#1
API Spec Q2 states in the last paragraph of clause 6.2.2.1: Outsourced suppliers that impact the quality of services or service-related product, located at the organization’s facility, shall be included as part of the internal audit of the organization.

So now my question is if this is only applicable if the outsourced supplier is located at the organization’s facility or also when they occasionally perform services at the organization’s facility.

Thanks,
Nes
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#2
It seems odd that the scope of an internal audit would include an in-house outside supplier. But, as the standard is unclear about external suppliers which are in house intermittently, to be safe, I would schedule an audit of the supplier while they are at your premises, just in case.
 

Eredhel

QA Manager
Trusted
#3
API Spec Q2 states in the last paragraph of clause 6.2.2.1: Outsourced suppliers that impact the quality of services or service-related product, located at the organization’s facility, shall be included as part of the internal audit of the organization.

So now my question is if this is only applicable if the outsourced supplier is located at the organization’s facility or also when they occasionally perform services at the organization’s facility.

Thanks,
Nes
I'm familiar with and have Q1, but I don't know Q2. Would you be able to quote the actual language? It almost looks like they're saying "outside suppliers that have an impact on stuff located at your facility". I'm completely guessing though since I'm only familiar with Q1.
 

Eredhel

QA Manager
Trusted
#4
Here's the Q1 language:

"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."

But this is for the internal audit only.
 
#5
Sorry for the late response but find below the original text from API Spec Q2.

6.2.2 Internal Audit

6.2.2.1 General
The organization shall maintain a documented procedure to define responsibilities for planning and conducting internal audits. The planning of internal audits shall take into consideration the results of previous audits and criticality of the process.

The organization shall define the audit criteria, scope, frequency, and methods to ensure that all elements of the management system claiming conformity to the requirements of this document are audited at least annually.

Outsourced suppliers that impact the quality of services or service-related product, located at the organization’s facility, shall be included as part of the internal audit of the organization.
 

Eredhel

QA Manager
Trusted
#6
I'm not an API expert but I think Sidney has a good approach. Be proactive and audit them while they're there sometime. I bet you could contact API for clarification, especially since they don't let anyone else to certification audits.
 

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