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by Denise E. Robitaille

It finally happened. On Dec. 16, 2003, the ISO 9000:1994 series became obsolete. The long-awaited deadline passed with much less fanfare than the hype that preceded it. Simply stated, the International Organization for Standardization along with all accreditation and certification bodies have stopped supporting ISO 9001/2/3:1994 as the approved standards for quality management systems. ISO 9001:2000 has replaced them.

What does this mean for companies that didn’t transition before the deadline? To answer that question, we must take a look at what did and didn’t happen.

Unregistered company blues

Organizations holding certificates for ISO 9001:1994 may no longer claim to be “ISO 9000-registered”--a phrase that, through common consensus, refers to companies which have successfully passed assessment audits conducted by auditors representing accredited registrars and, further, have undergone surveillance audits from the same bodies substantiating their continued conformance to the standard.

Companies that haven’t transitioned can no longer make statements about being registered, include registrar or accreditation body logos (such as ANSI-RAB NAP or UKAS) on their literature or sign off on supplier surveys as ISO 9000-registered businesses.

For companies whose customers require registration to ISO 9001 as a condition of continued contracts, their now-expired registrations portend the loss of critical accounts as well as a change in status among industry peers and competition. These represent the two greatest perils attending the loss of ISO 9001 registration: failure to fulfill customer requirements relative to maintaining a quality management system and loss of market share through diminished stature in a particular selling arena.

Both of these risks are real and shouldn’t be dismissed lightly. By not maintaining its registration, a company loses the entry ticket to many marketplaces and a basic tool for satisfying customers. An organization must weigh these risks against the costs associated with transitioning to the new standard.

The requirements and costs associated with upgrading to the revised standard vary for each organization. Consequently, the value a company places on registration, weighed against those requirements and costs, will also vary. Any top management team would profit from a discussion regarding the return on investment for such an expenditure, regardless of the economy’s effect on the company during the last two years. The economic climate has significantly influenced this deliberation for some companies as they struggle to make optimum use of shrinking resources. As with most critical decisions, there’s no easy answer. We all must determine what makes good fiscal sense for our companies.

Retaining customers through a specific ISO 9001 requirement might be the strongest justification for upgrading your QMS to the 2000 revised standard, but it’s not the only one. It’s important to remember that the best reason for implementing an ISO 9001-compliant QMS is to improve the way you do business. Inherent in ISO quality management system models is the critical goal of any company: to prosper through fulfilling customer-specified requirements. By consistently using the tools found in ISO 9001, an organization can fulfill its customers’ requirements. These tools include effectively allocating resources, controlling processes, training competent personnel, working with qualified suppliers, maintaining adequate documentation, conducting product and process monitoring, and applying appropriate metrics.

OK, so you didn’t make the transition. Does this mean you’re doomed? Not at all. The fact that you can no longer claim ISO 9000 registration doesn’t automatically degrade your system. You still have the same great company that existed before its registration lapsed. You didn’t arrive at work on Dec. 16 to find operators running amok, machines broken down, inspection records shredded, salespeople babbling nonsense, micrometers giving bad readings, material disintegrating and the lunchroom going up in flames. The only thing that changed was your ISO 9000 registration status.

Managers might ask, and rightfully so: “Then why bother transitioning at all? Why bother to even discuss this issue? And why did ISO change the standard in the first place?”

Taking the questions in reverse order, it’s worth exploring how we arrived at this need to “transition” out of what we thought were perfectly adequate systems.

Why did ISO change ISO 9000?

According to its own bylaws, ISO is required to review its standards at a minimum of five-year intervals to ensure their continued applicability and to make changes as deemed appropriate. This is similar to the requirements most organizations have for reviewing and monitoring their own systems. It reflects a commitment to continual improvement, one of the basic management principles found in the ISO 9000 family of standards.

It’s also a good idea.

When members of ISO Technical Committee 176 reviewed the standard, they realized they could improve it by making it more user-friendly and applicable to a typical organization. A tremendous amount of effort went into the revisions that followed. The standard’s structure was revamped and additions made in the areas of executive management, customer relations, and internal communications and interactions.

Why bother discussing the transition?

Discussing the benefits of transitioning to ISO 9001:2000 can yield important information about how your company might proceed with the project. Like all management decisions, this one must take into consideration another quality management principle found in the new standard, namely, a “factual approach to decision making.”

In other words, you shouldn’t expend resources without understanding the benefits such an outlay would bring or the implications it has for your bottom line. You shouldn’t transition to ISO 9001:2000 simply because your registrar recommends it. Rather, you should upgrade your system because you know, based on reliable research, that doing so would benefit your company. Without the discussion, the transition would strike many managers as just another unfunded, irresponsible mandate promulgated by disinterested entities with no connection to the business community. Given this attitude, it’s not surprising that managers would comply to the transition grudgingly and with a visible lack of commitment.

If your customers don’t mandate your registration to the standard, your industry and competitors don’t espouse quality management systems, you’re confident that you can maintain your system’s integrity without periodic audits from a registrar and you have limited cash flow, you may not need to upgrade your system.

It’s more likely, however, that one or more of the following is true:

Your customers have more confidence in ISO 9001-registered companies, regardless of what they demand of you. As the economy recovers, they might find it more cost-efficient to align themselves with suppliers whose systems are certified by independent, third-party assessors.

Few markets fail to recognize certified quality management systems as a basic benchmark--the minimum requirement for doing business in that particular industry.

It’s difficult to maintain a reliable quality management system without the support inherent in objective third-party audits.

