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The ISO 9001:2000 upgrade: tips for a smooth transition
by Mike Delpha
The Dec. 15, 2003, deadline to re-certify to ISO 9000:2000 is fast approaching. The International Organization for Standardization, the governing body of the ISO standards, requires all ISO 9001:1994-compliant companies to now re-certify under a new set of requirements as highlighted by ISO 9000:2000 (ISO 9001 is the actual specification in the ISO 9000 system). If this deadline isn’t met, certification may be withdrawn completely.
Is your company among the ISO-certified that still has yet to make the transition to ISO 9000:2000? If so, then you’re not alone. Currently, industry experts estimate that only about 10 percent of currently ISO-certified companies have completed the upgrade. While the time to get started is now, with the right tools, guidance and know-how, the entire upgrade can be completed in as little as three to six months.
On Dec. 15, 2000, ISO 9001:1994 (the specification for the quality management system) was officially replaced by ISO 9001:2000. In addition, ISO 9002:1994 and ISO 9003:1994 were discontinued. Rather than choosing a standard with the appropriate scope, all companies can now use ISO 9001:2000, but they will be allowed to reduce the scope of the standard to exclude requirements that don’t apply. The role of ISO 9004 in the series is unchanged. As in previous editions, ISO 9004:2000 is a guide for developing quality management systems, but has now been incorporated into ISO 9001:2000 for a streamlined approach.
The upgraded ISO standards demand a much more comprehensive and improved quality management system. The new ISO standard is more customer-focused and requires companies seeking ISO certification to achieve, measure, and monitor customer satisfaction as well as improve communication with customers. The 9001:2000 standard also emphasizes the need to make ongoing improvements and evaluate the effectiveness and suitability of quality management systems, and to identify and implement system improvements.
In 1987, the International Organization for Standardization, comprised of national standards bodies from 140 countries, developed a set of quality management documents to help facilitate global commerce. These documents – collectively called ISO 9000 – set forth specific guidelines and rules for best management and production practices.
The organization’s reasoning was simple: Meeting the ISO 9000 guidelines would enable the company to implement a quality management system in order to best manage the consistency and quality of output. The company’s ISO status alerts potential customers, partners and suppliers to this quality commitment. Additionally, manufacturers with multiple plants around the world would knowingly produce consistent products that meet specifications – whether produced in Canada or Russia.
Despite widespread belief to the contrary, the International Organization for Standardization itself does not certify companies that have implemented the ISO standards. Instead, independent quality system certification bodies conduct audits to determine if a company has successfully met the ISO 9000 requirements. If so, the organization receives a certificate of conformity and is free to leverage its new status in the marketplace.
A survey conducted recently by the Canadian Manufacturing Association showed that companies have recouped the costs of preparing for successful ISO 9000 registration within 18 months from business process improvements as a result of certification. Clearly, there is value in being ISO certified; it is a must for any company to issue bids, win business overseas and improve profits, not to mention improve customer service and communication.
Other documented benefits of ISO include:
• increased sales by 20 percent, on average;
• reduced costs by 35 percent in the first year; continual cost reductions averaging 61 percent by year five after certification;
• increased market share by an average of 51 percent;
• reduced waste by an average of 46 percent;
• increased exports by 37 percent;
• decreased product development time by as much as 50 percent, accelerating time to market;
• improved competitive advantage as reported by 72.3 percent of ISO-certified corporations;
• increased business opportunities; 69.3 percent of companies without an ISO 9000 system in place lost a customer or bid to an ISO-certified competitor; and
• increased employee retention by 20 percent.
Acording to ISO, a total of 408,631 ISO 9000 certificates have been issued worldwide.
Between 1999 and 2000 alone, nearly 65,000 new certificates were issued – representing the second highest growth in the number of certifications since 1993. The new standard can be used as a business management system and, therefore, it has a wider application to a range of industries and organizations. As a result, the number of certifications is expected to double.
What exactly is ISO 9001:2000?
A basic understanding of the 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 procedures for customer communication; and
• implement a system for obtaining and using information on customer satisfaction.
Together, these requirements demand organizations to 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 between 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 quality system; and
• 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 miscellaneous 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, the new 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. 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 and quality management systems are throughout the organization. Fortunately, there are time and cost-saving tools to make the ISO 9000:2000 upgrade a smooth transition.
Technology tools
Prism eSolutions offers one such tool, a Web-based platform called equationASP QMS Upgrade. It offers timesaving features to ease you through the upgrade process. equationASP QMS Upgrade cuts the time and cost of ISO implementation by 50 percent. The product includes updated ISO templates, samples, online training and proven ISO methodologies that decrease the time spent in developing additional documentation – a primary cause of upgrade delay and certification failures.
In addition, the product’s project management system outlines the complete project and sets deadlines for every step, assuring timely project completion and compliance. equationASP QMS Upgrade does not require a significant investment in hardware, software, or extensive internal IT/IS personnel support. In addition, it reduces the administrative costs of managing an ISO system by 80 percent and enables you to determine how much consulting time your business actually needs to upgrade to the new standard. For these reasons, it offers a cost-effective approach to the ISO-upgrade process.
Specifically, the equationASP QMS Upgrade features:
• document management system with archiving, version control and search capabilities;
• enhanced communication and collaboration tools;
• automatic e-mail alerts on expiring documents;
• easy, controllable access to the most up-to-date documents, 24/7;
• clear explanation of the differences between ISO 9001:1994 and ISO 9001:2000; and
• online on-demand training such as internal auditor, management overview and employee understanding and involvement.
Certification quick tips
ISO 9000 re-certification can be a fast, cost-efficient process. Here are a few other helpful hints to keep in mind as you prepare for re-certification under ISO 9001:2000.
1) Understand the new and changed requirements. The American Society for Quality (ASQ) at www.asq.org and ISO at www.iso.org are both good places to start.
2) 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 product category. However, not all requirements in the new standard will be relevant to all organizations. Under certain circumstances, an organization may exclude some specific requirements.
3) 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 quality management system.
4) Revise your quality manual and procedures. The documentation for a compliant quality management system must include the quality policy, quality objectives, quality manual, required procedures and other documents deemed necessary for its effective planning, operation and control.
5) Focus on the expanded top-management roles. ISO 9001:2000 defines top management as the person or group of people who directs and controls an organization at the highest level. Top management leadership, commitment and active involvement are essential for an effective quality management system.
6) Establish measurable quality objectives. Your organization needs to identify the key quality measures for evaluating the performance of your quality management system. 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.
7) Prepare your transition plan. To form your transition plan, assess your 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.
8) Inform your organization of changes and plans. It is important to keep everyone within the scope of your 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.
9) Update your audit program. Since the quality management system will be revised to comply with ISO 9001:2000, your internal audit schedule should focus on the areas of new and changed practices.
10) 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.
Prism eSolutions, LLC is an international Web-based applications, consulting and training company specializing in ISO 9000/QMS, ISO 14000/EMS and other areas of strategic process and business improvement. Mike Delpha is vice president of operations for Prism eSolutions. He can be reached at or .
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