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API Spec Q1 9th Edition Surveillance Audit - Questions about internal audits.

#22
I believe this is the requirement the OP is referring to. Note the text I emphasized in blue. It is similar to the ISO9001:2015 requirement with the additional prescription of auditing all processes at least every 12 months.

6.2.2Internal Audit

6.2.2.1General
The organization shall maintain a documented procedure to define responsibilities for planning, conducting, and documenting internal audits.
Audits shall verify that the quality management system is effectively implemented and maintained, and conforms to the requirements of this specification.
The planning of internal audits shall take into consideration the results of previous audits and criticality of the process being audited.
The organization shall identify the audit criteria, scope, frequency, and methods to ensure that all processes of the quality management system claiming conformity to the requirements of this document are audited at least every twelve months.

Outsourced activities that impact the quality of the product and that are performed at the organization’s facility shall be included as part of the internal audit of the organization.
Good afternoon,
My question is-can i use my last ISO internal audit for this process? Or is API asking for internal audits I perform at our shop withing each department. I am so confuse. Thank you.
 

Al Rosen

Staff member
Super Moderator
#23
Good afternoon,
My question is-can i use my last ISO internal audit for this process? Or is API asking for internal audits I perform at our shop withing each department. I am so confuse. Thank you.
What is the difference between "last ISO Internal audit" and "internal audits I perform at our shop withing each department"? Please describe them.
 
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