Question
There were some changes recently in the company where I work. Now, a quality manager or quality function does not exist in the our company; however, we do maintain the ISO certification. Our ISO certification applies to our corporate office and it applies also to the manufacturing facility located in a different city.
Is acceptable to have an ISO certification and not have a quality function?
Answer
There is no requirement for a quality function in ISO 9001:2015. I believe that this can be a positive move for your organization as it puts the job of quality upon the process owners, especially top management. This is where it should be.
It can be a little messy as these responsibilities are passed back to the process owners; but, it’s right!
For more on this topic, please visit ASQ’s website.
It is true that there is no such requirement in ISO 9001:2015 and I agree with George; however, I am very interested to know in the specific company who provides guidance/templates for the proper definition of processes or for risk management; who organises the internal audit program; ensures the availability of qualified auditors; performs internal audits (follows up on corrective actions, etc); gathers and analyses the information needed to formulate the Management Review and who indeed organises the Management Review. I am not implying anything, I am just interested to see practically how such activities can be done without a quality function/element. Thank you.