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
The Supplier shall maintain a Quality System that complies with the current revision of AS9100, ISO 9001, or 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. 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.
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.
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
Supplier is required to maintain on file all records pertaining to the completion of this Purchase Order for a minimum of 10 years. The Supplier may elect to send a copy of these records to Abbott Technologies in lieu of this storage requirement. This requirement shall be flowed down to all suppliers.
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.
QC-36. COUNTERFEIT PARTS PREVENTION
The seller shall maintain a method of item traceability that ensures tracking of the supply chain back to the manufacturer of all Electrical, Electronic, and Electromechanical (EEE) parts included in assemblies and subassemblies being delivered per this order. This traceability method shall clearly identify the name and location of all of the supply chain intermediaries from the manufacturer to the direct source of the product for the seller and shall include the manufacturer’s batch identification for the item(s) such as date codes, lot codes, serializations, or other batch identifications.
QC-37. PROCESS, PRODUCT, AND SERVICES REQUIREMENTS
The processes, products, and services to be provided to Abbott Technologies including the identification of relevant technical data (e.g. specifications, drawings, process requirements, work instructions) shall adhere to drawings and instructions provided with the purchase order.
QC-38. APPROVAL AUTHORITY
Abbott Technologies shall have approval authority for the supplier’s:
- Products and services;
- Methods, processes, and equipment;
- The release of products and services.
QC-39. COMPETENCY AND QUALIFICATIONS
Persons performing work related to Abbott Technologies purchase orders shall be competent and appropriately qualified.
QC-40. SUPPLIER INTERACTIONS
The supplier’s interactions with Abbott Technologies shall be as directed by the buyer.
QC-41. PERFORMANCE CONTROL AND MONITORING
Control and monitoring of the supplier’s performance to be applied by Abbott Technologies and communicated through a supplier score card.
QC-42. VERIFICATION AND VALIDATION ACTIVITIES
If required, verification or validation activities that Abbott Technologies, or its customer, intends to perform at the supplier’s premises will be supported by the supplier.
QC-43. DESIGN AND DEVELOPMENT CONTROL
Design and development control requirements flowed down with the purchase order shall be followed by the supplier.
QC-44. SPECIAL REQUIREMENTS
Special requirements, critical items, or key characteristics flowed down with the purchase order or associated documentation shall be followed by the supplier.
QC-45. TEST, INSPECTION, AND VERIFICATION
Test, inspection, and verification (including production process verification) requirements flowed down with the purchase order shall be followed by the supplier.
QC-46. STATISTICAL TECHNIQUES
The supplier’s use of statistical techniques for product acceptance and related instructions for acceptance is subject to Abbott Technologies approval.
QC-47. SUPPLIER REQUIREMENTS
The supplier must:
- Implement a quality management system;
- Use Abbott Technologies-designated or approved external providers, including process sources (e.g., special processes) when required
- Notify Abbott Technologies of nonconforming processes, products, or services and obtain approval for their disposition;
- Prevent the use of counterfeit parts (see 8.1.4 of AS9100D);
- Notify Abbott Technologies of changes to processes, products, or services, including changes of their external providers or location of manufacture, and obtain Abbott Technologies’ approval prior to changes;
- Flow down to external providers applicable requirements specified on this purchase order;
- Provide test specimens for design approval, inspection/verification, investigation, or auditing as required by Abbott Technologies;
- Retain documented information, including retention periods and disposition requirements as related to this purchase order.
QC-48. RIGHT OF ACCESS
The supplier will grant the right of access by Abbott Technologies, their customer, and regulatory authorities to the applicable areas of facilities and to applicable documented information, at any level of the supply chain.
QC-49. CONFORMITY, SAFETY, AND ETHICAL BEHAVIOR
The supplier will ensure that persons performing work relative to this purchase order are aware of:
- their contribution to product or service conformity;
- their contribution to product safety;
- the importance of ethical behavior.