What is a quality management system? Many people will have different definitions but, borrowing from ISO 9000:2005, Fundamentals and Vocabulary, a quality management system is a system to establish policies and objectives to direct and control an organization with regard to quality. Typically, a quality management system refers to an organization which is compliant with ISO 9001, or an ISO 9001-based standard such as TS16949, ISO 13485 and AS 9100, because ISO 9001 defines requirements for quality management systems. Whichever standard is selected, the requirements for creating the quality management system are the same.
Get Top Management On BoardThe first requirement is to ensure that top management sees the need for a quality management system and is committed to support its creation, implementation and maintenance. This may be a huge first step if management is satisfied with the status quo. They may not see any benefit to having standardized procedures which, even they must comply with. They may not understand the benefits of corrective action, management reviews, measuring quality or any other processes requiring them to change behaviors. Management also should understand that without the goal of certification to an ISO 9001-based standard, the likelihood that a quality management system will be created, implemented and maintained is nil.
While there is a cost associated with creating a quality management system and obtaining certification, if there were no substantial benefits, the ISO 9001 standard would not be nearly as successful as it has been, with phenomenal word-wide growth of more than 20-plus years. While an initial benefit may be to satisfy a customer’s requirement for ISO certification, organizations which focus exclusively on the commercial benefit of ISO certification realize few, if any additional benefits. The cost of creating a quality management system then outweighs the identified benefit.
Set Clear GoalsThe second requirement is for top management to establish the goals of the quality management system. These goals should be both general and specific. A general goal may be to obtain certification by a certain date. More specific goals may include the establishment of process measures and objectives; obtain more control over certain processes, improved efficiencies, etc. Establishing goals will help the organization focus on what is truly important. Goals for implementing the quality management system should include a commitment to a schedule. Without a schedule, the goal of certification will not happen.
The most successful implementations happen when the implementation schedule becomes part of every manager’s objectives. Otherwise, the schedule and the responsibilities for completing the necessary tasks will fall upon one person, typically the quality manager, who has little influence upon the priorities of others within the organization. A project plan approach is most effective.
Define the ScopeThe third requirement is for the organization to define the scope of the quality management system. This may be a simple exercise for organizations with one site and product line. However, it becomes a more complex task for organizations with multiple locations and product lines. Complex or multi-site organizations sometimes attempt to carve up their processes and designate those which will be subject to the requirements of the quality management system versus those which will do not need to comply. These decisions are often made based on internal politics rather than common sense. For example, the sales department may promote obtaining ISO 9001 certification but rarely sees the need to be part of the quality management system. Some departments may attempt to exclude themselves from the scope of the quality management system with the belief that they possess special circumstances which allow the exclusion. Top management will need to confirm that everyone is an active participant as most everything an organization does is related to the quality of its products and services.
A common misunderstanding about creating a quality management system involves the question of what is “auditable.” This issue usually comes up during the documentation creation phase when personnel state that they do not want to commit to documented requirements, because the requirements will be subject to the audit or they only want to commit to that which is specifically required by the ISO 9001 standard and nothing more.
The logic espoused is rooted in the belief that requirements are defined for the benefit of the auditor and not to achieve the organization’s objectives. If this approach is used throughout creation and implementation of the quality management system then what the organization will end up with is analogous to keeping two sets of books: one to show the auditor versus the all-inclusive version of how the organization really runs its business. This approach is generally unproductive and costly. The most efficient approach is to include everything needed to accomplish the objectives of the organization.
Create CustomizationAnother requirement for the quality management system is customization. It is unfortunate that some organizations are still attempting to purchase “off-the-shelf” documentation which, often, is general enough to apply to almost any organization, yet provides no real requirements. If there are no real requirements, then the documentation provides no instructional information to those internal to the organization.
Detailed customization also must be balanced with an eye to possible future organization changes and the need for flexibility in performing tasks which require flexibility for the benefit of the organization. The organization’s goals are a vital aspect of creating the structure of the quality management system and the specific requirements related to each process. For example, if the organization has a goal to have more control over product returned for servicing, it should ensure that a detailed procedure is created to effectively track returns and the associated records.
This procedure may include creating a tracking system and a process measure so that over time, management can ensure the process is meeting the organization’s objectives. Conversely, order entry may be a highly automated simple process that can be consistently executed without a documented procedure. What to document, how much to document, and what to measure are decisions which are unique to every organization.
Consider a ConsultantSome organizations get carried away with creating numerous task level instructions that provide little value and become a hassle to maintain. Sometimes, processes most critical to the organization’s objectives are ignored. An objective third party such as an experienced consultant can provide valuable guidance to the organization as to how to structure the quality management system and ensure it is structured in such a way that organizational objectives are met. A consultant can guide the organization through the process of creating a quality management system and keep everyone focused on the goals of the organization.
Once documentation is created the organization must take ownership of the quality management system by insisting on complying with specified requirements, measuring processes, reviewing and taking action to improve. These steps are often the most difficult ones to take because it typically requires organization cultural change. Requirements are sometimes put to the test because of “special circumstances” or exceptions. Leadership must be clear that requirements necessary to achieve organizational goals must be complied with.
In addition, many organizations struggle with process measures. Process measures must provide actionable information. If process measures do not provide accurate information regarding the effectiveness of a process, then organizational leadership must act to improve the types and accuracy of process measures. Valuable resources can be wasted on unsuitable process measures which don’t contribute to the overall goals of the organization.
While creating a quality management system is a huge challenge for most organizations, implementing, maintaining and improving the quality management system will be even a greater challenge without the on-going commitment by management.