Keep in mind that the requirement in section 4.2.2 of ISO 13485 applies to the medical devices industry, and this requirement will supersede any technical report or the information/guidance provided within it. Besides, TR 10013 was originally written around the ISO 9001 family of standards, and as such may not be fully applicable to ISO 13485. Especially the text italicized in blue...
I also realize that this may be a trivial requirement in the eyes of some, and there will be those who say "why does it even matter", but I say "if it doesn't matter that much, then why not do it by the numbers".
I still stand by my previous assessment, even though I would personally favor that approach, but I don't think doing it that way will technically meet the requirement as stated. I also did not see any ISO interpretations from ISO/TC 210 in Annex B (or any other source) regarding the precise application of this requirement, so if there is an elephant in the room, please let me know.
Brian
Fair enough. You may be right (BTW the quote from 10013 was just an illustration, not a punch line
)I always like to think that good auditors are focused on the intent behind a standard requirement, not on the mechanics, but maybe that's just wishful thinking. Time and again we read the testimonies of those who were not fortunate enough to have such auditors audit their companies.
Cheers,
Ronen.
