Revision History of Quality Manual Missing

K

kilas78

#1
Hello Everyone,

I have been browsing this forum for some time now and found it really helpful.

Was looking for some advice, I have joined a company recently and am taking them for their first certification audit for ISO 9001-2008.

The Gap analysis or Readiness evaluation audit has already been done.

Since the company is small, hence there quality manual contained all the procedures, policies and other relevant documentation.

As per the suggestion of the auditor and reading through various forums, I have updated the quality manual by separating Level 2 and Level 3 documents and referencing them in the Quality Manual, which reduced my quality manual from 120 pages to 23 pages.

Now I want to put a revision history page with the quality manual, and my company has not been following any revisions lately,

I have revision 1, 9 and 14 available , so I labelled my last revised quality manual as Rev 15. and now I am having trouble in putting together a revision history (please see attached), this is the page that I have included in my quality manual.

I do not want to build in fake data, please advise is this how we proceed.

Thanks.
 

Attachments

Last edited by a moderator:
Elsmar Forum Sponsor
#2
Why do you feel it's necessary to put the rev history IN the document? It's a burden which I've never found helpful! As with engineering drawings, (at least the system I used) we referenced an ECO (or DCN in the case of a QMS) and simply list which ECO was issued. The people who really, really need to know the history (very few, as it turns out) can access that.

I'd record the various changes in some Document Change Notice(s) referencing the manual and what happened and keep the boring stuff out of the actual manual.
 
T

Tara Monson

#3
I agree. I always found tracking the history in the document not only wastes time but SPACE! Some of our documents would have pages and pages of history recorded. We track them in a revision history log.

As far as not having history of of past revisions, simply state and document that. Unfortunately, that is part of obtaining certification. One finds out their QMS was not perfect when they started. :)

Good luck!
 
K

kilas78

#4
Thank you Tara and AndyN for the useful advise.

For the purpose of audit, I think I will separate the revision history log and keep it at a separate place, but last time the auditor was here he requested me to show previous revisions of the quality manual, which I don`t have, and I had to divert him to other topics.

As for keeping the revision history inside a document, I belive it varies from company to company, based on my current company situation, anyone puts a revision number to a document which they create or modify, thinking its just a number.

Where as if the document history is contained within a document, they would think twice before putting in a new document revision number, at least they would try to understand its importance, that some one is doing a back working in order to maintain a revision history log.

And the reason why a revision history log is necessary is also very important, recently we had an HR induction form for new employees, some one revised it such that it was confusing and people started missing out details of one field "Emergency Contact", the field existed but it did not provide white space for the user to fill in, hence this field was not filled by some temporary employees. This could have caused trouble if some of our employees got injured and we could not get hold of their contacts.
I had to issue a non-conformance for missing out revision control and not getting the form approved prior to use on a daily basis.

So I completely believe in maintaining history of documents, as a single change could be checked in the history to see why it was removed or modified.

The question now is, should I tell the auditor that my revision history is missing ? and how do I do that without risking losing my certification for the company.
 
T

Tara Monson

#5
Did this gap in revision history occur before or after you were certified?

I'd probably document it as a Corrective Action and show your actions to prevent this from happening again (better document control, record control, etc.)
 
K

kilas78

#6
We are not certified as of yet, I have a certification audit coming up next week.

The gap still remains, the company is recent and was founded in 2010 and quality manual was developed but no one was there to maintain or updated it, so everyone randomly used it
 
T

Tara Monson

#7
Are the revisions controlled now? is there an approval process for revisions?

I'd write up a CAR for the missing history, documenting what changes have been implemented to better control the documents.

I'd call that good. I don't see an auditor having a problem with an issue from pre-certification days, especially if it's been corrected and documented.
 
K

kilas78

#8
Yes I have tried to implement revision control as much as possible, but it would take time, I had only 2 months to get then ISO 9001:2008 certified :( .

Thats a good idea to write a CAR, this is a procedure that I recently developed for the company and will come in handy.

I cannot pull all editable documents, MS Word files from all the computers in my company, and give them a PDF,

but what I am doing is , I am revising most of the documents, and providing a PDF to respective departments, so that they do not have an EASILY editable copy which anyone can modify as per their convenience.

Any more suggestions on how to bring in revision control would be appreciated.
 
#9
You can, of course, simply base line the whole system at "0" again (or whatever is your "zero"). It's your prerogative. You could simply record that there were major changes, the system was devolved from 1 volume and you had to re-establish a base line, since it wasn't being maintained. End of story.

It also gives you time to sleep or worry about more important things to work on. If your auditor is so bound up in documents and controls, they need to get a life!
 
K

kilas78

#10
Can`t do that Andy as we have to submit manuals to our clients regularly for different projects, they would notice an immediate change in the Rev no.

