Document Controls and Changes Clause Samples
Document Controls and Changes. The Supplier shall establish a process for document control and control of changes related to product(s). Supplier shall not modify product or processes or location of manufacturer without Buyer’s written approval. Where Buyer provides such written approval Supplier shall maintain records of changes to documents related to the product(s) (e.g., DHR), which shall include a description of the change, identification of the affected documents, the signature of the approving individual(s), the approval date, and the effective date.
Document Controls and Changes. M▇▇▇▇ shall notify Medtronic through a Medtronic supplier change request system (i.e., the Medtronic Portal) of any material change to Quality Management, business location, acquisition, bankruptcy, Device Component supplier, Product, Product Design/Specification, Manufacturing Process, or Special Processes with respect to the Products. Changes to product Design, Specification, packaging and/or labeling are required at least sixty (60) days prior to M▇▇▇▇’▇ proposed implementation change. If circumstances allow, Medtronic shall have the option to make a last-time buy of the then-current product revision for the Product and/or product components before such change is implemented.
Document Controls and Changes. ▇▇▇▇▇ shall notify Medtronic in writing of any material change to Quality Management, business location, acquisition, bankruptcy, Device Component supplier, Product, Product Design/Specification, Manufacturing Process, or Special Processes with respect to the Products using Process Change Notification (PCN) form provided by Medtronic. PCN for changes to product Design or Specification are required at least sixty (60) days prior to Company’s proposed implementation change. Company shall submit PCN for any change in the packaging and/or labeling of the Products at least sixty (60) days prior to making any such change. If circumstances allow, Medtronic shall have the option to make a last-time buy of the then-current product revision for the Product and/or product components before such change is implemented.