Additional Control Measures for Outsourced Processes under ISO 9001:2008

A

Alex Brezinski

#1
#1
What are the additional controlling measures that an organization must take in respect of their processes outsourced to external party under ISO 9001:2008 compared to ISO 9001:2000? What are the major differences and how do we implement the additional requirement? Thank you.
 
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J

JaneB

#2
#2
Re: Additional control measures for outsourced processes under ISO 9004:2008

Alex Brezinski said:
What are the additional controlling measures that an organization must take in respect of their processes outsourced to external party under ISO 9001:2008 compared to ISO 9001:2000? What are the major differences and how do we implement the additional requirement? Thank you.
Click to expand...
It isn't an 'additional' requirement. At all. There are NO - repeat, NO, new or changed or additional requirements in the 2008 version.

All the 2008 version did was clarify some points that some folks appeared to be having difficulty with.

In a nutshell: if you outsource processes or parts thereof, YOU remain responsible for the quality of the product or service. (You always were in the 2000 version, but some misguided people apparently believed that the mere act of outsourcing removed all accountability and responsib ility from them! How on earth they managed this I have no idea).

Therefore, then and now, you must have reasonable controls in place to do that. The how depends upon what you do.
 
A

Alex Brezinski

#3
#3
Re: Additional control measures for outsourced processes under ISO 9004:2008

Hi Jane B,
Thank you very much for the reply. Appreciate it.
 
B

Big Jim

Admin
#4
#4
I wish to add to Jane's fine response.

What is required in 4.1 is that somewhere in your quality management system you need to define the controls for outsourcing. Some auditors seem to believe that this must be done in the quality manual. Some also believe that it must be written. Neither is correct although both are good ideas.

It would be wise to at least think it through so you can demonstrate that you have good outsourcing controls. Outsourcing is usually controlled through the purchasing process. Control usually involves passing the requirements on to your supplier with purchase orders or other purchasing documentation (such as contracts). Control also involves confirming that you got what you asked for, including certificates of conformance or certificates of analysis when needed. Confirming that you got what you asked for may be a little tricky when you are dealing with services, so make sure you address that too.
 
Q

qusys

Trusted Information Resource
#5
#5
Big Jim said:
I wish to add to Jane's fine response.

What is required in 4.1 is that somewhere in your quality management system you need to define the controls for outsourcing. Some auditors seem to believe that this must be done in the quality manual. Some also believe that it must be written. Neither is correct although both are good ideas.

It would be wise to at least think it through so you can demonstrate that you have good outsourcing controls. Outsourcing is usually controlled through the purchasing process. Control usually involves passing the requirements on to your supplier with purchase orders or other purchasing documentation (such as contracts). Control also involves confirming that you got what you asked for, including certificates of conformance or certificates of analysis when needed. Confirming that you got what you asked for may be a little tricky when you are dealing with services, so make sure you address that too.
Click to expand...
Agree.
Another way is to set KPI to monitor their performance , for instance.
Besides, in the case of outsourced maintenance process, you could think to have maintenance report prepared by your supplier and checked by the organization. These report of well dome maintenance could be records to show the control on the supplier. You can also have ad hoc meeting to monitor their services as well as supplier audit on their premises.
In case on construction, you can also organize audit during the time they performe agreed job. These are some examples:bigwave:
 
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