Keep documented information to the extent necessary to have confidence that the processes have been carried out as planned (possibly within its QMS, or integrated MS).Implement control of the processes, in accordance with the criteria (possibly through training and awareness).Establish criteria for the processes (possibly in work instructions). ![]() ![]() This also relates to implementing the actions determined in 6.1 (actions to address risks and opportunities) and 6.2 (objectives and plans to achieve them). The organization shall plan, implement and control the processes needed to meet its discipline-specific requirements. The overall process management includes having process criteria, controlling the processes within the criteria, controlling planned change and addressing unintended change as necessary. Whatever the organization is in business to achieve, clause 8 is it. Clause 8 addresses both in-house and outsourced processes, while the overall process management includes adequate criteria to control these processes, as well as ways to manage planned and unintended change. The bulk of the management system requirements lies within this single clause.
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