Change on the Change on the horizon

Change on the Change on the horizon

THE NEW ISO 9000: 2000 STANDARD WILL CHANGE THE WAY COMPANIES VIEW, IMPLEMENT, AND MAINTAIN QUALITY PROCEDURES.

THE NEW ISO 9000: 2000 STANDARD WILL CHANGE THE WAY COMPANIES VIEW, IMPLEMENT, AND MAINTAIN QUALITY PROCEDURES.

Roughly a quarter of a million firms have registered to ISO 9000 since it was originally conceived in 1987. This series of international standards that establishes Quality Management System (QMS) requirements hasn't changed much since then. However, a radical revision is about to take place at the end of the year. ISO 9000:2000 will not only require that previously certified organizations update their current quality systems, it will also change the ground rules for organizations currently seeking registration.

Like its predecessor, ISO 9000:2000 is really a series of interrelated documents. Each of the three documents has a different function: ISO 9000 deals with fundamentals and vocabulary; ISO 9001 — the heart of the new revision — states the requirements for the new system; and ISO 9004 provides guidance for implementation and fleshes out ISO 9001.

Undoubtedly, many organizations have several questions about the new standard. Here are the answers to the most frequently asked questions.

How does ISO 9000:2000 compare to ISO 9000:1994?
The two standards offer a different model for quality. ISO 9000:1994 defines quality around 20 key elements that a company uses to effectively and consistently produce products and services for customers. The standard was originally designed for manufacturing companies, although it can and has been adapted to apply to processing companies and service organizations. The primary purpose is to assure customers that the certified company produces products at a consistent level of quality. To register to ISO 9000:1994, companies must document what they do, do what they document, and be prepared to prove it.

The quality model in ISO 9000:2000 is quite different. Instead of 20 elements, it is based on a process model that enterprises can use whether they manufacture parts, process chemicals, or provide services. The process model, as laid out in the new ISO 9001, is composed of four sections: Section 5: Management responsibility; Section 6: Resource management; Section 7: Product realization; and Section 8: Measurement, analysis, improvement.

The other sections in ISO 9001 support the model: Sections 0 through 3 provide background information. Section 4: Quality Management System is a precursor to the process model itself, describing how organizations must establish documented quality management systems.

Sections 5 through 8 contain all the requirements for the new ISO stated in more generic and less prescriptive terms than in the previous 20-element model. This makes it easier for various enterprises to fit their operations to the new ISO.

Although the new model may be simpler and less prescriptive than its predecessor, the requirements are progressive. The model's four sections are similar to the Plan-Do-Check-Act (PDCA) improvement process popularized by W. Edwards Deming. This is much more rigorous than the 1994 ISO's watchwords: Do what you document, document what you do, and prove it.

How does ISO 9000:2000 go beyond its predecessor?
ISO 9000:2000 differentiates it-self from its predecessor in a number of ways:

  • Voice of the customer. Organizations must have methods in place to describe and monitor the needs and desires of each customer for every order. They will have to implement processes and procedures to measure and analyze customer satisfaction.
  • Continual improvement. Under ISO 9000:2000, companies can't simply measure customer satisfaction, they have to improve the level of satisfaction as well as measure and improve internal processes.
  • Management responsibility.

In the previous ISO 9000, management was required to establish quality policy, commit adequate resources, conduct a management review, and appoint a management representative to supervise the QMS. But, for the most part, under ISO 9000:1994, the quality management system was largely the responsibility of quality professionals.

The new standard calls for executive management to play a larger role. In ISO 9000:2000, management will now preside over a multi-step version of the Plan-Do-Check-Act process. This process includes five steps.

  • Step 1: Policy. Management establishes an appropriate quality policy that incorporates a commitment to continual improvement and meeting customer requirements.
  • Step 2: Objectives. Management devises a framework for reviewing quality objectives, which are set at relevant functions and levels within the organization.
  • Step 3: Planning. Management develops objectives and a plan that identifies the activities and resources necessary to accomplish the objectives. The planning must be consistent with other quality system requirements.
  • Step 4: Quality management system. Management is held accountable for establishing a QMS, which will enforce the quality policy as well as the requirements of the standard.
  • Step 5: Management review. Management reviews its policy and objectives to find opportunities for continual improvement.

On the basis of this review, management must take action to improve the quality system.

  • Resource management. The resource management section spells out a wide range of specific resources that management must either provide or make readily available. Resources include adequate numbers of competent people, training necessary to assure competence, suppliers and partners, financial resources, efficient and effective infrastructure, and other sources that affect the work environment, such as those that ensure proper safety, ergonomics, and hygiene.

Do organizations that are already registered to ISO 9000 have to start over?
Every element of the older standards can be mapped onto the new ISO 9001. Moreover, since the new version requires written procedures, the familiar four-tier pyramid structure for documentation does not need to be changed. It can, however, be simplified under the new standard.

