Document Control - Document Revision History Question

I

irish634

#1
I've been reading threads for a while but haven't really come across the answer I am looking for.

We are implementing our ISO QMS. For "Control of Documents" we have "to ensure that changes and the current revision status of documents are identified."

Most SOP and Work Instruction examples found on the net have a "revision table" of sorts embedded within the document.

However, in reviewing the IPC documents (ipc.org) (Standards and test methods) they do not include a revision table or revision history in the documents themselves. They do of course have revision letters. I presume they keep a separate document/database that keeps these revisions available.

I also presume an auditor/evaluator would question if we kept them apart from the documents. But for documents like forms, I don't think I have come across one with a revision history table. Revison status yes, table no.

So my question: Is the IPC incorrect in their method? I don't see where they are ISO certified, but reviewing document samples it was something I picked up on.

Are we likely to get 'dinged' if we keep the revision table separate?
Thoughts please and thank you.
 
Elsmar Forum Sponsor

Joe Cruse

Mopar or No Car
#2
Re: Revision History Question

I have seen customers do what I believe you are talking about, i.e. the document/forms having a revision status on it somewhere, and then a table at the very end that has a full revision history for that document/form. We especially see them with regards to purchase material specifications.

We do not handle documents that way, and have never been given any hassles about it. In our system, we have a document header, with the title of the doc and its revision status, among other things. We use a database to keep up with the revisions and status of all documents, and can produce a revision history of any document, when needed. I don't know how some of the other business systems like TS work, so maybe under others, putting a full revision history is necessary. Most of the time that I see this, the company has TS certification, not ISO9001.
 

Eredhel

Quality Manager
#3
Re: Revision History Question

Our documents have a header with the doc # and rev, who its owned by, who approved it, and what its title is. Then separately we have a master list that lists every document with its # and rev, date entered/revised, and ownership. I have one master list for docs and one master list for records. I have also hyperlinked the headers and master lists so I can easily go to either with a mouse click. Makes it easy to note rev changes.

Our system is new so I can't say it's great for the long haul. But we did pass our ISO certification handily recently.
 

Miner

Forum Moderator
Staff member
Admin
#4
Re: Revision History Question

Revision history may be handled many different ways. A table in the document is just one way, a database is another. Both are acceptable.

Keep it as simple as will work for you. Also, keep it lean. A revision letter, OR number, OR date is fine. No need to have rev letters AND a date.
 

Mark Meer

Trusted Information Resource
#5
I don't believe there's an explicit requirement to maintain revision history in ISO quality system standards (at least not, as far as I know, in 9001 or 13485). ISO 13485, for example, only requires maintaining "at least one copy of obsolete controlled documents"...no mention of revision history.

Certainly, there is no requirement to have revision history printed on every controlled document!

That being said, standards' requirements aside, I do think it is appropriate and valuable to maintain revision history summaries. ...but as already suggested, how you do this is entirely up to you...
 
I

irish634

#6
Thanks for the replies.

The clause in question that I am referring to is 4.2.3 line C (ISO 9001:2008)
"To ensure that changes and and the current revision status of documents are identified"

I guess I get hung up with "Ensuring changes are identified." To me, that means maintaining a revision history. Maybe I am wrong.

But I agree, no place does it state we need to maintain a history within the document itself.

I was only curious because the majority of the examples I find online have a revision history as a section within the document. I have found examples, like the IPC documents, that don't have a revision history within the document.
 
Last edited by a moderator:

Miner

Forum Moderator
Staff member
Admin
#7
The clause in question that I am referring to is 4.2.3 line C (ISO 9001:2008)
"To ensure that changes and and the current revision status of documents are identified"

I guess I get hung up with "Ensuring changes are identified." To me, that means maintaining a revision history. Maybe I am wrong.
Using change bars in the margin, underlining or using color also would identify changes.
 
T

Tara Monson

#8
We also keep an excel file with document revision history. No changes are ever noted on the document itself - only the current revision.

This works well for us. If we did keep a history on the document, some of the histories would be pages long. And that's just not worth it for us.

Good luck!
 
P

PaulJSmith

#9
To date, we've been keeping notes in the (electronic) document properties comments section of changes made, date, and person making the change.

We're currently looking to transition to a control software, which will make that unnecessary.
 

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#10
If, by IPC.org documents and standards you are referring to things like IPC-TM-650 test methods, I would consider them documents of external origin and as such the revisions are not controllable in the same way as your internal procedures.

I have seen many ways for ensuring changes are identified, including bold, colored or italics text, highlights, a summary in a revision history and a revision page like MIL-STDs used to have.

When considering making revision status known, I have been applying risk principles for a long time. That is,

- "How will the user know if this is the latest version?"
- "How do you make sure the user only accesses the correct version?"
- "How will the user know what has changed?"
- "If this page falls out of the binder and gets picked up, how would a person know what it belongs to and if it is current?"
- "If you need to research what used to be done, how would you do that?"

