The Process Approach & ISO Standard

Last updated Feb 24, 2017

The latest revision of the ISO standards, ISO 9001:2015, encourages a process approach when developing, carrying out and enhancing the strength of the quality management system. The aim of process mapping is to improve client satisfaction by meeting customer requirements. All organizations, in some manner, must structure a process based environment to fulfill their business objectives and financial goals.

Section 4.4 of the ISO 2015 requirements specifies the adaptation of a process approach as an input to the importance and the proficiency of the organization in achieving its planned results. This method allows the business to control the relationships and dependencies between system processes permitting a measurable output of the overall performance of the organization.

This approach calls for defining processes and systematic management of operations and their interactions, to achieve the expected results according to the quality policy and the strategic focal point of the ISO 9001:2015 quality system.

Management processes and system as a whole can be held using the PDCA Improvement Cycle with comprehensive access to risk-based thinking aimed at seizing opportunities and preventing unwanted results.

The PDCA process as specified by the ISO Standards regulation body includes:
Plan: Set the objectives of the system and methods to produce results (“What to do” and “how to do it”)
Do: Implement and control what was developed Check: Monitor and measure processes and results against policies, objectives, and requirements and define those results.
Act: Take action to correct the performance of processes

The application of the process methodology in a quality management system enables the understanding and compliance with the requirements consistent with consideration of the processes regarding added value, achieving an efficient process performance, and improved methods based on the evaluation of both empirical data and relevant information.

Process mapping of the business workflow is focused on the group components of the company. The mapping process provides a vision of the anticipated interchanges for the expected results. By regular review of the operations, duplicated methods are identified. These results are analyzed and may be considered for elimination or needed development to improve the company’s productivity.

Mapping process applications work very well in taking complex situations and dividing them into smaller macros. Process mapping shows the threads that will optimize the use of time and training efficiently achieving objectives, maximize resources, and allowing flexibility in adapting to change. As a tool, this map is easy to visualize to assist in defining and mapping procedures and to perceive risks and solutions to common problems that occur in all organizations.

There will be a transitional period while both revisions, ISO 9000:2008 and ISO 9000:2015, are concurrently in effect. The ISO Standards Committee strongly recommends to any organization, notwithstanding of size, industry or segment, to start as soon as possible the process approach in the transition to the new Standard ISO 9001:2015.

For more information on ISO Standards and Certifications, please contact Ledge Inc.


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Adam Marsh

Adam Marsh

President, Ledge Inc.

Adam is a Penn State engineer that has served as a Data Analyst and Engineer at St. Onge Company for 5 years, prior to establishing Ledge Inc. While maintaining a focus on simple solutions, Ledge Inc. has provided quality system implementation, process design, database development, quality tools, quality training, and data analysis to over 35 companies in South Central Pennsylvania and throughout the country. Adam currently serves as the sitting Chair for American Society for Quality Harrisburg Section 503 and as a member of the board for The Manufacturers’ Associations of South Central PA.



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