Exactly which are the records needed by ISO9001? or is it my decision?

Q

QAMTY

#1
Hi everybody.

I´m with the resposibility to create the Records control procedure
and several doubts arised, hope you can assist me.

I know we need to have records as an evidence
but also as an object used to improve the quality.

But have the next doubts:

1-There are some records already defined to take care of, but
exactly which are needed by ISO? or is my decision?

2-I have design and development, in the case of records for validation, revision of designs, should I have one record for every drawing to be revised,validated? suppose I generate a lot of drawings, will I have to keep tons of records?

3- in the case of records for preventive, corrective actions,
is it needed to keep only the CAR´s PAR´s forms?, or
also calculation sheets, checklists,letters, manufacturers, data?

Thanks for your help
 
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somashekar

Staff member
Super Moderator
#2
You decide it. The ISO9001 standard at several places helps you in this.
Now even without the ISO9001, you are maintaining so many records. I am sure you have a reason for it. If not, you would not have made then and maintained them.
If any of that reason touches your QMS requirement, you need them.
 
Q

QAMTY

#4
Thanks Marc

But in case of records for DESIGN AND DEVELOPMENT
should I keep every record for every drawing revised, verified?
also check-lists? calculation sheets?

In my case, I create about 3000 dwgs in every project
do I have to keep records of checking for all drawings?

I suppose records are evidence of the revisions, drawings
are not records.

Thanks
 

qusys

Trusted Information Resource
#5
Thanks Marc

But in case of records for DESIGN AND DEVELOPMENT
should I keep every record for every drawing revised, verified?
also check-lists? calculation sheets?

In my case, I create about 3000 dwgs in every project
do I have to keep records of checking for all drawings?

I suppose records are evidence of the revisions, drawings
are not records.

Thanks
As to what you are saying, you can decide as per your mandatory records control procedure, what you shall also include and how you deal with records related customer requirements as well as regulatory and statutory requirements.
For instance there are law in each country that oblige you to mantain some records related to your employees for all their working life plus 5 year after their retirement for your company or records related to production that you have to retain for 15 years after the last produced compenent ( this in the automotive market).
Hope this helps:bigwave:
 
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Marc

Hunkered Down for the Duration
Staff member
Admin
#6
Thanks Marc

But in case of records for DESIGN AND DEVELOPMENT
should I keep every record for every drawing revised, verified?
also check-lists? calculation sheets?

In my case, I create about 3000 dwgs in every project
do I have to keep records of checking for all drawings?

I suppose records are evidence of the revisions, drawings
are not records.

Thanks
In part it would depend upon how critical the product is. If you're making heart pacemakers or automotive airbags you're going to want an excellent revision history (think configuration management). If you're making rubber duckies for kids to play with in the bath design history is going to be less important.
 
Q

QAMTY

#7
Thanks Marc

But I mean the records are kept, for each drawing?
normally, we crosscheck them with other disciplines
and have comments of each drawing, also when it raises
to next revisions, is the same, we use a printout for mark up
and so on.

One final drawing, until it reaches the approval for construction
normally has up to 6 printouts of comments.

Do I have to keep all the printouts (records) of all the drawings?
or only picking up some of them as records?

Thanks for clarify
 

qusys

Trusted Information Resource
#8
Thanks Marc

But I mean the records are kept, for each drawing?
normally, we crosscheck them with other disciplines
and have comments of each drawing, also when it raises
to next revisions, is the same, we use a printout for mark up
and so on.

One final drawing, until it reaches the approval for construction
normally has up to 6 printouts of comments.

Do I have to keep all the printouts (records) of all the drawings?
or only picking up some of them as records?

Thanks for clarify
I guess you are speaking about constructions in facilities field. I think you have ad hoc package for each project, don't you?
My question is: which kind of regulations and country laws do you follow? Do you have customer requirements about the lenght of retention and what to retain?
If yes, this item will command you to retain record.
The record retention and the item shall comply with what you established in yor documented provedure for records control.
Marc raised a good point , as I said in my post too, automotive is a very stringent sector, You shall investigate yours and make benchamarkig to proceed in this sense:bigwave:
 

arios

Your Mexican Amigo
#9
There you go another list. The first two slides show records shared by ISO 9001 and ISO 13485, The last two ISO 13485 only
 

somashekar

Staff member
Super Moderator
#10
Thanks Marc

But I mean the records are kept, for each drawing?
normally, we crosscheck them with other disciplines
and have comments of each drawing, also when it raises
to next revisions, is the same, we use a printout for mark up
and so on.

One final drawing, until it reaches the approval for construction
normally has up to 6 printouts of comments.

Do I have to keep all the printouts (records) of all the drawings?
or only picking up some of them as records?

Thanks for clarify
Every time the pen touches paper, you are not creating your ISO records. Design and developments outputs are design records and not the engineers scrap book or working sheets. Before design release what comes out as drafts for trials, samples or prototypes are still design evolution records from where you get your first design release and then they are addressed as changes or revisions to them.
All other things beneath are a part of your engineers intelligence expressed from mind to paper/file in system. At times, some vital reasons for making a change are indeed documented and they come into the design history or engineering change details as the case may be. There are times when statutory requirements ask for certain information which gets the respect as a QMS record.
Keeping all this in mind I am sure you can make clarity about what IS and what IS NOT your design records.
 
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