Totally confused over changes to issue numbers - Quality & procedures manuals

J

J-F. G

#11
Well thank you again Andy.

I like the way you put it: changes = revision

I will modify the procedure to state that the changes shall appear only in the change log table and are to be incorporated in the body of the document only at the next revision of the document.

Our change log is a table on the front page and is prior to and part of the MS word document, is that OK or does the document change notice you are talking about have to be a separate electronic document ?

Thanks for the advices and have a great week end. /jf
 
Last edited by a moderator:
Elsmar Forum Sponsor

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#12
I would put the change notice on the document itself, where people are more likely to notice it.

And your coworkers are correct in that each time you do this, it becomes a new revision.
 
M

Mark R.

#13
jfg:

A simple note in the revision history is fine, as is noting the change in the margin next to the affected text. The primary concern is being able to identify what has been changed between revision #1 and #2....

There's a number of ways to be compliant here - make sure that whatever system you use is appropriate to your organziation and isn't too complicated.

Hope this helps,

Mark
 
Thread starter Similar threads Forum Replies Date
Ajit Basrur 20 British Words That Mean Something Totally Different in the U.S. Coffee Break and Water Cooler Discussions 38
B Terminating an Internal Audit - Area totally out of control Internal Auditing 41
J How to get Minitab to totally disregard empty cells Using Minitab Software 3
Antonio Vieira Totally against written procedures! Document Control Systems, Procedures, Forms and Templates 39
J MD Directive vs EMC Directive - Totally excluded (for both emissions and immunity)? ISO 13485:2016 - Medical Device Quality Management Systems 1
S Bogus ISO certification?? Entire systems totally ineffective or missing ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
D Essential performance, accompanying documents....confused IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
D Software as risk control - Confused on one aspect of IEC 62304 IEC 62304 - Medical Device Software Life Cycle Processes 20
E European Weld Callouts - Confused with the "/C" and the "a2" portions Various Other Specifications, Standards, and related Requirements 7
R Still confused on OPRP and CCP in an ISO 22000 Catering Business Food Safety - ISO 22000, HACCP (21 CFR 120) 3
S Pressure from Directors - confused! ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
R ISO 9001 Implementation in the Bus/Coach Industry - Confused and Help needed ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
A Confused about Document Levels and Quality Manual ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
J Confused about application of ISO 13485 - Manufacturer of Medical Equipment & Device ISO 13485:2016 - Medical Device Quality Management Systems 14
T TS 16949 Process Audit Help - Confused Process Audits and Layered Process Audits 8
K So confused with AQL - How does AQL (Acceptable Quality Level) fit with my company AQL - Acceptable Quality Level 7
N ISO 9001 Implementation - I am still confused on where to start ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 19
J Certification Audit - Confused Newbie Questions ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 15
T Confused on Work Instruction Requirements ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
C Confused with 7.4 Purchasing - We provide a "service" which is our "product" ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
M Confused about Writing Procedures ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
B Gage R&R Spreadsheet Results - Confused as to what the results mean Inspection, Prints (Drawings), Testing, Sampling and Related Topics 28
B IEC 60601-1: EMC problems: Confused about 915MHz ISM band in Europe IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
Q Confused: IEC 60601-1-2:YYYY and Required Compliance Dates IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
S Confused: Accreditation / Certification? General Measurement Device and Calibration Topics 13
K An MR (Management Representative) who's as confused as he* Career and Occupation Discussions 14
M Confused about Control Plan and PFMEA Retention Period Document Control Systems, Procedures, Forms and Templates 2
K Developing a PFMEA - Confused about Potential Failure modes FMEA and Control Plans 7
H Confused over the notion of "offline (engineering) analysis" Statistical Analysis Tools, Techniques and SPC 3
I Confused on PPAP re-submission - Help on PSW (Part Submission Warrant) APQP and PPAP 3
T Confused by chapter numbering scheme in new standard (IEC EN-60601-2-37:2007) IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
C CAP for Medical Device Class Is product - Slightly confused - ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 3
A Confused - Medical Device Reports and Corrections/Removals 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
Wes Bucey FWIW: FDA confused? US Food and Drug Administration (FDA) 3
M Confused about measurement of software - Section 7.6 of ISO 9001 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
WCHorn ISO/IEC 17025 Registrars - I'm confused about "accredited" registrars for ISO 17025 ISO 17025 related Discussions 18
M Predictive Maintenance - Confused about what can be considered predictive maintenance IATF 16949 - Automotive Quality Systems Standard 8
W Confused under what ISO 9001 clause would I place my Quality Process? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
J Confused about Calibration Tolerances of Plug Gauge, Ring Gauge & Snap Gauge General Measurement Device and Calibration Topics 4
S PPM vs. DPMO - Confused on how to use Six Sigma 2
A Still Confused About "Controlling Suppliers Records" AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
Q Confused about the machine capability index Cmk Capability, Accuracy and Stability - Processes, Machines, etc. 1
C Confused with Regression Analysis - What about the P-value? Six Sigma 2
B I am confused, which Cmk value should I take and use? Statistical Analysis Tools, Techniques and SPC 6
N Confused by calibration concepts - Seeking help with the basics General Measurement Device and Calibration Topics 9
D Confused about registration scope - Engine accessories supplier IATF 16949 - Automotive Quality Systems Standard 3
K Level 1, Level 2 Very Confused ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
D Confused over product=service=transport Service Industry Specific Topics 2
S Confused about the TS 16949 Deadline - Presumably a Big 3 mandate? IATF 16949 - Automotive Quality Systems Standard 4
D Strategies for Going In Blind - My employer is probably confused why I'm here Misc. Quality Assurance and Business Systems Related Topics 11

Similar threads

Top Bottom