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David Muil

Six Sigma

The Process Approach to ISO 9001

Adding value by assessing existing business procedures

Published: Wednesday, April 2, 2014 - 11:06

Management systems are sometimes misunderstood as nothing more than a heavy administrative burden providing limited business benefit. In fact, many organizations with management systems in place haven’t effectively defined the processes they actually employ at all. Perhaps it’s because they think management systems only pertain to standards, and “ISO 9001 is separate from how we run the business.”

By maintaining these beliefs, organizations are missing out on significant opportunities to improve their existing processes. This also brings the value of the ISO standards in question. How can an international standard unite with a strategic business plan and facilitate process improvement, and thus, efficiency?

Using the process approach

The process approach is more than an auditing technique: It’s a philosophy. It means shifting focus away from basic compliance to embrace an “improvement” mindset. When already-established activities and related resources are managed as a process, there’s no need to “invent” unnecessary paperwork just to show compliance. Any paperwork required for an audit is documentation necessary for quality management anyway; it’s simply documentation of processes currently employed to produce the desired output.

• A process is commonly defined as a number of reproducible, interacting activities that together convert an input into an output.
• An input is something that drives or starts the process, such as people, resources, or materials. Multiple inputs can, and usually do, exist.
• An output is a deliverable resulting from the process, addressing the expectation of a customer (either external or internal). Typically an output is a product, a service, or the input into another process.

The process approach is a review of the sequence and interaction of processes and their inputs and outputs. It looks at the management system not just as a document, but also an active system of processes that addresses business risk and customer requirements. A process-based audit would ask questions such as, “Who is the process owner?”, “What are your customer requirements?”, and “How do you demonstrate improvement?” Not, “Show me your procedure.”

The turtle diagram

A turtle diagram is just one of the auditing techniques that can be used to evaluate a process. Asking with what, with whom, how, and how many results in evidence of effectiveness, measurement to goal, evaluation of internal and external customers, and a focus on deliverables.

Turtle diagram. Click here for larger image.


• With what names the tools, equipment, and resources needed to perform an activity. This could include software, hardware, and support from other departments.
• With whom defines the human resources required for performing a task. This includes a definition of competency requirements such as skills, education, experience, and training.
• How identifies all the supporting documentation that may exist to support this process.
• How many is process monitoring—i.e., identifying the measurements needed to assess the effectiveness of the process in support of the business plan. There should be evidence of continuous improvement and corrective action in the process.

Process analysis with the turtle diagram can encompass many elements, including:
• Activities
• Resources and inks
• Methods and tools
• Measurements
• Regulatory requirements applicable to the process
• Risks associated with the process
• Effectiveness and efficiency
• Customer requirements, both external and internal

The results of the turtle diagram yield many benefits to the business. First and foremost, it provides process measurements that can be linked directly to the organization’s strategic plan. It provides a means to assess both external and internal customer expectations, as well as any business risks associated with the process. It allows for use of the plan, do, check, act (PDCA) cycle as it applies to the process. And finally, it allows for an important deliverable to the management team: a SWOT analysis.

SWOT analysis

SWOT is a business tool that translates “ISO language” into a format that senior management can more easily understand. A SWOT analysis provides feedback on the organization’s strengths, weaknesses, opportunities, and threats to the organization. This approach is widely used to assess risks, benchmark competitive differentiators, and determine new business strategy.

A SWOT analysis looks at:
• Strengths, present view. Best practices and benchmarks; learn from these and apply them to other processes.
• Weaknesses, present view. Areas that comply but are not fully effective, and therefore require correction.
• Opportunities, future view. Areas of improvement to consider.
• Threats, future view. Areas of high risk and noncompliance.

The results of this analysis can be summarized in a SWOT diagram, such as this one:

The effect of the process approach

Any organization seeking to certify its management system must still meet the requirements that are presented in the appropriate standard. But the standard by itself doesn’t necessarily add value to the organization, or bring benefit to senior management. By assessing the effectiveness of operational processes in achieving overall company goals and objectives, the concept of risk is now being considered.

What’s more, it results in solid feedback that’s presented in a language that the management team can understand.

A process-based management system isn’t an administrative burden. In fact it’s a necessity for a truly competitive business. It’s a critical tool that provides continuity throughout operations, forming the link between policy, requirements, performance, objectives, and targets.

David Muil is the director of business development for Intertek’s Business Assurance group, a Quality Digest content partner.


About The Author

David Muil’s picture

David Muil

David Muil is the director of business development for Intertek’s Business Assurance group. He has more than 18 years of experience in the third-party certification business, having held previous positions with several global organizations. His background also includes practical time spent in the aerospace and automotive industries, where he held various positions within quality and management. Muil holds a degree in business and economics from McMaster University, and continued post-graduate studies in business at the Henley Management College in London, England. He has also attained a Green Belt designation in Six Sigma.