SBS - The best value in QMS software

First Time Implementing Document Control for ISO-9001 - how far back do you go?

ISO_Man

Involved In Discussions
#1
If you are starting document control for a company that did not use it before, how do you address years worth of documents (hundreds of them) they weren't approved and released properly? The time to do re-approve and release them would be prohibitive.
 
Elsmar Forum Sponsor

Randy

Super Moderator
#2
Forget them! All you need to show control of are those that are relevant to your established system like ongoing procedures, policies, SOP's and stuff like that and of course any records you generate during and after the implementation of your MS....So you might need to update a few things, grandfather them or whatever and then just pick up the ball and run with it...The stuff in the past doesn't exist nor is there any requirement that you bust you backside trying to fix those things.
 

ISO_Man

Involved In Discussions
#3
Thanks for the feedback - assuming that one of the staff wants to keep these old documents as a sort of reference library and make them available to a small audience, can I put them in a controlled folder marked "for reference" and limit access?
 

Ron Rompen

Trusted Information Resource
#4
I agree totally with Randy. Trying to go backwards and correct those 'old' documents is a pointless task - i guarantee that if you try you will miss one (or more) anyway. Draw a 'line in the sand' and commit that from that given date everything will conform. The past is gone, and you can't correct it.
 

ISO_Man

Involved In Discussions
#5
I agree totally with Randy. Trying to go backwards and correct those 'old' documents is a pointless task - i guarantee that if you try you will miss one (or more) anyway. Draw a 'line in the sand' and commit that from that given date everything will conform. The past is gone, and you can't correct it.
Thanks for the feedback - assuming that one of the staff wants to keep these old documents as a sort of reference library and make them available to a small audience, can I put them in a controlled folder marked "for reference" and limit access?
 

Cari Spears

Super Moderator
Staff member
Super Moderator
#6
Thanks for the feedback - assuming that one of the staff wants to keep these old documents as a sort of reference library and make them available to a small audience, can I put them in a controlled folder marked "for reference" and limit access?
Yes - that's exactly what I did. I have a limited access "Obsolete" folder that only a couple of people and I can view; everyone knows whom to see if they would like to reference something in the Obsolete folder.
 

JoshuaFroud

Involved In Discussions
#7
Thanks for the feedback - assuming that one of the staff wants to keep these old documents as a sort of reference library and make them available to a small audience, can I put them in a controlled folder marked "for reference" and limit access?
I agree with Cari here as well. Keep them, restrict access and mark them as "Obsolete".

You could even go as far as an obsolete stamp if they are physical documents or watermark is they are digital and you wanted to make it very clear they were no longer current.

There is no requirement to go backwards when implementing a new system. Set a Day 0 and work from that point onwards.
 

ISO_Man

Involved In Discussions
#8
Yes - that's exactly what I did. I have a limited access "Obsolete" folder that only a couple of people and I can view; everyone knows whom to see if they would like to reference something in the Obsolete folder.
thanks - what I'm proposing would mean access for about 20 people rather than just me. Any thoughts there?
 

Golfman25

Trusted Information Resource
#9
Thanks for the feedback - assuming that one of the staff wants to keep these old documents as a sort of reference library and make them available to a small audience, can I put them in a controlled folder marked "for reference" and limit access?
That's a form of control, isn't it? We have the "secret drawer" which has all the original process info from the 60s, 70s, & 80s, just in case some didn't get completely transferred.
 
