Supplier Quality Terms and Conditions (SQTC.01)

General

Master Medical Equipment operates under a Quality Management System compliant to the ISO13485 standard. Acceptance of an MME 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 MME’s ability to meet its customer’s requirements.

Acceptance of MME PO

By accepting a MME 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 MME 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.
• MME reserves the right to identify the requirements for interaction with our external providers.
• MME reserves the right to cancel any open purchase order, prior to shipment, without penalty.
• MME 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 MME, our customer, and regulatory authorities access to perform verification / validation activities at the supplier’s premises (including access to all applicable records).
• MME reserves the right to require the supplier to
  • Establish a system for responding to complaints.
  • Notify MME of nonconforming processes, products, or services and obtain approval for their disposition prior to shipment to MME.
• 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 MME 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 MME 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 MME at time of supplier invoice. In cases where the duration of retention is increased (e.g., at the request of MME’s customers), specific instructions will be provided by MME.
• 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.
• Ensure all patient data has been erased.
• 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 MME self-evaluation and surveys, when requested.

Questions or concerns regarding these terms and conditions should be directed to our Purchasing team.