governing body. It is important for the N95 mask testing laboratory to be accredited to make sure that the N95 mask that is tested in the laboratory is of high quality. Also, this puts reliance on consumers, most especially hospitals which is the number one target for N95 mask distribution. Without the accreditation by an external governing body, the N95 mask that is tested in the unaccredited testing laboratory is null and void.

Accreditation acts as a diploma that certifies a laboratory to operate and test an N95 mask. The accreditation is a certification that allows the testing of the N95 mask possible in testing laboratories.

Testing laboratories for the N95 mask should uphold their standards, and the standards set by outside and recognized organizations. This is to keep the quality of the N95 mask to be on top; eliminating compromise in the health of people. 



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