General: As a supplier to IEC-Innovative Endoscopy Components, LLC it is understood that your organization agrees to meet the following stipulations / ISO 13485/ISO9001 requirements. These requirements are, therefore, to be considered as terms and conditions to all purchases.

1. Our organization reserves the right of final approval of product, procedures, processes, and equipment.

2. Our organization reserves the right to review and approve the Vendors Quality Management System.

3. The Vendor shall maintain the proper identification and revision status specifications, drawings, process requirements, inspection/verification instructions and other relevant technical data.

4. Our organization reserves the right to approve or specify any designs, tests, inspection plans, verifications, use of statistical techniques for product acceptance, and any applicable critical items, including key characteristics.

5. Our organization reserves the right to designate requirements for test specimens for design approval, inspection/verification, investigation or auditing.

6. The Vendor is required to retain all records associated with the purchase order as required by contract.

7. All Vendors providing calibration services must be certified to ISO17025 (or equivalent). All calibration certificates must identify standards used and must be traceable to NIST (National Institute of Standards Technology).

8. IEC-Innovative Endoscopy Components, LLC is to be contacted (by the supplier) in the event of nonconforming product/material. Arrangements for the approval of supplier nonconforming product/material must be as directed by an IEC-Innovative Endoscopy Components, LLC’s authorized manager or designee.

9. Furthermore, the supplier is required to notify IEC-Innovative Endoscopy Components, LLC of any changes to a product and/or process and to obtain approval from an authorized IEC-Innovative Endoscopy Components, LLC manager or designee (if applicable).

10. IEC-Innovative Endoscopy Components, LLC, and regulatory authorities retain the right of access to all supplier facilities involved in the order and to all applicable records.

11. The ISO 13485 standard requires that all applicable customer/regulatory/ISO 13485 requirements for the supplier to flow-down to sub-tier suppliers (includes requirements in the purchasing documents and key characteristics where required). However, IEC-Innovative Endoscopy Components, LLC does not allow its suppliers to subcontract any product or process to a sub-tier supplier without IEC-Innovative Endoscopy Components, LLC’s expressed written consent.

12. IEC-Innovative Endoscopy Components, LLC performs inspection activities to ensure that purchased product meets purchase requirements. They may include:

- Receiving inspections (of supplier products / services / documents) may be / are performed by a designated employee. IEC-Innovative Endoscopy Components, LLC verifies the authenticity of the appropriate certificate of conformity, material certificates, etc. and other accompanying documentation by review and comparison (as is appropriate) to the drawing and/or industry specifications or by other means. When necessary, IEC-Innovative Endoscopy Components, LLC may inspect or audit at the supplier’s facility.

- Furthermore, products are inspected to ensure they meet requirements (dimensions, etc.) and the results are recorded (as appropriate). All special processes (anodizing, heat treat etc.) where the compliance cannot be verified by inspections will require a Certificate of Conformity.

13. When appropriate, IEC-Innovative Endoscopy Components, LLC may delegate the inspection authority to one of its approved suppliers. IEC-Innovative Endoscopy Components, LLC will communicate the inspection requirements (including approved monitoring and measurement equipment/methods) and IEC-Innovative Endoscopy Components, LLC will maintain a record of those approved to carry out such inspections.

14. When IEC-Innovative Endoscopy Components, LLC intends to perform verification at the supplier’s premises; IEC-Innovative Endoscopy Components, LLC will first state the intended verification arrangements and the method of product release. This information will be communicated on the IEC-Innovative Endoscopy Components, LLC Purchase Order or via another acceptable purchasing arrangement.

15. To prevent the purchase of counterfeit or suspect/unapproved products and to ensure product identification and traceability (and for other reasons), IEC-Innovative Endoscopy Components, LLC will institute controls that include the requirement of Material Certificates, Certificates of Conformity, and/or other supporting documentation from its suppliers as is appropriate. These requirements may be specified on IEC-Innovative Endoscopy Components, LLC’s Purchase Order or may otherwise be communicated to the supplier.

16. Records are available for review by customers and regulatory authorities in accordance with contract or regulatory requirements.

17. IEC-Innovative Endoscopy Components, LLC may also require specific actions where timely and/or effective corrective actions to a supplier issue(s) are not achieved. These actions may include but are not limited to any or all of the following: withholding payment until the issue is resolved, removal of the supplier from IEC-Innovative Endoscopy Components, LLC’s Approved Supplier List, and legal actions.