Thread starter Similar threads Forum Replies Date
A Implementing a change for a particular Process - Document & Change Control ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
E Implementing Risk Management - Required Document Types ISO 14971 - Medical Device Risk Management 8
L Implementing ISO 9001 - Document every clause? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
H Implementing ISO22301 on a Limited Scope Business Continuity & Resiliency Planning (BCRP) 1
J Implementing an ISO 13485 QMS Software ISO 13485:2016 - Medical Device Quality Management Systems 6
Sravan Manchikanti How to interpret '8.3 Control of nonconforming product' for SaMD device while implementing ISO 13485 & MDSAP ISO 13485:2016 - Medical Device Quality Management Systems 7
L Implementing the PRRC role in a company EU Medical Device Regulations 7
A Implementing ISO 20000-1 - Where to start Other ISO and International Standards and European Regulations 2
B Lessons Learned Implementing ISO 50001 (Chemical Engineering Progress) Other ISO and International Standards and European Regulations 0
C How medical device manufacturers are implementing standards like GDPR and HIPAA Other ISO and International Standards and European Regulations 5
M Informational EU – Commission Implementing Decision (EU) as regards the designation of expert panels in the field of medical devices Medical Device and FDA Regulations and Standards News 0
R Implementing Design History Documents/ Technical Documents in the QMS ISO 13485:2016 - Medical Device Quality Management Systems 3
tnorton Lessons learned from implementing Customer Complaints Customer Complaints 1
M Informational Update – MDR and IVDR implementing measures rolling plan – 2 more NBs designated under the new regulations Medical Device and FDA Regulations and Standards News 0
S Implementing a 45001 Health & Safety standard - Internal audit plan wanted Internal Auditing 1
M Informational Commission Implementing Decision (EU) 2019/939 of 6 June 2019 designating issuing entities designated to operate a system for the assignment of Unique Medical Device and FDA Regulations and Standards News 0
J Implementing Machine Replacement Part Reverse engineering technology Manufacturing and Related Processes 3
Q Does anyone have experience implementing a QMS without ISO certification? Quality Manager and Management Related Issues 2
M Informational EU – April 2019 update of the MDR and IVDR implementing measures rolling plan Medical Device and FDA Regulations and Standards News 0
M Medical Device News Last update of the MDR and IVDR implementing measures rolling plan – December 2018 Medical Device and FDA Regulations and Standards News 0
J Implementing EN 62304:2006 on existing and proven medical devices IEC 62304 - Medical Device Software Life Cycle Processes 6
M Medical Device News MDR and IVDR implementing measures rolling plan EU Medical Device Regulations 0
B Implementing an Escalation Process and Andon system Supplier Quality Assurance and other Supplier Issues 1
K EQMS question - Implementing an electronic QMS to support ISO 13485:2016 Quality Assurance and Compliance Software Tools and Solutions 4
T Is there any requirement to be compliant with IEC 62304 while implementing ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 5
A Compliance Obligations - Implementing 6.1.1 and 6.1.3 NOTE - Determine risks and... ISO 14001:2015 Specific Discussions 1
G Heavy Civil Construction Company Implementing ISO 9001:2015 for Certification ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
K Implementing ISO13485:2016 in the Middle of a New Device Project ISO 13485:2016 - Medical Device Quality Management Systems 1
D Implementing 5S for Multiple Shop Floor Layout Workstations Lean in Manufacturing and Service Industries 2
N FDA Guidelines for implementing Continuous Improvement Process US Food and Drug Administration (FDA) 5
Q Easy Way of "Implementing" Risk in ISO 9001 2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
N Implementing ISO 17025 in a Calibration Laboratory ISO 17025 related Discussions 8
E Does anyone have experience implementing a Tiered QMS? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
A Implementing an AS9100 Aerospace Quality System AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 9
L Implementing ISO 9001 in small Trading Company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
C Implementing a set of bore gages at a machine Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 1
A Implementing Risk Management in a Medical Device "Distributor Only" company ISO 13485:2016 - Medical Device Quality Management Systems 2
T Implementing a Suspect Counterfeit Identification Program Quality Manager and Management Related Issues 3
O Implementing Lean Intranet Sharepoint Lean in Manufacturing and Service Industries 6
F Implementing ISO 9001:2008 in a new Food Processing company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
J ISO 22301 - Implementing a Business Continuity Management System Business Continuity & Resiliency Planning (BCRP) 15
M Does anyone here have experience implementing PCI DSS (Data Security Standard) IEC 27001 - Information Security Management Systems (ISMS) 10
L Implementing a new quality management system for a new engineering company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
M Implementing ISO 9001 in an Assembly Plant ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
D Understanding and implementing ISO 17025 ISO 17025 related Discussions 9
Q Implementing ISO 9001 and ISO 22000 systems at the same time Document Control Systems, Procedures, Forms and Templates 2
E Implementing a Production Accountability Program Manufacturing and Related Processes 3
J Implementing a TrackWise eQMS System Quality Assurance and Compliance Software Tools and Solutions 3
S Help for Implementing a Quality Management System Quality Management System (QMS) Manuals 3
L Implementing an improvement program is like cooking! Imported Legacy Blogs 0

Similar threads

Top Bottom