Quality Clauses

The following Supplier Purchase Order Quality Clauses, with their terms and conditions, become an integral part of the Purchase Order to the extent specified on the Purchase Order. Changes, additions, or deletions to the invoked Quality Clauses must be made by Purchase Order revision. Shipments will not be considered complete and invoices will not be honored until all requirements are fulfilled.

 

QC-1. CERTIFICATE OF CONFORMITY (C of C)

A legible and reproducible Certificate of Conformity must accompany each shipment. This Certificate must bear the signature and title of an authorized representative of the Supplier stating the materials or processes supplied meet applicable specifications cited in the Purchase Order. The specifications and revision must be listed. Supplier shall certify that documentary evidence in the form of physical and chemical test results and inspection records of these materials and/or processes indicating conformance to applicable Purchase Order specifications are on file and available for review by Abbott Technologies or its authorized representative.

 

QC-2. QUALITY MANAGEMENT SYSTEM-AS9100 or ISO 9001 or MIL-I-45208 EQUIVALENT

The Supplier shall maintain a Quality System that complies with the current revision of AS9100, ISO 9001, or specification MIL-I-45208 equivalent. Third party registration by an accredited registrar will be accepted. Suppliers declaring compliance to AS9100 or ISO 9001 with no formal accredited registration may require review. All Suppliers declaring MIL-I-45208, MIL-Q-9853 or equivalent system, will be subject to further review to assure the QMJ system meets the intent of ISO 9001. Notwithstanding the provisions of this clause, the Supplier is in no way relieved of the final responsibility to furnish the supplies or services specified herein. The Supplier’s system will be subject to review and approval at all times by Abbott Technologies.

 

QC-3. INSPECTION AND TEST REPORTS

Each shipment must be accompanied by a legible and reproducible copy of reports of actual results identifying test parameters and products submitted. These reports must contain the signature and title of the authorized representative of the agency performing the test and must indicate conformance to specified requirements.

 

QC-4. SOLDER PER J-STD-001, IPC-A-610

The product(s) listed on this Purchase Order requires soldering in accordance with the current revision of J-STD-001 or IPC-A-610. Please provide certification of these standards for each product or part number and include it with this shipment.

 

QC-5. SOURCE INSPECTION–ABBOTT TECHNOLOGIES

Abbott Technologies personnel must inspect all items covered by this Purchase Order at Supplier’s facility prior to shipment. This will include surveillance of the Supplier’s procedures and facilities. The Supplier shall furnish, at no cost to Buyer, necessary facilities, supplies and equipment, and test data. Supplier shall perform tests as required by applicable drawings, specifications, and inspection instructions. Note: When requesting source inspection, call the Abbott Technologies Buyer at least forty-eight (48) hours in advance.

 

QC-6. SOURCE INSPECTION–GOVERNMENT

Government inspection is required prior to shipment from Supplier’s plant. Immediately notify the government representative, who normally services your plant, and the Abbott Technologies Buyer of the planned inspection date. Upon receipt of this order, promptly furnish a copy of the Purchase Order to the government representative who normally services your plant, or if none, contact the Abbott Technologies Buyer immediately.

 

QC-7. FIRST ARTICLE APPROVAL REQUIRED

A first article produced under this Purchase Order must be submitted to Abbott Technologies for inspection prior to making further shipments. This inspection is solely for Abbott Technologies’ convenience and shall not waive Abbott Technologies’ right to reject any parts not conforming to this Purchase Order.

 

QC-8. SPECIAL HANDLING REQUIRED

The parts sent to Supplier’s facility for processing are easily damaged. Handle with care to prevent damage during processing and packaging.

 

QC-9. PACKAGING

Each part submitted to Abbott Technologies must be wrapped and/or packaged in such a manner to prevent damage during shipment.

 

QC-10. ESD SENSITIVE DEVICES

The products being purchased are sensitive to electro static discharge. The use of ESD barrier containers and ESD handling procedures must be used during the performance of this Purchase Order. Certifications must also state that ESD prevention measures were in place and were used during the performance of this Purchase Order.

 

QC-11. LIMITED SHELF LIFE

Supplier shall ensure that at least 85% of the material’s shelf life is remaining upon delivery to the Buyer. Supplier shall ensure that containers are plainly and legibly marked as to the contents, expiration date, warnings and precautions, instructions, and storage requirements. Certification for shelf life and conditions is required to be shipped with this order.

 

QC-12. MERCURY FREE PRODUCT

By accepting this Purchase Order, Supplier certifies that the product or service supplied to Abbott Technologies is free from mercury contamination. If mercury is a component of Supplier’s processes, please contact the Abbott Technologies Buyer for direction.

 

QC-13. AUTHORIZATION TO SHIP EARLY

Supplier is authorized and encouraged to ship the items referenced on this Purchase Order line as early as possible.

 

QC-14. DO NOT SHIP WITHOUT AUTHORIZATION

Prior to shipment, please contact the Buyer to receive authorization to ship the products referenced on this Purchase Order.

 

QC-15. NO OVER SHIPMENT ALLOWED

Over shipments against this Purchase Order are expressly prohibited. If Supplier wishes to ship more components than the number required, contact the Buyer for authorization prior to shipment.

 

QC-16. MATERIAL SAFETY DATA SHEETS REQUIRED

Material Safety Data Sheets are required for the product identified on this line of the Purchase Order. In addition to the Packing List, please include these sheets in an envelope that is labeled M.S.D.S.

 

QC-17. CALIBRATION

The Supplier’s calibration system must comply with ANSI/NCSL Z540.3 or ISO 10012-1. All Certificates will include, at a minimum, a list of standards used, confirmation that all standards used are traceable to the National Institute of Standards and Technology, date of calibration, date of expiration, and the technician’s signature.

