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by Denise E. Robitaille

The ISO 9001:2000 transition has held center stage in the quality arena for almost three years now. Since the middle of 2000, when the draft issue was circulated, it has dominated the profession. And considering that the number of ISO 9001 registrations in North America exceeds 50,000, the attention is warranted.

There's no denying that the clock is ticking --counting down to Dec. 15, 2003. The ultimatum: transition or expire. Sounds dire, almost apocalyptic.

Let's all take a deep breath, pause, ignore the ticking clock for a few minutes and take stock of the facts. It's true that:

On Dec. 15, 2003, registrars and accreditation bodies will cease to support ISO 9001/2/3:1994 as the recognized, approved international standard for quality management systems.

Any company that hasn't had its system certified by a recognized body to the revised standard, ISO 9001:2000, will have its certificate lapse.

Companies whose customers mandate ISO 9001 registration as a contingency for doing business with them will have a problem if they don't transition.

So, the transition is important. However, it's equally true that despite it's importance, many companies have had to place their transition project in the queue of initiatives that have languished in limbo as organizations struggle to revitalize their particular market sectors in this troublesome economy. Companies have legitimate reasons for diverting resources into other endeavors; this isn't about blame or snickering at the procrastinators. So, again, take a deep breath, cut yourself some slack, and let's take a realistic look at what must be done.

Simply because the transition is important (actually, very important) doesn't mean that it's insurmountable. It will consume time. But that doesn't make it difficult, nor is there any reason why it should disrupt your business. There's still time to accomplish your transition to the ISO 9001:2000 standard. It's even possible to make it a value-added activity that improves your quality system and the way you do business. Instead of grudgingly viewing this as an onerous mandate from an external authority, seize this opportunity to overhaul your system. The benefits of an ISO 9001:2000 transition project include:

Rejuvenation of your quality management system

Introduction of practices that will enhance communication with your customers and your ability to serve them

A documentation structure more closely aligned to how your business operates

Better employee understanding of how your quality system works

A more efficient and meaningful ISO 9000 system

In fact, there's no reason why you shouldn't expect a return on investment from this project. Let's look at what's the same, what's changed and what you must do.

What stayed the same

A lot has stayed the same. All the requirements organized into clauses such as "contract review," "design control," etc., are still applicable. If you take a quick look at Annex B at the back of the ISO 9001:2000 standard, you'll see where the requirements from the 1994 version wound up in the revised standard.

Many companies are overwhelmed by the notion that they must trash their system and start all over again, but nothing could be further from the truth. Much of your ISO 9000:1994-compliant system is fine just the way it is. You're still required to define those activities that are needed to fulfill requirements, implement them under appropriately controlled conditions and provide records as evidence of fulfillment. As long as you're in compliance with your own procedures and with the ISO 9001 standard, you can leave those processes alone and focus on what really must be addressed.

There is, however, one caveat: This process will be of limited value to companies that have allowed their systems to lapse or have permitted glaring nonconformities to go unresolved. If you have major gaps in your system, transition shouldn't be your main focus; you must first regain control. However, it's possible that doing so will help you address some of those issues and/or shed light on a process that has received little attention and is beginning to show signs of inconsistencies.

What changed

The standard has been reformatted and renumbered. It's now structured to more closely parallel how businesses operate. You set up a system, provide resources, perform all the activities that allow you to bring product to market (such as plan, get customer specifications, design, purchase raw materials, produce product, inspect it, identify, store and ultimately ship it), review the results to see what worked, decide what must be improved and act on your decision. That's the way ISO 9001:2000 is laid out --pretty much the way most business operation models work.

You don't need to renumber your documentation to reflect the revised standard. The numbers have value only as they aid you in quickly referencing the applicable ISO standard chapter and verse. Renumbering procedures is a time-consuming activity with little ROI.

Much has been said about the "six mandated procedures." The standard now only makes six references to the need for what we formally refer to as procedures. This doesn't mean that you can get rid of all the other documents. But the shift does acknowledge that the methods of implementing, controlling and monitoring processes are unique to each organization. What constitutes adequate definition and control for a hardware distributor will substantially differ from that of a biopharmaceutical manufacturer.

This approach is consistent with one of the general requirements of the standard. Clause 4.1 of the revised standard clearly directs a company to identify its processes and determine sequence, interaction and criteria for operation and control. In this case, the good news and the bad news are the same: The decisions are yours. You have the freedom to document your system so that it's meaningful to you within the framework of the ISO 9001 standard. You even have the option (limited to Section 7) to exclude certain requirements if you can justify that they're not applicable to your company. In a service industry, the need to control measuring devices --often titled calibration --is a good example of an allowable exclusion.

