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Old 22nd November 2000, 07:19 PM
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From: ISO 9000 Standards Discussion
Date: Fri, 17 Nov 2000 15:57:56 -0600
Subject: Re: Auditing and the new standard /Oliveira/Green

From: Joseph & Susan Green

"Marcos Oliveira" stated and asked:
>
> I would like to propose a question:
> In the old version of ISO 9001/2, auditors compare procedures
> with records of actions. At that time, we had, as a minimum,
> 17 procedures.
>
> In the new standard we will have, as a minimum, 6 procedures.
> How do we audit without a procedure? It will depend more on
> auditors habilities?
>
> Marcos Oliveira

Joe Green's response:

1.
If an organization generates a product, the methods used to produce that product are to be defined by the organization. (call them processes, or whatever you like) ISO happens to use the term processes.
(To comply with 9K2K "realization processes" must be adequate to the task)

2.
Methods used to generate a product start somewhere advance in a sequence, interact with other methods and the logical result is finished product. (To comply with 9K2K "sequence and interactions must be identified")

3.
Methods used to generate a product must be capable, measurable, and analyzed to ensure product conformity and process effectiveness. (Hopefully those methods may be also subjected to scrutiny for improvement opportunities).

4.
An organization with no "visible" methods would be easy to identify.

5.
9K2K Standard Users are required to include "visible" (audit able) methods in their QMS.

6.
Auditor's are required to determine "visibility" and "effectiveness"
(Not Efficiency; though efficiency should be included sought by a sane organization.)

7.
The following minimum methods (processes) (procedures) must also be "visible". They are necessary to any organization who thoughtfully chooses to voluntarily comply with ISO 9001;2000 Document control
Records
Control of nonconforming product
Audits
Corrective/preventive action
Preventive action

I purposely numbered the above comments so that others may comment on the accuracy or lack of accuracy contained in each premise.

Joe Green

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