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Manufacturing solutions and keeping records on quality Content

#1
Hello everyone,

Our notify body we collaborate with requires theese documents (manufacturing solutions and keeping records on quality) to get the CE certificate.

Does anyone have any idea what this document might include, or does anyone have a template for this?
 

yodon

Staff member
Super Moderator
#2
Were you given a nonconformance? If so, can you please provide the (exact) wording? Did they cite chapter and verse of the requirement you were failing to meet? I think we probably need a little more info here.
 
#3
Our "phototherapy lamp with UV radiation" is a UV radiation emitting medical device designed for use in hospitals and consulting rooms and is used in the treatment of skin diseases (conditions), like vitiligo and psoriasis.



Our notify body we collaborate with requires theese documents (manufacturing solutions and keeping records on quality) to get the CE certificate.

I think that the manufacturing solutions is about what kind of technical solutions, processes, technologies we use for manufacture this product.

The keeping records on quality might be a process or flow chart in which you describe the way you follow the quality records, the way you keep them, from where you collect informtions and what kind of documents you use to ensure the quality.



I want to ask you to give your opinion about this topic, what you’re thinking abut this documents have to contains.

If you have a template for this document I will fully appreciate.
 

yodon

Staff member
Super Moderator
#4
It's still not clear to me and, again, if you were given a nonconformance, providing the exact wording will be helpful.

If you look at 13485 (harmonized standard), you see requirements for:
  • purchasing information (7.4.2) & records verifying purchases (7.4.3)
  • documented procedures for the control of production (7.5.1)
  • records related to qualification of infrastructure (7.5.1)
  • procedures for monitoring and measuring process parameters and product characteristics (7.5.1) (and, of course, the records arising from those activities)
  • defined procedures for labeling and packaging (7.5.1) (and any records arising from those)
  • procedures for product release, delivery, and post-delivery (7.5.1)
There are more but this is likely what they're getting at. All (and more), IMO, are likely "manufacturing solutions" and the records arising from the actions would be considered quality records. Again, without knowing specifics - both of the feedback from the NB and your processes, it's difficult to get into details.
 
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