The manufacturer shall ensure the adequacy of specified purchase requirements prior to their communication to the supplier. To the extent required for traceability, the manufacturer shall maintain documents and records of relevant purchasing information. 7.4.3 Verification of purchased product: The manufacturer shall establish and implement the inspection or other activities necessary for ensuring ...

7.4.3 Verification of purchased product: The manufacturer shall establish and implement the inspection or other activities necessary for ensuring that purchased product meets specified purchase requirements. Where the manufacturer intends to perform verification at the supplier's premises, the manufacturer shall state the intended verification arrangements and method of product release in the purc ...

If the product is cleaned in accordance with clause (a) or clause (b) above, the requirements content in clauses (a) and (b) of sub-paragraph 6.4 do not apply prior to the cleaning process. 7.5.1.2.2 Installation activities If appropriate, the manufacturer shall establish documented requirements which contain acceptance criteria for installing and verifying the installation of the medical device o ...