Mark Hammar In a Quality Management System (QMS) there is a distinct difference between what is meant by a process and what is meant by a procedure, and confusing these two concepts can become a problem during your implementation of ISO 9001. In a previous article, Watch Your Language! Don’t confuse processes with procedures, there was a discussion on the differences between a process and a procedure, but it is often helpful to understand this discussion better with some examples.
What is a QMS process?
ISO 9000:2005 is the document that records the definitions for the QMS specific terms used within the ISO 9001 requirements, and according to this definition, a process is a “set of interrelated or interacting activities which transforms inputs into outputs.” In a QMS, as in any business, there are many processes; in fact, almost anything you do in an organization can be classified as a process. You will have a process for doing your accounting, for purchasing supplies, for hiring a contractor, or for confirming a purchase order from a customer.
The key for a process is that it takes an input, performs some activities using that input, and then creates an output. For the accounting example above, your accounting process will take reports of expenses, income, and purchases, then create or change any necessary account records, and finally create financial reports for management and shareholder review. Likewise, a process for hiring a contractor will start with a request to hire the contractor, investigation into the right contractor to hire including quotes, and presenting the selected contractor with a purchase order to perform the job.
So, anything that you do in your organization that takes an input, does an activity with that input, and then creates an output is a process; but how is this different from a procedure? Not all processes need to have a procedure – the main decider is if you need to follow a certain series of steps or not.
What is a QMS procedure?
Again, per ISO 9000:2005, a procedure is a “specified way to carry out an activity or a process.” So, when you have a process that needs to occur in one specific way, and you have specified how it is to happen, you have a procedure. An example of a procedure that would accompany a contract review process might be that you have determined one way that customers will give you a purchase order, there is a defined set of steps to review, approve, and accept that order, and then the order is recorded and distributed in a certain way to your employees.
It is important to note that not every process needs to have a procedure. For instance, if you have a process that you only buy product from an approved supplier, but you do not have a defined way to add a supplier to that list, then you have a process but not a procedure to go with it. Likewise, in software development there is not one right way to code, and the software developers will write their code differently not following a procedure; or, when a trained and certified machinist is given a drawing and decides how to make a machined part, there may be no one right way to do it, so that person will rely on their skills and knowledge to decide how to make the part.
Does every procedure need to be documented?
Having a process that does not have a procedure is particularly noticeable in processes where you rely heavily on the knowledge and skills of the person doing the job. When a doctor is performing brain surgery, they do not have a documented procedure to do this because it relies heavily on their experience in dealing with what they find as they go. There may be some procedures that are followed as they go, but there is no documented procedure for this.
The discussion of whether you need to document a procedure is yet another step, but also an important one. In ISO 9001:2008 there are six identified documented procedures that are needed for a QMS, but with the new version of ISO 9001:2015 there is no mandated documented procedure. It is the responsibility of the company to determine if they need to document a procedure in order to ensure consistent results from the process and the associated procedure.
Understanding processes and procedures is an important part of a QMS
The process approach is one of the eight quality management principles that are the foundation of ISO 9001, and understanding what a process is and how they interact is an important part of being able to implement and improve your QMS. By knowing your processes, you can better understand which ones need to have a specified way of creating the output, which will let you know when you need to have a procedure to go along with your process. You can then further determine if you need to document that procedure or not to ensure consistent results.
Understand your processes and their interactions, and you will be able to more effectively implement your QMS for better customer satisfaction and improvement. This is why you are implementing a QMS in the first place, isn’t it?
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