Supplier Quality Agreement

The Subcontractor Committed to act according to the following terms to his activities relating to the above products which are assembled and supplied to Wesper Inc.:

General

1. Perform all product-related activities in full compliance with quality standards:

ISO 9001 and / or ISO 13485.

2. Keep all documents and documentation related to the product provided for a period of five years and/or a different period at the company's request, whichever is later. These records will be available for review by the Company's representative or available for mailing, faxing or email.

All such records shall be backed up for a reasonable period of time, under the responsibility of the supplier.

3. All activities related to the product will be carried out by employees who have been trained and certified for their work. These training and certification will be documented.

4. All activities involved in the production and inspection of the product (including but not limited to raw materials and components, acceptance inspection, final inspection, raw materials warehouse, labeling, assembly, etc.) shall be performed in accordance with written work instructions approved by the supplier.

Before manufacturing, if necessary, provide a list of materials and/or components related to the product and obtain the approval of the company representative for the list.

5. Make sure that internal inspections or any other controls are performed on the main suppliers of the products and/or materials related to the product.

6. Production of the product supplied to Wesper Inc. will be carried out in accordance with the requirements of ISO 9001 and/or ISO 13485 (including but not limited to document control, calibration, testing, measuring instruments, control of unsuitable products, corrective and preventative actions, Process control, test and test status, customer complaints, management responsibility, statistical techniques.)

7. The products purchased from approved suppliers will be manufactured according to specifications, lists of parts and instructions and are approved by Wesper Inc.. Any deviation from the product specifications must be immediately and officially reported to Wesper Inc.. No production shall be carried out as long as the deviation in writing has not been approved by Wesper Inc..

8. The supplier will work according to the documentation of Wesper Inc., if necessary, the supplier will also prepare documentation for the execution of the processes according to the production process according to the data received from Wesper Inc..

Wesper Inc. reserves the right to receive an updated copy of this file or document for internal documentation. In any event, the binding documentation shall be the documentation sent to the contractor by Wesper Inc..

9. In the absence of any other special requirement the first product in the work order will be sent for approval by Wesper Inc..

10. Any change in the materials list (BOM), drawings, criteria for final tests and / or changes in critical components requires the prior written approval of Wesper Inc. and will be carried out by email between the quality and/or operation department of Wesper Inc. and the supplier's relevant authority department.

11. Any shipment provided to Wesper Inc. will be marked with an identification number for complete traceability (batch number, serial or production date) according to a defined requirement.

12. Quality assessment for the supplier: Wesper Inc. or a representative from a third party related to the Company (including but not limited to the ISO / CE / FDA certifying inspector), must be allowed access to all processes and documentation related to the product supplied to Wesper Inc., including conducting an unplanned assessment.
    
    

13. Supply

Each batch of products supplied to Wesper Inc. will be accompanied by the following documents, signed by authorized positions:

• (COC) Certification of Compliance.

• Process tags and / or test reports - COT (if applicable).

• Delivery note with full description of the contents, description, number and order number of Wesper Inc., batch / serial numbers, etc.
  
  

14. General

1. All shipments must include following details:

   1. Manufacturer's name.

   2. Manufacturer part number.

   3. Wesper Part Number

   4. Wesper Inc. Purchase order number.

   5. Delivered quantity.

   6. Date code (if relevant).

   7. Lot-Number (if relevant).

2. All deliveries\shipment must be accompanied with Invoice\Shipping document.

In order to prevent payment delay, it is recommended to send 2 copies of the invoice with shipment. It is also possible to send an invoice later directly to our finance department of Wesper Inc.

3. It is mandatory to get COC\COT\COA signed by the manufacturer\vendor with every shipment.

4. Shipments coming from Europe that have an estimated value up to 6000€ must have Euro-Declaration.

5. Wesper will conduct incoming quality inspections on all products arriving at Wesper’s warehouse. Parts found damaged as a result of wrong shipment process\wrong manufacturing process may be returned to Supplier and relevant costs will be charged to Supplier.

6. Shipments from the US must have Certificate of Origin.
   
   

15. Electronic Components

1. All components without any exception must be packed inside the ESD package.

2. Components defined in Wesper inc.’s PO under RoHS will be marked clearly both on relevant shipping documents and package itself.

3. Electronic Components found damaged as a result of wrong shipment process\wrong manufacturing process will be returned to vendor and relevant costs may be charged to vendor\subcontractor.

16. Mechanical Parts

1. Mechanical parts will be supplied together with the final QA inspection report and raw material COC.

2. Sub- contractor's final inspection report will include all drawing's dimensions that can be measured. Actual results will be in handwriting. Each such report will be signed by the sub-contractor's inspector and QA manager.

3. In case a subcontractor uses outsourcing during the manufacturing process, there is a need to add the same reports from the outsourcer.

4. Mechanical parts found damaged as a result of wrong shipment process\wrong manufacturing process will be returned to the vendor and relevant costs may be charged to the vendor\subcontractor.
   
   

17. Printed Card Boards (PCB)

1. PCB will be shipped with COC, dimensions report, electrical test report (COT), metallographic report (coupon) and test report (upon request).

2. PCB will be delivered in vacuum packages including humidity absorber and indicator. PCB part number and quantity must be marked clearly on the package.

3. Damaged boards which are part of the matrix will be marked clearly by the vendor.

4. PCB found damaged as a result of wrong shipment\packing\manufacturing process, will be returned to the vendor and the vendor will be charged for relevant costs.
   
   

18. Hazardous materials 

Material defined as hazardous will be shipped in standard suitable package\container accompanied by the original manufacturer's MSDS.

19. Exceptions

Any deviation from the above said needs to get a written approval from Wesper Inc.'s QA Manager.