Updating from ISO 9001:2000 to ISO 9001:2008

B

blue moon

#1
pleade advise

i implement a system ISO 9001:2008 for a company certified before for ISO 9001:2000 they will go for a new certification body and i am not refere that they are certified before we make all the procedure and forms versin zero

but using the same procedure and forms as example

1- for quality manual we use the old word define the interaction of process not new word determin the intetaction of process

2- in the old system they didn't refer how they control outsource process because they didn't have outsourced process and also i didn't refere or explain how to control the outsourced process they already didn't have outsourced process

I am in the right way or in the wrong way ?
 
Elsmar Forum Sponsor

Stijloor

Staff member
Super Moderator
#2
Re: Updating from ISO 9001:1994 to ISO 9001:2008

Please advise

I implement a system ISO 9001:2008 for a company certified before for ISO 9001:2000 they will go for a new certification body and i am not refere that they are certified before we make all the procedure and forms version zero

but using the same procedure and forms as example

1- for quality manual we use the old word define the interaction of process not new word determine the interaction of process

2- in the old system they didn't refer how they control outsource process because they didn't have outsourced process and also i didn't refere or explain how to control the outsourced process they already didn't have outsourced process

I am in the right way or in the wrong way ?
Any suggestions?

Thank you very much.

Stijloor.
 

Colin

Quite Involved in Discussions
#3
Re: Updating from ISO 9001:1994 to ISO 9001:2008

The changes from the 2000 version to 2008 were negligible, mostly clarifications so it would be a picky auditor who found fault with using the word define rather than determine for example.

I would suggest that you do change any references to the year to the 2008 version and because the point regarding outsourced processes has had its profile raised, you should probably add a line about it. There are also a couple of name changes such as 7.6 which might as well be changed whilst you are in there.

I wouldn't bother re-setting the issue numbers, just update where necessary and update those you change e.g. the quality manual. By the way, there are a few examples of cross reference tables which have been posted which summarise the changes and their impact. Just do a search or if you can't find them, drop me a PM and I will forward one I did.
 

jerry_Malaysia

Quite Involved in Discussions
#4
Re: Updating from ISO 9001:1994 to ISO 9001:2008

The changes from the 2000 version to 2008 were negligible, mostly clarifications so it would be a picky auditor who found fault with using the word define rather than determine for example.

I would suggest that you do change any references to the year to the 2008 version and because the point regarding outsourced processes has had its profile raised, you should probably add a line about it. There are also a couple of name changes such as 7.6 which might as well be changed whilst you are in there.

I wouldn't bother re-setting the issue numbers, just update where necessary and update those you change e.g. the quality manual. By the way, there are a few examples of cross reference tables which have been posted which summarise the changes and their impact. Just do a search or if you can't find them, drop me a PM and I will forward one I did.
I agree with Colpart.
Generally I wouldn't not worry so much about issue numbers and wording.
But since different auditor interpret clauses differently, it is better to make sure that what you have has already cover all the requirements.
 
B

blue moon

#5
Re: Updating from ISO 9001:1994 to ISO 9001:2008

Thanks Mr. Colpart

but may be i have a question generally with documentation i make my documents code as follow:

P 05:00
P: mean procedure
05 : the number of procedure
00 : revision statuse when make change

and i mention this in my procedure and mention the way to change documents

Now assume that i want to change a phrase in page no 5 inside this procedure, as in my procedures i must collect all copies at point of use and change the phrase, and obsolete the old copies and print a new copies and issue it again as P 05:01 and mention in change page that what page changed and why make this change?

can i have another way because this way is very costly ?




Regards

The changes from the 2000 version to 2008 were negligible, mostly clarifications so it would be a picky auditor who found fault with using the word define rather than determine for example.

I would suggest that you do change any references to the year to the 2008 version and because the point regarding outsourced processes has had its profile raised, you should probably add a line about it. There are also a couple of name changes such as 7.6 which might as well be changed whilst you are in there.

I wouldn't bother re-setting the issue numbers, just update where necessary and update those you change e.g. the quality manual. By the way, there are a few examples of cross reference tables which have been posted which summarise the changes and their impact. Just do a search or if you can't find them, drop me a PM and I will forward one I did.
 
#6
Re: Updating from ISO 9001:1994 to ISO 9001:2008

can i have another way because this way is very costly ?
There is no requirement to collect old documents when new versions are issued. You do have to ensure that relevant versions are available at points of use and prevent unintended use of obsolete documents. This can be achieved by giving the users the task to discard the obsolete copys when they recieve new ones.

One obvious way around the problem would be not to distribute procedures as paper. If you have the possibility to reach those concerned via an intranet for instance, that would be perfectly in order.

/Claes
 
B

blue moon

#7
Re: Updating from ISO 9001:1994 to ISO 9001:2008

Hi

But i think that i must mention this change in procedure and change the revision status to show that is a new verision

Right ?


===========================================
another questions

if network and internet is not aviable ?

can i print two copies one for document control and one in the work shop where all people will able to access to the procedures ?


There is no requirement to collect old documents when new versions are issued. You do have to ensure that relevant versions are available at points of use and prevent unintended use of obsolete documents. This can be achieved by giving the users the task to discard the obsolete copys when they recieve new ones.

