ISO Services Contract - CK DENTAL IND - CO.,LTD

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CR#: 4030250270

VAT#: 301128864700003

Ref#: Ref#: CK-DENTAL/SER-0041 Date: 09-01-2023

ISO SERVICE PROPOSAL CONTRACT

M/s. Mawj Al Sama Medical Company


Jeddah| Saudi Arabia

Dear Sir/Madam,

First Purple Cont. Est. is a highly professional consulting firm, providing consultancy for pre
qualifications, support for broad range of certification support for various modern management systems,
documentation, implementation, periodic internal audit, management reviews and corrective actions to
management system standards in accordance with the following standards: -

☐ ISO 9001 ☐ ISO 14001 ☒ ISO 13485 ☐ ISO 45001


☐ ISO 10001 ☐ ISO 10002 ☐ ISO 10003 ☐ ISO 10004
☐ ISO 27001 ☐ ISO 31000 ☐ ISO 55001 ☐ ISO 22301
☐ ISO 41001 ☐ ISO 18788 ☐ ISO 20121 ☐ ISO 20000
☐ ISO 37001 ☐ ISO 26000 ☐ SEDEX ☐ ISO 29990
☐ WRAP ☐ ISO 22846-1 ☐ ISO 22846-2 ☐ ISO 17065
☐ REACH ☐ ISO 10002 ☐ ISO 10004 ☐ OSHAD
☐ ISO 12870 ☐ ISO 12944-9 ☐ ISO 21716 ☐ ICV Certification
☐ ADNOC PQ ☐ R2 Standard ☐ GMP ☐ Audit Financials
☐ ISO 22000 ☐ OHSAS 18001 ☐ ISO 22716 ☐ ISO 37001
☐ BRC ☐ GDPR ☐ ISO 13666 ☐ Canada Health
☐ SFDA AR Services ☐ SFDA AR License ☐ SFDA MDMA1 ☐ SFDA MDMA2
☐ SFDA TFA ☐ SFDA MDIL ☐ SFDA Customs Clearance Application
☐ SFDA Saudi Company Registration ☐ SFDA MDEL (Medical Devices Est. License)
☐ SFDA Pesticides Registration ☐ SFDA Cosmetics Registration (Est. & Manufacturer)
☐ SFDA Food Products and Establishment Reg. ☐ CE MDR (Medical Device Regulation)
☐ SFDA Warehouse Registration/Notification ☐ CE Full Quality Assurance Certificate
☐ CE Certificate of Compliance ☐ SABER Establishment Registration
☐ Saber Product Listing Self Declaration ☐ Saber Shipment Certificate
☐ Saber Certificate of Conformity Regulated ☐ Saber Test Report
☐ Saber IECEE ☐ Saber QM
☐ Certificate of Free Sales from EU Competent Authority, SFDA Requirement for Non-EU Manufacturer.

PO Box 7880, Al-Raghama 5198, Jeddah 23336, Saudi Arabia


CR#: 4030250270
VAT#: 301128864700003

We are pleased to offer you consultancy and certification assistance support for the requested ISO
13485:2016- Quality Management System (Medical Devices) Certification.

First Purple Cont. Est. is highly grateful in receiving an opportunity to be a consulting partner for your
prestigious Organization and appreciate your decision for achieving modern management system within
your organization.

Commercial (A)

S.# Service Description No. of Certificates Charges Total


ISO 13485 Certificate
1 1 15,000 SAR 15,000 SAR
C-K DENTAL IND.CO.,LTD.
Total Amount without VAT 15% - 1 Year 15,000.00 SAR

S.# Payment Terms % age Amount

1 Payment on signing the proposal (without VAT 15%) 1 Year 50% 7,500.00 SAR
2 Payment on acceptance of ISO by SFDA (without VAT 15%) 1 Year 50% 7,500.00 SAR

S.# Payment Terms Amount

1 1st Year Surveillance Charges Mawj Al Sama Medical Company (Year 2024) if required 4,500.00 SAR
2 2nd Year Surveillance Charges Mawj Al Sama Medical Company (Year 2025) if required 4,500.00 SAR

NOTE: The above price matrix is valid only for 2 weeks from the issuing date, where the client must
finalize and sign the contract with us, in order to secure the above price, the amount paid once are
nonrefundable if any delay happens from client side or because of any regulatory constraints. However
will be refunded in case First Purple Cont. Est. will fail to complete the proposed certification.

Initial Documents Required


a. Valid Trade License/CR.
b. Signed Service Proposal.
c. VAT Certificate.

PO Box 7880, Al-Raghama 5198, Jeddah 23336, Saudi Arabia


CR#: 4030250270
VAT#: 301128864700003

Terms and Applicable Conditions

1. This service proposal shall deem treated as confidential document and shall not publish or disclose for
whatsoever reason without prior permission of its author i.e. First Purple Cont. Est.

2. Above package is for ISO 13485:2016 Certification Support Services.

3. 100% payment shall be given at the time of signing the proposal in order to start the process successfully.

4. 15% VAT will be applicable on each invoice as per KSA Law & directives.

5. All cheques shall be drafted to “First Purple Cont. Est.”, for online remittances company account details
will be forwarded along with the invoice.

6. Client shall not offer any kind of additional job to the representative send by First Purple Cont. Est. during
or after current assignment.

7. The project will be completed in 3 to 4 weeks after signing this contract and completion of documents
collection from client (if and when required).

8. First Purple Cont. Est. can sub-contract partially or full scope of work to their approved strategic partners,
only if necessary.

9. First Purple Cont. Est’s representative undertakes not to disclose any confidential client information to
a third party.

On behalf of M/s. First Purple Cont. Est. On behalf of M/s. Mawj Al Sama Medical Company
Name: Saleh Abdullah Rabya Alzahrani Name:
Signature/Stamp: Signature/Stamp:

PO Box 7880, Al-Raghama 5198, Jeddah 23336, Saudi Arabia

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