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Guide to ISO 9001's Process Management Requirements PART ONE: UNDERSTANDING PROCESSES

THE COMPLETE GUIDE TO UNDERSTANDING & IMPLEMENTING ISO 9001's PROCESS MANAGEMENT REQUIREMENTS
by Christopher Paris
VP Operations, Oxebridge Quality Resources, Inc.

[For a printable Adobe PDF file of this entire four-part series, click here.]

INTRODUCTION

The concept of applying a "process approach" to managing a quality management system is clearly the most radical change made to ISO 9001 with the release of the 2000 version of that standard. Summarized in the innocuously named Clause 4.1 "General Requirements," the requirements for a process approach may be the single most important section of the entire standard. The concept, however, has become the source of great confusion across all affected parties: registered companies looking to update their systems, companies looking to register to ISO 9001 for the first time, consultants aiming to teach the new standard's requirements, and even the registrars themselves. International accreditation bodies such as RAB have now become alert to this issue, and are tightening registrar requirements to ensure registrant companies have fully implemented the process approach.

To summarize, ISO 9K2K requires that your processes be identified, controlled, analyzed, audited and reviewed. This four-part guide will take you through all those steps to help your company ensure compliance with the new standard while eliminating unnecessary work and documentation. Portions of the standard that are not process-related are not discussed here, so this is not meant to be a guide on full transition to ISO 9001:2000, but rather a complete guide on adopting the process approach.

Specifically, this guide will show you how to:

Understand what a process is, and what it isn't
Adopt the process approach by easily identifying your processes in full compliance to ISO 9001
Easily mapping your processes' "sequence and interaction"
Assigning quality objectives to your processes
Auditing processes, while treating auditing itself as a process

As always, Oxebridge aims at making this affair simple and intuitive. Be sure to provide us feedback on this article if you have any questions; this way we can update the series to help others with similar problems.

PART ONE: UNDERSTANDING THE PROCESS APPROACH

In addition to Clause 4.1, the methods of utilizing a process approach are elaborated in Clause 0.2 which, although not auditable, defines the basic expectations of a process model. The Clause also presents an overall process diagram which I would strongly recommend companies ignore completely until they have implemented their own process models. The reason for this is that the diagram presented within the text of ISO 9001:2000 is a generic model taking a rather macro look at the relationship between company and customer. Many companies feel that by including some version of this diagram in their Quality Manual they have met the requirements of the process approach, only to find out that they have failed to meet the other, more specific requirements.

Instead, a unique system must be developed for each company, dependent on its own processes. The end result may be a diagram that looks similar to, or nothing like, the diagram offered in Clause 0.2. Or, as some companies are now discovering, the model may not be a diagram at all.

ANATOMY OF A PROCESS

To start, let us define what a process is not.

A process is not a procedure; the two are vastly different concepts, yet even to this day many consultants confuse the two. A "procedure" is a written description of a process, but a process exists whether it is written down or not.

A process is not a diagram, or map. While the defining of a process may take the form of a map, simply drawing a flowchart does not convert a procedure into a process, nor does it make an intangible activity into an "ISO-style process." Again, a process exists whether it is mapped or not.

What is a "process," then? Simply put, a process is an activity; more accurately, it is an activity that converts a thing into something else. ISO 9000:2000, the vocabulary guidance document, defines "process" as a "set of interrelated or interacting activities which transforms inputs into outputs." I would argue, however, that a process may still be a single activity, not solely a "set."

Breathing is a process. We breathe in air (the input) and convert it to oxygenated blood and carbon dioxide exhalant (the outputs.) Likewise, activities such as walking, reading, driving, typing and managing are all processes, with inputs and outputs. This really isn't complicated, and thinking of your company's activities as "breathing" is a great tool. In, and out... something is taken in, processed, and results are generated.

That's it.

This diagram shows the basic construction of a process:

Various inputs are fed into a process, which result in one or more outputs; these then may feed other processes.

Processes may also be "nested," as in the example below. Here each process (red) may be made of numerous sub-processes (tan). The permutations are based on the complexity of your operations.

The next illustration presents a more detailed look at a process (in this case, "painting") and it's surrounding input and output processes; in this example, the process we are examining is an industrial painting activity.

Notice how the Painting process is "fed" by three separate processes. Painting itself is made of four sub-processes, and then the entire result is a new set of three output processes. Those outputs then become the inputs for subsequent processes.

These illustrations are provided just to give you a sense of the way ISO 9001 is asking you to start thinking.

"PROCESS APPROACH" REQUIREMENTS

While there is no industry standard for adopting a process approach, ISO 9001 does provide its own requirements on how it expects companies to do. Using language from Clauses 0.2, 4.1 and the other process-related clauses within ISO 9001:2000, we can define the following basic requirements for a process approach:

All processes must be identified, including subcontracted processes
The sequence and interaction of processes must be determined (read: defined)
Inputs and outputs of processes must be identified
Responsible authorities for each process must be identified ("process owners")
The control methods for each process, as well as the measurement criteria, must be defined
Objectives for each process must be defined
Resources & information must be made available to support the processes (which infers, then, that such "resources and information" must also be defined.)
Each process must be monitored and measured
Actions must be taken on the results of monitoring and measurement, which generally constitute reaction plans for negative results("actions necessary to achieve planned results"), and continual improvement plans for positive results ("actions necessary to achieve continual improvement".)

[You will notice that within these requirements is the PDCA (Plan-Do-Check-Act) approach to management.]

Given all these requirements, it is best to organize them into useful steps, defining your processes much the way an artist paints: starting with broad strokes, and gradually adding sharper lines until the picture is crisp with detail. To accomplish this, we will use two specific tools: a "process map" and a "process model." The "map" will lay out the sequence and interaction of overall processes, and then the "model" will define each process in greater detail.

STEP ONE (rough detail): Define processes, sequence and interaction (process map)
STEP TWO (clear detail): Define authorities, inputs, outputs, control methods and criteria, reaction plans (process model)
STEP THREE (crisp detail): Define objectives, control methods and criteria, reaction plans (process model)

NEXT: Part Two of this series explains defining and mapping your company's processes.

(c) 2003 Oxebridge Quality Resources. All rights reserved. For reprint permission, contact OQR at www.oxebridge.com.

Christopher Paris is an ANSI-RAB accredited registration auditor, a former chemical process engineer and has been implementing ISO 9001 systems since 1988.