ISO 9001:2015 Insight: Process Approach

by Breda Kearney | February 19, 2019 | Blog , ISO 9001:2015 , Process Approach , Quality , |

ISO 9001:2015 Insight: Process Approach

A Quality Management System (QMS) is made up of the organizations core/value chain, support and management processes. The core/value chain processes deliver the organizations products and services to its customers and typically include sales & marketing, production, post-delivery activities such as installation or the organizations specific service. Support provides provide the organizations resources and typically include purchasing, human resources and finance. Management processes oversee the organization and typically include executive management, regulatory affairs or quality management.

Quality Management Principle 4 – Process Approach Video:

Each process is made up of series of interacting activities, that use resources to transform inputs into outputs.

Inner Process Approach Image

Although the process approach is not a new concept for ISO 9001:2015, it is often poorly understood and organizations can find it difficult to differentiate between a process, department or procedure. To clarify, a process may consist of several departments, each one representing one of the activity steps in the process. For example, the Sales process may include the marketing, sales order processing and customer services departments. On the other hand, a procedure is used by the organization to describe how the process activities are performed.

Once the organization has determined the QMS processes and the relevant activity steps, the next step is to determine the process inputs and outputs. The inputs refer to what is needed to perform the process activities (e.g raw materials, sales orders, product specifications), while the outputs refer to what is created by the process (e..g finished product or undesirable outputs such as scrap or waste). It’s important to note that the processes do not work in isolation, as the output from one process may form the input to another process. Therefore, the organization also needs to identify the sequence of its processes and how they interact with one another – the effectiveness of the entire QMS is determined by the ability of each process to achieve its intended result in an efficient manner and the effectiveness of the process interactions.

Once the process inputs, outputs, sequence and interactions have been determined the organization is required to:

  • Define suitable metrics to enable the organization to monitor and measure process performance – For example, Right First Time Quality, On-Time Delivery, Sales Quote Conversion
  • Determine the resource requirements (e.g people, infrastructure, work environment)
  • Assign responsibility and authority for the process
  • Address risks and opportunities to process performance
  • Evaluate each process and implement actions to address poor/low performance
  • Take appropriate actions to improve overall process performance

If you would like to learn more about ISO 9001:2015, including the Process Approach, Comply Guru offer Online ISO 9001:2015 Requirements Training that can be completed anytime, anywhere.

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