ISO 9001 Implement Process Approach

By Scott Dawson
March 20, 2014

Leveraging ISO 9000 for Real Business Value

Ensuring that ISO 9001:2008 remains a vital, relevant tool for your top management to improve business performance is often of concern by those responsible to oversee the “ISO program” within your organization. It is too common for ISO to become “yesterday’s news” if you’ve been certified for several years and today’s “big event” is the annual return of the Registrar’s auditors. If your organization has struggled to show measurable and sustainable improvements in performance for your customers or toward top-priority management goals, then ISO may be thought to be in “maintenance mode” within your organization, rather than a vital tool to address today’s critical business needs. The observable symptoms of this situation might include:

  1. The same corrective actions come up again and again.
  2. Audit reports identifying seemingly “petty” issues.
  3. Management review meetings “going through the motions” and often poorly attended.
  4. Improvements made in the past don’t show sustained results today.
  5. There is a “burn out” factor within your internal auditor team.

These indications point to a quality management system (QMS) that has generally lost its focus. But, why does this occur?


offtrack-in-ISOIn many organizations, a careful “root cause” investigation may point to a lack of understanding about how processes drive performance or a lack of effective implementation of what ISO 9000 calls the “process approach”. In previous editions of ISO 9000, the standard was organized for auditors, not managers. The requirements were structured around 20 “elements” (whatever that means!) and read like an auditor’s checklist. The central theme of these earlier ISO versions was to “document what you do, and do what you document”. In other words, procedures! In many of today’s certified companies, this legacy mentality still reigns and numerous documents that were written to “get ready for ISO” now gather dust unless an auditor stumbles across them. Many managers ask (rightly) “what’s the point of that!”
A change in focus in the current standard

To cure us of our fixation on documents (as if that was the point of ISO anyway) the year 2000 version of the standard introduced the process approach to turn our attention toward a means to drive real business value with our QMS. In the words of the introduction of ISO 9001:2008:

This International Standard promotes the adoption of a process approach when developing, implementing and improving the effectiveness of a quality management system, to enhance customer satisfaction by meeting customer requirements.

For an organization to function effectively, it has to identify and manage numerous linked activities. An activity using resources, and managed in order to enable the transformation of inputs into outputs, can be considered as a process.

… the application of a system of processes within an organization, together with the identification and interactions of these processes, and their management. can be referred to as the “process approach”(ref. 0.2).

More simply, in order to improve business results, both for the customer and the company, your approach to your QMS should be built around processes … namely, those processes that have the biggest impact on your business performance.

In a related article, we discussed the importance of identifying the most critical cross-functional processes that most impact the customer and business performance and formally managing them as the central theme of your QMS. Once in place, these key processes serve as the focal point for management planning, resource allocation, performance monitoring and continual improvement efforts. Your documentation, training and corrective actions should also stem from these processes. In some respects, your key processes and their improvement become the chief targets of your QMS.

So, the selection of your key processes and their day-to-day management by assigned “process owners” is among the most important responsibilities of the management representative (see 5.5.2 a) and top management (see 5.4.2).

The problem of white space in the organization

whitespace-in-organizationA question might come to mind, then, “Why do processes need to be managed?”. Or, “why don’t they manage themselves?”. This uncertainty often springs from an assumption that if we put procedures in place, and manage them (including auditing the @%#& out of them) doesn’t that make our processes work right? The answer can be found by looking more closely at our procedures. Most company procedures are written by a specific department within our organization. Each department looks at how they do things and documents the general steps in a written procedure. They might also check the ISO standard to see if there are any changes they need to make to stay out of audit trouble. A procedure, then, is focused on the activities within the department who develops it.
Some examples
The limitation of that approach is that key processes are bigger than individual departments. Consider the following examples:
What’s clear about these processes is that they span several departments within an organization. It takes the efforts and good performance from each department to get good results from the process. And it takes more.
What is “white space”?
In most businesses, the most common areas where obstacles to processes arise are in the hand-offs between departments, groups or individuals, or what is called the “white space” of an organization(*). The term white space comes from looking at a typical organization chart or diagram showing the reporting relationships of the various departments. The common chart shows job titles and how people fit in the overall organization. The intention of such a diagram is to show where people are focused in their jobs. Managers, then, place their attention on making sure each person fulfills their responsibilities within their defined job duties.

Where there is NO focus is on the spaces between the boxes on the organizational chart – or the “white space” on the chart. This tends to be “no mans land” in the organization where no one claims to have full responsibility or accountability. As work flows through the organization within larger processes, problems crop up when “balls get dropped” or “things fall into a black hole” in the white space.