 

QC-18. CHEMICAL / PHYSICAL TEST REPORTS

The Supplier must furnish chemical / physical analysis and test reports with each shipment. Reports must include heat or lot number, actual test results, test specifications, the company name, and signature and title of an authorized representative of the company. A legible and reproducible copy of all reports identifiable to this Purchase Order must accompany each shipment with materials submitted.

 

QC-19. ABBOTT TECHNOLOGIES FURNISHED MATERIAL

The Supplier shall certify that material used in fabrication is the material furnished by Abbott Technologies.

 

QC-20. RIGHT OF ACCESS

By accepting this Purchase Order the Supplier agrees to allow representatives of Abbott Technologies (the Buyer), the Buyer’s Customer, and/or representatives of the Government or any Regulatory Agency to review or inspect the Supplier’s quality control and/or manufacturing systems or processes during the performance of this Purchase Order.

 

QC-21. M.R.B. AUTHORITY

Material Review Board authority is NOT granted under this Purchase Order. Any deviations to this Purchase Order and/or the listed specifications must be coordinated with Abbott Technologies before shipment.

 

QC-22. TOOL PROOFING

Acceptance of production tooling on this Purchase Order shall be contingent upon inspection and acceptance by Abbott Technologies. The tooling and dimensional samples produced by this tooling must conform to the tolerance limits of engineering drawings and specifications stated on the Purchase Order. An Abbott Technologies Quality Representative may conduct this inspection at the Supplier’s facilities or the items may be shipped to Abbott Technologies for inspection, as directed by the Buyer. Dimensional samples should be identified with the tool number.

 

QC-23. INSPECTION AND / OR PRODUCTION TOOLING

Other than normal wear, Supplier is held responsible for the protection, calibration, and care of all Production and/or Inspection tooling furnished by Abbott Technologies for use in the performance of this Purchase Order. All tooling shall be subject to Abbott Technologies’ surveillance and/or inspection upon notice. Said tooling, or replacement tooling of equal quality, shall be returned in an acceptable condition upon demand or notice.

 

QC-24. PROCESS CERTIFICATION

The Supplier must furnish chemical / physical analysis and test reports with each shipment. Reports must include actual test results, test specifications, the company name, and signature and title of an authorized representative of the company. A legible and reproducible copy of all reports related to this Purchase Order must accompany each shipment with materials submitted. WHEN PARTS ARE SERIALIZED, SERIAL NUMBERS MUST APPEAR ON THE CERTIFICATE.

 

QC-25. PROCESS CONTROL

Supplier must notify Abbott Technologies of any proposed changes to items ordered (i.e., materials, processes, etc.) and obtain written approval prior to shipment.

 

QC-26. NONDESTRUCTIVE TEST REPORTS

A legible and reproducible copy of actual Nondestructive Test results, with acceptance limits and material submitted clearly identified, must accompany each shipment. These reports must contain the signature and title of the authorized representative of the agency performing the inspection and must ensure conformance to specified requirements.

 

QC-27. SAMPLING INSPECTION

Sampling inspection may be performed in conjunction with this Purchase Order. Note: The use of a sampling plan in no way affects Abbott Technologies’ right to reject any unit(s) of product found defective.

 

QC-28. FINAL ACCEPTANCE

Final acceptance will be based on Abbott Technologies’ inspection and testing results at destination.

 

QC-29. LOT CONTROL–MIXED LOTS

The Supplier may furnish material from different heats, lots or batches as applicable. Suppliers providing material with limited shelf life must include the material’s expiration date(s) for their product for each shipment. Where shipments contain parts with different expiration dates or are from different heats, lots, or batches, separation into sublots with separate certification of sublots is required. One (1) copy of each Certificate must be included with each shipment for each lot or sublot.

 

QC-30. LOT CONTROL–SAME LOT

All items on this Purchase Order are to be from the same manufacturing / processing lot and shall all bear the same lot code identity. All suppliers of limited shelf life material shall include the material’s expiration date(s) for their product for each shipment. Shipments shall contain material with the same expiration dates and must be from the same heats, lots or batches. One (1) copy of the Certificate shall be included with each shipment.

 

QC-31. RECORD RETENTION ― 10 YEARS or the life of the product(s).

Supplier is required to maintain on file all records pertaining to the completion of this Purchase Order for a minimum of 7 years. The Supplier may elect to send a copy of these records to Abbott Technologies in lieu of this storage requirement.

 

QC-32. PURCHASE ORDER CONFLICTS

In the event of any inconsistency or conflict between or among the provisions of this Purchase Order, please contact the Abbott Technologies Buyer for resolution.

 

QC-33. LEAD FREE PRODUCT

By accepting this Purchase Order, Supplier certifies that the product or service supplied to Abbott Technologies is free from lead contamination. If lead is a component of Supplier’s processes, please contact the Abbott Technologies Buyer for direction.

 

QC-34. SPECIALTY METALS (DFARS 252.225-7014)

By accepting this order, Supplier certifies that the steel and titanium supplied under this Purchase Order to Abbott Technologies as raw material have been domestically melted in the United States or one of the qualifying countries listed in DFARS 252.225-7014.

 

QC-35. NONCONFORMING PRODUCT NOTIFICATION

Material that departs from drawing or specification shall be identified and controlled to prevent unauthorized use or delivery to Abbott Technologies or other designations. Supplier shall provide prompt written notification to Buyer at Abbott Technologies if nonconforming product or materials are identified after being shipped to Abbott Technologies.