Revisions in ISO 9001 QMS Documents - Where to keep the record of revisions?

S

sundara03

#1
#1
How do you keep the record of revisions that that had taken place in a proceure? Is it kept separately as another or written down in the revised document itself?
Hope I am clear. I mean the reoed of reviosns - rev 1, rev 2 etc. I know the actual revision will be done in the procedure itself only but where to mention such & such revison has been done? As seaparate record or as a part of the proceudre itself.

SRajan
 
Download Free White Paper
Elsmar Forum Sponsor
S

sundara03

#3
#3
Re: Revisions in the ISO documents

rnsvasan said:
Amendment record sheet -
Click to expand...
Don't you think there is a problem? When I view a particular procedure I won't know the modifications/ revisions that had taken place prior to that issue. I have to go back to the amenment sheet , scan the entire page(s) look for the all the amendments for that particualr procedure - I hate it. It would be better, like any engineering drawing, the revison is recodrd in the procedure itself. This is my view, I solicite honest opnions

SRajan
 
H

harry

Trusted Information Resource
#4
#4
Re: Revisions in the ISO documents

sundara03 said:
........ When I view a particular procedure I won't know the modifications/ revisions that had taken place prior to that issue. I have to go back to the amenment sheet , scan the entire page(s) look for the all the amendments for that particualr procedure - I hate it. It would be better, like any engineering drawing, the revison is recodrd in the procedure itself........... SRajan
Click to expand...
Welcome to the Cove.

You've answered your own question. Do it in a way (and in a logical manner) that suits you best.
 
R

rnsvasan

Involved In Discussions
#5
#5
Re: Revisions in ISO QMS documents - where to keep the record of revisions?

Good, but my other notion is; whether it may not require searching total procedure to find out where we have made revision. In engineering drawing it ends there itself with in a page or two and may not require amendment sheet of course.

But, it’s all upto you to decide the method that suits you.
 
L

LeanMfgGuru - 2010

#6
#6
Re: Revisions in ISO QMS documents - where to keep the record of revisions?

Some of the methods I have seen used to document revisions changes are:

(1). revision block at the end of the document
(2). changes, additions or revisions in different color font
(3). seperate electronic folders with older revisions filed

Hope this is of some help to you
 
E Wall

E Wall

Just Me!
Trusted Information Resource
#8
#8
sundara03 said:
How do you keep the record of revisions that that had taken place in a proceure?
Click to expand...
I developed a database and maintain a record of all changes for documents controlled at our local level. Corporate document control office does same for shared global, regional and business level documents. For us the decision was made depending on the document type with the last 3 revisions are included in specs and work instructions (higher level) but none are in point-of-use work instructions (we call these SOPs) or forms.

