Where in the ISO 9001 standard it asks for process based auditing?

Timothy1

Involved In Discussions
#1
Hi Pl let me know where in the ISO 9001 standard it asks for process based auditing? If somebody say that they have audited a process (say Design process), are they expected to show what elements/ clauses of 9001 covered by that process audit?
 
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dsanabria

Quite Involved in Discussions
#2
Hi Pl let me know where in the ISO 9001 standard it asks for process based auditing? If somebody say that they have audited a process (say Design process), are they expected to show what elements/ clauses of 9001 covered by that process audit?
The standard does not tell you what type of audit to perform. That should be part of your procedure.

Having said that - process audit will add more value to your system than isolated audits.

To your question - you should be able to examine the objective evidence collected from the audit in order to determine that all areas of the process were covered.

when you get a chance read - ISO 19011 Guidelines for auditing management system.
 

John Broomfield

Staff member
Super Moderator
#3
Hi Pl let me know where in the ISO 9001 standard it asks for process based auditing? If somebody say that they have audited a process (say Design process), are they expected to show what elements/ clauses of 9001 covered by that process audit?
Timothy,

System auditing of your management system for conformity to ISO 9001 clauses is of limited value. Every now and again, maybe, but once your management system conforms to the standard, that is about it.

Process auditing provides the payback especially when you examine evidence of how well the processes fulfill their objectives (see 4.1c) and how well the other processes in the system are serving the process you are auditing.

Of course, when you do this you are asking questions that arise from any clause in the standard. Your process auditing checklist may note this for the audit record if you find it valuable.

Process auditing also reminds everyone that their's is a process-based managemenr system and that they should be monitoring, correcting and improving their processes (see 8.2.3 and 8.4c) before the auditor arrives.

It can also transform your organization's perception of their management system from something thet called an "ISO System".

John
 

somashekar

Staff member
Super Moderator
#4
Hi Pl let me know where in the ISO 9001 standard it asks for process based auditing? If somebody say that they have audited a process (say Design process), are they expected to show what elements/ clauses of 9001 covered by that process audit?
>> The organization shall conduct internal audits at planned intervals to determine whether the quality management system is effectively implemented and maintained.
>> The organization shall establish and maintain a quality manual that includes a description of the interaction between the processes of the quality management system.
>> The organization shall determine the processes needed for the quality management system and their application throughout the organization and determine the sequence and interaction of these processes, determine criteria and methods needed to ensure that both the operation and control of these processes are effective.
>> + read 0.2 Process approach

The above are cut-paste from the ISO9001, which keeps on telling me that the key to QMS success is processes determination., its interactions and the effectiveness.

So when I audit design and development, I not only audit to see if there are appropriate
information for purchasing, production and service provision, but must also test if this information is indeed appropriate at Purchase process, Verification process. production process, testing process ... and such. (an example)
This does not mean that the process based auditing is completed by one auditor. The outputs of one audit is taken up with the audit of another interacting process, by an other auditor.
Just like a relay race, each person runs his best, but the handover of the baton is the key for effectiveness. Your audit must be designed to verify this.
So 20 individual process may be good in the audit, but if this is the overall audit outcome, then the effectiveness implementation and maintaining and improving upon of the QMS is never tested to the demand of the situation.
ISO does not ask of you anything directly saying process based audit.
 
#5
Hi Pl let me know where in the ISO 9001 standard it asks for process based auditing? If somebody say that they have audited a process (say Design process), are they expected to show what elements/ clauses of 9001 covered by that process audit?
You can audit anything you want! An audit of a process isn't required and isn't always needed either. You are perhaps overlooking two important things mentioned in the standard: "Scope" and "criteria". These define the boundaries of the audit and may only be a small part of the QMS - and not even (specifically) related directly to ISO 9001 - that the auditor would know.
 

Big Jim

Super Moderator
#7
It is very good that you found the APG. There is a lot of very useful information there.

I hope you also checked the links for further insight.

Be aware that this information is directed to certification body auditors so some of it may not quite match what you are doing, but it is still very insightful.
 
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