Manufacturing material. Where a manufacturing material could reason- ably be expected to have an adverse ef- fect on product quality, the manufac- turer shall establish and maintain pro- cedures for the use and removal of such manufacturing material to ensure that it is removed or limited to an amount that does not adversely affect the de- vice’s quality. The removal or reduc- tion of such manufacturing material shall be documented.
Appears in 6 contracts
Samples: Quality Management System Agreement, Quality Assurance Agreement, Quality Management System Agreement