With the freedom to choose comes the responsibility to give proper and conscientious consideration to the manner in which your system is defined, provisioned, deployed, controlled, monitored and improved. This responsibility lies at the foundation of one of the other changes: Section 5 of ISO 9001:2000. Management involvement must be consistent and visible. The requirements for management review have been more explicitly outlined, and the responsibilities of top management are more detailed. Consequently, it's important that it contributes input into this transition process.

Other changes include:

A heightened requirement to ensure that customer requirements are communicated and understood within the organization

More attention to establishing measurable objectives

The need to define the criteria for competency for training effectiveness

Enhanced requirements for qualification and monitoring of suppliers

The need to define, monitor and analyze customer satisfaction

Increased need to gather and analyze data relative to product conformity, process trends, and other applicable performance indicators

Focus on continual improvement

There are other minor changes. Some of these are logical outcroppings of existing good practices; for instance, 5.5.3 requires management to ensure that appropriate processes exist for internal communication.

Although some of the changes and additions target specific features, others permeate the entire quality system. The process approach is the most prominent. It requires you to structure your system as a series of processes. These create the inputs and outputs that move you from concept to product delivery. Once this system's logic becomes apparent, the new version of the ISO 9000 family of standards becomes much more user-friendly.

There's a fundamental shift in the entire focus of the quality management system. The 1994 version of the standard was based on 20 elements. These were unique features that articulated a quality system's requirements, organized by activities of similar profile. Inspection is the best example: You had inspection of raw materials, inspection of work in progress and final inspection to release goods for shipment. Their connection to the proceeding or succeeding processes wasn't defined. The value of many activities was often difficult to perceive because their justification was obscured by a structure of compartmentalized requirements. ISO 9001:2000 requires you to structure, define, implement, audit and maintain your system based on the premise that no activity is without an input. You must have a reason to do something.

Here are some examples of inputs:

A purchase order is the input that creates the need to receive product. The criteria for receiving and accepting product should be part of the specification on the purchasing document.

The justification for in-process inspection is based on the determined need to evaluate product after one or more defined manufacturing processes. Without manufacturing, the need to do in-process inspection is moot.

The need to inspect may create the input to procure gages.

Generating a work order may be the input to purchase raw materials.

The output of one process may be the input of the next. Everything is an interrelated network of inputs and outputs forming a long chain of many strands with a customer's request for a quote at one end and a trailer-load of goods shipping out at the other. This approach to your quality management system must be apparent to your personnel and visible to your auditors.

What must be done

It's quite possible that you've already implemented some of the requirements of ISO 9001:2000. As mentioned before, these made such simple business sense that companies implemented them as a matter of course. Other requirements, such as enhanced attention to supplier performance, might have been driven by the nature of companies' particular industries.

There isn't one cookie-cutter kit of what must be done. It will vary for every company precisely because this new version endorses a system that best meets an individual company's needs. However, there are some general guidelines you can follow.

Start with a methodical approach to determine what processes are currently compliant and which need some work. Culling the vital few will streamline the process and dispel most of the confusion. Use the appendices at the back of the ISO standards to help you. I've used the very basic device of simply spreading all the current procedures out on a large conference table and then matching them against the requirements of the revision. If the procedure complies with ISO 9001:2000, it goes in the "done" pile. Any requirement left over for which the company doesn't have a document or a controlled process goes into the "to do" pile. That defines the scope of your transition project.

Ensure that key people understand the process approach. This will increase the odds that additions and revisions to the system are meaningful and compliant with the intent of the new standard.

Gather all your data and conduct a management review. The output from the review should result in:

Measurable objectives for enhanced monitoring and analysis requirements

Increased awareness of top management's role in the quality system

Consensus on decisions relative to formatting documentation and control processes

Assigned action items directly related to the transition shared among several stakeholders

Try not to protract the transition process. You will diffuse the focus and end up wasting time. Implement the changes that you must make incrementally. And don't wait to approve all the changes all at once; use the current good practices you have in place relative to controlling document change and training on new procedures.

Remember that this is your system. It must work for you.

It's not too late. There's still time, and it's worth the effort. Given adequate attention, your ISO 9001 transition can be a beneficial and value-added experience for your company.

About the author

Denise E. Robitaille is a consultant, writer and trainer. She's also a lead assessor and certified quality auditor. Much of her work involves assisting companies with implementing and maintaining ISO 9001-compliant quality management systems. She is the author of The Corrective Action Handbook, The Preventive Action Handbook and The Management Review Handbook, all available from Paton Press (www.patonpress.com). Letters to the editor regarding this article can be sent to letters@qualitydigest.com.