ISO 9001:2008 | An Opportunity to Drive Performance Improvement By Malcolm Hay
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ISO 9001:2008 - An Opportunity to Drive Performance Improvement By Malcolm Hay

ISO 9000, the most successful standard in the history of the International Standards Organization, is being updated with the anticipated adoption of ISO 9001:2008 prior to year-end. This is not news to you, but is it good news? Well, that depends on whether you view the new standard as an opportunity or a burden. This article will argue that ISO 9001:2008 should be viewed as an opportunity to drive performance improvement.

Based upon ISO/DIS 9001:2008 as further elaborated by ISO/DIS 9004, the revised standard is potentially quite different in intent, scope and structure from its predecessors.

ISO 9001:2008 describes a QMS that is much more business-like. It is one that is focused on driving measurable performance improvement toward achieving and sustaining customer satisfaction. It is no longer adequate to have a QMS that is merely well documented and consistently implemented. An effective QMS now should deliver and sustain measurable and meaningful performance improvement.

So what does it take to effectively implement ISO 9001:2008 so that it drives performance improvement? Our analysis suggests a quite different approach from the traditional QMS implementation is necessary. Our approach involves sound business management techniques, with business management-based objectives, integrated with the more traditional QMS documentation approaches. The result is a QMS clearly focused on improving customer satisfaction and enhancing the company's competitive position, with resulting bottom-line impact.

The first step of this approach is to develop a business operating system by defining objectives, key processes and performance measures based upon a thorough analysis of customer needs and expectations. The processes are "key" because they are essential to achieving the objectives. By identifying performance measures related to customer needs and expectations, the key processes can be effectively monitored to drive them to achieve customer satisfaction.

Next, the key processes, which should now reflect how the organization actually operates, are documented. Documentation not only involves detailing each process step or activity making up the process, but testing that step for its relevance to the objectives. This is an opportunity to refine and simplify the key processes while simultaneously documenting them. The result is relatively simple and efficient QMS documentation.

Then the "realization processes," or those processes that directly add value to products and services, are analyzed to develop the most appropriate ways to direct them toward achieving the customer's requirements. This is an opportunity for organizations to refine and focus their management effort so that it is directed toward the most important steps of their key processes. A QMS should significantly "add value." This approach is the beginning of the process by which value is added and waste reduced.

Finally, the QMS is launched with specific goals for incremental and achievable performance improvement related to the objectives. It is not launched solely for the purpose of ensuring that everyone performs in the same manner. It is launched with improvement in mind and improvement is expected.

We believe that by following this approach to its implementation, ISO 9001:2008 will be a major catalyst for significant performance improvement. But this approach is not for the faint of heart. The implementation process is demanding, and requires significant senior management commitment and involvement; however, as with anything worth doing right, the rewards amply justify the effort.

Key Differences Between ISO 9001:1994 and ISO 9001:2008

ISO 9001:2008 views a quality management system (QMS) as a continual "process" rather than a series of 20 elements - beginning with management's responsibility to provide direction and resources, moving on to planning and controlling the processes that deliver products and services, and concluding with measurement and monitoring with a goal of improvement. Of particular significance is that inputs to the process are "customer requirements" and output is "customer satisfaction.

"There is a new emphasis on determining "customer needs and expectations," converting to requirements, and fulfilling "with the aim of achieving customer satisfaction" (5.2). This is much more proactive than the current wording stating the quality policy "shall be relevant... to the expectations and needs of its customers.

ISO 9001:2008 places much more emphasis on quality objectives. They now command a separate section (5.4.1) and include requirements that objectives be established "at relevant functions and levels" and that they be "measurable."

Quality planning (5.4.2) is no longer to "define and document how the requirements of quality will be met." It is about top management ensuring that "the resources needed to achieve quality objectives are identified and planned." It includes consideration of processes, resources and continual improvement and is now more akin to business planning - meaning an effective QMS now should incorporate a business plan which should be directed toward achieving specific performance objectives.

Management is no longer required to review the quality system merely to "ensure continuing suitability and effectiveness" during management review (5.6.1). It now must also "evaluate the need for changes" in the system. Outputs from management review are now prescribed to include "improvements." Action is now expected!

The scope of what used to be inspection and testing has been dramatically expanded to include analysis of data (8.4). Instead of checking product (or service) at various stages simply to "verify that the specified requirements for the product are met," an organization now must analyze the data resulting from measurements. As a result, there is a new and significant emphasis on being proactive and preventive - the beginning of continual improvement.

The new standard now specifically calls for both the planning and facilitating of continual improvement of the QMS (8.5.1). This includes "use of the quality policy, objectives, audit results, analysis of data, corrective and preventive action, and management review."

For more information on OMEC's approach to implementing ISO 9001:2008 call or visit our website at: www.omnex.com.

Malcolm Hay is a senior consultant for OMEC who brings to bear 35 years of broad experience in executive and senior management positions in product development and marketing, mergers and acquisitions, operations management, and quality assurance.

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