Adoption of the Process Approach in Quality Management System

Adoption of the Process Approach in Quality Management System

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ISO 9001:2015 QMS standard promotes adoption of process approach. It is one of the seven quality management principles, on which ISO 9001:2015 QMS standard was developed. Let us understand first, what is a process? An activity that comprises set of interrelated or interacting activities which transform inputs into outputs can be termed as a process. In organization's activities, output from one process can form the input to the next process. The application of a system of processes within an organization can be said the 'process approach'. Process approach requires determination of processes, interaction of determined processes and their management. Management of determined processes and the system as a whole can be achieved using a PDCA methodology with an overall focus on 'risk-based thinking'. Risk based thinking helps at preventing undesirable outputs.

Thus, we can state that the process approach is a way of thinking about and organizing work that emphasizes the importance of understanding and managing business processes. In the context of ISO 9001:2015 QMS, the process approach is an overarching philosophy that underpins the entire quality management system (QMS) standard. It is the intention of ISO 9001:2015 QMS standard that the organization must adopt process approach when developing, implementing and improving the effectiveness of its quality management system. The main objective behind adoption of process approach is to enhance customer satisfaction by meeting customer requirements.  

 

The process approach involves breaking down an organization's activities into individual processes, each of which is designed to achieve a specific objective. These processes are interconnected and depend on each other to achieve overall organizational goals. By understanding and managing these processes, an organization can improve its efficiency, reduce waste, and ensure that customer and legal requirements are consistently met. A desired output (consistent and predictable result) can be achieved more efficiently when all related resources and activities are understood and managed as a coherent system that functions as interrelated processes. To function effectively and efficiently, an organization has to determine and manage numerous linked activities.

 

The process approach also involves a focus on continual improvement. By monitoring and measuring key performance indicators (KPIs) related to each process, organization can identify areas for improvement and take corrective actions to address any issues that arise. Over time, this can help an organization achieve better results and create a culture of continual improvement.

 

Overall, the process approach is a powerful tool for an organization seeking to improve its operations and deliver better products and services to its customers. By adopting the process approach, an organization can create a more efficient, effective, and customer-focused quality management system that can help them achieve its goals and objectives.

 

In short, process approach may be termed as managing organization's processes as a system as a whole. Organization using process approach along with PDCA (Plan-Do-Check-Act) cycle and risk-based thinking brings, takes advantages of opportunities and prevent undesirable results. The process approach involves managing an organization's processes as a system, which means taking a holistic view of how different processes interact and work together to achieve organizational goals. By using the PDCA cycle and risk-based thinking, organizations can identify opportunities for improvement and take corrective actions to prevent undesirable results.

 

The PDCA (Plan-Do-Check-Act) cycle is a management tool that supports the process approach by providing a framework for continual improvement. The cycle involves four stages: planning (P), executing (D), evaluating (C), and taking action (A). By following this cycle, organizations can identify areas for improvement, develop and implement solutions, evaluate the effectiveness of those solutions, and take corrective actions as necessary.

 

Risk-based thinking is another key component of the process approach. By identifying and assessing risks associated with different processes, an organization can take proactive steps to mitigate those risks and prevent potential negative outcomes. This can help organizations avoid costly mistakes and improve overall performance.

 

In short, the process approach, along with the PDCA cycle and risk-based thinking, can help an organization take advantage of opportunities, prevent undesirable results, and continually improve its operations to achieve their goals and objectives.

 

Process approach is helpful in ensuring: understanding and consistently meeting requirements, consideration of processes in terms of added value, the achievement of effective process performance, and improvement of processes based on evaluation of data and information.

Benefits that may be derived from use of 'process approach' principle include:
- Effective use of resources
- Lower cost
- Shorter cycle times
- Improved, consistent and desired outputs

 

Best wishes,

- Keshav Ram Singhal

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