One obvious way around the problem would be not to distribute procedures as paper. If you have the possibility to reach those concerned via an intranet for instance, that would be perfectly in order.

/Claes
 
Thread starter Similar threads Forum Replies Date
A What ISO 9001:2015 clause could be used to write nonconformance for not updating licensed driver list? General Auditing Discussions 8
T Design & Development in Updating Machines and Equipment - ISO 9001 Help Design and Development of Products and Processes 4
F Updating a Quality Manual from ISO 9001 to ISO TS 16949 - Process Mapping IATF 16949 - Automotive Quality Systems Standard 2
M Updating a Quality Manual from ISO 9001:2000 to ISO 9001:2008 Quality Management System (QMS) Manuals 57
T Updating to ISO 9001:2008 - I need to add section 7.3 Design and Development ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 28
J ISO/AS Surveillance Audit - Minor for not updating my QA Manual to ISO 9001:2008 Quality Management System (QMS) Manuals 95
I Updating Lead Auditor Certifications to ISO 9001:2008 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
B Tips on updating our Quality Systems Manual from ISO 9001:1994 to ISO 9001:2000 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
B Timeframe for updating QMS / transitioning from ISO 14971:2012 to ISO 14971:2019 ISO 14971 - Medical Device Risk Management 5
C ISO 13485 Gap Analysis Checklist - Updating ISO 13485 from the 1996 standard to 2003 ISO 13485:2016 - Medical Device Quality Management Systems 2
H Updating Quality Manual to API Q1 Service Industry Specific Topics 4
Z Minitab - Updating Graph with specific data points Using Minitab Software 2
N Updating the website of the manufacturer EU Medical Device Regulations 1
A Technical File - Updating Applied Standards EU Medical Device Regulations 4
N Updating QM to 13485:2016 - We do not make medical devices ISO 13485:2016 - Medical Device Quality Management Systems 1
B Site Move - Question about Updating Product Labels 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
O Updating "opportunities" resulting from Corrective Actions Nonconformance and Corrective Action 2
N Updating class I device IFU with instructions to use class II cleared device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
V Periodic review criteria for reviewing/updating SOPs US Food and Drug Administration (FDA) 1
T Design Changes - Updating the Design and Development File EU Medical Device Regulations 5
L Clinical Evaluation Report Updating Procedure Other Medical Device Related Standards 5
A Changing a Form Template & Updating Records ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
M AS9100D - Updating Scope Exclusions AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 9
E Updating DHF (Design History File) to include Alternative Component 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
W ISO9001:2015 - Clause 7.5.2 - Requirements for Creating & Updating Documents ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
Q Actions Taken - Updating a FMEA for the addition of a downstream poke yoke FMEA and Control Plans 3
I NCR for Customer not updating their drawings AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 14
P Updating a Medical Device's Intended Use Other US Medical Device Regulations 2
N Updating Job Titles - Does This Mean There Needs to Be a rev change? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
shimonv Updating Safety Test Report when changing component supplier IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
K Updating Outdated Calibration Procedures Document Control Systems, Procedures, Forms and Templates 2
J Is the SFDA in China in the process of updating their Medical Device Regulations ISO 13485:2016 - Medical Device Quality Management Systems 3
B Requirement for Updating Medical Device Software (Firmware) in the Field 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 11
S IPC 620 updating from Class 1 to Class 3 Inspection, Prints (Drawings), Testing, Sampling and Related Topics 6
C Updating (Revising) Documents with a New Logo Document Control Systems, Procedures, Forms and Templates 3
O Sum of Cpk - Updating Product Tolerances Capability, Accuracy and Stability - Processes, Machines, etc. 6
R Standard Relevance & Updating - ASME B&PVC Various Other Specifications, Standards, and related Requirements 4
J Declaration of Conformity - Updating the DofC to MMD 2007/47/EC EU Medical Device Regulations 4
C Updating our Laboratory Calibration / Verification Procedures IATF 16949 - Automotive Quality Systems Standard 5
V Updating Quality Manual - Adding the word Statutory in front of laws and regulations Quality Management System (QMS) Manuals 3
M Updating Certificate of Foreign Government (CFG's) Other US Medical Device Regulations 18
ScottK How is this for extremes in updating to the ISO9001:2008 rev ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
A FDA - Registration & Listing Updating + when Purchasing another Company 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 8
K Updating Procedures because they are bland and wordy Document Control Systems, Procedures, Forms and Templates 12
C Updating the IPC1752 info RoHS, REACH, ELV, IMDS and Restricted Substances 3
W Standards Updating Service? Current Revision Level of Standards Other ISO and International Standards and European Regulations 11
J Updating a PFMEA (Process FMEA) after a Process Failure FMEA and Control Plans 3
S Requirements for Updating a Medical Device Technical File EU Medical Device Regulations 11
D Updating Training Procedures when other documents change - Over Kill? Training - Internal, External, Online and Distance Learning 14
D Updating Flow Diagrams - Internal Critical Characteristic Identified FMEA and Control Plans 4

Similar threads

Top Bottom