Change request procedure

In ISO 13485:2016, in requirement 4.1.4, there is no request to have a documented procedure for change control. In this requirement is stated that changes need to be made, evaluated for their impact on the quality management system and medical device, and controlled. In our documentation toolkit, in procedure 21_Procedure_for_Management_Review_Premium_EN, in section 3.2.1 Review inputs is stated that one of the inputs is Changes that affect the quality system. The section about changes is also stated in form 21.2_Appendix_2_Management_Review_Minutes_Premium_EN.

In our procedure 14_Warehousing_Procedure_Premium_EN is stated that the purpose of this procedure is to describe the process of warehousing and planning warehousing resources. The warehousing process includes, but is not limited to: storage of raw materials, products, clients’ property, nonconforming products, and hazardous waste. This procedure excludes: Storage, transport, and handling of medical products; and Temporary storage in case of incidents and emergency situations. In section 4.1 is stated that both FEFO and FIFO can be used. It is up to you to decide which approach is most suitable for you.

There is no direct requirement in the ISO 13485:2016 in section 7.5.11 to have documented Goods in and Goods out procedure.