Definition of "Product Conformity to Requirements" in ISO 9001 Clause 4.1

[ogghall]

Thanks for responses.

The essence of the question is by the standard stating that outsourced processes which affect "product conformity to requirements" limiting those quality system processes which are outsourced to be controlled? Typically the wording is thought out so being this specific must have had some reason to differentiate it from the example of controlling any outsourcing of a process in the quality system.

All the processes of a qms, in some way, shape, or form, directly or indirectly affect product conformity but is that the intent of the statement? Outsourcing of internal auditing is a somewhat poor example for this question because of the requirement of a procedure. That is how it is controlled. But say outsourcing of a customer satisfaction survey, does that need to be, (not should be which is a completely different question.) controlled by this requirement of teh standard?

If the answer to the question is that all processes that are outsourced that directly or indirectly affect quality are required to be controlled then then point of discussing further is moot.

 

[somashekar]

Thanks for responses.

The essence of the question is by the standard stating that outsourced processes which affect "product conformity to requirements" limiting those quality system processes which are outsourced to be controlled? Typically the wording is thought out so being this specific must have had some reason to differentiate it from the example of controlling any outsourcing of a process in the quality system.

All the processes of a qms, in some way, shape, or form, directly or indirectly affect product conformity but is that the intent of the statement? Outsourcing of internal auditing is a somewhat poor example for this question because of the requirement of a procedure. That is how it is controlled. But say outsourcing of a customer satisfaction survey, does that need to be, (not should be which is a completely different question.) controlled by this requirement of teh standard?

If the answer to the question is that all processes that are outsourced that directly or indirectly affect quality are required to be controlled then then point of discussing further is moot.

The type and extent of control to be applied to these outsourced processes shall be defined within the quality management system.
Lets not get too tight on the word control of outsourced process as in a cnc machine or any other controlled chemical reaction.
The above sentence in blue asks you to decide the type and extent of control to be applied.
Customer satisfaction is a vital monitoring and measuring process for your QMS continual improvement, and formation of objectives and so I would say YES, it needs to be controlled since I am not performing this myself, but I desire that an outsourced agency (professional agency) does this for me such that I get the most accurate customer perception of my product and service.
In the case of customer satisfaction, if it is outsourced, all the activities you do in:
1. Evaluating and Selecting the agency
2. Discussing and agreeing to the method they would adopt
3. The timing
4. Your interfacing them with customers
5. Agreeing on the output style and type that will be provided by them
6. ... Any more you can think, please add.
can just be the controls.
You decide the type and extent. If you personally want to get involved with the outsourced agency in case of few of your selected customers, get this aspect also included.
NOTE 1 Processes needed for the quality management system referred to above include processes for management activities, provision of resources, product realization, measurement, analysis and improvement.
NOTE 2 An “outsourced process” is a process that the organization needs for its quality management system and which the organization chooses to have performed by an external party.
This NOTE 1. and 2. in 4.1 also helps me in deciding ~~~
... and for an enterprise in any service provision business with a large customer base, customer satisfaction could be one of the very important aspects in his "product conformity to requirements" and as unstated requirements increase or hold key to service provider acceptance, this gets a very accurate measure for planning actions.

 

[JaneB]

All the processes of a qms, in some way, shape, or form, directly or indirectly affect product conformity but is that the intent of the statement? Outsourcing of internal auditing is a somewhat poor example for this question because of the requirement of a procedure. That is how it is controlled. But say outsourcing of a customer satisfaction survey, does that need to be, (not should be which is a completely different question.) controlled by this requirement of teh standard?

If you outsourced a customer satisfaction survey, then yes of course you must control that process. If you didn't, how on earth could you then rely upon the results?

If the answer to the question is that all processes that are outsourced that directly or indirectly affect quality are required to be controlled

Correct.

Why the phrase? It limits the scope. For example, it restricts what an auditor can audit against - for example, one might come across an outsourced process which is not part of the QMS (ie, doesn't affect the results) - this limitation restrains them from pursuing it further. A possible example off the top of my head might be an outsourced financial audit process. Now, yes, you can pursue this rabbit endlessly down a hole arguing that if the financial audit isn't done properly, then the company may not have accurate financial information and this might affect product/service conformity... but unless there was good evidence of same, if any external auditor attempted to hold that line, I'd resist strongly.