Internal Audit
- Thread starter AQARA
- Start date
MaHoDie
Starting to get Involved
Short answer: yes.
Yes, because according to ISO 13485* Section 8.2.4:
[...]
The selection of auditors and the execution of the audits must ensure objectivity and impartiality of the audit process.
Auditors are not allowed to audit their own activities.
Records of the audits and their results, including the identification of the processes and areas audited and the conclusions, must be maintained.
[...]
Therefore, as long as you ensure that the Head of QA provides objectivity and impartiality and there are no connections/ interfaces to own activities I would say: it is acceptable
What does the others say?
*(Attention I use: German version EN ISO 13485:2016+AC:2018+A11:2021)
Yes, because according to ISO 13485* Section 8.2.4:
[...]
The selection of auditors and the execution of the audits must ensure objectivity and impartiality of the audit process.
Auditors are not allowed to audit their own activities.
Records of the audits and their results, including the identification of the processes and areas audited and the conclusions, must be maintained.
[...]
Therefore, as long as you ensure that the Head of QA provides objectivity and impartiality and there are no connections/ interfaces to own activities I would say: it is acceptable
What does the others say?
*(Attention I use: German version EN ISO 13485:2016+AC:2018+A11:2021)
Quality-Nation
On Holiday
No standard was mentioned in the OP. ISO 19011 does not prohibit the scenario described. Audits should be independent, auditors should be objective and free from bias.
Randy
Super Moderator
I still see the "shall not audit" during my work...It's normally as a BMP by those folks
Quality-Nation
On Holiday
There could be many reasons, including, it used to be in ISO 9001, plus many CB auditors and consultants/self proclaimed experts etc confuse the word “independent”.
Please enlighten us all on what independent means in this context.