And "they need to get a life!" I will convey it to the auditor on your behalf ;)
 
Thread starter Similar threads Forum Replies Date
M Quality Manual Change History - Can I eliminate the revision record from the manual? Quality Management System (QMS) Manuals 33
M Is There a Revision History or Change Log for Canadian Regulations? Canada Medical Device Regulations 3
C SOP unification. Revision No, Revision history Document Control Systems, Procedures, Forms and Templates 4
I Dating controlled documents after changes - Revision History Document Control Systems, Procedures, Forms and Templates 13
I Revision History Date - date of updates or date of release? ISO 13485:2016 - Medical Device Quality Management Systems 2
Sam Lazzara Preferred Location for Revision History Section in Documents Document Control Systems, Procedures, Forms and Templates 16
I Document Control - Document Revision History Question Document Control Systems, Procedures, Forms and Templates 16
B Revision history for FDA's CFR 21 US Food and Drug Administration (FDA) 1
T 510(k) Revision Level History and Submission Requirements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
S Advice on moving QMS Documents and Maintaining Revision History Quality Manager and Management Related Issues 9
G Document Revisions - How do I track the Form Revision History/Approvals? Document Control Systems, Procedures, Forms and Templates 5
P Revision History in an MS Word document Document Control Systems, Procedures, Forms and Templates 37
J Drawing Revision History Question... Signature on EO or ECO Document Control Systems, Procedures, Forms and Templates 18
J Print (Drawing) Document Revision History Identification Indicators Document Control Systems, Procedures, Forms and Templates 5
C Revision History Page on Procedures Back/Front of Doc Document Control Systems, Procedures, Forms and Templates 10
C Revision History Page on Forms Document Control Systems, Procedures, Forms and Templates 3
L Should templates have a revision history? Document Control Systems, Procedures, Forms and Templates 4
D Documenting Revision History - Single ?Revision Record? Document Document Control Systems, Procedures, Forms and Templates 4
T Revision History in a Documentation Database - Necessary? Document Control Systems, Procedures, Forms and Templates 3
R Control of Documents - Change history question - Changes from previous revision OK? Document Control Systems, Procedures, Forms and Templates 11
C Guidelines on record retention of obsoleted calibration procedures (Revision History) Records and Data - Quality, Legal and Other Evidence 9
T Document Control Revision History in Manually Created BOM's (Bill of Materials) Document Control Systems, Procedures, Forms and Templates 6
M Revision History - How Specific? Document Control Systems, Procedures, Forms and Templates 6
M Missing a Revision in a Document's Revision History Document Control Systems, Procedures, Forms and Templates 2
J ISO 14001 revision process ISO 14001:2015 Specific Discussions 1
B CQI-11 (Plating Audit) - New revision updates IATF 16949 - Automotive Quality Systems Standard 0
P Proposed revision of IEC 62304 - 2019 IEC 62304 - Medical Device Software Life Cycle Processes 6
I Tracking Protoype Changes; 8D or simple document revision? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
A The latest revision number and changes in automotive core tools IATF 16949 - Automotive Quality Systems Standard 1
L Getting Notice of Revision and Accessing Public Draft Copies of ISO Standards Service Industry Specific Topics 2
A Domain of the component (EASA CM No.: CM-SWCEH-001 Issue 01 Revision 02) Point 9.3.3 (Usage domain aspects) EASA and JAA Aviation Standards and Requirements 0
M Informational ISO 14971 / ISO TR 24971 revision update – atualizações sobre a revisão Medical Device and FDA Regulations and Standards News 1
M Document Control - Revision Number in Document Names Document Control Systems, Procedures, Forms and Templates 4
L VDA 1 Documented Information and Retention (new revision 4, August 2018) VDA Standards - Germany's Automotive Standards 0
M Informational ISO TC 210 JWG 1 meeting in São Paulo – Revision of ISO 14971 and ISO TR 24971 – Medical Device Risk Management Medical Device and FDA Regulations and Standards News 0
M Revision of a Form which is a Procedure Attachment Document Control Systems, Procedures, Forms and Templates 1
S IMS Manual Review and Revision Prior to Audit ISO 14001:2015 Specific Discussions 4
2 First Article Requirements for Revision Changes of Engineering AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 0
ScottK Question for Auditors on 7.1.4 in the ISO9001:2015 revision ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
C Document Control - old revision vs new revision Document Control Systems, Procedures, Forms and Templates 22
R Clinical evaluation Meddev (2.7.1 revision 4) - Example or Template EU Medical Device Regulations 4
Paul Simpson Informational The role of Annex SL - High Level Structure of ISO MSS's - Revision Update February 2019 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 26
T ISO 9004:2018 Revision - Released April 2018 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
Brizilla Knowledge of the upcoming ISO 17025 Revision ISO 17025 related Discussions 5
Q Change revision number in document when only codification was changed Document Control Systems, Procedures, Forms and Templates 8
Marc When will Revision 5 of the AIAG FMEA Manual be released? FMEA and Control Plans 93
S Pre-release version of the upcoming AIAG FMEA Revision 5 FMEA and Control Plans 1
J Is there a specification that provides directions on Drawing Revision Changes Inspection, Prints (Drawings), Testing, Sampling and Related Topics 5
L Supplier Revision Confirmation of Received Engineering Documents ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
M ISO 14971 and ISO TR 24971 revision ISO 14971 - Medical Device Risk Management 32
Similar threads


















































Top Bottom