These are questions the organization can address to help make sure the right thing happens when and where it needs to. How you do it is up to the organization; an auditor should have an open mind as to options.
:2cents:
 
Thread starter Similar threads Forum Replies Date
I Document Control on Log Files ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
Q Tracking Procedure Revisions (Document Control) Document Control Systems, Procedures, Forms and Templates 9
C Document Control Stamps - Does anyone still stamp their documents? Document Control Systems, Procedures, Forms and Templates 24
I Control of Documentation Distribution - Document Control ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
T Control of downloaded document copies by employees Document Control Systems, Procedures, Forms and Templates 3
T Document control ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 5
O Vendor vs Engineering Document Control ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
A ISO9001:2015 Document control and training aids ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
GreatNate Document Control info - What is required on a controlled form/document for ISO 9001: 2015? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
J Document Control Software Needed ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
M Document Control - Revision Number in Document Names Document Control Systems, Procedures, Forms and Templates 4
I First Time Implementing Document Control for ISO-9001 - how far back do you go? Document Control Systems, Procedures, Forms and Templates 15
I Document Control Workflow Document Control Systems, Procedures, Forms and Templates 2
D ISO 9001:2015 8.5.6 and 7.5.3 Document Control Questions Document Control Systems, Procedures, Forms and Templates 50
R Changing Document Control software. Must I transfer EVERYTHING? Document Control Systems, Procedures, Forms and Templates 3
B Referencing to Supplier Outputs within our Document Control System 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
Sidney Vianna IAF Mandatory Document #23 - Control of CB Franchisees and Agents Registrars and Notified Bodies 3
C Document Control - old revision vs new revision Document Control Systems, Procedures, Forms and Templates 22
D Software for advancing with Document Control Quality Assurance and Compliance Software Tools and Solutions 4
L IATF 16949 Cl. 7.1 - Lotus Notes for Document Control IATF 16949 - Automotive Quality Systems Standard 0
A Removing purchase order form from document control - should it be done? Document Control Systems, Procedures, Forms and Templates 9
I Video under Document Control SOP ISO 13485:2016 - Medical Device Quality Management Systems 2
S Change Control Form vs. Document Change Notification ISO 13485:2016 - Medical Device Quality Management Systems 3
S Document control for tooling drawings (Document control clause 7.5.3) IATF 16949 - Automotive Quality Systems Standard 5
J Document Control Newbie - Control of Nonconforming / Returns Log AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
P Document Control - Do hard copies of documents need to be signed? Document Control Systems, Procedures, Forms and Templates 3
R External Standards List (Document Control) Document Control Systems, Procedures, Forms and Templates 3
M Retiring documents in Document Control Procedures ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
R Managing Level 3 Production Documents - Document Control System Help Document Control Systems, Procedures, Forms and Templates 6
M Cross Function Process Map for Document Control Process Maps, Process Mapping and Turtle Diagrams 3
0 How to deal with resistance to GDP Document Control Discipline Document Control Systems, Procedures, Forms and Templates 7
dubrizo Restructuring Document Control Numbering System Document Control Systems, Procedures, Forms and Templates 3
G Migrating to an ISO 13485:2016 Compliant Document Control System ISO 13485:2016 - Medical Device Quality Management Systems 6
E Document Control MS Access Database Document Control Systems, Procedures, Forms and Templates 39
S Looking for Document Control Templates Document Control Systems, Procedures, Forms and Templates 1
S Document Control Guidelines in Engineering Projects - Excel sheets with VBA coding Document Control Systems, Procedures, Forms and Templates 3
E Challenges in document control, revisional control, and change control Document Control Systems, Procedures, Forms and Templates 8
tony s Performance Indicators for Document Control ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 22
M Document Control Management - External documents flowed down from customers Document Control Systems, Procedures, Forms and Templates 2
T Document Control of FMEAs and Control Plans FMEA and Control Plans 5
T Is there a difference between form control and document control ? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
x-files Proper Document Control Requests Document Control Systems, Procedures, Forms and Templates 1
D Nonconformance on document control - Unapproved document on production server Document Control Systems, Procedures, Forms and Templates 4
M Where does Document Revision Control Start? Rev 0 or Rev 1 Document Control Systems, Procedures, Forms and Templates 19
I How to build a Microsoft Access MDB Database for Document Control Document Control Systems, Procedures, Forms and Templates 6
M I Attached My first Document Control Procedure for your Review ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
L ISO 13485 Document Control - Document Changes - Needing Suggestions ISO 13485:2016 - Medical Device Quality Management Systems 1
Gman2 My Attached Document Control Procedure for your Review ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
K Simple ISO 9001 Compliant Document Control Quality Manager and Management Related Issues 24
J Document Control Features (Document Content Requirements) and 21 CFR 820.40 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4

Similar threads

Top Bottom