It is the policy of Canfield Scientific, Inc. to purchase only from those Suppliers who consistently meet Canfield Scientific, Inc.'s requirements for quality, delivery, reliability, and service. Failure to comply with any requirement invoked by the purchase order may be cause for rejection. Corrective action measures for purchased product, purchased systems, and purchased services may be requested of the Supplier.
- Quality System Requirements
It is preferred that Suppliers are certified to ISO 13485 and/or ISO 9001.
The Supplier will notify Canfield of any change(s) that may affect the ability of the purchased product to meet specified purchase requirements prior to implementation of the change(s).
- Material Supplied by Canfield Scientific
If Canfield Scientific provides Supplier with parts or materials to be further manufactured, Supplier acknowledges that Canfield Scientific is and shall continuously remain the legal and equitable owner of any materials delivered by or on behalf of Canfield Scientific to Supplier for the entire period during which the materials are in transit, to or from, reside at, or are being processed at, Supplier's premises.
- Supplier Inspection and Testing Equipment
Supplier shall maintain equipment for the inspection and testing of products in good working order. Supplier shall establish and maintain a calibration system for control of inspection and test equipment. Calibration standards shall be traceable to National Institute for Standards and Technology (N.I.S.T.) or other recognized bodies.
- Quality and Inspection Records
Quality and Inspection records must be maintained by the Supplier for a period of seven (7) years, minimum, unless otherwise stated in the Purchase Order, and shall be made available for examination by Canfield Scientific, Inc. upon request.
- Certificate of Conformance
If required by the Purchase Order, a legible "Certificate of Conformance" (C of C) statement shall be provided with each shipment submitted to Canfield Scientific, Inc. C of C's must be maintained by the Supplier for a period of seven (7) years, minimum, unless otherwise stated in the Purchase Order, and shall be made available for examination by Canfield Scientific, Inc. upon request. The C of C statement shall be in the Supplier's format and may either be a separate document or may be included within the packing list. The C of C statement shall state that the items were produced in conformance with requirements as specified in the Canfield Scientific, Inc. purchase order. As a minimum, the C of C shall note:
- the manufacturer or distributor's name and address
- the Canfield Scientific, Inc. purchase order number
- the part number(s) and revision(s) when applicable
- traceability information including serial numbers, lot codes, or date codes as appropriate
- shelf-life expiration date codes if applicable
- signature of the Supplier's authorized representative.
Sellers/Distributors shall also provide original OEM (Original Equipment Manufacturer) and/or OCM (Original Component Manufacturer) Certificates of Conformance, if applicable.
When required by the Purchase Order, the Supplier shall maintain a system of traceability on all raw materials, purchased components, and manufactured parts used to supply items on the Purchase Order. Material shall provide easy traceability to receiving inspection reports, purchase orders, specifications, drawings, and other documented data. Where required, purchased items shall be serialized in accordance with industry standards and Canfield specified requirements.
The Supplier shall ensure that all items shipped under this Purchase Order are adequately packaged to prevent damage, contamination, or deterioration.
Material shipped to Canfield Scientific, Inc., should be identified with the Canfield Scientific, Inc. part number (if applicable) and Purchase Order Number on the Packing List. Additional marking and/or identification may be as required by specification, drawing or Purchase Order.
- Canfield Scientific, Inc. Receiving Inspection
Parts and/or Product will be subject to receiving inspection of all characteristics. Material that does not conform to specification may be returned for replacement and / or refund. Latent defects not discovered during source inspection or receiving inspection, but disclosed during assembly or use, shall be cause for rejection.
- Sub-Contractor Quality Assurance
If applicable, Supplier shall be responsible for ensuring that all products, parts, components, and processes procured from every tier of its Sub-Contractors conform to the requirements and obligations of Section 2 of this Agreement. Supplier shall ensure that these requirements and obligations are included in its procurement documents with Sub-Contractors. Supplier's quality system shall provide a method by which the Sub-contractor's conformance to these requirements and obligations can be verified.
- Restriction of Hazardous Substances (RoHS)
All parts including but not limited to raw materials, components, subassemblies, assemblies, and labels supplied to Canfield Scientific for use in electrical and electronic equipment (EEE), or combined with other products, as part of a Canfield Scientific EEE end product, must comply with the current RoHS EU Directive of the European Parliament, RoHS 2 (Directive 2011/65/EU) and RoHS 3 (Directive 2015/863) currently:Cadmium (0.01 %)Lead (0.1 %)Mercury (0.1 %)Hexavalent chromium (0.1 %)Polybrominated biphenyls (PBB) (0.1 %)Polybrominated diphenyl ethers (PBDE) (0.1 %)Bis(2-ethylhexyl) phthalate (DEHP) (0.1 %)Butyl benzyl phthalate (BBP) (0.1 %)Dibutyl phthalate (DBP) (0.1 %)Diisobutyl phthalate (DIBP) (0.1 %)
Evidence of compliance must be maintained by the supplier for two years after shipment.
All castings shall be hardened to T51 or T6 specification, unless otherwise specified on the drawing or Purchase Order.
- Aluminum Machined Parts
All aluminum shall be 6061, unless otherwise specified on the drawing or Purchase Order.
All welding shall be performed in accordance with the AWS D1.1 and D1.2
- PC Boards
PC Board Assemblies are to have unique serial number labels indicating the board part number, manufactured revision, manufacture data and unique serial number, unless otherwise agreed-upon with Canfield.
- Computers, Cameras, and Electronic Equipment
As per industry standards, computers, cameras, and electronic equipment are to have unique serial number labels.
- Calibration Services
Suppliers providing Calibration Services must be certified to ISO 17025.
- Supplier Performance
Canfield will periodically monitor its Supplier Quality, Delivery, and Service, as applicable. Poorly performing suppliers may be notified of concerns associated with their performance.
- Regulations Affecting Supplier
Regulatory authorities for medical devices may require unannounced audits of Canfield subcontractors and suppliers.
Additional regulatory requirements may be recorded on Canfield Purchase Orders or drawings to suppliers based on final equipment destination.
This policy is effective as of 05 October 2022.