STEPS TO HANDLE

INTERNATIONAL
TECHNICAL
ASSISTANCE SERVICE
 VERIFICATION OF ISO 9001 CERTIFICATION

If the company ISO certified under ISO

9001 and/or ISO 13485, the company
should provide the following documents:
a)Copy of ISO 9001 and/or ISO 13485
Certificates
b)After Sales Service (Technical
Assistance) process
c)“Follow up and Measurement devices
control” proceeding
d)“Documentation Control” proceeding
e)“Registering Control” proceeding
 VERIFICATION OF ISO 9001 CERTIFICATION

If the company IS NOT certified under

ISO 9001 and/or ISO 13485:
• the Technical Service Manager of
OSATU must visit and AUDIT the
facilities of the company and give a
favourable report of the company
 ADDITIONAL DOCUMENTS

The following documents must be provided:

a)Copy of the calibration certificates of at
least the following tools:
• Defibrillator tester with energy and
synchronism time measurement
capacity
• ECG signal simulator
• Digital oscilloscope
• Others required by the Quality
Manager of OSATU
b)Example of the registers /records that
have been generated in reparation
 CONTRACT

OSATU will provide a TECHNICAL

ASSISTANCE SERVICE CONTRACT that
must be signed and stamped in two copies:
One for the international company that will
be homologated and the other one for
OSATU.
 TRAINING COURSE

The training will :

 
• Be instructed by the Technical
Assistance Service Manager of OSATU

• Can be provided:

• In OSATU facilities
• In the company facilities