Which documents to control apart from QMS related procedures?

[RunnyBabbit]

Hi all,

I'm in the process of going for ISO certification and need about which documents need to be controlled.

It's a small company with 8 employees simply re-selling industrial equipment. Initially I included documents like : Customer enquiry form, Quotation, Sales Order, Delivery Note, Invoice and on the purchasing side : Purchase Order, Goods receipt.

Everything is done on SAP Business One and the templates for all those documents are all held on this system and I am the only person who has access to change the document templates and assign them to the system. Ie. the users have no option but to use the template which I have assigned, it is impossible to use a previous version in error.

I would ideally like to exclude most of these documents - only keeping the Customer enquiry form which I feel maybe should be controlled as it is used to record customers enquiry/requirement and so relates to quality of our service.

Can anyone offer advice? I can't find any threads relating to those types of documents - most seem to be about controling procedures and which I have done..

 

[Pancho]

Re: Which documents to control

Welcome to the Cove, RunnyBabbit,

Your QMS includes any and all documents that your organization determines are necessary to ensure the effective planning, operation and control of its processes (Section 4.2.1d of ISO 9001).

Templates and Forms are documents. Presumably, the reason these templates exist is that you need them to run your processes effectively. You should control them as required by 4.2.3.

If you don't need some template to run your processes effectively, then it may be best to just can it. If you find that difficult probably means that the document should be controlled.

Good luck!
Pancho

 

[somashekar]

Re: Which documents to control

Hi all,

I'm in the process of going for ISO certification and need about which documents need to be controlled.

It's a small company with 8 employees simply re-selling industrial equipment. Initially I included documents like : Customer enquiry form, Quotation, Sales Order, Delivery Note, Invoice and on the purchasing side : Purchase Order, Goods receipt.

Everything is done on SAP Business One and the templates for all those documents are all held on this system and I am the only person who has access to change the document templates and assign them to the system. Ie. the users have no option but to use the template which I have assigned, it is impossible to use a previous version in error.

I would ideally like to exclude most of these documents - only keeping the Customer enquiry form which I feel maybe should be controlled as it is used to record customers enquiry/requirement and so relates to quality of our service.

Can anyone offer advice? I can't find any threads relating to those types of documents - most seem to be about controling procedures and which I have done..

Hii RunnyBabbit, Welcome here ~~~

You must be talking about records control or control of records procedure.
Am I correct ?
You want to identify those records that you require to have control on.
The ISO9001 standard at several places guides you about the necessary records that need to be maintained. So that is the first place to see and identify which among them are made and kept in the SAP Business One. If some are not within the SAP, then your other methods of records control must be established and mentioned within the records control procedure.
If I were you, I would let all the SAP records to be controlled as the SAP is versatile to manage all the records control requirements.
From the QMS point of view, I am not much concerned about the template style as long as all the required information are available on all the records.

 

[Mikey324]

Re: Which documents to control

We have a similar situation where some of our records are created in this way, work orders and sales orders for example. We do control these, even though users have no way to use an obsolete document. We control them because they have required retention times, disposal methods, etc. If it is necessary to run the buisness you should have these requirements too. Just my understanding of it all. Hope it helps

 

[AnaMariaVR2]

Dear RunnyBabbit:

I read that your company is reselling industrial equipment. I comes to mind that relevant equipment related documentation needs to be controlled. Some of them include but not limited to:

• IQ/OQ/PQ
• CoC
• Troubleshooting and/or calibration manuals
• Test procedures, specifications
• Maintenance/calibration

Good luck!

 

[AnaMariaVR2]

ISO 9001 explicitly requires 3 documents:

1. Quality policy [5.3]
2. Quality objectives [5.4.1]
3. Quality Manual [4.2.2]

Another way to think about which documents to control is to identify the procedures that by ISO requires documentation, as it applies to your systems. These 6 documented procedures are:

1. Document control [4.2.3]
2. Record control [4.2.4]
3. Internal audit [8.2.2]
4. Control of nonconforming product [8.3]
5. Corrective action [8.5.2]
6. Preventive action [8.5.3]

[subclause reference]

These topics must be documented if relevant to your scope of work.

 

[kgott]

Hi all,

which documents need to be controlled.

..

Use this rule of thumb as a starting point. All documents subject to revision must be controlled.

This applies to two sorts of documents, internal documents and documents of external origin.

 

[kgott]

Use this as rule of thumb. All documents subject ot revision are to be controlled. This applies to internal documents and documents of external origin

 

[qusys]

Hi all,

I'm in the process of going for ISO certification and need about which documents need to be controlled.

It's a small company with 8 employees simply re-selling industrial equipment. Initially I included documents like : Customer enquiry form, Quotation, Sales Order, Delivery Note, Invoice and on the purchasing side : Purchase Order, Goods receipt.

Everything is done on SAP Business One and the templates for all those documents are all held on this system and I am the only person who has access to change the document templates and assign them to the system. Ie. the users have no option but to use the template which I have assigned, it is impossible to use a previous version in error.

I would ideally like to exclude most of these documents - only keeping the Customer enquiry form which I feel maybe should be controlled as it is used to record customers enquiry/requirement and so relates to quality of our service.

Can anyone offer advice? I can't find any threads relating to those types of documents - most seem to be about controling procedures and which I have done..

Starting from the clause 4.1 ( The organization shall establish, document, implment and mantain up to date its QMS...) and 4.2.1 c) ( The documentation of QMS shall include the documents necessary to the organization to assure the effecitve planning, functioning and controll of its processe...) of ISO 9001, I would suggest that all these documents could be controlled but the decision is on the side of the organization, to select which documents atre vital and necessary of its QMS.
As suggestion as a select criteria, I would say all those put in jeopardy the QMS of the organization and those all legal/safety/enviromental impact too.

 

[vanputten]

Hello Runny Rabbit:

I think the first thing to be understood is what you mean by a "controlled document" or the "control of documents." 4.2.3 of ISO9001 is titled "Control of documents."

Based on what you have shared, it seems that you have already implemented most of the requirements for the control of documents as listed in 4.2.3.

Are the documents in SAP already under control?

Another things that catches my eye is the title of the thread. QMS related? Business system related? Documents "apart" from the QMS? I would suggest that the things you need to run the business be "controlled." If these documents are outside of your definition/scope of the QMS, then the requirements of ISO 9001 don't even apply, at least from a compliance standpoint.