New ISO 9001 Standard May Require Effective Process Management

July 21, 2014

by Mike Stimson

Recently we explored the upcoming changes to the ISO 9001 standard, due to take effect in 2015. One of the key differences between 9001:2008 and the proposed new standard is a greater emphasis on effective process management. With this in mind, I want to take a deeper look at the ways enhanced process management can benefit companies of all sizes and industries.

ISO 9001:2008 encourages the examination of one’s business in terms of processes. 9001:2015 is likely to go one step further, requiring a process-based Quality Management System (QMS).

Your QMS as a Business Strategy

The benefits of a process-based approach are very real, enabling better organizational management, improving risk mitigation, and more. A formal QMS, meanwhile, is an important part of any robust business strategy. When properly executed, a process-focused QMS will not only be a requirement for ISO compliance, it can be an important resource to ensure that your business continues to meet customer/stakeholder needs.

In CONNSTEP’s experience, the most effective Quality Management Systems are an integral part of an overarching business strategy. The most successful companies view their QMS as a valuable resource, something they can leverage to enable growth, rather than a “necessary evil” or a “cost of doing business.”

The proposed changes to ISO 9001:2008 recognize and reinforce this concept in some important ways.

First, let’s consider the addition of two new clauses. Section 4.1 requires companies to “…determine external and internal issues that are relevant to its purpose and its strategic direction and that affect its ability to achieve the intended result(s) of its quality management system…”.

Section 4.2 goes on to require an understanding of the needs and expectations of interested parties by determining “…the interested parties that are relevant to the quality management system…” and “…the requirements of these interested parties that are relevant to the quality management system…”.

Second, the proposed standard makes the adoption of a process-based QMS more explicit than the current version. To quote the Draft International Standard, the reason for this is “…the process approach ensures:
a) understanding and consistently meeting requirements;
b) consideration of processes in terms of added value;
c) the achievement of effective process performance;
d) improvement of processes based on evaluation of data and information.”

New Standard Encourages Effective Process Management

The following graphic, taken from the Draft International Standard, illustrates how various sections of 9001:2015 support and encourage effective process management.

9001-2015 Process Based QMS Model

 

 

 

Here we can see the process linkages between the standard’s various clauses. The figure illustrates the importance of considering customers and other “relevant interested parties” when developing the QMS, as well as including customer feedback to help determine how well a company meets those requirements. You will also note that the wheel in the center of the graphic represents the classic Deming PLAN – DO – CHECK – ACT improvement cycle and shows how the QMS structure supports this concept (i.e. 6. Planning [PLAN] – 8. Operations [DO] – 9. Performance Evaluation [CHECK] – 5. Leadership [ACT]). The schematic highlights the concept of a more process-based QMS shift that directly supports overall business strategy and objectives.

An effective QMS can be a catalyst for growth, not to mention a valuable lever to help a company achieve its overall business objectives. The upcoming ISO 9001:2015 transition formalizes the need for enhanced process management as part of a QMS. If you’re going for certification under the new standard, consider registering for our upcoming ISO 2015 updates seminar and find out how to make this change most successful.

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