As others have said your system needs to be designed to suit your business needs.
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
L Preparation for ISO 9001:2015 - Required Document Revisions Document Control Systems, Procedures, Forms and Templates 10
N ISO 9001:2000 version to ISO 9001:2008 - Necessary Document Revisions ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
A Training on Document Revisions - ISO 9001 Clause 6.2.2 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
P Next Revisions to ISO 9001 - 2008 Addendum - 2010 Revision ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 45
Marc ISO Releases DIS Versions of ISO 9001 Year 2000 Revisions ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 0
D Recent changes to ISO 14971 - SOP required for managing standard revisions ISO 13485:2016 - Medical Device Quality Management Systems 1
E ISO 15223-1 (Medical Device Label Symbols) - Revisions, EU commission? Other ISO and International Standards and European Regulations 1
M Automated Revision Updates - Notifications of new revisions for ISO's to subscribers Document Control Systems, Procedures, Forms and Templates 2
J ISO 20000 Revisions for 2011 Standard Version IT (Information Technology) Service Management 2
N ISO 14001 Lead auditor certification under 1996 & 2004 revisions ISO 14001:2015 Specific Discussions 1
I BS EN 1041 - BS EN 980 - BS EN ISO 14630 revisions - What are the changes Other Medical Device Related Standards 4
A New Revisions to ISO 17020:1998 Other ISO and International Standards and European Regulations 4
H What are the Current OHSAS 18001 & ISO 14001 Revisions & Combined Systems Various Other Specifications, Standards, and related Requirements 37
M How to answer ISO9001:2015 audit finding of old revisions of documents being used? Document Control Systems, Procedures, Forms and Templates 8
S Baselines vs revisions AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 0
G Supplier flowdown verification of tests and revisions Supplier Quality Assurance and other Supplier Issues 0
Q Tracking Procedure Revisions (Document Control) Document Control Systems, Procedures, Forms and Templates 9
R Training Matrix for Document revisions ISO 13485:2016 - Medical Device Quality Management Systems 4
M Informational Health Canada – Notice: Revisions to the Guidance Document: Management of Applications for Medical Device Licences Medical Device and FDA Regulations and Standards News 0
V Who should define and own the Design and Development Plan and how to maintain the updates and revisions. ISO 13485:2016 - Medical Device Quality Management Systems 2
D Document Management System - Revisions & Out of Date Documents Document Control Systems, Procedures, Forms and Templates 17
J 3rd Party Certification and QMS Revisions Registrars and Notified Bodies 4
L Medical Device Electrical Safety Standards - Gap Analysis of Latest Revisions Other ISO and International Standards and European Regulations 2
I Curious if a List of Current Standards Revisions Exsists Other Medical Device Related Standards 3
E PMDA Act, Nov 2014 revisions - source in English? Japan Medical Device Regulations 3
J Question about training on document revisions Training - Internal, External, Online and Distance Learning 3
U Document Revisions Required in DMR Index? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 10
C Incremental revisions to Quality Manual, and Training Records Document Control Systems, Procedures, Forms and Templates 2
P EU MDD revisions white paper on the proposals for the Medical Device Regulations EU Medical Device Regulations 1
S FMEA Revisions - Recommended Actions to Actions Taken FMEA and Control Plans 5
J PPAP for New Family Revisions when the Part has not changed APQP and PPAP 4
T Staff Acknowledgements for Policy Revisions Quality Manager and Management Related Issues 17
C SOP Work Instruction (Job Card) Template Revisions question Document Control Systems, Procedures, Forms and Templates 6
Q AS9102 Handwritten Revisions on Ballooned Drawing AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 20
S How to document revisions after Periodic Review of documents ? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
L Quality Manual Revisions and Revision Levels ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
D Procedure for Maintaining Industry Standards and Identifying Revisions Document Control Systems, Procedures, Forms and Templates 1
A How to handle the various Document Revisions Document Control Systems, Procedures, Forms and Templates 2
J File Name Revisions in SharePoint Document Control Systems, Procedures, Forms and Templates 5
S Quality Plan Revisions and Numbering ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 14
G Document Revisions - How do I track the Form Revision History/Approvals? Document Control Systems, Procedures, Forms and Templates 5
N Identifying Changes and Revisions in QMS Documents - 4.2.3.c Requirements Document Control Systems, Procedures, Forms and Templates 13
M 7.6.2 Revisions following Engineering Changes - What is the right meaning? IATF 16949 - Automotive Quality Systems Standard 4
R Document Changes (Revisions) and associated Risk Analysis ISO 13485:2016 - Medical Device Quality Management Systems 15
V Latest revisions of Core Tools Manuals from the AIAG (APQP, PPAP, FMEA, SPC and MSA) IATF 16949 - Automotive Quality Systems Standard 3
M Document Control (with Revisions Control) Management Database Document Control Systems, Procedures, Forms and Templates 4
JoCam Issue Dates/Revisions of Standards referenced in Internal Documents ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
I Service Manual Revisions - How do you go about obtaining it? General Measurement Device and Calibration Topics 3
D Document Revisions when a different company takes control ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
T Document Control Checklist for use after Document Revisions ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5

Similar threads

Top Bottom