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ISO 9001:2015 Certification Application Form
To Obtain A Detailed Quote, Kindly Provide Us With The Following Information
Organisation Information
Company Name:
Trading Name:
Company/Organisation Type:
Company Reg. No:
VAT No:
SAHPRA Licence information
SAHPRA Registered Wholesaler: (Yes/No)
SAHPRA Wholesaler Licence Number:
SAHPRA Registered Manufacturer: (Yes/No)
SAHPRA Manufacturer Licence Number:
SAHPRA Registered Distributor: (Yes/No)
SAHPRA Distributor Licence Number:
Contact Details of the Organisation
Telephone Number:
Mobile Number:
Website:
Street Address:
City:
Province/State:
Country:
Postal/Zip Code:
Key Personnel Details
Company CEO/MD Name:
Position:
Phone number:
Email address:
Authorised Representative Name:
Position:
Phone number:
Email address:
Accounts Payale Contact Name:
Phone number:
Email address:
Scheme Certification Services Required (ISO 13485:2016 / ISO 9001:2015)
Which Service do you wish to apply for?
Site Information (where audits will take place)
Main Site
Number of Employees at Site:
Activities at the Site (Manufacturing/Distribution/Wholesaling):
Street Address:
City:
Province/State:
Postal/Zip Code:
Country:
Contact Person Name:
Position:
Phone number:
Email address:
Additional Site 1
Does the entity have-Additional Site 1:
Number of Employees at Site:
Activities at the Site (Manufacturing/Distribution/Wholesaling):
Street Address:
City:
Province/State:
Postal/Zip Code:
Country:
Contact Person Name:
Position:
Phone number:
Email address:
Additional Site 2
Does the entity have-Additional Site 2:
Number of Employees at Site:
Activities at the Site (Manufacturing/Distribution/Wholesaling):
Street Address:
City:
Province/State:
Postal/Zip Code:
Country:
Contact Person Name:
Position:
Phone number:
Email address:
Additional Site 3
Does the entity have-Additional Site 3:
Number of Employees at Site:
Activities at the Site (Manufacturing/Distribution/Wholesaling):
Street Address:
City:
Province/State:
Postal/Zip Code:
Country:
Contact Person Name:
Position:
Phone number:
Email address:
Additional Site 4
Does the entity have-Additional Site 4:
Number of Employees at Site:
Activities at the Site (Manufacturing/Distribution/Wholesaling):
Street Address:
City:
Province/State:
Postal/Zip Code:
Country:
Contact Person Name:
Position:
Phone number:
Email address:
How many Additional Sites are to be audited over and above the ones mentioned above ?
Management System Information
Type of audit to be conducted (Initial Audit/Surveillance Audit/Re-certification Audit/Special Audit):
When do you expect the management system to be ready for the audit?
Is a Management Review conducted?
Is the system you are seeking assessment for integrated with any other management system?
Is an internal audit conducted?
Do you currently have any other management system certified by any other Certification body?
If Yes; Please provide the following: (Certification Body, Standard, Scope, Ceritifiocation No.)
Have you used a Consultant to develop and implement your System?
If Yes; Provide the Name and contact details of the Consultant:
Is any process used by the organisation outsourced?
If Yes; Please provide the details of the outsourced processes
Is the last audit report available with outstanding non-conformities?
Any complaints received from customers or other parties?
Any current engagement by the organisation with regulatory bodies in respect of legal compliance?
Any technological and regulatory context IBRATSA needs to take into consideration?
Indicate the Language of communication for all employees in the organisation:
Where did you hear about IBRATSA?
General Business Information ISO 13485
For each medical device category, please answer all the following Questions.
1. MEDICAL DEVICES TECHNICAL AREAS
A. NON-ACTIVE MEDICAL DEVICES:
GENERAL NON-ACTIVE, NON-IMPLANTABLE MEDICAL DEVICES:(Yes/No)
NON-ACTIVE IMPLANTS:(Yes/No)
DEVICES FOR WOUND CARE:(Yes/No)
NON-ACTIVE DENTAL DEVICES AND ACCESSORIES(Yes/No)
B. ACTIVE MEDICAL DEVICES (NON-IMPLANTABLE)
GENERAL ACTIVE MEDICAL DEVICES(Yes/No)
DEVICE FOR IMAGING(Yes/No)
MONITORING DEVICES(Yes/No)
DEVICES FOR RADIATION & THERMOS THERAPY(Yes/No)
C. ACTIVE IMPLANTABLE MEDICAL DEVICES
GENERAL ACTIVE IMPLANTABLE MEDICAL DEVICES(Yes/No)
D. MEDICAL DEVICES INCORPORATING SPECIFIC SUBSTANCES OR TECHNOLOGIES(Yes/No)
E. IN-VITRO MEDICAL DEVICES (IVDS)(Yes/No)
F. MEDICAL DEVICES OTHER THAN SPECIFIED ABOVE(Yes/No)
IF "F" IS "YES" PLEASE SPECIFY
G. Sterilization Methds for Medical Devices
Does your organisation use the following Sterilization Methds for Medical Devices(Yes/No)
If your answer is YES, which methods as defined are provided
Ethylene oxide gas sterilization (EOG)(Yes/No)
Moist heat(Yes/No)
Aseptic processing(Yes/No)
Radiation sterilization (e.g., gamma, x-ray, electron beam)(Yes/No)
Low temperature steam and formaldehyde sterilization(Yes/No)
Thermic sterilization with dry heat(Yes/No)
Sterilization with hydrogen peroxide(Yes/No)
Sterilization method other than specified above(Yes/No)
If the above answer is "Yes", please specify.
H. PARTS OR SERVICES
Does your organisation provide the following part or services?(Yes/No)
If your answer is YES, which services or part as defines are provided?
H. PARTS OR SERVICES
Does your organisation provide the following part or services?(Yes/No)
If your answer is YES, which services or part as defines are provided?
GENERAL ACTIVE IMPLANTABLE MEDICAL DEVICES(Yes/No)
GENERAL ACTIVE IMPLANTABLE MEDICAL DEVICES(Yes/No)
QMS Implementation Date:
Preferred Date for Initial Audit:
