A process is a set of interrelated or interacting activities that use inputs to deliver an intended result.ISO 9001 promotes and encourages use of the Process Approach when developing, maintaining or improving the quality of a management system in order to achieve customer satisfaction by meeting the customer requirements.

The diagram of a single process as given by ISO 9001:2015 standard is reproduced below:

ISO 9001 certification

As the reader can see sources of Inputs are from predecessor processes which can be internal or external to the organization, at providers, at customers or at other interested parties. The Inputs or outputs can be tangible (e.g. materials, components or equipment) or intangible (e.g. data, information or knowledge). The activities are performed on the inputs and they are transformed into outputs. Controls and check points are applied at each stage in the process to monitor and measure performance. The level of controls depends on the risk at each process, the greater the risk the greater the organizational control and need for information. The receivers of outputs can be subsequent processes at internal or external customers and at other relevant interested parties.

The organization is managed as a system of interrelated and interacting processes.The benefits of using the Process Approach are as follows:

  • Understanding and consistency in meeting requirements
  • Processes being considered as added value
  • Effective Process performance achievement
  • Using data and information to continuously improve processes

The organization can enhance the effectiveness and efficiency of achieving its intended results by understanding and managing interrelated processes as a system. The process approach makes the organization able to manage the interrelationships, interdependencies and interconnectedness between the various processes so that the overall performance of the organization can be improved.

To obtain the results matching the Quality Policy and strategic direction of the organization, systematic definition and management of processes and their interactions has to be done under the process approach.This is achieved by using the Process Approach along with the PDCA cycle (Plan, Do, Check and Act) and the Risk based thinking so that the organization takes benefits from the opportunities and avoids the undesirable results.

The PDCA cycle can be used to manage individual processes as well as the whole Quality Management System and becomes an essential requirement for ISO 9001 certification. It can be summarized as below:

Plan: First establish the objectives and the processes of the system in accordance with the customer requirements and organizational policy and provide the resources for achieving the objectives and identify and address risks and opportunities.

Do:  Implement the activities as planned

Check: Monitor and where applicable measure processes and products in accordance with policies and requirements.

Act: Take steps to improve performance from the results of the Check step.

Risk based thinking

Risk is the effect of uncertainty on an organization or a single process or an event. ISO 9001 promotes the assessment of risks faced by the organization and the opportunities available in the planning stage and requires controls to be placed in areas of risk and information to be collected to ensure that the processes are performing as planned. Risks can be positive or negative. The organization has to take advantage of positive risk and save and protect itself from negative risk. The organization has to decide the level of risk it is prepared to take or it can take steps to remove the risk or mitigate the risk.

The following sequence of activities provide a way of how an organization can choose to build and control the processes of its quality management system. Performance is managed and improved by applying the PDCA cycle.

 

Steps in the process approach What to do
PLAN
Define the context of the organization 

Define the scope, objectives and policies of the organization

The organization must identify its responsibilities, the interested parties and their requirements as well as needs and expectations to define the intended purpose of the organizationEstablish the scope, objectives and policies based on the analysis of the needs, expectations and analysis of the requirements.
Determine the processes in the organization You should find out the processes needed to meet the objectives and policies and to produce the intended output. These processes should include management, resources, operations, measurement analysis and improvement.
Determine the sequence of the processes Determine how the processes are able to flow in sequence and their interaction.
Determine people who take process ownership and accountability Assign authority and responsibility for each process
Define the need for documented information Determine the processes which are to be formally defined and how they are to be documented.
Define the interfaces, risks and activities within the process Determine activities that are needed to achieve the intended outputs and risks of unintended outputs.
Define the monitoring and measuring requirements The ISO 9001 implementer should determine where and how the monitoring and measuring should be applied. It should be for control as well as improvement of the processes and the outputs. The need for recording results should also be documented.
DO
Implement Implement the actions required for achieving planned activities and results.
Define the resources required Determine the resources that are required for the operation of each process. They may include Human Resources, Infrastructure, Environment, Information, Natural Resources including Knowledge, Materials and Financial Resources
CHECK
Verify the process against the planned objectives You should confirm that the process is effective and the process characteristics are consistent with the purpose and objective of the organization.
ACT
Improvement At this stage you can change and improve the processes in order to ensure that they continue to deliver the intended results and outputs. You can use corrective action to find out the root cause of problems and take steps to improve the processes.

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