What is the intent of a Quality Management System? How would having a formalized QMS benefit your organization?
After almost three decades of working in the QMS industry, I’ve heard hundreds, if not thousands of interpretations of QMS requirements and yet little is discussed regarding a QMS intent.
I also hear organizations try to explain what “it” is…and not describe what “it” is supposed to do. Years ago, well-meaning individuals sought to push the concept of positioning a QMS as a BMS or Business Managing System stating a QMS/BMS is how you run your business.
However, it is not how you run your business, a QMS includes requirements for organizations who want to fulfill requirements and improve operational effectiveness. QMS standards even state as a requirement that leaders ensure, “…the integration of the quality management system requirements into the organization’s business processes” (ISO 9001:2016, cause 5.1.1.c). With this in mind, many still want to argue their position and interpretation. That’s OK, however when a QMS is framed in this way in the marketplace, it becomes the catalyst for blame when an organization fails to be profitable, or fails to make good business decisions, or the organization hires the wrong people, or its desired discipline is overcome by culture, etc., etc., etc.
The fundamental concept of a QMS is that it exists to help an organization reach its objectives with regards to quality (ISO 9000:2015), then to determine resources and processes to achieve those objectives. A QMS empowers leaders to optimize and align resources to assist them in the objectives they set for their QMS. Let me side bar for just a moment…these objectives are theirs, not objectives set by anyone else. Customers will flow down requirements; however, it is up to the leaders of the organization to determine what their objectives are regarding quality (perhaps with help from their quality manager?). Leaders, by virtue of their position, are responsible for the resources of the organization and how those resources will be utilized. Does it make sense to align quality objectives with those of the needs and expectations of customers? Yes, however, these objectives are still determined by the organization who fall under the direction of leaders.
Having a formal QMS, aligned to an organization strategy, is one that is defined, implemented, understood, and utilized, which makes the QMS a potential profit engine. Let’s be frank, your QMS is not a set of documents or flow diagrams that sit on a self or reside on a server. Your QMS happens in the real world and is used to provide products of services to your customers so you can be profitable, provide people opportunities and to bring value to customers.
A management system is defined formally as a “set of interrelated or interacting elements of an organization to establish policies and objectives, and processes to achieve those objectives”. A quality management system is then, “part of a management system with regard to quality”. (ISO 9000:2015 sections 3.5.3 and 3.5.4 respectively)
Every organization has many objectives and systems. For example, an environmental management system should be assisting leaders in achieving their environmental objectives. A financial management system should be helping an organization achieve its financial objectives and so forth.
Get the picture?
In any organization, if the organization is not meeting customers’ requirements, needs, and expectations regarding the quality of products or services and if those products and services are not provided on time then there creates a risk with sustainability of the organization. Customers are expecting more from their suppliers and competitors are hungry for you to miss a beat.
A formal QMS is defined using macro systems maps, made up of processes, and other documented information or other controls or management methods. This accumulation of information describes work which transpires in the real world and helps to assure consistency and stability of processes, and measured results. The net result is proven processes which are capable and stable.
A formal QMS is auditable so an independent body or person can check to see how the actual results are measuring up to the controls deployed. A formal QMS has proven conventional methods to solve problems, to learn from those problems which in turn reduces costs and improves performance. A formal QMS has regularly planned leadership reviews of data so leaders can see and understand how their system is functioning so they can direct or redirect resources to improve.
Let’s end where we began.
What is the intent of a Quality Management System? To help leaders achieve their objectives regarding quality.
How would having a formalized QMS benefit your organization? A formal QMS provides data for leaders to see where improvement is needed. Leaders gain an increased ability to see where they can reduce costs or increase profitability.
In its earliest form a QMS was utilized to place needed requirements on suppliers, so customers had confidence in supplier capabilities. As we are all part of the supply chain at some level, it’s become a proactive tool to become more competitive and sustainable.