IBRATSA ISO QMS Certification Services

ISO 13485:2016 Certification Application Form

To Obtain A Detailed Quote, Kindly Provide Us With The Following Information (NOTE: Do not leave empty spaces rather type N/A if not applicable)

Section A1: Registration Information of the Organisation Company Name: Trading Name: Company/Organisation Type: Company Reg. No: VAT No:

Section A2: SAHPRA Licence Information SAHPRA Registered Wholesaler: Wholesaler Licence No: SAHPRA Registered Manufacturer: Manufacturer Licence No: SAHPRA Registered Distributor: Distributor Licence No:

Section A3: Contact Details of the Organisation Telephone Number: Fax Number: Website(e.g. https://www.ibratsa.co.za): Street Address: City: Province/State: Country: Postal/Zip Code:

Section A4: Key Personnel Details CEO/MD Name: Position: Phone Number: Email Address: Authorised Representative Name: Position: Phone Number: Email Address: Accounts Payable Contact Name: Phone Number: Email Address:

Section A5: Certification Services Required Which Service Do You Wish To Apply For?

SECTION B: Site Information

B1: Main Site No. of Employees at Main Site: Activities at Main Site: Street Address: City: Province/State: Postal/Zip Code: Country: Contact Person Name: Position: Phone Number: Email Address:

B2–B5: Additional Sites How many additional sites (up to 4)?

Additional Site 1

No. of Employees: Activities at Site: Street Address: City: Province/State: Postal/Zip Code: Country: Contact Person Name: Position: Phone Number: Email Address:

SECTION C: Management System Information Type of audit to be conducted: When do you expect the management system to be ready for audit?

Answer Yes or No:

Management Review conducted? Integrated with another management system? Internal audit conducted? Other system certified by another body? If Yes, details (body, standard, scope, cert no.): Consultant used to develop/implement your system? If Yes, consultant name & contact: Any outsourced processes? If Yes, describe outsourced processes: Outstanding non-conformities in last audit? If Yes, details: Any complaints from customers or other parties? Any current engagement with regulatory bodies?

SECTION D: Medical Devices Technical Areas

Please indicate Yes or No for each category:

A. Non-Active Medical Devices GENERAL NON-ACTIVE, NON-IMPLANTABLE: NON-ACTIVE IMPLANTS: DEVICES FOR WOUND CARE: NON-ACTIVE DENTAL DEVICES:

B. Active Medical Devices (Non-implantable) GENERAL ACTIVE MEDICAL DEVICES: DEVICE FOR IMAGING: MONITORING DEVICES: RADIATION & THERMOTHERAPY:

C. Active Implantable Medical Devices GENERAL ACTIVE IMPLANTABLE:

D. Devices with Specific Substances/Technologies: If Yes, specify: E. In-Vitro Medical Devices (IVDs): F. Other Medical Devices: If Yes, specify:

SECTION E: Occupational Health & Safety Information

Select any PPE or induction requirements that apply:

Safety Shoes Safety Induction Required

If you checked any of the above, please explain:

Scope of Certification sought:

SECTION F: Terms & Conditions I agree to the use of ICT tools (video, document sharing, etc.): If No, please specify concerns or limitations:

I the undersigned confirm all information is accurate and accept IBRATSA's certification terms and conditions:

Name of Responsible Person: Date: