Contents
Article 3Contracting external reprocessors#
1.If reprocessing is carried out by an external reprocessor, the health institution and the external reprocessor shall conclude a written contract.
2.The contract shall include the following elements:
(a)the attribution of tasks, obligations, and responsibilities of the two parties;
(b)the arrangements for transition from one external reprocessor to another and responsibilities of the external reprocessor that is a party to the contract;
(c)the requirements related to the qualification and expertise of the personnel participating in the reprocessing activities;
(d)the requirements for the reprocessing, collection of information related to the reprocessed devices and information exchange between the health institution and the external reprocessor;
(e)the requirement to ensure compatibility of the quality management systems (QMS) of the parties, as referred to in Article 21;
(f)the procedure for monitoring of the quality of the reprocessing performed by the external reprocessor via on-site audit(s).
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