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View Full Version : Health of Employees in Work Environment - ISO 13485, Section 6.4(a) superdave 15th August 2007, 12:35 PM Regarding 13485, Section 6.4(a), how do I determine the "health" of the employees? Does anyone know of a questionnaire that can be used (legally)? Also noted in 14969, @ 6.4.3.1 (re; microorganisms). Sidney Vianna 15th August 2007, 12:46 PM Regarding 13485, Section 6.4(a), how do I determine the "health" of the employees? Does anyone know of a questionnaire that can be used (legally)? Also noted in 14969, @ 6.4.3.1 (re; microorganisms).I am no 13485 expert, but it seems to me that you would satisfy the requirement by having policies that clearly inform the workforce that if they have a contagious disease, they should communicate that to the employer and probably abstain from performing work that could contaminate the products being realized. I believe that employers would have the right to enforce periodical screening of the employees in that context. Product sterilization could obviously mitigate the problem for end users and customers. :2cents: which costs $0.03 to produce.:frust: jem63 15th August 2007, 02:12 PM Regarding 13485, Section 6.4(a), how do I determine the "health" of the employees? Does anyone know of a questionnaire that can be used (legally)? Also noted in 14969, @ 6.4.3.1 (re; microorganisms). Develop an environmental control procedure to identify the requirements for handling sterile or nonsterile products. In doing so communicate this to your HR department and ask for their input. In addition these requirements should be communicated to employees and potential employees via the job description. hope this helps. :) Al Rosen 15th August 2007, 10:28 PM I am no 13485 expert, but it seems to me that you would satisfy the requirement by having policies that clearly inform the workforce that if they have a contagious disease, they should communicate that to the employer and probably abstain from performing work that could contaminate the products being realized. I believe that employers would have the right to enforce periodical screening of the employees in that context. Product sterilization could obviously mitigate the problem for end users and customers. :2cents: which costs $0.03 to produce.:frust:Exactly! |
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