Vertex Supplier Requirements

Vertex reserves the right to perform source inspection at a supplier facility.
o Vertex reserves the right of access to supplier facilities for its customer and authorities for verification of products and processes to ensure conformity to specified requirements
o Supplier notification of product/ process readiness (target: 48 hours) will be made by Vertex
o Purchasing, who will make arrangements with customers for verification.
o The supplier shall make available the resources, facilities, and equipment to facilitate any such inspections required
o This right extends to our customers, applicable regulatory agencies, and any sub-tier suppliers used to fulfill a purchase order.

Vertex suppliers are required to ensure that persons are aware of their contribution to product or
service conformity, their contribution to product safety, and the importance of ethical behavior.

Certificates of Conformance are required as identified in a Vertex Purchase Order (PO).

The Quality Plan referenced on the Purchase Order must be followed – no exceptions.

Documents and records associated with a PO are to be retained for a minimum of 7 years.

Vertex Suppliers must maintain conformance and traceability records regarding the product or service
provided.

When utilizing sampling inspection, the sampling must follow a statistically valid standard (i.e., ANSI
Zl.4 or equivalent)

Shipments with known nonconformities will not be accepted without prior authorization.

All “special processes” required by this PO must be performed by qualified personnel, and the processes
require validation periodically to ensure output meets requirements. Process validation records must be
available upon request.

Any differences between product requirements and what the provided by the supplier must be identified,
communicated, and approved before shipping.

Suppliers are not, under any circumstance, granted authority to alter the product design and characteristics.

Supplier detection of a nonconforming product must be communicated in writing to the Vertex quality
department for a risk assessment.

Outsourcing a Vertex PO to your suppliers requires communication of all applicable requirements
and specifications to your sub-tier supplier.

If providing calibration services, all certificates must identify standards used and must be traceable to NIST Standards.

Vertex’s quality personnel may use Source Inspection/ Surveillance to evaluate the following:
o Supplier capability assessment
o The review of the Supplier Quality Management System
o Supplier / Subcontractor conformance to Vertex and customer requirements.
Vertex will accommodate customers’ requests for source inspection. If required, Vertex will
inform the supplier of the customer visit. The supplier will provide all the necessary facilities, equipment,
documentation, etc., needed by Vertex’s customers.