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Manufacture of Contracted Precision Medical Parts/Components for the Medical Industry: DOWNLOAD

Manufacture of precision machined parts for the aerospace, defense, and commercial and medical industries: AS9100 Certificate, ISO 9001 Certificate

ITAR stands for The International Traffic in Arms Regulations and is a set of government regulations related to defense exports. The regulations include policies and provisions related to prohibited exports, imports and sales to or from specific countries, exceptions among many others.

Q1       –       INSPECTION AND TEST SYSTEM REQUIREMENTS
The supplier shall establish and maintain an Inspection and Test System in compliance with the requirements of AS9100 or equivalent quality standards. The supplier Inspection and Test System is subject to audit, verification and approval and/or disapproval by 5th Axis designated representatives.

Q2       –       MRB AUTHORITY
Material review board authority is not authorized on this purchase order.

Q3       –       APPROVAL & CHANGES
The supplier shall notify the buyer of any proposed changes in the design, fabrication methods, material supplier, manufacturing/processing location, which has the potential to affect the conformity of the final product supplied to 5th Axis.

Suppliers with previously approved/locked down processes shall obtain written approval of changes from the buyer. Changed articles shall be clearly identified and in a different manner from the previous articles. When the buyer procures a proprietary item, the supplier shall notify the buyer of changes.

Q4       –       RAW MATERIALS
Raw materials shall be accompanied with certifications, chemical and/or physical test results. The supplier shall certify the specific requirements defined on the face of the purchase order.

Q5       –       IDENTIFICATION & DATA RETRIEVAL
Where and to the extent that traceability is a specific requirement, the supplier shall apply a unique identification to the individual product, material or batch. This identification data shall be recorded on and traceable to related suppliers records (see supplier quality records)

Q6       –       SUPPLIER QUALITY RECORDS
The supplier shall maintain suitable inspection and test records to serve as evidence of conformance with specified requirements. Such records shall be legible and traceable to the product involved. These records shall be maintained for a minimum period of seven (7) years from the date of final manufacture or as stated otherwise in the contract.

Q7       –       SUBMISSION & RESUBMISSION OF NONCONFORMING ARTICLES OR MATERIALS
Do not send nonconforming products or materials to 5th Axis without prior written authorization.

Nonconforming articles and/or materials returned by the buyer and subsequently resubmitted by the supplier shall bear adequate identification of such nonconformance, on the articles, materials, or applicable supplier’s records. The supplier shall provide evidence that the cause of the nonconformance was corrected and that actions were taken to preclude any reoccurrence.

Q8       –       ACCESS TO SUPPLIER’S FACILITIES AND RECORDS
The supplier shall grant reasonable access to all the supplier’s facilities and records to representatives of 5th Axis, 5th Axis’ customers, US government and/or regulatory agencies for the purpose of evaluation of supplier’s conformance to all PO/Contract requirements. When applicable, the access requirement shall be flowed-down by the supplier to the supplier’s sub-tier sources.

Q9       –       FIRST ARTICLE
The Seller shall perform a First Article Inspection (FAI) of one item from the first production lot, or as required by the Buyer. The FAI shall consist of recorded actual drawing, specification values, and/or requirements (dimensional, test data, processes, drawing notes, etc.) and may be documented on the drawing or on a separate report form. The first article item shall be clearly identified by a tag attached to the item or a label applied to the bag, and a copy of the FAI shall accompany the First Article part. The Buyer reserves the right to verify any or all of the characteristics documented on the FAI report at the seller’s facility.

Q10    –       CERTIFICATE OF COMPLIANCE
Supplier shall provide evidence that the processes requested in this purchase order were performed by approved sources. The supplier shall maintain such evidence on file. Included with each shipment to the buyer shall be a certificate of compliance indicating as a minimum the process description, process number, name and address of the process supplier, the purchase order and part number.

Q11    –       MATERIAL TRACEABILITY
Identification of each piece of material and each report is required by specification to provide traceability to heat lot or batch number

Q12    –       GRAIN DIRECTION IDENTIFICATION REQUIRED
(where applicable)

Q13   –        CONTROL OF SUB-TIER SOURCES
The supplier, as the recipient of the PO or Contract, is responsible for meeting all PO/Contract specified technical and quality requirements, whether the supplier performs the work or the work is performed by the supplier’s sub-tier sources. When the supplier uses sub-tier sources to perform work on products and/or services scheduled for delivery to 5th Axis, the supplier shall include (flow-down) on Purchase Orders of Contracts, to their sub-tier sources, all of the applicable technical and quality requirements of the 5th Axis P.O. or Contract, including, when applicable the requirement to document and control “key characteristics” and/or “key processes”, and to furnish certifications and test reports required by the applicable P.O. Quality requirements.

Q14    –       SUPPLIER NOTIFICATION OF NONCONFORMING PRODUCTS DELIVERED TO 5TH AXIS.
When the supplier has determined that the nonconforming product(s) have been delivered to 5th Axis, the supplier shall notify 5th Axis within twenty-four (24) hours of the initial discovery. The supplier shall use receipt acknowledgement e-mail or other positive notification method. The notification shall include the supplier name, 5th Axis PO/Contract number, part number and description, affected quantity and serial numbers (if known), dates delivered (if known), brief description of the nonconforming condition.

Q15    –       REQUIREMENTS FOR QUALIFICATION OF PERSONNEL
Where applicable, only qualified/certified personnel shall be used based on process specification requirements (NDT, etc). Records shall be maintained of the personnel qualifications/certifications.

Q16    –       DELEGATED AUTHORITY OF INSPECTION FOR RAW MATERIAL
Where applicable, 5th Axis authorizes the supplier to perform receiving inspection on all raw materials, purchased by 5th Axis, which was shipped directly to the supplier from another 5th Axis supplier.  When the order is complete, the supplier shall ship the original packing slip and material certification to 5th Axis with the order.

Q17    –       CONTROL OF ITAR REQUIREMENT
The supplier shall hereby acknowledge that any information exchanged between 5th Axis and the supplier may include documents which contain technical data, export of which is restricted by the INTERNATIONAL TRAFFIC IN ARMS REGULATIONS (ITAR). Disclosure to foreign persons without prior U.S. Government approval is prohibited. Violations of these Export Laws and Regulations are subject to severe Civil and Criminal penalties.

Q18    –       HARDWARE/COUNTERFEIT PREVENTION PROGRAM
Distributors or brokers that supply non-electrical standard parts (Hardware), like fasteners, nuts, washers, springs, o-rings, inserts, and pins, must be shipped in a sealed OCM (Original Component Manufacturer) container, which contains the name of the OCM, Part Name/Number, and a Heat/Lot/Control Number at a minimum.  If that is unavailable, the original OCM Certification must be included with the shipment.

Q19    –       CALIBRATION STANDARDS
The supplier shall comply with the requirements of ANSI/NCSL Z-540-1 and  ISO/IEC 17025:2005. All standards used in the calibration process shall be traceable to the National Institute of Standard (NIST). A Certificate of Calibration is required for all items calibrated.