Operating a business to the best of your capacity requires a clear and well-defined overview of each of the organisational aspects involved. When it comes to quality management, it often becomes difficult to understand the subtle difference between a process and procedure as per the ISO 9001 standard, which are its two vital elements. Despite appearing to be intimately linked, these two terms have their own individual meanings and understanding the very same has become elemental for businesses to implement an efficient quality management system.
While going through the definition of ‘process’ and ‘procedure’, you can find a number of results online. As defined by the International Organisation for Standardisation (ISO), a process is mainly “a set of correlated or interactive activities that transform inputs into outputs”. On the contrary, a procedure is defined as “the specified way of carrying out an activity or process”. To put it simply, a process defines the things that need to be done and the purposes behind, whereas a procedure details on how that process will be done. To help you dig into the differences further, we’re here to offer you a better understanding of the two to so that the differences in between the two becomes clear.
A process is defined as an activity or set of activities in which resources are being used to transform the inputs into outputs. The ISO 9001 standard is mainly based on a process approach which aims at establishing efficient and effective processes that are improved and followed continually. The processes should always have well-defined and measurable inputs, outputs, objectives, and resources. Some of the crucial elements which must be included while defining a specific process are:
• Specific requirements including the information required to work and from where you need to extract the same
• Activities that are interacting and interrelated, which deploy resources to achieve a defined output
• All the activities, operations, and sub-processes that are carried out to produce desired results
• Satisfying or fulfilling the requirements such as how to find out whether the job is being done correctly or who is receiving the outcome of work done
Procedure is typically a uniform method which outlines how you should perform a process such as how you deal with your suppliers. It is comprised of certain elements like:
• Purpose behind the procedure
• The output that needs to be fulfilled and how it will be done
• Assigning responsibilities of performing the tasks
• Source of the inputs and destination of the outputs
• Locational requirements if any
• Definitions, terminology, explanations, and more
• Information, tools, and other resources required
Here are some important guidelines which you can always keep in mind to consider the points of differences between these two terms while documenting your quality management system.
• You should always start with the processes of ISO 9001 which you need to document. The total number of processes will mostly determine on the number of procedures. Though the total number of procedures required to control desired outcomes is mostly determined by the present situation, it is always recommended not to document more procedures than the required figure.
• In most of the cases, businesses create one ISO 9001 procedure individually for each of the processes. Often companies document too many procedures when they should be ideally document those directives as particular work instructions.
The process approach is undoubtedly one of the core quality management principles of ISO 9001. Understanding the meaning of a process and how it interacts with the organisational structure is crucial to improve and implement your QMS efficiently. By having a clear overview of all the processes, you will be able to identify the specific ones which have a certain way of delivering outputs and will help you figure out when you specifically need one procedure that goes along with the process. Then after, you will be able to understand whether you should document the procedure to ensure consistent results.
Considering the entire scenario, we hope by now you can understand why it’s important to have a good idea of the difference between a process and procedure of the ISO 9001 standard. But diving deep into such nuances of the quality management system can be quite a daunting process for you with limited resources. This is the reason why you must try to consult ISO consultants who have rich professional experience and are competent in handling similar projects on a continual basis.
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