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Hi All,
Setting the scene;
I work for a Medical Device Manufacturer. We are a head office facility, that holds the CE Mark for approximately 6 different product family's, with all the manufacturing, packaging and logistics sub-contracted out to 3rd parties.
I am the Lead Auditor for the company, and well as the managing the audit program. We are a small company of approximately 25 office staff.
The company operates a mature and complaint ISO 13485 QMS.
My question is this;
This year, during the Internal Audits, I noticed that I didn't feel that the Internal Audit process was adding any benefit to some of the more mature processes that we have. As an example, i'll use the recently audited purchasing process.
The system is well established, using approved suppliers (that don't change), and an ERP system that is globally recognised. The system very rarely goes out of control. While I was auditing this system, it was clear that we were going over old ground and it was more of a 'compliance' exercise as opposed to adding valve to the process.
I have done a risk based audit, and a process approach audit to many of these mature processes, but again, its fairly well established. Any further improvement to the process will require longer term improvement plans, such as six sigma studies, which fall outside of the Internal Audit process.
Does anybody have any suggestions on how to energise or envigorate these audits so that they don't become repetertive exercises?
Thanks to you all

Setting the scene;
I work for a Medical Device Manufacturer. We are a head office facility, that holds the CE Mark for approximately 6 different product family's, with all the manufacturing, packaging and logistics sub-contracted out to 3rd parties.
I am the Lead Auditor for the company, and well as the managing the audit program. We are a small company of approximately 25 office staff.
The company operates a mature and complaint ISO 13485 QMS.
My question is this;
This year, during the Internal Audits, I noticed that I didn't feel that the Internal Audit process was adding any benefit to some of the more mature processes that we have. As an example, i'll use the recently audited purchasing process.
The system is well established, using approved suppliers (that don't change), and an ERP system that is globally recognised. The system very rarely goes out of control. While I was auditing this system, it was clear that we were going over old ground and it was more of a 'compliance' exercise as opposed to adding valve to the process.
I have done a risk based audit, and a process approach audit to many of these mature processes, but again, its fairly well established. Any further improvement to the process will require longer term improvement plans, such as six sigma studies, which fall outside of the Internal Audit process.
Does anybody have any suggestions on how to energise or envigorate these audits so that they don't become repetertive exercises?
Thanks to you all