Implementing the Process Approach

The new ISO 9001:2008 standard requires the adoption of a process approach when developing, implementing and improving a quality management system (QMS).

ISO 9000 Clause 2.4, The Process Approach states:

"Any activity or set of activities that uses resources to transform inputs to outputs can be considered as a process."

For organizations to function effectively, they have to identify and manage numerous interrelated and interacting processes. Often, the output from one process will directly form the input into the next process. The systematic identification and management of the processes employed within an organization and particularly the interactions between such processes is referred to as the "process approach".

The new ISO 9001 is structured in a process approach, replacing the "20 element" structure of year 1994 edition. Two of the eight quality management principles on which the new standards are based relate to the "Process approach" and the "System approach to management" as follows:

Process Approach: a desired result is achieved more efficiently when activities and related resources are managed as a process.

System approach to management: identifying, understanding and managing of interrelated processes as a system of for a given objective contributes to the effectiveness and efficiency of the organization.

The process approach aims at achieving a dynamic cycle of continual improvements and allows significant gains to the organization, typically in terms of product and business performance, effectiveness, efficiency and costs. The process approach also facilitates customer focus and increased customer satisfaction through the identification of the key processes within an organization, their subsequent development and continual improvement. Self-assessment methodologies such as the one proposed in annex A of ISO 9004:2000 may be used to evaluate process maturity levels.

The process approach encourages the organization to develop a clear understanding of all its processes, not only those that are needed for its quality management system. A process consists of one or more activities that transform inputs into outputs. Inputs and outputs are generally products that may be tangible and/or intangible. Examples of inputs and outputs may include equipment, materials, components, energy, information and financial resources, among others. To perform activities within the process appropriate resources have to be allocated. A measurement system can be used to gather information and data to analyse process performance and/or input and output characteristics.

Within the context of ISO 9001, the process approach requires an organization to identify, implement, manage and continually improve the effectiveness of the processes that are necessary for the quality management system, and to manage the interactions of these processes in order to achieve the organization's objectives. This includes top management, product realization and relevant support processes, as well as monitoring and measurement processes.

Process effectiveness and efficiency can be assessed through internal or external review processes and evaluated on a maturity scale. These scales typically range in degrees of maturity from "no formal system" to "best-in-class performance". An advantage to this approach is that results can be documented and monitored over time to reach improvement goals. Numerous maturity tables have been developed for different applications. One such model is contained in ISO 9004:2000 annex A, Guideline for Self-Assessment.

The P-D-C-A cycle and the process approach

PDCA ("Plan-Do-Check-Act") is a dynamic cycle that can be deployed within the organization's processes. It is intimately associated with the planning, implementation, control and continual improvement of both product realization and other quality management system processes.

Maintaining and continually improving the process capability can be achieved by applying the PDCA concept at all levels within the organization. This applies equally to high-level strategic processes, such as quality management system planning, or management review, and to simple operational activities carried out as a part of product realization processes.
The Note in Clause 0.2 of ISO 9001:2000 explains that the PDCA cycle applies to processes as follows:

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  "Plan"
  establish the objectives and processes necessary to deliver results in accordance with customer requirements and the organization's policies;


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  "Do"
  implement the processes;


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  "Check"
  monitor and measure processes and product against policies, objectives and requirements for the product and report the results;


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  "Act"
  take actions to continually improve process performance;

The management of interacting processes

The interdependency of an organization's activities can sometimes be complex, resulting in a network of various processes and sub-processes. Inputs and outputs of these processes relate to both external and internal customers. The "System Approach" to management allows for the coordination and compatibility of an organization's planned processes and a clear definition of their interfaces.

ISO 9001 specifies a number of requirements for the control of an organization's processes. These requirements are applicable to any type and size of organization and are typically met by defining and linking those processes that are needed for quality management and integrating them into a system.

Implementation of the process approach in relation to ISO 9001 requirements

Clause 0.2 in the introduction of ISO 9001 states:

When used within a quality management system process approach emphasizes the importance of:

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  the understanding and fulfilment of requirements,
  


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  the need to consider processes in terms of added value,
  


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  obtaining results of process performance and effectiveness, and
  


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  continual improvement of processes based on objective measurement.

Within the context of ISO 9001:2000, the process approach includes the processes needed for product realization, and the other processes needed for the effective implementation of the Quality Management System (QMS).

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  Requirements for these processes are stated in the following clauses of the international standard:
  Clause 4: Quality management system
  Clause 5: Management responsibility
  Clause 6: Resource management
  Clause 7: Product realization
  Clause 8: Measurement, analysis and improvement

The general requirements for a QMS are defined in clause 4.1 of ISO 9001:2000. Some guidance is given below on what an organization may choose to ask itself in order to address these requirements, though it is stressed that these are only examples, and should not be interpreted as the only way to meet the requirements:

a) Identify the processes needed for the quality management system, and their application throughout the organization.

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  What are the processes needed for our QMS?
  


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  Are any of these processes out-sourced?
  


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  What are the inputs and outputs for each process?
  


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  Who are the customers of the processes?
  


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  What are the requirements of these customers?
  


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  Who is the "owner" of the process?

b) Determine the sequence and interaction of these processes.

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  What is the overall flow of our processes?
  


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  How can we describe this? (Process maps or flow charts?)
  


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  What are the interfaces between the processes?
  


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  What documentation do we need?

c) Determine criteria and methods required to ensure that both the operation and control of these processes are effective.

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  What are the characteristics of intended and unintended results of the process?
  


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  What are the criteria for monitoring, measurement and analysis?