Document Control Procedure - Please Critique

Elsmar Forum Sponsor

Jim Wynne

Staff member
Admin
#2
First swag at a new Doc Control procedure to move us from an ISO 9000:1994 system towards an ISO 9001:2008 system. Please comment, TIA for your inputs.
Here are the requirements from ISO 9001:2008, 4.2.3:

A documented procedure shall be established to define the controls needed
a) to approve documents for adequacy prior to issue,
b) to review and update as necessary and re-approve documents,
c) to ensure that changes and the current revision status of documents are identified,
d) to ensure that relevant versions of applicable documents are available at points of use,
e) to ensure that documents remain legible and readily identifiable,
f) to ensure that documents of external origin determined by the organization to be necessary for the planning and operation of the quality management system are identified and their distribution controlled, and
g) to prevent the unintended use of obsolete documents, and to apply suitable identification to them if they are retained for any purpose.


I don't see anything addressing (b), (d) or (f) in your procedure. Also, in your section 6.5, it would be a good idea to tell who has authority to redline documents.
 
B

BubbaDog56

#3
Jim,
Thanks for the feedback. We're still struggling on how to best address b), ideas are appreciated.

As far as d), we'll add more detail on how documents are issued to production work orders, and their constant availability in our electronic retrieval system.

As far as f), i agree that our cursory mention of controlling external documents is also in need of more 'meat'. There are lots of industry specifications and such floating around all over our place that can be used to make quality-related decisions, but no mechanism in place to control them.
 
S

ssz102

#4
i have no idea, as all of though just mentioned by Jim
it will be better if the contents can be details such as documents numbering, obsolete and update or revision
 
G

guruprasadb

#5
to review and update as necessary and re-approve documents may be identified during internal audits, management reviews, change in process or change in requirements etc.
as i have seen some companies they prepare the procedures long back , some still may be relavent to current practices but some may not.

I think there should be some review mechanism with some time frame to review the suitability of documents
 
Thread starter Similar threads Forum Replies Date
shimonv Document Control Procedure Header Content Document Control Systems, Procedures, Forms and Templates 3
L How to add exemption or statement to control of document procedure? ISO 13485:2016 - Medical Device Quality Management Systems 5
Q Tracking Procedure Revisions (Document Control) Document Control Systems, Procedures, Forms and Templates 9
M I Attached My first Document Control Procedure for your Review ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
Gman2 My Attached Document Control Procedure for your Review ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
C How to document many document control systems with one Document Control Procedure? Document Control Systems, Procedures, Forms and Templates 6
L Document Control Procedure - Revision Control ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 15
J Document Control Procedure for the Construction Industry - Help Document Control Systems, Procedures, Forms and Templates 4
B Document Control Procedure - Critique Wanted Document Control Systems, Procedures, Forms and Templates 5
D Converting to Electronic Document Control - Procedure Content ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 19
A Document Control Procedure Change 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
W Please review and critique our new Document Control Procedure ISO 13485:2016 - Medical Device Quality Management Systems 4
Crusader Local Control Document procedure....define it or not? Document Control Systems, Procedures, Forms and Templates 24
J Document Control Procedure - Review and Feedback Needed Document Control Systems, Procedures, Forms and Templates 9
J Are these things really required in a document control procedure? Document Control Systems, Procedures, Forms and Templates 17
Q Document Control Procedure - Too much detail? Document Control Systems, Procedures, Forms and Templates 8
T Document Control System and Procedure Advice wanted Document Control Systems, Procedures, Forms and Templates 3
S Outdated Document Control Procedure & Upcoming Audit Document Control Systems, Procedures, Forms and Templates 7
J Feedback on Document Control Procedure Document Control Systems, Procedures, Forms and Templates 20
P Feedback on Document Control procedure please ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
S Document Control Procedure Please Review Document Control Systems, Procedures, Forms and Templates 37
H External Document Control Procedure advice wanted ISO 13485:2016 - Medical Device Quality Management Systems 9
L Sample of Control of Document Procedure and Control of External Documents Document Control Systems, Procedures, Forms and Templates 2
T Changes to document control procedure - need review Document Control Systems, Procedures, Forms and Templates 4
J Document and Record Control - One Procedure or Two? TS 16949 Document Control Systems, Procedures, Forms and Templates 9
A Document Control Procedure needed Document Control Systems, Procedures, Forms and Templates 1
J Document Control Procedure Examples Document Control Systems, Procedures, Forms and Templates 11
J Corporate Procedures and document management/control procedure IATF 16949 - Automotive Quality Systems Standard 6
T Please Comment on my Document Control Procedure Document Control Systems, Procedures, Forms and Templates 8
W Why is a Document Control Procedure necessary? Small 2 Person Business Document Control Systems, Procedures, Forms and Templates 14
G ISO 9000:2000 Document Control Procedure P423 Document Control Systems, Procedures, Forms and Templates 7
D Document Control Procedure - Ideas - Examples Attached Document Control Systems, Procedures, Forms and Templates 40
J Document Control Metrics Document Control Systems, Procedures, Forms and Templates 3
I Document Control Software Document Control Systems, Procedures, Forms and Templates 2
T Controlling Expandable Forms in Paper-Based Document Control System Document Control Systems, Procedures, Forms and Templates 10
I Document Control on Log Files ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
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 51
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

Similar threads

Top Bottom