Steps in the process approach What to do? Guidance PLAN Define the context of the organization The organization should identify its responsibilities, the relevant interested parties and their relevant requirements, needs and expectations to define the organization’s intended purpose. Gather, analyze and determine external and internal responsibilities of the organization to satisfy the relevant requirements, needs and expectations of the relevant interested parties. Monitor or communicate frequently with these interested parties to ensure continual understanding of their requirements, needs and expectations. Define the scope, objectives and policies of the organization on the analysis of the requirements, needs and expectations establish the scope, objectives and policies that are relevant for the organization’s quality management system. The organization shall determine the scope, boundaries and applicability of its management system taking into consideration the internal and external context and interested party requirements. Decide which markets the organization should address. Top management should then establish objectives and policies for the desired outcomes. Determine the processes in the organization Determine the processes needed to meet the objectives and policies and to produce the intended outputs. Management shall determine the processes needed for achieving the intended outputs. These processes include management, resources, operations, measurement, analysis and improvement.
Determine the sequence of the processes Determine how the processes flow in sequence and interaction. Define and describe the network of processes and their interaction. Consider the following: The inputs and outputs of each process (which may be internal or external). Process interaction and interfaces on which processes depend or enable. Optimum effectiveness and efficiency of the sequence. Risks to the effectiveness of process interaction. Note: As an example, realization processes (such as those needed to provide the products or services delivered to a customer) will interact with other processes (such as the management, measurement, procurement in the provision of resources). Process sequences and their interactions may be developed using tools such as modeling, diagrams, matrices and flowcharts. Define people or remits who take process ownership and accountability Assign responsibility and authority for each process. Top Management should organize and define ownership, accountability, individual responsibilities, working groups, remits, authority and ensure the competence needed for the effective definition, implementation, maintenance and improvement of each process and its interactions. Such individuals or remits are usually referred to as the Process Owners. To manage process interactions it may be useful to also establish a management system team that has a system overview across all the processes and may include representatives from the interacting processes and functions.
DO Implement Implement actions necessary to achieve planned activities and results. The organization should perform activities, monitoring, measures and controls of defined processes and procedures (which may be automated), outsourcing and other methods necessary to achieve planned results. Define the resources needed Determine the resources needed for the effective operation of each process. Examples of resources include: Human resources. Infrastructure. Environment. Information. Natural resources (including knowledge). Materials. Financial resources. CHECK Verify the process against its planned objectives Confirm that the process is effective and that the characteristics of the processes are consistent with the purpose of the organization. The organization should compare outputs against objectives to verify that all the requirements are satisfied. Processes are needed to gather data. Examples include measurement, monitoring, reviews, audits and performance analysis.