Building A Strong Foundation
What you need to develop a sustainable QMS
by John E. "Jack" West and Charles A. Cianfrani
As organizations approach the 2018 deadline for migrating their quality management systems (QMS) from ISO 9001:2008 to ISO 9001:2015, it is useful to remember the primary objective of a QMS should not be to achieve compliance and certification, but rather to provide a foundation on which an organization can achieve sustainability and ensure customer satisfaction.
What are the components of such a foundation? Is any one component the keystone of a QMS? Probably not. Several activities must be considered and aligned to ensure the QMS has a rock-solid foundation.
The purpose of alignment is to enable everyone in an organization to behave in a way that furthers the organization’s interests and those of its relevant interested parties. This notion of alignment is to ensure a common understanding of the elements of the QMS foundation by everyone in the organization. Alignment supports achievement of the objectives.
Four key components of a sustainable QMS foundation that often are ignored or not rigorously considered are:
- Quality management principles (QMP).
- The organization’s vision statement.
- The organization’s mission statement.
- The organization’s objectives.
The seven QMPs
Why is it important to review, understand and use the QMPs? One good reason is they underlie the intent of ISO 9001:2015. In theory, at least, the standard’s drafters have based the content of ISO 9001:2015 on the QMPs that were reviewed and updated concurrently with the development of the standard.
The QMPs are:
- Customer focus.
- Engagement of people.
- Process approach.
- Evidence-based decision making.
- Relationship management.1
A more complete description of each principle is included in ISO 9000:2015, subclause 2.3, which also includes a statement, rationale and key benefits for each principle, and possible actions an organization can consider implementing to address each QMP. Also, there is further elaboration of the QMPs on the International Organization for Standardization website at www.iso.org.
A review of the QMPs, their statements, rationale and approaches to consider may provide insight into developing and implementing processes to strengthen the content of a QMS.
Many organizations have devoted a lot of energy to developing vision statements. The concept is simple—it must answer questions such as:
- What do we want our business to be like in the future?
- Why is this important to consider when developing or updating our QMS?
If a QMS does not align with the strategies an organization is employing to sustain its existence for the next five years, the QMS will be viewed as irrelevant and will not be embraced. It will be an impediment to management and not a dynamic element for achieving the organization’s objectives.
So, it is imperative the QMS be aligned with and viewed as a contributor to the achievement of an organization’s vision. This creates a framework for the QMS to be enthusiastically embraced. A good question to ask of those in an organization is: "How do you view your QMS? Is it a positive or negative factor? Or, worst case, a non-factor?"
Like the crafting of a vision statement, developing an organization’s mission statement is an activity that top management gives considerable thought. A mission statement is a simple concept. It attempts to answer the question, "What is our business?"
It is critical for the QMS to consider this because if the QMS does not address the business purpose of the organization, achieving compliance with its requirements and intent will be futile. If the organization’s QMS does not align with its mission, the result often is lots of conflict and effort spent trying to avoid conforming to its requirements. This means wasted time and effort that will not contribute to efficiency or effectiveness.
Integrating mission and vision
Unlike an organization’s mission, its vision may change over time. Vision is developed by first gaining a clear picture of the organization’s current situation and picturing what it wants to look like in the future. The process starts with top managers, who formulate their picture of the organization’s future and share it with employees.
Their objective should be to get employees to understand the vision so everyone is heading in the same direction and has the same ultimate destination. An organization’s leadership might visualize it becoming something different from what is described in its current mission statement. For example, leadership might have the vision of abandoning its current lines of business in favor of growth in other areas.
These notions often are given little real emphasis, and creating mission and vision statements sometimes is an isolated, idealistic exercise that brings little benefit to most members of an organization. This often is due to a lack of honest dialogue among leadership about the real purpose and vision of the organization.
Poor communication leads to problems such as quality policies that aren’t linked directly to the organization’s real reasons for existing. This is where a formal QMS built around ISO 9001 comes in and why it is essential to ensure the vision and mission are consistent and understood throughout the organization.
Objectives of many different forms abound. Are these objectives clearly understood and aligned with an organization’s mission and vision? The QMS also should align with an organization’s objectives and drive the use of those objectives throughout the organization. When alignment is considered and addressed, implementation of the QMS and meeting its requirements will be viewed as an essential component of achieving the objectives of the organization.
The question, "What are the quality objectives?" shouldn’t be asked in isolation. Rather, the question should be, "What are the things related to quality that support our organizational mission, vision and overall business objectives, and what is our policy as it relates to those things?"
