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Related Topic Tags
outsourced products and processes, 4.1 - general requirements, 7.5.1 - control of production & service provision, quality system manuals, checklist or check sheet, process controls and control plans
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  #1  
Old 24th June 2009, 09:39 AM
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Please Help! Type and Control of Outsourced Processes - ISO 9001 Clause 4.1

What is your interpretation and how to ensure compliance to the following paragraph in req 4.1 (provide a couple of examples please):

ISO 9001: 2008

"Where an organization chooses to outsource any process that affects product conformity, the organization shall ensure control over such processes. The type and extent of control to be applied to these outsourced processes shall be defined within the quality management system. Can you expand and interpret the underlined words in order to be in compliance. I am a bit confused with this statement. Appreciate your input.

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Old 24th June 2009, 10:02 AM
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Re: ISO 2--9001 2008 req 4.1 type outsourced processes

Outsourced Processes - Type and Extent of Control to be Applied - ISO 9001:2008 DIS

Guidance on Outsourced Processes
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Old 24th June 2009, 05:51 PM
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Re: ISO 2--9001 2008 req 4.1 type outsourced processes

There is no need to interpret...which I don't do...Simply put, if you outsource a process you must define how it will be controlled by you through the appropriate mechanisms in 9001
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Old 24th June 2009, 06:29 PM
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Re: ISO 2--9001 2008 req 4.1 type outsourced processes

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In Reply to Parent Post by Randy View Post

There is no need to interpret...which I don't do...
Ok, but keep in mind that ISO states (in part)
Quote:
63. What do quality management practitioners (consultant, auditor, or trainer) need to know about the standards?

As a minimum, quality management practitioners should familiarize themselves with the requirements of ISO 9001:2008, and also with the content and philosophies of ISO 9000:2005, ISO 9004 and the Quality Management Principles.
Practitioners who are already familiar with ISO 9001:2000 should become aware of the clarifications introduced in ISO 9001:2008, and their implications, prior to conducting audits to that standard, or giving training and consultancy.
They should understand their client’s activities and processes, before providing appropriate interpretations of the requirements of the standards, to add value to the client's operations.
And they also created a formal interpretation process. Personally, I do believe that we MUST interpret the requirements of any generic management system standard to the organization at hand.
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Old 24th June 2009, 06:42 PM
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Re: ISO 2--9001 2008 req 4.1 type outsourced processes

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In Reply to Parent Post by Sidney Vianna View Post

And they also created a formal interpretation process.
The most recent interpretation is from August 2006. Now, I *wonder* what that tells us....
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Old 24th June 2009, 06:51 PM
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Re: ISO 2--9001 2008 req 4.1 type outsourced processes

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In Reply to Parent Post by Marc View Post

The most recent interpretation is from August 2006. Now, I *wonder* what that tells us....
I was against the establishment of that group from the beginning: Official ISO Interpretations - A Formal Process for ISO9001 Interpretation Requests but that does not negate the need for interpretation of the requirements. That is exactly why consultants and auditors must be competent, just like everyone else....
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Old 24th June 2009, 07:26 PM
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Re: ISO 2--9001 2008 req 4.1 type outsourced processes

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In Reply to Parent Post by Randy View Post

There is no need to interpret...which I don't do...
Which is followed by Randy explaining (i.e., interpreting) the requirement:

Quote:
In Reply to Parent Post by Randy View Post

Simply put, if you outsource a process you must define how it will be controlled by you through the appropriate mechanisms in 9001
I don't think the word means what you think it means.
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Old 24th June 2009, 09:31 PM
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Re: ISO 2--9001 2008 req 4.1 type outsourced processes

Quote:
In Reply to Parent Post by Jim Wynne View Post

Which is followed by Randy explaining (i.e., interpreting) the requirement:


I don't think the word means what you think it means.
There is a difference between interpretation and explanation and define means exactly what I think it means.

Either that or there's a few hundred people and some very large organizations doing stuff backwards.
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