Shared Processes - How do I reflect them in my QMS Procedures and Manual?

[baynoli]

Hi All,

Good Day to all,

I have a question regarding on documentation process and in the implementation of ISO 9001.

Company A and company B are sister company, company A is iso 9001:2008 certified while company B is not, but planning to be certified.

Company B share some processes with company A such as HR, Accounting, Finance (just to name a few) and also approval of some documents or contracts, since the there's only one CEO for both company.

My question is that, since company B planning to be ISO certified,
1. How do I reflect this shared processes in my Quality Manual?
In terms of documentation,
2. do I have to copy the procedures company A and just change to company B?
3. Can I exclude these processes? or exempt some clause in the standards.

just an example:

company B don't have HR department, but in case we need some trainings, or need additional manpower we use the HR process of company B.
same also, company A handles all accounting and finance transaction of company B.


Hope someone can give their opinions.

Thanks,

klooden

 

[qusys]

Hi All,

Good Day to all,

I have a question regarding on documentation process and in the implementation of ISO 9001.

Company A and company B are sister company, company A is iso 9001:2008 certified while company B is not, but planning to be certified.

Company B share some processes with company A such as HR, Accounting, Finance (just to name a few) and also approval of some documents or contracts, since the there's only one CEO for both company.

My question is that, since company B planning to be ISO certified,
1. How do I reflect this shared processes in my Quality Manual?
In terms of documentation,
2. do I have to copy the procedures company A and just change to company B?
3. Can I exclude these processes? or exempt some clause in the standards.

just an example:

company B don't have HR department, but in case we need some trainings, or need additional manpower we use the HR process of company B.
same also, company A handles all accounting and finance transaction of company B.


Hope someone can give their opinions.

Thanks,

klooden

You can ask to your certification body.
I do not know if you are pursuing a site certification or one with a corporate scheme.
Also for this talk with CB.

However, when you defined your QMS process as per 4.1 clause of ISO 9001, you shall also identified the relantioship with remote and support processes, if they are part of your QMS.
As to the documented procedures, it is the same. You could have corporate procedures and to think to have local addenda, if applicable.
Just to give you a suggestion a Corporate scheme will function and allow you to optimize costs as well.

 

[pearsonow]

Simply state which clauses are handled by the parent company in the Quality Manual and state they are ISO certified.

Easy.

 

[lamorenita_QA]

Hello, I have a similar problem that i am requesting advice on.. during our ISO 13485 re-certifcation audit, a minor finding was that our 'electronic file back up procedure is not controlled as required by 'XXX-XXXX' while needed to support the record control process'. We use an outside consultant to store and back up our data. He has a controlled process that he follows, my question is.. could we just state this is controlled by a third party,? or should we list him as an outside source and put processes in place to demonstrate that we control his process for backing up our electronic (record) data?

 

[qusys]

Hello, I have a similar problem that i am requesting advice on.. during our ISO 13485 re-certifcation audit, a minor finding was that our 'electronic file back up procedure is not controlled as required by 'XXX-XXXX' while needed to support the record control process'. We use an outside consultant to store and back up our data. He has a controlled process that he follows, my question is.. could we just state this is controlled by a third party,? or should we list him as an outside source and put processes in place to demonstrate that we control his process for backing up our electronic (record) data?

You shall have a documented procedure for record control. THe back up and storage perfomed by your consultant can be configured as an outsourced service and you shall have in place how to control this outsourced activity.

 

[Sidney Vianna]

My question is that, since company B planning to be ISO certified,
1. How do I reflect this shared processes in my Quality Manual?

Hope someone can give their opinions.

What you are describing fits the bill of (intra-company) outsourced processes. The following paragraph of the ISO 9000 Introduction and Support Package: Guidance on 'Outsourced Processes' document CLEARLY mentions the situation

As mentioned in the Note, in some situations, the organization might not “purchase” the outsourced process in the traditional sense; it might, for example, receive the service from a corporate head office or from another division within a group of organizations, without any monetary transaction taking place (see 2.1 above). Under these circumstances, however, ISO 9001:2008 Clauses 7.4 and 4.1 are still applicable.

Firstly, you have to assess which of those outsourced processes are part of your (Company B) QMS. For example, how does Finance affect your QMS? Or does it?

For those that are part of the QMS, you have to describe (in the manual for Company B) how you "control" that such processes satisfy the intent of ISO 9001:2008. Hint: they are ISO 9001:2008 certified, as you say.

 

[vanputten]

Call A and B one company with one scope and forget the confusing "sharing" and outsourcing. One scope, one system, one certificate.

 

[lamorenita_QA]

You shall have a documented procedure for record control. THe back up and storage perfomed by your consultant can be configured as an outsourced service and you shall have in place to control this outsourced activity.

Again Thank you for Your Advice!

 

[ssz102]

ensure to these dept&function or documents are shared in company A and B and marking in quality manual of both company