Your company has been certified to ISO9001, AS9100, ISO13485, and IATF16949 for several years then you get a new auditor and they say you need to make changes. Don’t let any auditor tell you your system is wrong and you need to change it. If there is an issue with your QMS ask your auditor to write a nonconformance report with the section of the standard that is non-conforming. If they don’t write a nonconformance it is because there is NOT a nonconformance just their opinion. Don’t change your QMS because the auditor says there is an issue, challenge them but say it nicely.
Here is a great example – you do a complete audit of your system once a year then an auditor tells you internal audits need to be done every 6 months. Immediately pick up a copy of your standard (ISO9001, AS9100, ISO13485, IATF16949) and ask them nicely “What section of the standard are they looking at?” Then say I am looking at section 9.2 (8.2 in ISO13485) Internal audit and it says ‘the organization shall conduct internal audits at planned intervals, Not every 6 months.
Now if you have several nonconformances during your internal audits the auditor might suggest you do your internal audits every 6 months but it is up to the company to decide how often you do your internal audits.
Once you bring out a copy of your standard (ISO9001, AS9100, ISO13485, IATF16949), ask your auditor what section they are referring to, believe me, they will back down really quick. I have enough experience with auditors that every time I have a copy of a standard and ask them what section they are looking at their attitudes changes quickly. If you don’t have a copy of the standard your company is certified to buy a copy today. Finally, contact us today for all your QMS needs.