For example, the policy manual and Tier 1 procedures can be combined. Thus, an organization's current ISO system acts as a foundation for its successor.

Yet, in many cases, revisions may be substantial. As an indication of the degree of change, 12 of the elements in ISO 9000:1994 have been reduced to subclauses. Also, some new procedures are necessary to accommodate additional changes. For instance, ISO 9000:1994 does not address elements such as customer focus, planning, internal communication, human resources, identification of customer requirements, customer communication, customer satisfaction, improvement, and so on — items that are all called out individually in ISO 9000:2000.

But this need not be as over-whelming as it seems. Most organizations already have business processes in place to reach at least some of the requirements of ISO 9000:2000.

What are the advantages and disadvantages of ISO 9000:2000?
Many believe the new standard yields a more effective platform by incorporating such advances as continual improvement and customer satisfaction. For example, it should help companies streamline their QMS and business management systems. Many organizations separate the two; however, ISO 9000:2000 encourages enterprises to combine them.

It should also help companies become more competitive. If an enterprise enjoyed a marketing advantage being registered to the 1994 ISO, the new ISO should give it an even greater edge.

The downside of the new standard is that it will, over time, require currently certified organizations to invest additional time and resources in meeting the requirements of the new standard.

Some organizations will find this less of a challenge than others. For example, those companies already using strategic/business planning processes and procedures to measure customer satisfaction will have a head start, as well as companies that have previously achieved ISO 9000.

How does the transition work for companies that are already registered to ISO 9001, ISO 9002, or ISO 9003? What's the timeframe?
The transition is essentially the same whether a company is regis-tered to ISO 9001, 9002, or 9003. ISO 9001:2000 contains a clause for excluding or modifying requirements so that companies registered under the old ISO 9002 and ISO 9003 can adapt their quality management systems to the new standard. ISO 9002 and 9003 thus become obsolete.

Although three ISO 9000:2000 documents — ISO 9000, ISO 9001, and ISO 9004 — have been circulating in various draft forms since December 1998, no certifications based on the draft documents will be acceptable. The final draft of ISO 9000:2000 is scheduled to be published as an International Standard in the fourth quarter of 2000. Upon publication, an organization will have a maximum of three years to adopt the new standard. In those three years, quality management systems conforming to either the 1994 or 2000 standard will be acceptable. To meet the deadline, organizations should start adopting the new requirements during their surveillance audits. Thus, if all goes according to plan, the conversion process would be complete by the beginning of 2004.

As a rule of thumb, organizations that are either already in the process of registering to ISO 9000 or who want or need to get registered by the end of 2000 can register to the current 1994 version. However, they should begin modeling their system around ISO 9000:2000 in anticipation of the upcoming conversion.

How do we implement the new standard? Will the process be any different than for the 1994 revision?
In general, the implementation process for the 2000 revision should not be much different than the previous version. However, under ISO 9000:1994, an organization could choose to exclude activities they performed, such as design control, from the scope of their registration and seek certification to ISO 9002. Under ISO 9001: 2000, businesses will no longer have the option of excluding activities they actually perform. If companies perform an activity, they must include it as part of their ISO 9001 system.

Basic conversion steps

  1. Obtain copies of the standard and review them. Although ISO 9001 is the key document, ISO 9004 is central because it contains the requirements.
  2. Set up a core implementation or conversion team. If possible, re-constitute the group you used in your original registration effort. This team will bear the primary responsibility for managing the initiative.
  3. Contact your registrar to discuss options and obtain input. If you decide you don't have the expertise internally to carry out the transition, consider hiring an outside consulting and training organization.
  4. Conduct a gap analysis to determine the holes between your current systems and the requirements of the new ISO 9000. Start with Annex B of ISO 9001, which provides tables that show the correspondences between the 1994 and 2000 versions.
  5. Don't confine the gap analysis to your quality management system. Also consider the elements of your business management system and other business processes that may be incorporated into ISO 9000:2000. For example, if you survey your customers to get feedback on your organization's products and performance, you have the initial groundwork for the customer satisfaction process required in the new version.
  6. Decide how you will structure your documentation. The best route is to renumber and restructure your current documentation into the new system. This will take more work up-front but will create a more streamlined system in the long run.
  7. Determine whether or not you have new training needs. Consult with instructors who can help you set up a business operating system based on the Plan-Do-Check-Act process, establish a continuous improvement system, or design customer satisfaction processes.

Clyde Pearch is president and CEO of Eagle Group USA Inc., a training and consulting company based in Troy, Mich. Jill Kitka is a field consultant and the management representative for Eagle Group's ISO 9001 QMS and ISO 14001 EMS.

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