Quality Code

Title

Requirement

QC01 - Standard

Sub-Contractor Flow Down

External Provider (AKA Supplier/Vendor) is required to flow down the requirements of this purchase order, including terms and conditions to the External Provider (AKA Supplier/Vendor)'s subcontractors. Flow down of key characteristics is required when specified on the face of purchase order. External Provider (AKA Supplier/Vendor) is to notify Technovare of changes in product and/or process, changes of External Provider (AKA Supplier/Vendor) s, changes of manufacturing facility location and, where required, obtain organization approval within 24 hours.

QC02 - Standard

Documented Information Retention and Disposition

As a minimum, the External Provider (AKA Supplier/Vendor) is to retain documented information for at least 7 years from the date of shipment under each applicable order for all products/part numbers unless otherwise specified in the order. In special circumstances, the purchase order will identify the actual required number of years that the documented information should be maintained. After the minimum retention period is achieved, External Provider (AKA Supplier/Vendor) s may disposition the documented information as archive or destroy at their discretion.

QC03 - Standard

Nonconformance/Corrective Action

The External Provider (AKA Supplier/Vendor) is to notify Technovare of a Nonconformance prior to shipping parts. In addition, the External Provider (AKA Supplier/Vendor) will maintain a system of handling non-conformances and corrective actions.

QC04 - Standard

Right of Entry

Technovare, our customers, and/or any applicable regulatory authority reserve the right to access the External Provider (AKA Supplier/Vendor)’s applicable areas of all facilities, at any level of the supply chain, involved in the order and to all applicable records. Reason for access may include inspection of the item on order, status of the item, or reviewing quality records pertaining to the purchase order in question.

QC05 – Standard

QMS Awareness

External Provider (AKA Supplier/Vendor) s Personnel must be made aware of:

•     their contribution to product or service conformity;

•     their contribution to product safety;

•             the importance of ethical behavior.

QC06 - Standard

Control & Monitoring Requirements

External Provider (AKA Supplier/Vendor) s must maintain a Quality Level ≥95% and an OTD level ≥95%. If levels drop below target, External Provider (AKA Supplier/Vendor) will be notified and may be placed on conditional status or disapproved if not corrected.

Quality Code

Title

Requirement

QC07

Quality System

External Provider (AKA Supplier/Vendor) shall establish and maintain a Quality System acceptable to Technovare, for the goods and/or services purchased under this purchase order.

QC08

ISO Quality System

As a minimum, the External Provider (AKA Supplier/Vendor)'s Quality System must meet the requirements of ISO9001 or better.

QC09

External Provider (AKA Supplier/Vendor) Furnished Material

External Provider (AKA Supplier/Vendor) shall submit Chemical and Physical test reports in accordance with the latest material specifications and revision. Distributors must provide a certification verifying the materials traceability to the Mill test reports when supplied.

QC10

Calibration

The External Provider (AKA Supplier/Vendor)'s equipment shall be calibrated in accordance NIST standard (ISO 17025/ISO 10012-1/ANSI Z540-1) traceable to national or international measurement standards.

QC11

BUY AMERICA ACT

Items procured under this purchase order must be compliant with DFAR 252.225-7000.