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Hi there,
I've been searching for information on how the CE mark technical files be integrated to our current QMS system, but to no avail. I was wondering what kinda documents should they be classified under the ISO9001 standard. We have defined our QMS documentation to a 4 tier approach. Quality Manual, Quality Procedures, Work Instructions and records. The CE mark technical files are not really related to the QMS but I'd like to include them as part of controlled documents. I'll be extremely happy if someone could shed some light on this. Thank you!
I've been searching for information on how the CE mark technical files be integrated to our current QMS system, but to no avail. I was wondering what kinda documents should they be classified under the ISO9001 standard. We have defined our QMS documentation to a 4 tier approach. Quality Manual, Quality Procedures, Work Instructions and records. The CE mark technical files are not really related to the QMS but I'd like to include them as part of controlled documents. I'll be extremely happy if someone could shed some light on this. Thank you!