The ROI usually outweighs the negative effects of the initial outlay for the transition project.

In short, you should have the discussion, but the conclusion most organizations will reach is that upgrading to ISO 9001:2000 is a prudent expenditure of resources that will yield significant results.

Why transition if you already have a great system?

Aside from the customer-requirement motivation, you might also decide to transition because ISO 9001:2000 includes some great tools to help you run your organization more efficiently. For one thing, it’s been reformatted to parallel more closely how businesses operate.

Typically, businesses set up a system, provide resources, perform the activities that result in bringing a product to market (such as planning, getting customer specifications, designing, purchasing raw materials, producing the product, then inspecting, identifying, storing and, ultimately, shipping it), review the results to see what worked, decide what must be improved and act on that decision. ISO 9001:2000 is laid out in the same way most business operation models work.

The new standard’s organization reflects the process approach, an underlying quality principle from ISO 9004:2000 and a feature that permeates the entire quality system. Basically, you structure your system as a series of processes. These create the inputs and outputs that move you from concept to product delivery. Initiating an activity directly results from fulfilling the preceding one; nothing happens without a requirement. There are no purposeless or isolated activities. Everything is linked, providing traceability and increased accountability.

The standard places a greater emphasis on management’s involvement and attention to processes that ensure customer requirements are communicated and understood throughout the organization. Other additions to ISO 9001 that will benefit your organization include:

Enhanced requirements for qualifying and monitoring suppliers

Defining, monitoring and analyzing customer satisfaction

Establishing measurable objectives

Defining the criteria for competency and training effectiveness

Focusing on continual improvement

Gathering and analyzing data relative to product conformity, process trends and other applicable performance indicators

Beyond the benefits of the revised standard, the transition project itself carries its own payback. This includes:

Rejuvenating your quality system

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

Creating a documentation structure more closely aligned to how your business operates

Increasing employee awareness of how your quality system works

Creating a more efficient and meaningful ISO 9001 system

Improving control over your supply chain

Assuming you’ve decided to proceed with the transition, here are a few things to bear in mind:

A lot stayed the same. Although the requirements have been shuffled around a bit and renumbered, the standard’s intent remains unchanged. All the requirements organized into clauses such as “contract review,” “design control,” “purchasing” and “inspection” still apply. If you take a quick look at Annex B at the back of ISO 9001:2000, you’ll see where the requirements from the 1994 version landed in the revised standard.

A complete overhaul isn’t necessary. Many companies are overwhelmed by the thought of trashing their systems and starting 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.

The December 2003 expiration date has passed. Whatever timetable you establish for transitioning will be based on your requirements--and probably partially driven by your customers. Make this project work for you; insist that it have value.

The transition process remains essentially the same. Just because the December deadline passed doesn’t mean you can’t transition. True, your registrar must conduct a new assessment audit, rather than a transition or special surveillance. And you’ll probably incur additional costs that accompany new registration. Whatever the registrar calls it, though, it’s still a transition to you. You’ll be performing the same tasks and activities as companies that transitioned before the deadline. You don’t have to apologize to anyone about when you decided to upgrade to ISO 9001:2000.

There is, however, one caveat: If you have major gaps in your system, transitioning shouldn’t be your main focus. You must first regain control of your system. It’s possible that the transition project will help you address some of the troublesome issues that have received little attention in the past or give you a fresh look at inconsistent areas.

What must you do?

Keep in mind the following general guidelines to facilitate your transition project and keep you on track:

Contact any customers who require you to have ISO 9001 registration, and tell them you’re working on it. Customers don’t want to lose good suppliers or incur the costs of evaluating and qualifying a new vendor. If you’ve provided them with great service in the past, they should be willing to continue business with you as you transition. Negotiate a no-later-than date and stick to it.

Don’t let any great practices you currently have in place degrade. Don’t fix what isn’t broken. A measure of how good your current system is might be how well it functions in the midst of change.

Use your system’s tools. You have a document control procedure that describes how you review current documents for revision and how you create new ones. Refer to that procedure for guidance throughout this process. If your procedure doesn’t help you, then maybe it’s also a good candidate for revision.

Do a gap analysis to figure out what doesn’t have to be changed. There are lots of good books on the subject to help you out. The tools to achieve this transition have already been created; use them to your benefit.

Hold a management meeting. Discuss the changes and what they mean to your organization. There’s a lot more flexibility built into the new standard, particularly about deciding on the volume and depth of your documentation. For example, you might decide to use flowcharts displayed on bulletin boards instead of procedures or opt for photos and graphics instead of text. You must make decisions about monitoring key processes and gathering data. You also must determine the best way of assessing your customers’ satisfaction. You all must agree on the process and who will be responsible for overseeing various tasks.

Don’t renumber your system to match the new standard unless doing so creates value for you. Don’t allow a registrar or consultant to convince you that renumbering is a requirement. You can show them instead where and how the requirement is addressed in your system for the purpose of conformance.

Retrain your auditors. They must understand the changes to ISO 9001 requirements as well as the new emphasis on process approach. This will ultimately result in more productive audits.

Relax. If you have a question, feel free to contact me.

Good luck with your transition project. Make it a value-added experience for your organization.

About the author

Denise E. Robitaille is a consultant, writer and trainer. She’s also a lead assessor and certified quality auditor. She is the author of The (Almost) Painless ISO 9001:2000 Transition, The Corrective Action Handbook, The Preventive Action Handbook and The Management Review Handbook, all available from Paton Press (www.patonpress.com).