Labelling External Documents - Documents of External Origin

M

Meggsy

#1
I apologise if I'm repeating a question that's already been asked - I looked through some other posts about external documents, but couldn't find anything on this.

How do you label external documents (if at all)?

I've developed a template for all internal documents that show name, title, authorisations, etc, as well as "not controlled if printed". Would I need to do something similar for external documents? I'm worried that if I don't, they will be downloaded from the controlled area, and stored on local computers, where the filename can be changed and they'll no longer be recognised as part of the QMS (and possibly be used after they've been superseded or withdrawn)

Also, do external documents need to be approved prior to use? Obviously we can't make changes to it; but so that someone verifies that it's the appropriate document for use in our application/company?

:thanks:
 
Elsmar Forum Sponsor

Stijloor

Staff member
Super Moderator
#2
Re: Labelling External Documents

I apologise if I'm repeating a question that's already been asked - I looked through some other posts about external documents, but couldn't find anything on this.

How do you label external documents (if at all)?

I've developed a template for all internal documents that show name, title, authorisations, etc, as well as "not controlled if printed". Would I need to do something similar for external documents? I'm worried that if I don't, they will be downloaded from the controlled area, and stored on local computers, where the filename can be changed and they'll no longer be recognised as part of the QMS (and possibly be used after they've been superseded or withdrawn)

Also, do external documents need to be approved prior to use? Obviously we can't make changes to it; but so that someone verifies that it's the appropriate document for use in our application/company?

:thanks:
Simple. Develop an "inventory" of external documents.
Assign responsibility to verify the latest version to the document user.

Have you looked here?

Stijloor.
 

Wes Bucey

Quite Involved in Discussions
#3
I apologise if I'm repeating a question that's already been asked - I looked through some other posts about external documents, but couldn't find anything on this.

How do you label external documents (if at all)?

I've developed a template for all internal documents that show name, title, authorisations, etc, as well as "not controlled if printed". Would I need to do something similar for external documents? I'm worried that if I don't, they will be downloaded from the controlled area, and stored on local computers, where the filename can be changed and they'll no longer be recognised as part of the QMS (and possibly be used after they've been superseded or withdrawn)

Also, do external documents need to be approved prior to use? Obviously we can't make changes to it; but so that someone verifies that it's the appropriate document for use in our application/company?

:thanks:
You work for a big company - what is the scope of documents which will be under your purview? a department? or enterprise-wide?
 
Last edited by a moderator:
P

Phil Fields

#4
I apologise if I'm repeating a question that's already been asked - I looked through some other posts about external documents, but couldn't find anything on this.

How do you label external documents (if at all)?

I've developed a template for all internal documents that show name, title, authorisations, etc, as well as "not controlled if printed". Would I need to do something similar for external documents? I'm worried that if I don't, they will be downloaded from the controlled area, and stored on local computers, where the filename can be changed and they'll no longer be recognised as part of the QMS (and possibly be used after they've been superseded or withdrawn)

Also, do external documents need to be approved prior to use? Obviously we can't make changes to it; but so that someone verifies that it's the appropriate document for use in our application/company?

:thanks:
Meggsy,
Are these external documents "necessary for the planning and operation of the quality management system"? The quote is from ISO 9001:2008 4.2.3.f.

If the external documents do not impact the planning and operation of the quality management system they do not need to be controlled.

Phil
 

Stijloor

Staff member
Super Moderator
#5
Meggsy,

Are these external documents "necessary for the planning and operation of the quality management system"? The quote is from ISO 9001:2008 4.2.3.f.

If the external documents do not impact the planning and operation of the quality management system they do not need to be controlled.

Phil
Regardless, the organization may choose to do so.

Stijloor.
 

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#6
How do you label external documents (if at all)?
I haven't seen many companies actually put a label on documents of external origin. Typically each document is identified on its cover or somewhere.

The important aspect of external documents is that relevant documents are identified (such as customer prints, relevant specifications) and controlled.

As an FYI, here is a quick search for a few related threads: External Documents
 
S

suffelde

#7
A little suggestion to help the auditors not look for this kind of low hanging fruit is to put into you 4.2.3 document that any document that has not undergone the QMS document control process is considered reference only and should be treated as such whether internal or external. Then make sure any process which requires a specific external document's requirements be used to make "buy" decisions are controlled by your QMS.
 

CarolX

Super Moderator
Super Moderator
#8
I apologise if I'm repeating a question that's already been asked - I looked through some other posts about external documents, but couldn't find anything on this.
Don't sweat it, Meggsy!!!!

How do you label external documents (if at all)?
Really any way that works for you. What type of external documents are you talking about? Customer drawings? ASTM specifications?

I've developed a template for all internal documents that show name, title, authorisations, etc, as well as "not controlled if printed". Would I need to do something similar for external documents? I'm worried that if I don't, they will be downloaded from the controlled area, and stored on local computers, where the filename can be changed and they'll no longer be recognised as part of the QMS (and possibly be used after they've been superseded or withdrawn)
Address this in your QMS, that only documents found in the controlled area are authorized for use.

Also, do external documents need to be approved prior to use? Obviously we can't make changes to it; but so that someone verifies that it's the appropriate document for use in our application/company?
Not a bad idea. For example, if it is a customer drawing, you would want to verify revison levels.

Hope this helps a bit!
 
M

Meggsy

#9
Meggsy,
Are these external documents "necessary for the planning and operation of the quality management system"? The quote is from ISO 9001:2008 4.2.3.f.

If the external documents do not impact the planning and operation of the quality management system they do not need to be controlled.

Phil
I would say so. If the customer says they want to buy a widget to their specification 123, then we need to have a controlled copy of their specification 123, right? The only other way I can think of to make sure that old versions of the spec are not used is to make sure the customer supplies a copy of specification 123 with every order?

