With the deadline just 20 months away, there is no time to waste for converting current certifications to the ISO 9001: 2000 standard. Here's a guide to clearing some of the hurdles.

December 2003 may seem far in the future. But for companies currently certified to the ISO 9001: 1994 standard, time is running out to upgrade to the new version, ISO 9001: 2000. The International Organization for Standardization (ISO), the governing body for the ISO standards, requires all ISO-certified companies to upgrade to ISO 9001: 2000 by Dec. 15, 2003. Otherwise, certification may be withdrawn.

According to ISO, a total of 408,631 ISO 9000 certificates have been issued worldwide, including nearly 65,000 new certificates during 1999 and 2000. Unlike ISO 9000: 1994, which emphasized an individual quality discipline approach, the new standard can be used as a business management system and, therefore, it has application to a wider range of industries and organizations. As a result, the total number of certifications is expected to double within the next few years.

ISO says a survey revealing the number of companies that have upgraded to the 2000 version will be available in June, but some experts estimate that 5% to 10% of organizations have completed the upgrade process.

There are a number of important benefits to making the upgrade--the ability to improve business performance, to heighten customer satisfaction and to bolster profits. With a few pointers in the right direction, the 20 months remaining before the deadline will provide an adequate timeframe to complete the ISO 9001: 2000 upgrade without disrupting normal business practices or draining the budget. But there is no time to put off the project.

A basic understanding of the necessary revisions and preliminary planning can make the upgrade simple and cost-efficient for any company. New requirements are predominantly in the areas of customer-related processes and continual improvement.

With regard to customer processes, the new standards require top management to:

  • Ensure that customer needs and expectations are identified and converted into specific requirements
  • Demonstrate its commitment to creating awareness of the importance of fulfilling customer requirements, needs and expectations
  • Make employees aware of the importance of meeting customer requirements
  • Establish processes for customer communication
  • Implement a system for obtaining and using information on customer satisfaction.

Together, these requirements demand that organizations expand their quality systems to all departments and functions that deal with and represent customers. Typically, these departments include marketing, sales, customer service, billing and servicing.

In the area of continual improvement, many of the elements supporting the continual improvement cycle were already required in previous editions of the standard. But now there is a new, stronger linkage among these elements, and there are several completely new requirements to:

  • Establish quality objectives, and plan activities and resources needed to achieve quality objectives
  • Provide a framework for the development and periodic review of quality objectives
  • Ensure management's commitment to meeting requirements and reviewing the quality system on an ongoing basis
  • Collect and analyze data to determine effectiveness of the quality system
  • Establish a procedure for the use of quality policy, objectives and quality-related data and information to facilitate continual improvement.

ISO 9001: 2000 also includes new requirements pertaining to process control, measuring and monitoring devices, training and awareness, internal communication, work environment, and legal and regulatory requirements.

Rather than being grouped in specific, additional clauses, ISO 9001: 2000 requirements are spread throughout the standard and are often restated and expanded upon under multiple sections. For example, requirements pertaining to process control are first introduced in Section 5, are developed in two separate clauses of Section 7, and then restated in Section 8.

Logical but difficult
This approach follows the logic of the standard's new organization, but it also makes it difficult to identify and interpret the requirements. Often, the intent of the standard can be interpreted only after related requirements are culled from different sections and analyzed together. Identifying the requirements that pertain to continual improvement is also not an exact science.

The effort necessary to implement the new requirements will depend on the complexity of marketing, sales and customer service operations, and how widespread a company's documentation is, and the pervasiveness of its Quality Management System (QMS) within the organization.

To make the upgrade process less daunting, ISO 9002 and ISO 9003 have been eliminated, and their requirements have been incorporated into ISO 9001, resulting in a more simplified QMS implementation. As before, ISO 9004 still serves as an internal guide to the ISO 9001 requirement.

Nonetheless, upgrading to ISO 9000: 2000 will still require dedication, focus and due diligence. The requirements in the ISO 9001: 2000 standard are less prescriptive, but more improvement oriented than the 1994 version. The goal is a better business overall. ISO 9001: 2000 demands that companies achieve, measure and monitor customer satisfaction, as well as improve customer communications. Continual process improvement is also a main priority under the revised ISO 9000 standards.

Getting started
With the correct solution, upgrading to the new ISO 9001: 2000 standard can be a fast, cost-efficient process. To help you get started, Larry Whittington, president of Whittington & Associates (Atlanta), a quality systems training and consulting firm, has provided a few other helpful hints to keep in mind:

  • Understand the new and changed requirements. The American Society for Quality, at www.asq.org, and ISO, at www.iso.org, are both good places to start.
  • Determine the project scope and permissible exclusions. ISO 9001: 2000 is intended to be generic and applicable to all organizations, regardless of type, size and industry. However, not all requirements in the new standard will be relevant to all organizations. Under specific circumstances, an organization may exclude certain requirements.
  • Adopt the process approach. A process is a system of activities that uses resources to transform inputs into outputs. The process approach promoted by ISO 9001: 2000 systematically identifies and manages these processes and their interaction within a QMS.
  • Revise your quality manual and procedures. The documentation for a compliant QMS must include the quality policy, quality objectives, quality manual, required procedures and other documents deemed necessary for its effective planning, operation and control.
  • Focus on expanded top-management role. ISO 9001: 2000 defines top management as the person or group of people who direct and control an organization at the highest level. Top management leadership, commitment and active involvement are essential for an effective QMS.
  • Establish measurable quality objectives. Your organization needs to identify the key quality measures for evaluating the performance of your QMS. Use your quality policy statement as the framework for establishing your process and product goals. Then set specific, measurable targets on the path to attaining these goals.
  • Prepare a transition plan. To form a transition plan, assess the current system against the requirements of the new standard. This gap analysis will identify any missing documentation and practices. Knowing the needed deliverables, you can better determine the appropriate activities and assignments to enhance your current system for compliance with ISO 9001: 2000. Develop the transition schedule in consultation with your registrar.
  • Inform your organization of changes and plans. It is important to keep everyone within the scope of the quality management system informed of your plans and progress. Providing this information will involve everyone in helping to improve performance and meet the established objectives for their areas.
  • Update your audit program. Since the QMS will be revised to comply with ISO 9001: 2000, the internal audit schedule should focus on the areas of new and changed practices.
  • Identify areas for continual improvement. Continually seek to improve process effectiveness through the use of quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions, and management review.

    Tech Tips

    • ISO 9001: 2000 upgrades must be completed by Dec. 15, 2003. Otherwise, an organization's certification may be withdrawn.
    • Only 5% to 10% of organizations have upgraded to the 2000 version.
    • The effort necessary to implement the new requirements varies from organization to organization.

    Documentation System Changes
    The ISO 9001: 2000 standard clarifies the need for documentation and simplifies the documentation process. With the new standards, only six documented procedures are necessary for administration of the system, whereas the 1994 standard required 15.

    However, an organization may choose to document additional procedures beyond the ISO requirements in order to best manage the Quality Management System (QMS). The amount of necessary documentation will vary depending on the size of the organization, types of activities in which the organization is involved, and the complexity of each activity.

    Modifying an existing system to comply with the new ISO 9001: 2000 standard does not require an organization to change its documentation structure, unless areas for improvement or change have been identified. Most of the existing documentation will fold into the new QMS. It is likely, however, that adjustments will be needed to address new specific requirements.