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.