Is my thinking right here?
 
M

Meggsy

#10
A little suggestion to help the auditors not look for this kind of low hanging fruit is to put into you 4.2.3 document that any document that has not undergone the QMS document control process is considered reference only and should be treated as such whether internal or external. Then make sure any process which requires a specific external document's requirements be used to make "buy" decisions are controlled by your QMS.
Thanks, Suffelde. Is there a risk to doing this too early in the development of the system? At the moment we have plenty of documents floating around that are being used (that are not reference only), that we are slowly and surely implementing into the QMS (it's not an overnight exercise, I'm sure you can imagine!). If we put this into our document control process before the certification audit, and before we have transferred everything into the QMS, that is a huge loop-hole isn't it?
 
Thread starter Similar threads Forum Replies Date
A Medical device labelling Date of manufacture US Food and Drug Administration (FDA) 2
M Labelling - Is there a guidance or regulations that specifically defines the 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
C Barcode Labelling - Mistake Proofing Ideas & Systems Manufacturing and Related Processes 2
Z Labeler Code - Private labelling for OTC (Over the Counter) Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 0
Z NHP Health Canada Private Labelling Other ISO and International Standards and European Regulations 4
P New Global HQ Suggestions for Virtual manufacturing/own brand labelling of medical devices? EU Medical Device Regulations 4
Anonymous16-2 Labelling Training Training - Internal, External, Online and Distance Learning 3
D IVD (in vitro diagnostic) Labelling Requirements - 98/79/EC CE Marking (Conformité Européene) / CB Scheme 2
S Article 22 Procedure Pack Labelling EU Medical Device Regulations 4
F Labelling requirements for a medical device containing fragrance allergens EU Medical Device Regulations 3
H Re-labelling in IVDD - Re-label two products and package them as one CE Marking (Conformité Européene) / CB Scheme 5
S Industry Labelling Standards - non medical Manufacturing and Related Processes 0
JoshuaFroud Serial numbers and labelling when sharing device components ISO 13485:2016 - Medical Device Quality Management Systems 1
T Colour of symbols on Medical Device labelling and packaging Other Medical Device Related Standards 1
B Practical ideas for information labelling in healthcare environment IEC 27001 - Information Security Management Systems (ISMS) 2
G FDA UDI markings "label" vs. "labelling" (labeling)? US Food and Drug Administration (FDA) 4
R US FDA Mandatory Labelling contents for an OTC medical device US Food and Drug Administration (FDA) 0
M Technical File (STED) labelling - When you compile tech files do we have to include all the product labels? EU Medical Device Regulations 2
M Over-labelling - Any requirements or best-practices? Other Medical Device Regulations World-Wide 0
TheMightyWife Address Change - Medical Device Packaging Labelling Requirements EU Medical Device Regulations 7
S Labelling in Medical Device Software IEC 62304 - Medical Device Software Life Cycle Processes 8
M Is "Made in (Country)" a labelling requirement? Other Medical Device Regulations World-Wide 8
N Own brand labelling/virtual manufacture of IVD's EU Medical Device Regulations 2
M EN 374-2 One time test and labelling Other Medical Device Related Standards 0
V Software medical device labelling EU Medical Device Regulations 5
JoCam UDI - Direct Labelling EU Medical Device Regulations 9
JoCam Medical Device Final Assembly Labelling EU Medical Device Regulations 2
J Malaysia - Full Labelling Local Language Translation Other Medical Device Regulations World-Wide 1
S Adding claims on medical device labelling 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
M Labelling Requirements for USB-Powered Device Other Medical Device Related Standards 1
JoCam Over-labelling the manufacturers name at the front of the device EU Medical Device Regulations 31
J0anne Alternatives to 'Latex Free' Labelling Other Medical Device Related Standards 9
P CE Marked IVD Labelling Canada - Conformity symbol? Canada Medical Device Regulations 6
B Own Brand Labelling and Distributors - Self Test IVD's EU Medical Device Regulations 3
M Fabric Composition Labelling required for Medical Devices? Other US Medical Device Regulations 1
M Labelling and the harmonized EN ISO 14971:2012 ISO 14971 - Medical Device Risk Management 9
S Is Energy Labelling Directive appliable to the Medical Devices? CE Marking (Conformité Européene) / CB Scheme 2
J Packaging and Labelling Regulatory Reporting EU Medical Device Regulations 12
P OBL (Own Brand Labelling) - Technical Files/Risk Management ISO 13485:2016 - Medical Device Quality Management Systems 3
F FDA Device Labelling/Packaging Information Requirements Other US Medical Device Regulations 3
L Do we need a Labelling SOP for ISO 13485? ISO 13485:2016 - Medical Device Quality Management Systems 5
M IVDD ER 8.3 Vs. Hazard Labelling Regulations - Which outranks? EU Medical Device Regulations 2
E Labelling for 510K submission for a Class II medical device - suture passer 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
K Labelling Requirements for Class 1 Medical Device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
R Regulation/Standard for Labelling in the UK - Medical Device Directions for Use ISO 13485:2016 - Medical Device Quality Management Systems 7
N What needs to be on the label? Medical Device Labelling Requirements EU Medical Device Regulations 12
U Issue with Labelling of Outer Container - help needed for clarification EU Medical Device Regulations 3
L Identification, Labelling, Maintenence and Calibration Procedures wanted Document Control Systems, Procedures, Forms and Templates 1
R Labelling Requirements - Bare minimum Class I Medical Device Instrumentation EU Medical Device Regulations 5
D Labelling of Medical Devices with DEHP (Di(2-ethylhexyl) phthalate)? Other Medical Device and Orthopedic Related Topics 7

Similar threads

Top Bottom