8 Operation 8.1 Operational planning and control Documented information to show The organization shall plan, How are processes needed to implement and control the meet requirements for provision of processes have been carried out as processes, as outlined in 4.4, products and services planned, planned and can demonstrate needed to meet requirements for implemented and controlled? conformity of products and services. the provision of products and How are requirements for products services and to implement the and services determined? actions determined in 6.1, by: How is criteria for processes and a) determining requirements for acceptance for products and the product and services; services determined? b) establishing criteria for the How are resources determined? processes and for the acceptance How is process control of products and services; implemented? Show me the documented c) determining the resources needed to achieve conformity to information that shows 8.1 product and service requirements; confidence in that the processes q1 d) implementing control of the have been carried out as planned processes in accordance with the and can demonstrate conformity of criteria; products and services. e) Retaining documented information to the extent necessary to have confidence that the processes have been carried out as planned and to demonstrate conformity of products and services to requirements. The output of this planning shall How have you determined that the be suitable for the organization's output from the planning process operations. is suitable for your operations? 8.1 q2 The organization shall control How do you control planned planned changes and review the changes? How do you review the consequences of unintended consequences of unintended changes, taking action to mitigate changes? What action is taken to 8.1 any adverse effects, as necessary. mitigate any adverse effects? q3 The organization shall ensure that How do you control outsourced outsourced processes are processes? controlled in accordance with 8.4. 8.1 q4
8 Operation 8.1 Operational planning and control 8.1 q1 The organization shall plan, implement and control the processes, as outlined in 4.4, needed to meet requirements for the provision of products and services and to implement the actions determined in 6.1, by: a) determining requirements for the product and services; b) establishing criteria for the processes and for the acceptance of products and services; c) determining the resources needed to achieve conformity to product and service requirements; d) implementing control of the processes in accordance with the criteria; e) Retaining documented information to the extent necessary to have confidence that the processes have been carried out as planned and to demonstrate conformity of products and services to requirements. How are processes needed to meet requirements for provision of products and services planned, implemented and controlled? How are requirements for products and services determined? How is criteria for processes and acceptance for products and services determined? How are resources determined? How is process control implemented? Show me the documented information that shows confidence in that the processes have been carried out as planned and can demonstrate conformity of products and services. Documented information to show processes have been carried out as planned and can demonstrate conformity of products and services. 8.1 q2 The output of this planning shall be suitable for the organization's operations. How have you determined that the output from the planning process is suitable for your operations? 8.1 q3 The organization shall control planned changes and review the consequences of unintended changes, taking action to mitigate any adverse effects, as necessary. How do you control planned changes? How do you review the consequences of unintended changes? What action is taken to mitigate any adverse effects? 8.1 q4 The organization shall ensure that outsourced processes are controlled in accordance with 8.4. How do you control outsourced processes?
Portrait-Audit-Checklist.docx