The process approach looks at the business differently. Instead of the top-down (vertical) view through the organization chart, a process view sees how work flows horizontally through the business. In reality, the most important work flows across the company without regard to the reporting structure of the organization. Yet, that same organization structure often impedes the performance of the process.

This occurs because of how goals are set departmentally and how problems get addressed by having to go “up in the chain of command” for resolution, especially when there are particularly sticky issues to resolve. This only creates delays in decision making and typically removes those closest to the work and the problem being discussed, from the final decision made. These management decisions can be subject to compromise between conflicting priorities of the process and department goals. In process terms this is called sub-optimization.
The importance of managing white space
To balance the top-down view, processes need to be managed horizontally within their own structure. The ISO 9001:2008 process approach provides such a structure. The horizontal view does not conflict with the company reporting structure but complements it. By identifying the few key processes that are essential to business performance and assigning responsibility for management and improvement of these processes, this can pull everyone involved together in understanding how to better arrange the process for best results. The key then is to define how to manage cross-functional processes within a functional organization. The remainder of this article will focus on some proven suggestions to how to structure your QMS to maximize process performance across your company.

A cross-functional approach to managing key processes

The ISO 9001:2008 does not specify the structure to use to manage your processes. It simply states that you must:

  1. Identify your key processes, how they flow though the organization and their relationships to one another.
  2. Establish methods to measure the performance of the processes.
  3. Make sure resources and information needed are available.
  4. Monitor, analyze and improve the processes.

(see section 4.1 in the ISO standard) But how to set all this up within your QMS is up to you. We should say it is more than simply putting a list of your processes in your quality manual. In some companies, that’s about all the thought that is put into their processes.

Questions to consider
An effective approach to process management would address these questions:

  1. Who “owns” each process? That is, is there an individual assigned to be responsible and accountable for the performance of the process?
  2. What departments and job positions are involved in the execution of the process? What does each one need to successfully support the process?
  3. Where are the most common “white space” breakdowns in the process? How can they be more carefully managed?
  4. How do we keep everyone involved informed as to how the process is performing and what problems need to be addressed?
  5. What day-to-day obstacles do people run into in performing the process? Do we have an official way for these type of problems to be easily reported and addressed?
  6. How to we measure the progress of our ability to manage processes? If one process is “better managed” than another, what’s the difference in approach between them?

There are certainly more questions to consider, but these should serve as a starting place for setting up a “process management process” in your organization.

Getting your process management process started
Here are some general suggestions for getting started:
Assign “ownership” of each process to a member of the top management team. This will ensure there is enough clout and visibility to process management.

Recruit a cross-functional team to work with the process owner to oversee the process on an ongoing basis.

Have the process management team formally document the process in a process flowchart showing all of the hand-offs and white spaces.

Determine and implement formal measures of effectiveness for each process that are reported as part of top management meetings and management review.

Authorize your process management teams to make changes to their processes for improvement, even if it disrupts the current organizational structure and job responsibilities.

Set process goals based on top-level company and quality objectives.

Provide training to your process management teams on process improvement techniques and their role within the organization.

Also provide training to your teams on how to analyze data, how to investigate root causes to process issues and how to take effective corrective and preventive action.

Review your current procedures to see which processes they support and if they are aligned with the purpose of the processes. Consider eliminating procedures that don’t support a key process.

Establish formal criteria for process management teams and their effectiveness. Rate them against the criteria to measure progress.

Write a QMS procedure on your process for managing processes and ensure it is audited as part of your internal audit schedule.

You’ll have to tailor some of the suggested steps above to your organization depending upon its size and organizational complexity. Be sure to work closely with your top management in setting up your “process approach” so that you have their support and involvement. It’s an ideal situation when the top management team integrates process management into their normal business management activities and regularly identifies processes requiring change or improvement when business issues or opportunities arise.

Driving sustainable improvement

driving-sustainable-improvementHaving an effective process management process may be a “missing link” in your current QMS and this gap may be a key reason ISO has lost some of its luster in recent years. You may be weathering your audits just fine with only a handful of minor findings each time. But passing the audit may be all the benefit you’re getting from your investment in ISO 9001:2008 certification.

By managing processes with a more structured approach, you can turn your ISO QMS into a lever for addressing nagging problems with customers, recurring wastes internally and for taking advantage of new business opportunities that require your business to “move up a notch” in its capabilities. A practical approach is found in the ISO 9000 process approach and you’ll find your efforts to re-tool your QMS will pay back benefits for years to come.

(*) See the book “Improving Performance“, Rummler & Brache, Jossey-Bass Publishers, for the original discussion about “White Spaces” in an organization and how to manage processes to overcome them.

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