Scheduling & Quoting
Form used by TUV SUD America sent to utilize subcontractors
What is the Work Agreement Form or MHS_F_03.01?
Location for CRT2 submissions
What is MEDICI?
Document/form used to find the type of Change Notice that needs to be reviewed
What is the Appendix D?
The primary contact in the US for regional subcontracting requests
Who is Ally/Alesandra Forziati?
The TPS Number is assigned from this document
What is the iBSC Information Sheet?
PTDE (Full name / description)
What is a Project Temporary Direct Employee?
The current revision of the Audit Plan as per RoXtra
What is Revision 24?
In PSE project setup, the CBW details field site
What is the site affected by the Change notice?
"Product field" type of audit that is used to categorize regional subcontracted projects
What is Special Audit?
NaLE stands for
What is National Legal Entity?
The tool used to send out quotations to clients
What is the Applications Console?
The UCB Process Lead of Certifications
Who is Brittany Provost?
Used as the "PSE Model" instead when an application does not have an Application ID number
What is the date of the application was signed by the client?
Listed under the PO section for UAA in project info
What is, As Per Contract?
A direct contract between PS GmBH and the customer for MDR/IVDR Conformity Assessment projects
What FWA (Framework Agreement)?
EAC is to MDT, as MDA/MDN is to
What are NBOG codes (MD Codes)?
The date TUV SUD stopped issuing MDD and AIMDD certificates
What is May 26th, 2021?
4 types of review processing for Change Notifications
What is to be handled at next audit, TD Review, Special Audit, TD Review w/ Special Audit?
The three required documents for an UAA submission
What are, the Company Profile, Assessment Plan, Confidential Audit Report?
No later than 6 months after the Stage 2 audit, this must be completed
What is the TD Review?
MED_W_06.16
What is the work instruction for Audit Planning?
Submission type for MEDICI to add or remove an NBOG code from a client’s profile in CBW
What is a Change of CBW Metadata?
6 scenarios for when a Contract Review is needed for UCB
What is Initial Audit, Upgrade in standard, Scope change affecting codes, New to UCB, New facility for MDSAP, Upgrade to MDSAP?
The QUANTITY and GRADE of non-conformances that triggers a mandatory MDSAP UAA (Hint there are 2 grades)
What is, one or more grade 5 OR more than two grade 4?
The application in which we would locate the MDR codes
What is Appendix A?