Objectives are only one piece of the puzzle. Without a clear vision and mission, and a policy statement aligned with them, quality objectives won’t achieve the intended results.
Planning for the future
An organization’s QMS must be able to track what changing conditions require major adjustments to maintain market relevance. It’s crucial to recognize when dramatic system changes are needed. It’s also important to be innovative when developing those changes and to consider the issues to be addressed prior to implementing them.
The objective is to keep the organization and its QMS relevant in the face of change. Maintaining an aligned mission, vision, plan and policy is only part of what is needed for sustainable success. Organizations that succeed over time also must consider whether:
- They’re focused on continual learning and growth.
- They have a way to determine the need to make basic changes in their products and management systems.
- They’re innovative about making those changes.
In other words, successful organizations can sustain their success long term regardless of external forces. They remain competitive despite conditions that drive their competitors out of business. They thrive on innovation and change.
Long-term sustained growth depends on an organization’s ability to address a variety of activities simultaneously. An organization’s leaders should consider asking questions like:
- Do we use internal scans, external scans and self-assessment to understand future requirements?
- Do we use innovation to understand future missions, visions and strategies needed to meet new requirements?
- Do we change objectives, targets and key processes to meet new needs?
- Do we prepare the workforce for inevitable changes?
- Do we implement, maintain and improve the QMS to meet future requirements?
Planning for the future is essential for sustainability. The strategic part of planning often is overlooked with the emphasis on evaluating current and projected market conditions, and forecasting short-term sales trends, revenues and margins. These tactical activities might be needed, but they scratch only the surface of future market conditions.
A logical extension of a management system is to ensure an organization has processes in place to understand the future market and business conditions it will face, and to compare current and projected products and processes with that picture of the future. This applies to more than just an organization’s products and services. An organization also must plan changes to its QMS to meet future needs. Clauses 4 and 6 of ISO 9001:2015 subtly address this issue.
The most important aspect of planning is determining key processes. Yesterday’s processes may not be adequate to meet future needs. The need to maintain registration to management system standards such as ISO 9001 should never be viewed as an impediment to change.
Rather, innovation should be used to achieve better processes that still meet the standard’s requirements. If this is done well, the time and money an organization invests in optimizing processes will be well spent, and there’s a high probability for long-term success. If this part of planning isn’t performed well, there could be dire consequences.
An organization needs action plans to describe how it will identify the processes most important to creating change, meeting the new vision and achieving the new objectives. This work should start with top leadership and involve others at appropriate levels.
Most organizations will have determined key processes appropriate for the current conditions. The issue is to determine which processes are important to achieving the vision and required future results.
An action plan must assign responsibility for developing these processes and integrating them with other system processes so the system is reoptimized to meet its new objectives. See Figure 1 for ideas on assessing how to fit such planning into your QMS.
As the old saying goes, "Plan well but don’t plan forever, for without action all planning is useless." It’s important to act when it’s needed, but without a robust planning process, organizations can miss critical opportunities to ensure their long-term success.
Developing, maintaining and improving a QMS is a responsibility that requires careful thought and intense, professional attention. It requires great leadership, a good grasp of the business purpose and the ability to align the QMS with that purpose. This thought process is multilayered and is hard but vital work. It is not good management to tweak or create processes merely to comply with ISO 9001:2015 requirements.
The creators of the standard were not conscious of the nature of your organization. Rather, their intent was to provide a minimum set of requirements for quality management that would give your customers confidence that whatever goods and services you provide will conform to requirements. Building your QMS only on such minimum requirements may not be efficient or effective, and may not be sufficient to enhance sustainability.
Your challenge is to build your QMS on a firm foundation crafted to meet the needs of your organization and your customers. It is hard work that requires creativity. Merely tweaking your past processes may not enhance your organization’s sustainability prospects.
- International Organization for Standardization (ISO), ISO 9001:2015, Quality management systems—Requirements, subclause 0.2.
John E. "Jack" West is a member of Silver Fox Advisors in Houston. He is past chair of the U.S. Technical Advisory Group to the International Organization for Standardization (ISO) Technical Committee (TC) 176 and former lead delegate of the committee responsible for the ISO 9000 family of quality management system standards. He is an ASQ fellow and has co-authored several ASQ Quality Press books.
Charles A. Cianfrani is a principal consultant for Green Lane Quality Management Services in Green Lane, PA. An ASQ fellow, Cianfrani is a U.S. expert representative to ISO/TC 176 and has co-authored several ASQ Quality Press books. He holds an MBA from Drexel University in Philadelphia and a master’s degree in applied statistics from Villanova University in Pennsylvania.