SBS - The Best Value in QMS software

Document Changes not affecting the process - Adding Logos, etc.

M

mark_s

#1
Our group has more than one program. Each program uses the same audit documentation and adds their logo. Since a logo does not affect the process, my audit report noted the added logo but no non-compliance was found. Feedback received is that adding a logo is an AS9100C non-compliance because the document is changed and it is no longer a controlled document. Any thoughts appreciated:D
 
Elsmar Forum Sponsor
M

mark_s

#3
Thank you. That will work well for the future.
Is the adding of a logo a AS9100C non-compliance?
 

sagai

Quite Involved in Discussions
#4
I do not know AS9100, but first, there should be a clear reference to the exact sub-chapter of the standard when there is registered non compliance.
(otherwise who a hack can tell after half year what the problem was :tg:
moreover non compliance is not an impression of the auditor, it is a lack of objective evidence based on the requirement defined in the standard :notme:)

I would not bet on non compliance based on the situation you gave, but the general practise is that for quality records there are templates in the qms and those templates also change controlled. In case the template has changed (due to non defined logo content interpreted as non controlled change in a template) than it could be minor non conformity, due to the document management process was not effectively implemented (because someone is hacking the template :lmao:).

Regards
Szabolcs
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#5
Feedback received is that adding a logo is an AS9100C non-compliance because the document is changed and it is no longer a controlled document. Any thoughts appreciated:D
Is the adding of a logo a AS9100C non-compliance?
Absolutely NOT. As you mentioned yourself, the logo is inconsequential to the process. So, adding a logo does not equate to making the document uncontrolled. One day, I will be able to package common-sense, sell it on
and I will retire a Billionaire...:tg:
 

sagai

Quite Involved in Discussions
#9
Absolutely NOT.
If their own QMS defines the template for this record and that template or the related work instruction clearly defines how the use it, and there is no definition of the need of logo, I tend to say D form PDCA is not effective, and as such if it is not an only example I would raise a finding against 4.1 (ISO9001) .
Regards, Sz.
 
Thread starter Similar threads Forum Replies Date
I Tracking Protoype Changes; 8D or simple document revision? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
H Drowning in ECR/ECO/ECN Document Changes Document Control Systems, Procedures, Forms and Templates 7
L Procedure Change Request Form - "ISO Procedures" Document Changes Document Control Systems, Procedures, Forms and Templates 5
L ISO 13485 Document Control - Document Changes - Needing Suggestions ISO 13485:2016 - Medical Device Quality Management Systems 1
M Is a New Revision Required for Minor Document Changes? Document Control Systems, Procedures, Forms and Templates 15
C Identification of Document Changes in a Wiki Document Control Systems, Procedures, Forms and Templates 6
R Document Changes (Revisions) and associated Risk Analysis ISO 13485:2016 - Medical Device Quality Management Systems 15
P Software Changes - Is an FDA guidance type of document available from SFDA (China)? China Medical Device Regulations 2
2 Minor Document Change Control - Minor text changes to work procedures Document Control Systems, Procedures, Forms and Templates 9
I ISO 10993-10:2010 Guidance Document for Irritation and Sensitization Test - Changes ISO 13485:2016 - Medical Device Quality Management Systems 3
Q Redlined Document for Changes kept as Records Document Control Systems, Procedures, Forms and Templates 2
T Maintain a Document for Changes in Forms and Procedures? Document Control Systems, Procedures, Forms and Templates 10
S Control of Documents - Showing Document Changes Document Control Systems, Procedures, Forms and Templates 12
T Inquiry about the number of changes in a document Document Control Systems, Procedures, Forms and Templates 7
L Changes in Revised Document are not Highlighted and Communicated ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
V IMO our people don't need to read manuals or procedures and document changes to them Document Control Systems, Procedures, Forms and Templates 60
G To ensure that document changes are identified... Document Control Systems, Procedures, Forms and Templates 11
T Changes to document control procedure - need review Document Control Systems, Procedures, Forms and Templates 4
Q Global change software where changing one document changes all documents Quality Assurance and Compliance Software Tools and Solutions 1
I Handwriting/changes on controlled document ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 20
F Document Control - Informing People of Document Changes Document Control Systems, Procedures, Forms and Templates 37
V Document and Data Changes ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
M Document Changes - How do you handle document and procedure changes? Document Control Systems, Procedures, Forms and Templates 1
Ed Panek MR Mandate Document EU Medical Device Regulations 0
C Document Index Document Control Systems, Procedures, Forms and Templates 4
K ASME, ANSI, ASTM and similar specifications and their requirements for document control. Inspection, Prints (Drawings), Testing, Sampling and Related Topics 8
H If we use agile - do we still need to document TF as a waterfall just for the notified bodies need? IEC 62304 - Medical Device Software Life Cycle Processes 2
Q ISO 9001/IATF 16949 Audit Finding Question - Document Retention IATF 16949 - Automotive Quality Systems Standard 10
B Document Issued with incorrect Document number code Document Control Systems, Procedures, Forms and Templates 2
J Requirement for Signature on Document Document Control Systems, Procedures, Forms and Templates 10
J Document Control Metrics Document Control Systems, Procedures, Forms and Templates 3
A Document Review and Document Approval --- 2 Signatures needed acc. §820.40? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
Sidney Vianna Interesting Discussion Should ISO 9004 be changed from a guidance document to a requirements standard? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
I Document Control Software Document Control Systems, Procedures, Forms and Templates 2
K 25-year lifetime of medical device - document storage period EU Medical Device Regulations 1
J UDI - Where to document it? EU Medical Device Regulations 8
T Controlling Expandable Forms in Paper-Based Document Control System Document Control Systems, Procedures, Forms and Templates 10
S Changing revision status of a reviewed document Manufacturing and Related Processes 11
shimonv Document Control Procedure Header Content Document Control Systems, Procedures, Forms and Templates 3
A Document release vs its related training. Which should come first? ISO 13485:2016 - Medical Device Quality Management Systems 18
Q Document ownerships Document Control Systems, Procedures, Forms and Templates 14
E Document Change Request forms (or no forms)? ISO 13485:2016 - Medical Device Quality Management Systems 9
O Any info on release date of FDA “Computer Software Assurance for Manufacturing and Quality System Software” document? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
B Document Approval Matrix Benchmarking Document Control Systems, Procedures, Forms and Templates 3
J Document Approval Signature Order Document Control Systems, Procedures, Forms and Templates 10
L How to add exemption or statement to control of document procedure? ISO 13485:2016 - Medical Device Quality Management Systems 5
M What is the proper way to document measurements Measurement Uncertainty (MU) 1
P Equipment 21 CFR 820.70(g) - User Requirements Document for Off the shelf equipment 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 7
B Do IFU designs have to be document controlled under ISO 13485? Document Control Systems, Procedures, Forms and Templates 2
C Certificate of Conformance Form - COC for each customer a controlled document? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2

Similar threads

Top Bottom