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Does ISO 9001 *require* that Internal Audits be Process Audits?

Marc

Fully vaccinated are you?
Staff member
Admin
#1
Does ISO 9001 *require* that Internal Audits be Process Audits? I know it says it "promotes" a process approach, but is there a specific requirement in the standard that I am missing?
 
Elsmar Forum Sponsor
#2
In clause 0.2 it defines the process approach, but there are no "shalls" included. 8.2.2 indicates that the audit program will take into account "the status and importance of the processes", and also includes "areas to be audited". But again no "shall" for auditing to be process-based audits. And there are portions of the QMS that are not really process based anyways. The requirements of 4.2.2 and some of 5.3 are not processes in themselves.

Do I believe that internal audits need to include process-based audits? Absolutely! But is there a specific "shall" that mandates it? Not that I can find in ISO 9001.
 

somashekar

Staff member
Super Moderator
#4
Does ISO 9001 *require* that Internal Audits be Process Audits? I know it says it "promotes" a process approach, but is there a specific requirement in the standard that I am missing?
It is not a requirement for:
1. The IA is to determine the conformance to the planned arrangements to the requirements of the standard, and to the QMS requirement established by the organization. Here all the established process can be standalone audited.
However ...
2. The IA is also to determine if the QMS is effectively implemented and maintained.
Some key lines here...
* Status and importance of the processes and areas to be audited
* Plan and develop the processes needed for the product realization
* Consistent with the requirements of the other processes of the QMS
* Determine the processes needed for the quality management system and their application throughout the organization
* Determine the sequence and interaction of these processes,
* The Quality manual requires a description of the interaction between the processes of the quality management system.

So I deduce that for the conformance it can be plain process audit, however for effectiveness it must be processes based audit.
 

Marc

Fully vaccinated are you?
Staff member
Admin
#5
<snip> Do I believe that internal audits need to include process-based audits? Absolutely! But is there a specific "shall" that mandates it? Not that I can find in ISO 9001.
Yeah - Just checking.

As an aside, I have always, even in the 1990's, audited processes with the addition of mapping to the requirements of the standard to show evidence of compliance. I think we all did. I think most just did't think of it as process auditing at the time.
 

qusys

Trusted Information Resource
#6
Does ISO 9001 *require* that Internal Audits be Process Audits? I know it says it "promotes" a process approach, but is there a specific requirement in the standard that I am missing?
Agree with the other exper Covers, no "shall".
However the internal audit program shall includes all QMS processes and , to provide value added audits to mgmt, the internal auditors should also assess the links and the interactions across all QMS processes to determine "whether the QMS conforms to the planned arrangements and is effectiviley implemented and maintained" as per 8.2.2 clause of ISO 9001.
In other words, for instance when assessing a production area, the auditor could also assess the interactions with "pre process" and "post process" of the current audited process, to follow a trail using "process approach". In my experiences during mgf process audit I took the occasion to assess the interaction with procurement process for the spare part replacements or raw material acceptance criteria in incoming.
The suggestion could also be to start from the the sequence and the processes interaction of QMS , that is mandatory for 4.1 clause.
Hope this can help as well:bigwave:
 
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