Document Change Notice vs complete System re-write

#1
Hello to all.

I am on the final stages of a complete system re-write of ISO 17025. I am a production testing facility which is integrated with the ISO 9001. The ISO 9001 writes most of the procedures of which I utilize while incorporating the requirements per 17025. Now to get to the point, 9001 system states that we use a Doc Change Notice for any change to be implemented. This is good and ok for individual doc's, form's, etc... but what if you have taken the entire 17025 system, "trashed it", and re-wrote the system where jsut about every piece of the system has changed from what it was. numbering system, locations, splitting up docuemt to make 2 docs... etc..... I do not want to create or dedicate an entire filing cabinet filled with change notices... plus there is almost no way of knowing what changed all of the time.

Ideas please????
 
Elsmar Forum Sponsor

Tagin

Trusted Information Resource
#2
Can your Doc Change Notice reference the task#/project#/etc. you are using to manage the rewrite, and so just have a single Notice that says 'see this reference for details'?

Another approach might be to consider this rewrite as 'above' the role of the Doc Change Notice; e.g. a continuous improvement action that supersedes the Doc Change Notice routine. In practical terms, what does the Doc Change Notice do for your org? What would be missing if that Notice wasn't created (aside from a variance from procedure)?
 
#3
Hmm, A CI could be the huckleberry, as this will explain the 5Wives without having to create 300 DCN for every item changed,moved,disreguarded, or added.

Further ideas are welcomed.
 

Ninja

Looking for Reality
Trusted Information Resource
#4
Not too familiar with 17025, but when I rewrote an entire section in ISO9001 (procedures, test methods, equipment, spec layout, PM etc.) when I first joined my last company...I used one DCN and did the whole thing, listing the docs and status in a list attached to the change notice
Test 1 - discontinued
Test 2 - rewritten
Proc 1 - unchanged
Proc 2 - rewritten
etc.

The doc controller made me issue all at once, which made sense to me, so the DCN was never "partway done"...
HTH
 

Pjservan

Involved In Discussions
#5
Just discuss it as part of Management Review as a Continuous Improvement project as well as change to the Quality System.
 
Thread starter Similar threads Forum Replies Date
S Is the document author required to be identified as part of Document Change Notice? ISO 13485:2016 - Medical Device Quality Management Systems 5
J Document Change Notice Content Document Control Systems, Procedures, Forms and Templates 24
J Engineering/Document Change Notice Procedure required? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
P Document Change Notice (DCN) vs. Document Release Notice (DRN) - Differences Document Control Systems, Procedures, Forms and Templates 7
B Document Change Notice - looking for examples Document Control Systems, Procedures, Forms and Templates 4
I Is highlighting on a printed document considered a change? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
D Are medical device companies required to document every change made to their website? Document Control Systems, Procedures, Forms and Templates 2
XRAY_3121 Informational MDSAP Audit Findings - Document change orders Other Medical Device Regulations World-Wide 12
Ajit Basrur FDA News FDA Guidance Document: Manufacturing Site Change Supplement US Food and Drug Administration (FDA) 0
T How to Document Risk Effects on Design Change(s) ISO 14971 - Medical Device Risk Management 3
S Change Control Form vs. Document Change Notification ISO 13485:2016 - Medical Device Quality Management Systems 3
Q How do we document a department name change? Document Control Systems, Procedures, Forms and Templates 3
Q Change revision number in document when only codification was changed Document Control Systems, Procedures, Forms and Templates 8
C Change Order necessary to document FMEA Updates? FMEA and Control Plans 1
L Procedure Change Request Form - "ISO Procedures" Document Changes Document Control Systems, Procedures, Forms and Templates 5
E Challenges in document control, revisional control, and change control Document Control Systems, Procedures, Forms and Templates 8
M Document Change Control for a Very Small Business Document Control Systems, Procedures, Forms and Templates 12
E FDA Significant Change Interpretation - Guidance Document EU Medical Device Regulations 2
JodiB Is DCR (Document Change Request) Needed for Initial QMS Procedures? Document Control Systems, Procedures, Forms and Templates 16
J Change in our SharePoint Document Control Process - Is this ok? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
E Help with ECR/DCR Document Change Control Software Validation Qualification and Validation (including 21 CFR Part 11) 6
S Change and Revision Status Identification for a Document ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
A Document Control Procedure Change 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
Q Document Control ECO (Engineering Change Order) or QMS? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 14
J Function of a Change Number in our ECN / document vault program as a tie-in Problem Solving, Root Cause Fault and Failure Analysis 3
J What should be included in the Design Change Document 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
A Implementing a change for a particular Process - Document & Change Control ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
2 Minor Document Change Control - Minor text changes to work procedures Document Control Systems, Procedures, Forms and Templates 9
C Document Change Request Flowchart - Please critique Document Control Systems, Procedures, Forms and Templates 32
K Form 42-2 for Document Initiation and Change Record - Template wanted Document Control Systems, Procedures, Forms and Templates 3
H Product Non-Conformity and Document Change Request Forms - Corrective Action needed? Nonconformance and Corrective Action 16
D Specifications - All the same type of document? Change Management part of our QMS Document Control Systems, Procedures, Forms and Templates 4
M Examples of DCR (Document Change Record) Log and Document Controlled Log Document Control Systems, Procedures, Forms and Templates 3
M Definition Engineering Change and Document Change - Definitions Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 2
H Example of DCR (document change request) form needed Document Control Systems, Procedures, Forms and Templates 14
V What Constitutes a Document Change? Company Logo Revision Miscellaneous Environmental Standards and EMS Related Discussions 12
M Engineering Change Request/Order (ECR/ECO) or Document Change Request/Order (DCR/DCO) Document Control Systems, Procedures, Forms and Templates 30
Q Global change software where changing one document changes all documents Quality Assurance and Compliance Software Tools and Solutions 1
H Formats for Master List of Quality Records (MQR) & Document Change Request Form (DCR) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
C Document Change Order - DCO templete which complies with FDA QSR requirements? ISO 13485:2016 - Medical Device Quality Management Systems 0
K Change the way we need to document our work - Copies of requirements? QS-9000 - American Automotive Manufacturers Standard 2
B Do IFU designs have to be document controlled under ISO 13485? Document Control Systems, Procedures, Forms and Templates 1
C Certificate of Conformance Form - COC for each customer a controlled document? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
A Document "Correspondence IATF 16949 vs ISO13485" available? IATF 16949 - Automotive Quality Systems Standard 0
R Document Retention - Discard hard-copies after scanning? ISO 13485:2016 - Medical Device Quality Management Systems 2
P Mylar plot suppliers in accordance with D6-51991 document AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 4
Q Document approval through SharePoint (without signature) Records and Data - Quality, Legal and Other Evidence 4
S What is considered a "core algorithm"? (From an FDA guidance document) Medical Information Technology, Medical Software and Health Informatics 4
U Document Approval - Software company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
O Please, help with document on ISO/ TS 17758 and (IDF 87: 1979). Thank you. Manufacturing and Related Processes 1
Similar threads


















































Top Bottom