General
ReNew Biomedical Services operates under a Quality Management System compliant to the ISO13485 standard. Acceptance of a ReNew Purchase Order (PO) signifies that the supplier agrees to the terms and conditions described in this document. In this document, “supplier” refers to the organization that provides raw materials, products, or services that impact ReNew’s ability to meet its customer’s requirements.
Acceptance of ReNew PO
By accepting a ReNew PO, the supplier (external provider) agrees to the following.
- Provide Certification of Compliance – When requested, supplier shall provide an authorized certification to attest that the product or process supplied conforms to ReNew order requirements.
- Where stated, supplier shall use only approved products, sub-suppliers, methods, processes, and equipment.
- Maintain proper identification and revision status for all relevant technical data (e.g., specifications, drawings, process requirements, and work instructions).
- Demonstrate ability to meet any special requirements, critical items, or other key characteristics communicated by PO or other method; e.g., emails, written notifications.
- Establish criteria for testing, inspection, and verification (including production process verification) of product to requirements, where applicable, prior to release.
- External providers are expected to ensure competence and document qualification of applicable personnel.
- ReNew reserves the right to identify the requirements for interaction with our external providers.
- ReNew reserves the right to monitor our external provider’s performance, including supplier risk, Quality of Product and Service delivered, and the on-time delivery of product or service.
- With advanced notification, provide ReNew, our customer, and regulatory authorities access to perform verification / validation activities at the supplier’s premises (including access to all applicable records).
- ReNew reserves the right to require the supplier to
- Establish a system for responding to complaints.
- Notify ReNew of nonconforming processes, products, or services and obtain approval for their disposition prior to shipment to ReNew.
- Supplier must prevent the use of counterfeit or substitute material, parts, or product as required by AS9100.
- Supplier shall provide, in writing, advance notification to ReNew of any change(s) to processes, products or services, tooling, facilities, or materials, at the supplier or the supplier’s sub-tier that could affect the contracted product. A copy of the signed ReNew approval document shall be retained by supplier.
- Retain and maintain appropriate records (may be electronic) of the activities listed herein. Records must be legible and retrievable for a minimum of fifteen (15) years after product acceptance, after which they may be dispositioned according to the supplier’s own procedures. Alternatively, supplier may meet this requirement by providing all requested records to ReNew at time of supplier invoice. In cases where the duration of retention is increased (e.g., at the request of ReNew’s customers), specific instructions will be provided by ReNew.
- Ensure supplier’s employees are aware of their contributions to product or service conformity, product safety, and ethical behavior.
- Ensure that materials are packaged in a manner to preserve product, dimensional, functional and aesthetic integrity.
- Ensure traceability of materials back to original source.
- Where metals are used, supplier will not knowingly purchase any unauthorized raw materials listed by US Government; e.g., those of section 1502 of the Dodd-Frank Conflict Minerals Act.
- Complete ReNew self-evaluation and surveys, when requested.
Questions or concerns regarding these terms and conditions should be directed to our Purchasing Management.