© ISO 2000 – All rights reserved
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7.1.3 Managing processes 7.1.3.1 General
Management should identify processes needed to realize products to satisfy the requirements of customers and other interested parties. To ensure product realization, consideration should be given to associated support
processes as well as desired outputs, process steps, activities, flows, control measures, training needs, equipment, methods, information, materials and other resources.
An operating plan should be defined to manage the processes, including — input and output requirements for example specifications and resources,
— activities within the processes, — verification and validation of processes and products,
— analysis of the process including dependability, — identification, assessment and mitigation of risk,
— corrective and preventive actions, — opportunities and actions for process improvement, and
— control of changes to processes and products. Examples of support processes include
— managing information, — training of people,
— finance-related activities, — infrastructure and service maintenance,
— application of industrial safetyprotective equipment, and — marketing.
7.1.3.2 Process inputs, outputs and review
The process approach ensures that process inputs are defined and recorded in order to provide a basis for formulation of requirements to be used for verification and validation of outputs. Inputs can be internal or external to
the organization.
Resolution of ambiguous or conflicting input requirements can involve consultation with the affected internal and external parties. Input derived from activities not yet fully evaluated should be subject to evaluation through
subsequent review, verification and validation. The organization should identify significant or critical features of products and processes in order to develop an effective and efficient plan for controlling and monitoring the activities
within its processes.
Examples of input issues to consider include — competence of people,
— documentation, — equipment capability and monitoring, and
— health, safety and work environment. Process outputs that have been verified against process input requirements, including acceptance criteria, should
consider the needs and expectations of customers and other interested parties. For verification purposes, the outputs should be recorded and evaluated against input requirements and acceptance criteria. This evaluation
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© ISO 2000 – All rights reserved
should identify necessary corrective actions, preventive actions or potential improvements in the effectiveness and efficiency of the process. Verification of the product can be carried out in the process in order to identify variation.
The management of the organization should undertake periodic review of process performance to ensure the process is consistent with the operating plan. Examples of topics for this review include
— reliability and repeatability of the process, — identification and prevention of potential nonconformities,
— adequacy of design and development inputs and outputs, — consistency of inputs and outputs with planned objectives,
— potential for improvements, and — unresolved issues.
7.1.3.3 Product and process validation and changes
