The ISO 9001:2000 requirements document follows a concept called the Plan-Do-Check-Act model—a process that is designed for continual improvement of any management system. This cycle is critical to understand the new standard and its requirements. Keep this in mind as you read ISO 9001:2000 and ISO 9004:2000 because you’ll see some, if not all parts, of the PDCA cycle in nearly every clause.

The basic concepts of the PDCA cycle were originally used in the ISO 14000 series of Environmental Management System standards and are pretty straightforward:

Plan—This is a critical stage, and ISO 9001:2000 is riddled with proper planning requirements and suggestions in nearly every clause. But the basic concept is simple—formulate a plan to fulfill your quality policy and the objectives of the system. But just remember the old adage—if you fail to plan, plan to fail. It is certainly applicable with ISO 9001:2000.

Do—This is a fairly simple concept as well. It means implement the processes you’ve laid out in your plan.

Check—This means monitor and measure what you’re doing so that you have data to evaluate and improve the processes and overall system.

Act—After you have data, you must do something with it to improve, and, of course, plan for the improvement (which begins the cycle again). The "act" usually stems from management reviews, internal audits, customer audits, data gathering or even third-party assessments. More information on all of these items is discussed later in this Module.

Continual improvement is a fairly simple concept to grasp—whatever you do in your business, implement a process to ensure it is done better the next time.

In ISO 9000:2000, "continual improvement" is defined this way: "Recurring activity to increase the ability to fulfill requirements." However, the definition has a specific note attached to it to add clarity. It states that the process "of establishing objectives and finding opportunities for improvement is a continual process through the use of audit findings and audit conclusions, analysis of data, management reviews or other means and generally leads to corrective or preventive action."

In terms of requirements to the quality system, think of continual improvement as the common thread woven throughout ISO 9001:2000. It really is the stitch that holds it all together, because it requires a commitment from top management to improve the system and the business holistically. From the planning phase to management reviews, continual improvement affects all aspects of everything you do, because at the end of the day, improving the business will enhance customer satisfaction and increase the business’ bottom line.

The concept of improvement is somewhat new to ISO 9001:2000 and it even has its own section to ensure it occurs at every level (clause 8.5). In the old standard, it was implied but never explicitly required.

In short, management should proactively seek to improve process effectiveness rather than wait for problems to reveal opportunities for improvement. When a problem does occur, the cause must be determined and a corrective action taken to prevent its recurrence. The management system includes a formal way to trigger this action and see it to closure. The standard requires a trend analysis of those business problems.

The new standard emphasizes planning for the system, its resources, its processes and the measurements necessary to evaluate performance. Part of the planning is to anticipate what might go wrong and try to prevent the occurrence of these potential problems.

Even when processes are producing compliant products (to regulatory and customer requirements), the processes could be more efficient and effective. The aim of a continual improvement program is to increase the odds of satisfying customers by identifying areas needing improvement. After setting improvement objectives, the organization searches for possible solutions, selects and implements the appropriate one and evaluates results to confirm objectives are met.