[ISO 13485 Cl 7.5.3] 

Clause 6.4.1 (a) of ISO 13485:2016 focuses on the health, cleanliness, and clothing requirements for personnel working in environments where product quality could be affected. This is crucial because personnel can be a significant source of contamination, introducing microorganisms, dust, or other particles that could compromise device functionality or sterility. The standard emphasizes that documented requirements should be established for:

Health Requirements: Organizations need to establish criteria for the health of personnel who are involved in operations that can impact product quality. This could involve screening or monitoring personnel health to minimize the risk of transmitting diseases or contaminants to medical devices.

Cleanliness: Clear guidelines on cleanliness standards for personnel must be established and enforced. This can include specific procedures for entering and exiting controlled environments, use of sanitizing stations, and regular inspections.

Clothing: Personnel must wear appropriate protective clothing to minimize contamination risks. For example, sterile devices might require cleanroom garments like gowns, gloves, and hair covers. The organization should have clear policies regarding uniforms and other clothing requirements, ensuring they are suitable for the specific tasks and environments involved.