Month: August 2022

Why doesn’t the auditor like our QMS?

Why doesn't the auditor like our QMS?

My auditor does not like my Quality Management System (QMS)

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.

Make your auditor understand your QMS

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.

Get out a copy of your standard

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.

 

 


Is it okay to disagree with your auditor?

It is okay to disagree with an auditor.

ABSOLUTELY. Auditors are human beings and sometimes they don’t understand the way you are doing things so you need to make them understand your processes.

Here is a great example I was auditing a company they had job descriptions and group training records but I wasn’t seeing how they showed an employee was competent in the job they were doing. After a while and several employees later, they told me there was a training matrix which showed the level of competency each employee was at in their positions. But because I did not ask to see ‘the training matrix’ no one was showing it to me. Sometimes an auditor does not speak the same language as you but if you have a good auditor, they should keep asking you questions to hopefully get the answer they need.

Looking for you to be compliant

An auditor is looking for you to be compliant to the standard, sometimes they are asking for certain things, they aren’t sure what you have named the document so it might take a while. Don’t get nervous just keep showing the auditor what documents you have.

Tell your auditor to go ahead and write a nonconformance report

If your auditor says they are going to write a nonconformance ask your auditor, what section of the standard will they be writing the nonconformance against? Take the time to read that section of the standard then look at your internal audits also previous audit reports and see what the auditors wrote under that section. This might help you see what documents were looked at under this section of the standard. Then show your auditor what previous auditors accepted.

If you show your auditor proof and the auditor stills writes the nonconformance ask your registrar what their appeal process is, this means you do not agree with the nonconformance. Once your registrar has all the evidence, they need they will make a determination if the nonconformance is legitimate or not. Most of the time the registrar will withdraw the nonconformance.