Beyond the Requirements
ISO 9001 compliance alone isn’t
sufficient to sustain an
by John E. "Jack" West and Charles A. Cianfrani
Let’s start with a brief history lesson. From its inception in the early 1980s, ISO 9001 was never intended to be a comprehensive set of requirements for an ideal quality management system (QMS).
Instead, it was created to articulate a set of minimum characteristics for a QMS. It provided confidence that any products or services offered by an organization that complied with ISO 9001 would meet identified requirements, thereby leveling the playing field for international trade.
If a supplier anywhere in the world met the minimum ISO 9001 requirements, a customer could have confidence that any product obtained from that supplier would meet the stated requirements for the product or service.
The important point is that, from its onset, ISO
9001 was intended to contain minimum requirements for a QMS. Since its initial
publication in 1987, ISO 9001 certification has morphed into an industry, and
ISO 9001 certification has been embraced by the world as a representation of
high quality—more than
1 million organizations are certified as complying with ISO 9001 requirements worldwide.
You could ask, "Is ISO 9001 compliance sufficient to ensure the sustainability of an organization?" The answer to that question is, "Not necessarily."
Foundation of the QMS
From the beginning, the International Organization for Standardization committee responsible for ISO 9001 always considered ISO 9001 part of the family of standards that consisted of ISO 9000, ISO 9001 and ISO 9004.
ISO 9000 provided the fundamentals and vocabulary for QMSs. ISO 9001 provided minimum QMS requirements, and ISO 9004 provided guidance on how to manage for sustained success. By its functional design, ISO 9004 was intended to provide guidance to an organization on how to progress from a management system that met minimum requirements to one that possessed and exhibited world-class performance levels.
The concept of progressing from meeting minimum requirements to operating at world-class QMS performance levels seems to have been lost in many organizations today.
So, what should today’s quality professional do to address organizational sustainability while still meeting ISO 9001:2015 minimum requirements? The answer is to consider the foundation of the organization’s QMS and ensure the processes of the QMS are aligned with the organization’s vision, mission, values and objectives. Help on how to proceed with such activities can be found in ISO 9004:2009 (and its soon-to-be-released update, tentatively scheduled for 2017).
Those responsible for quality management and the establishment of the QMS processes of an organization should contemplate the breadth and depth of the processes of their organization to ensure sustainability in at least the following areas:
- Context of the organization and interested parties.
- Mission, vision and objectives.
- Process management (measurement, corrective action and improvement processes, design of internal processes and competence).
- Management review effectiveness.
- Expansion of internal auditing to self-assessment.
The organization shouldn’t view each of these areas as requirements but rather as processes to add value and ensure organizational sustainability. We can provide only limited examples of the possibilities that exist in this article. It’s the responsibility of quality professionals to consider the opportunities for value-added processes that are consistent with the mission, vision and objectives of their own organizations.
Context of the organization and interested parties
Clause 4 of ISO 9001 incorporates concepts and words that will be new to many who are familiar with prior editions of ISO 9001. Some of the new concepts introduced in clause 4 include:
- Understanding the organization and its context.
- External and internal issues.
- Interested parties that are relevant.
This clause requires an organization to understand external and internal issues that are relevant to its:
- Strategic direction.
- Interested parties.
- Ability to achieve intended results of its QMS.
The organization also is required to monitor and review information on these internal and external issues.
There is an enormous opportunity for quality professionals to work with other functions in their organizations to create and introduce processes that expand and add vibrancy to strategic planning processes. Opportunities also exist for value-adding creativity to be employed in areas that may be weak (this relates to the interested parties).
Mission, vision and objectives
Several processes that quality professionals can assess for adequacy and value-adding potential include:
- What are the processes for keeping the mission and vision fresh?
- What are the processes for developing and deploying objectives?
- How is alignment assessed?
There is considerable potential for making organizational processes more robust.
The requirements for leadership in ISO 9001:2015 have been enhanced from earlier editions of the standard. These enhancements include:
- Expansion of the specific requirements (in clause 5.1.1).
- Requirement of policy and objectives to be compatible with strategic direction.
- Expansion of the requirements (communicated, understood and applied) related to quality policy.
- Integration of the QMS into business processes.
- Active participation in management review.
The list of top management responsibilities in clause 5.1.1 provides a lot of opportunity for quality professionals to enhance processes by getting direct involvement of top managers. Quality professionals must take ownership of this to ensure top management is constructively engaged in the development and deployment of the QMS.
The importance of process management to the effectiveness of an organization’s QMS cannot be overemphasized. Process management permeates every aspect of the QMS. Consider the following aspects of your QMS:
- Product and process design.
- Inputs to processes.
- Process activities.
- Process outputs.
- Measurement of process performance.
- Feedback from inputs and outputs to improve process performance.
- Customer perceptions.
- Continual improvement of process performance.
Are any of these dimensions operating at world-class levels of performance? If not, you have opportunities to drive improvement of processes to not only ensure compliance with ISO 9001:2015 requirements, but also—more importantly—to meet organizational objectives and add value.
Management review effectiveness
ISO 9001:2015 has a significant emphasis on reviewing trends in customer satisfaction, nonconformities, results of monitoring and measurement, and audit results.
Earlier versions of ISO 9001 had no specific requirement for the review of these trends. This is an opportunity to introduce trend analysis processes.
The status of preventive actions is not included as a required input to management review because it has been deleted as an ISO 9001:2015 requirement.
The implications of preventive action being replaced with risk-based thinking provide quality professionals an opportunity to think creatively about how to effectively incorporate preventive action into management review. This assumes controlling risk and liability mitigation is important to the organization’s leaders.
Expansion of internal audit to self-assessment
The requirements of ISO 9001:2015 for internal audits have not changed much since 1987. Still, new thinking can be applied to expand the value the organization can derive from investing resources in its auditing processes.
Consider expanding the scope of the internal audit process to include training and requiring auditors to seek opportunities to improve the efficiency and effectiveness of processes they are auditing.
This means looking with care at processes that conform to requirements and those that do not. It might also mean identifying best practices you observe that may apply to other areas of the organization.
Also, if an organization has not developed and deployed a self-assessment process, establishing this activity has the potential of adding value by providing management with insight into the maturity of the organization’s processes.
Above and beyond
Quality professionals must be concerned about complying with the requirements of ISO 9001:2015, but the job does not stop there.
To be successful, you need a sharp focus on developing and deploying processes that add value.
These processes must be aligned with the mission, vision and objectives of the organization to ensure its sustainability.
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 Technical Committee 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.