ISO 11607-2 Process Specification

Philip B

Quite Involved in Discussions
#1
ISO 11607-2 5.1.3 requires a 'process specification' to be established. I understand what this means but am unsure how to document it. In a procedure? In a validation report? Any suggestions gratefully received.
 
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planB

Super Moderator
#2
ISO 11607-2:2019 - quote:

3.15
process specification

documented procedure that includes all equipment, process parameters, monitors and materials required to manufacture a product that consistently meets requirements
So any (single or multiple) document(s) determined being suitable for this purpose in your QMS may be adequate, including among others procedures, or validation reports, as you mentioned

HTH,
 
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