How to Implement and Audit the Process Approach

by J.P. Russell

By organizing your management system according to how business processes work instead of by departments or elements of a standard, you’re using the system-process management approach.

Since ISO 9001:2000 was published, continual increased interest in the process management; a good approach whether you’re interested or not in International Organization for Standardization, known as ISO.

One of the clever tools we can use to develop the process approach is the plan-do-check-act (PDCA) cycle. We can say applying the PDCA cycle to how we do business is the process approach. (Editor’s note: For example, see ISO 9001:2015 Quality Management Principles.)1

The ISO standards community has provided several guidance documents to help organizations implement and better understand the requirements in the ISO 9001 standard. These documents are free to anyone, but unfortunately the guidance documents are seldom used.

One of the documents providing guidance on the process approach is being revised.2
The revised document is likely to delete a section I find particularly helpful for auditing and implementing the process approach. I am concerned that once the revised document is issued, the original version’s valuable implementation question section may not be available for referencing.

To preserve the implementation questions section for future reference, I will share my version of these questions with you in the remainder of this column.

The Questions

The requirements for the quality management system (QMS) are defined in clause 4.1 of ISO 9001:2000. The following questions, identified
by PDCA stage and by ISO 9001 clause, could be used by those wanting to implement or audit the system-process approach of an organization:

Plan–4.1a. Identify the processes needed for the QMS and their application throughout the organization:

  • Are the processes needed for the management system defined? What are they?
  • Are the customers of each process (internal and external) identified? Who are they?
  • Are the customer requirements known? What are they?
  • Are the process owners identified? Who are they?
  • Are any of the QMS processes outsourced to other organizations? What are they?
  • Are the inputs and outputs for each process defined? What are they?

  Plan–4.1b. Determine the sequence and interaction of these processes:

  • Is the overall flow of the processes known? What is it?
  • Are the sequence and interaction of processes described in some manner such as process flow diagrams, process maps, flowcharts or other means? What is it?
  • Have the interfaces between processes been identified? What are they?
  • Have documentation needs been decided? What are they?

Plan-do–4.1c. Determine criteria and methods required to ensure both the operation and control of these processes are effective:

  • Are the characteristics of the intended and unintended process results known? What are they?
  • Are there criteria for monitoring, measurement and analysis? What are they?
  • Are economic issues (cost, time and waste, for example) considered? What are they?
  • Are there methods for data gathering? What are they?
  • Are criteria and methods considered during management system planning? How?

Plan-do-check–4.1d. Ensure the availability of resources and information needed to support the operation and monitoring of these processes:

  • Are resource needs defined for each process? What are they?
  • Are the communication channels defined? What are they?
  • Does the organization provide internal and external information about the process? How is it done?
  • Is feedback obtained? How is it done?
  • Are needed process data defined? What are they?
  • Are needed records defined? What are they?

Plan-do-check–4.1e. Measure, monitor and analyze these processes:

  • Is process performance (process capability, customer satisfaction) measured? How is it done?
  • Are necessary measurements determined? What are they?
  • Is the gathered information analyzed? How is information analyzed (statistical techniques)?
  • Are the results of analysis known? What do the results tell the organization?

Plan-do-check-act–4.1f. Implement action necessary to achieve planned results and continual improvement of these processes.

  • Are the processes improved? How are they improved? What improvements were made?
  • Are necessary corrective/preventive actions identified? What are they?
  • Are corrective/preventive actions implemented? When?
  • Are corrective/preventive actions effective? How is effectiveness determined?

Function vs. Process

Most businesses and organizations start off using the process approach, but as they grow, functional departments are formed. Managing by department or function leads to more emphasis on function performance and less on the processes for providing a value-added product or service and achieving customer satisfaction.

Whether or not your organization claims to conform to ISO 9001 requirements, the previous questions can identify management system opportunities. Organizations that use the system approach to management benefit in the following ways:3

  • Their processes are integrated and aligned.
  • They have the ability to focus efforts on key processes.
  • They have greater confidence they are operating in a consistent, effective and efficient manner.


  1. ISO 9001:2015 Quality Management Principle
  2. 2. ISO 9000 Introduction and Support Package: Guidance on the Process Approach to Quality Management Systems, ISO Technical Committee 176, Subcommittee 2/N 544R, 2001.
  3. 3. Quality Management Principles brochure,,
    Sept 22, 2003. Note: This website has been replaced by the link in reference 1 above.

About the author

J.P. Russell is an ASQ Fellow and a voting member of the American National Standards Institute/ASQ Z1 committee. He is a member of the U.S. Technical Advisory Group to Technical Committee 176, the body responsible for the ISO 9000 standard series. Russell is the managing director of the internationally accredited Quality Web-Based Training Center for Education,, an online auditing, standards, metrics, and quality tools training provider. A former RAB and IRCA lead auditor and an ASQ Certified Quality Auditor, Russell is author of several ASQ Quality Press bestselling books, including Process Auditing Techniques; Internal Auditing Basics; ISO Lesson Guide 2015: Pocket Guide to ISO 9001:2015; and he is the editor of the ASQ Auditing Handbook.

This article first appeared in the ASQ Quality Progress Standards Outlook column December 2003.
The content of this article is important because of the valuable implementation questions it preserves.