CE Mark Technical Files as controlled document in ISO9001 QMS

F

fEArmE

#1
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!
 
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F

fEArmE

#3
I'm thinking to classify them as record too but the technical files will be revised in the future which makes it kinda weird revising a record.
 

Le Chiffre

Quite Involved in Discussions
#4
Hmmm, I see it differently. The technical file is made up of records and documents, with an index that cross references the revisions and dates of each part.
 

somashekar

Staff member
Super Moderator
#5
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!
Your CE mark technical file is indeed related to your QMS, if you have identified say the MDD as a regulatory requirement in your ISO 13485 QMS. As said by Le, its a compilation of several documents and records which by themselves are under your documents and records control process. and thus the Technical file is indeed under document management. I do not see here any problem for you. As long as you have a well maintained and updated technical file covering all engineering changes, significant changes handling, and records meeting to your set harmonized standards, why bother about any classification for the technical file ?
 
F

fEArmE

#6
Hi Somashekar,

Thanks for your feedback. The reason I'm bothered by classification is that our current document change notice procedure only have room for quality manual, quality procedures and work instructions. Records are considered to be documents that do not need revision(correct me if I'm wrong). If I classify them as record, it sounds weird to revise a record. The other option I could think of is to redefine our documentation procedure to include Technical Files but I'd like to hear what the pro says first. Thanks.
 
I

iansawyer

#7
The reason I'm bothered by classification is that our current document change notice procedure only have room for quality manual, quality procedures and work instructions.
Hi fEArmE - You are right that the Technical File does not fall into one of those categories. The best option is to amend your document control procedure to cover "quality manual, quality procedures, records, and technical files".
 
W

Watchwait

#8
We have, in fact, incorporated our Technical Files into our controlled document system. Maintenance thereof is a bit of a task, but not an overly burdensome one due to the way we structured the TFs. Basically, the TF is a list of documents - some controlled, others not. For the controlled documents, we list the basic document number, but not the revision, e.g. WI-12345-XXX. Then, in the preface of the TF we indicate the the latest revision of any referenced document is contained within the controlled document system itself. This way, we only need to revise the TF when a document is added or subtracted from the DMR - not when they are merely revised, which is by far the more frequent occurrence. To be sure, the TF contains many more documents than those listed in the DMR or the QSR, but those types of documents, once incorporated, rarely change. FYI, our Notified Body has reviewed this approach and is fine with it.
 
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