ISO 13485:2003 Health requirements per para 6.4a

T

TNHunter

How do other covers cover the require of para 6.4a of ISO 13485:2003 that deals with the establishment of documented requirements for health...

Should this cover physical sicknessess such as flu, contagious diseases,etc and should it be covered in an SOP, human resources policy, etc?

Any advice would be appreicated.:thanx:
 

yodon

Leader
Super Moderator
Re: Health requirements per para 6.4a

Be sure to read the rest of the story...

...if contact between such personnel and the product or work environment could adversely affect the quality of the product

So if you're developing software, there's probably not a lot you can or should do. If you are manufacturing devices that would fail or potentially contaminate the end user if, say,someone sneezed into it, then you'll need to establish an environment that (verifiably) minimizes that potential.

So the answer to your question about whether you need to cover physicall illness depends on whether or not someone with those conditions could adversely effect the quality of your product. If so, you can cover it however best suits your needs but probably a work instruction would suffice. Something at the beginning saying something to the effect of "You may not perform this activity unless you are feeling well and in good health. If you have recently run a fever, you may not perform this action for 24 hours after the fever is gone." I know that's a bit vague so if it's applicable, be sure to put it in the language that will be understood.
 
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