Documented processes cover products and manufacturing processes that relate to product safety and, where applicable, address thirteen elements, including: identifying the statutory and regulatory requirements for product safety and informing the customer of them; special approvals for design FMEAs, control plans and process FMEAs; identifying safety-related characteristics and controlling them where manufacture takes place; reaction plans; set responsibilities with an escalation process and a flow of information that reaches top management and the customer; training for the staff involved; approving any change to product or process before it is made, with an assessment of how it affects safety; passing product-safety requirements through the supply chain, customer-designated sources included; traceability through the supply chain, at least by manufactured lot; and lessons learned for introducing new products. A special approval is an extra approval by the function, usually the customer, responsible for documents whose content bears on safety. As revised: SI 2 (October 2017): the note on special approval is clarified as an approval that the customer, or the organization's own processes, may call for.
This control maps to 1 controls across 1 other frameworks. If you already hold one of them, the evidence you collected for it is the starting point here rather than new work.
Every mapping shown was judged rather than inferred from wording similarity, and the ones that failed review are published too. See the coverage reports and what was rejected.
The graph holds this control, the 1 it maps to, and the evidence behind each claim, over MCP and REST.