Preparation for ISO 9001:2015 - Required Document Revisions

[Lougee]

Hello again .

I was currently working with a company with existing document system. My question is, since their current revision onprocedure/w.i are for example rev. 5, whenwe prepare for ISO 9001:2015(document registration), do we need to reset the form to rev.0 since it will be the first time the document will be controlled?

TIA

 

[AMIT BALLAL]

Hi!

Its a good choice to reset revision dates of forms against a new issue number. But is optional, its up to your organization how you do it. Standard doesn't mandate this.

What do you mean by Document control for first time?
Since you are already having a management system, document control system might be in place.



Thanks,
Amit

 

[Lougee]

Thanks Amit. But I have additional question. How about during audit, can we present those document(records) which were not yet controlled?

 

[AMIT BALLAL]

Thanks Amit. But I have additional question. How about during audit, can we present those document(records) which were not yet controlled?

What do you mean by not yet controlled?

 

[somashekar]

Hello again .

I was currently working with a company with existing document system. My question is, since their current revision onprocedure/w.i are for example rev. 5, whenwe prepare for ISO 9001:2015(document registration), do we need to reset the form to rev.0 since it will be the first time the document will be controlled?

TIA

The standard has changed and will change again after some years. Your QMS just improves. There is nothing to reset. Its only revision to next if you want to do.

 

[Lougee]

I mean, there was no established ISO during our 1st 12mos of manufacturing but we have those documents (forms/checksheet/w.I) it has revision (currently #5) but no document control/not registered to dcc.

I was asking if we are going to established now the ISO QMS:
1. is my current revision#5 for document will be reset to 0 once registered to dcc?
2. if answer to question1, is yes. How about our previous record for the last 12mos, are we going to present it to the iso audit?

 

[AMIT BALLAL]

I mean, there was no established ISO during our 1st 12mos of manufacturing but we have those documents (forms/checksheet/w.I) it has revision (currently #5) but no document control/not registered to dcc.

I was asking if we are going to established now the ISO QMS:
1. is my current revision#5 for document will be reset to 0 once registered to dcc?
2. if answer to question1, is yes. How about our previous record for the last 12mos, are we going to present it to the iso audit?

1. If you were not having a proper document control system in place in past, you can reset revision numbers against a new issue number (i.e. Issue no.2 in your case). This will help to start fresh and maintain things properly. You'll have to write the details of revision in your document change history stating "new issue no. was raised and therefore all forms reset to 0 to upgrade to ISO9001:2015".

2. No problem even if you change revision numbers. Your old records will still remain valid. Revision in any form means from that date / as per your company policy, only the new format should be used.

 

[howste]

I mean, there was no established ISO during our 1st 12mos of manufacturing but we have those documents (forms/checksheet/w.I) it has revision (currently #5) but no document control/not registered to dcc.

I was asking if we are going to established now the ISO QMS:
1. is my current revision#5 for document will be reset to 0 once registered to dcc?
2. if answer to question1, is yes. How about our previous record for the last 12mos, are we going to present it to the iso audit?

The answer to question 1 is no.

At the time of certification to ISO 9001, the auditor(s) will expect to see evidence of conformity to the standard for some period of time. If you show every document at Rev 0 it wouldn't show evidence that the document change process is working. Just because your system wasn't certified doesn't mean that the documents weren't controlled. I would recommend that all of your documents keep the revisions they are at currently.

 

[Lougee]

1. If you were not having a proper document control system in place in past, you can reset revision numbers against a new issue number (i.e. Issue no.2 in your case). This will help to start fresh and maintain things properly. You'll have to write the details of revision in your document change history stating "new issue no. was raised and therefore all forms reset to 0 to upgrade to ISO9001:2015".

2. No problem even if you change revision numbers. Your old records will still remain valid. Revision in any form means from that date / as per your company policy, only the new format should be used.

So you mean, if ISO QMS updates, ISSUE NUMBER for my document will be set to issue# 3; rev. 00?

The answer to question 1 is no.

At the time of certification to ISO 9001, the auditor(s) will expect to see evidence of conformity to the standard for some period of time. If you show every document at Rev 0 it wouldn't show evidence that the document change process is working. Just because your system wasn't certified doesn't mean that the documents weren't controlled. I would recommend that all of your documents keep the revisions they are at currently.

That is what I was thinking too; auditors won't see evidence of controlling the document. I know there's no specific way to control document according to the standard and I was just preparing for possible query of the auditor.

Does adding ISSUE # + rev # will be insufficient? Document will be issue#2; rev. 00 from issue#1:rev5.

QUestion:
If I am going to retain REV5 on registration of the document, all previous rev(1 to 4) shall reflect the history right?

Same with if I am going to adopt ISSUE# plus REV #..

Big thanks to you guys

 

[howste]

I wouldn't bother with an Issue #. Your system is your system. You don't need to change your revision indicator if an ISO standard changes. If you make changes to a document because a requirement in ISO 9001 has changed, just increment your number up one.

It's good practice to maintain a history of the document revisions. Previous versions of ISO 9001 required records of this, but the 2015 version doesn't.