ISO 9001 was created in response to customers who wanted an assurance of quality. The concept was to limit the risk of delivering defective products to customers, with a focus on prevention, detection and correction. ISO 9001 replaced many customer-specific requirements, which suppliers needed to meet in order to make it easier for them to bid for work.
But ISO 9001 should be a quest for improving quality in all operations and not simply getting and keeping a certificate. It should be viewed as a guide for a management system to satisfy its customers and stakeholders with continual success.
ISO 9001 requires organizations to establish a quality management system to meet customer requirements. There are many factors needed to achieve product quality, such as: quality of management, quality of design and quality of conformity. There are eight quality management principles as another set of factors, such as people, machines, methods, materials, measurement and money.
What this means is that a whole lot of things have to be right for the organization to produce quality products. It is not sufficient to simply focus on the production or delivery processes as these depend on the processes for their inputs. All organizations depend on a system of managed processes to produce the desired outcomes if they have to satisfy their customers and stakeholders.
ISO 9001 also requires top management to review the management system and to ensure its continuing suitability, adequacy and effectiveness. What many fail to realize is that there is no right or wrong way to do this. The tendency is to create a system to fit the standard, forgetting what you already do and the “language” of your organization. The problem with this is that the focus is on conforming to the procedures of the standard, and not on improving processes. As a result, management can become preoccupied with documentation, instead of corrective actions. Your goal should be to establish an effective system, without abandoning what you already have in place.
The question is: Is our management system the way we run our business or is it simply a set of documents we used to show compliance with ISO 9001? There has to be some driving force behind your compliance. It can’t just be a pile of papers. Are you thinking, “I want to get this certification,” or are you thinking, “How can we improve our performance?”
Standards such as ISO 9001 have been created to address a need for customers but they serve an equal benefit for organizations — Continuous Improvement.