ISO 9001 ISO 9001 2000 in the USA article

Why ISO 9001 in the USA?

Since the 92-nation International Organization for Standardization (ISO) issued a set of standards for assessing potential suppliers' quality control systems in 1987, worldwide interest in the standards, known as ISO 9001 2000, has virtually exploded. Sixty countries already have adopted ISO 9001 2000. In the United Kingdom alone, over 20,000 plant sites are certified. ISO 9001 2000 may have become the price of admission for doing business in the European Community.

Increasingly, ISO 9001 2000 is becoming the price of admission for doing business in the United States, too. In 1992, only 400 U.S. plants were certified as in compliance with ISO 9000. By July 1993, almost 1,500 U.S. plants had been certified. In all likelihood, thousands more U.S. plants eventually will seek to comply with ISO 9000 standards. A survey of mid-sized manufacturers released last November projected that as many as 20,000 plants could be certified by the end of 2004.

Why should CPAs be interested in the standards?
(1) CPAs can give their companies or clients a competitive edge by providing advice on this emerging domestic and international business issue, before certification becomes a standard business practice.
(2) CPAs can expand their repertoire of audit services by becoming certified to perform ISO 9001 2000 quality system audits.

This article explains the regulatory and business reasons why companies seek ISO 9001 2000 certification, describes the certification process and tells CPAs where to get information on obtaining certification to perform quality system audits.

WHAT ISO 9000 MEANS TO U.S. COMPANIES

U.S. companies obtain ISO 9000 certification for four reasons.

	The EC legally requires suppliers of certain regulated products to have ISO 9001 2000 certification. Regulated products are those that have important health, safety or environmental implications, such as medical devices, construction products or telecommunications equipment. Since about half of the more than $100 billion in U.S. exports to the EC are regulated products, this requirement has a significant impact on American companies.
	ISO 9001 2000 certification enables companies to compete for business from individual customers (both foreign and domestic) that contractually require their suppliers to be certified. This is not just an overseas issue. American companies such as Motorola, Xerox, IBM, General Electric, Eastman Kodak and the three largest U.S. auto makers require certification. The North Atlantic Treaty Organization and the U.S. Department of Defense also require suppliers to obtain ISO 9001 2000 certification.
	Certification enables companies to differentiate themselves from non-certified competitors. For example, Dow Corning sees certification as a way to establish a competitive advantage and has 12 certified sites.
	Most important, many managers insist the process of creating, documenting and establishing the controls for a quality system actually is a catalyst for improving quality. For example, half of DuPont's 240 worldwide facilities are certified. At its Emigsville, Pennsylvania, plant, which makes plastic connectors for computers, employees claimed the defect rate fell from 30% to 8% as a result of participating in the ISO 9001 2000 program. European DuPont sites reported benefits such as increased manufacturing yields and a decrease in customer complaints. In addition, Rockwell International's Allen-Bradley plant in Twinsburg, Ohio, improved productivity 21% and decreased cycle time and product defects by 18% and 32%, respectively, since obtaining certification.

OBTAINING CERTIFICATION

ISO certification is not given to products or companies. It applies only to individual plant sites.

ISO 9001 2000 is by far the most the most comprehensive standard released and is intended for use in companies that take products from the drawing board to the consumer. Companies that design and develop, produce, install and service their products seek ISO 9001 certification.

After determining how the ISO 9001 2000 standard applies to their operations, companies should obtain as much information as possible, the articles on this web site is a good starting place These articles provide guidance on applying ISO 9001 2000 to the processes affecting quality within your business and on installing mechanisms to ensure workers follow through on the documented procedures.

For instance, a company seeking ISO 9001 2000 certification must have an internal team verify that written procedures, actual practices and records are in compliance with the requirements of ISO 9001 2000. It is always advisable to employ a quality expert or consultant to carry out the initial gap analysis audit, because if you start off in the wrong direction you will just be wasting valuable time, resources and money.
A qualified external certification body inspects the company's quality system, and if appropriate, awards a compliance certificate. (The certification body's role is explained in the next section.) If any problems (called nonconformances) are found during an audit, they must be corrected before certification can proceed. Such an audit can take 2 to 10 days depending on the size of the business and the number of nonconformances. Registration fees can exceed $10,000 to $20,000 per site. Maintaining certification requires periodic visits from the certification body (usually every six months) that cost between $2,500 and $5,000 per visit, and a reaudit every three to four years. Fees for a reaudit normally are about two-thirds of those for an initial audit.

SELECTING A REGISTRAR

Forty companies in the United States perform ISO 9001 quality system audits. However, only eight of them are accredited by the Registrar Accreditation Board (RAB), which is the official accrediting body in the United States (see exhibit 2 for its address). Selecting an accredited registrar is generally desirable but is not a foolproof strategy because recognition of accreditation internationally does not yet exist.

Given the lack of mutual recognition of accrediting bodies, the key to selecting a registrar is client or customer needs. For companies that have European subsidiaries seeking ISO 9000 certification, the best option is to select a registrar accredited by the appropriate board in a subsidiary's home country. Sites on U.S. soil that sell to U.S. customers should select one of the registrars accredited by the RAB. There are multiple options for U.S. sites that want to sell to customers in the EC: Such companies can seek certification from the U.S. division of a European registrar (such as Lloyd's Register Quality Assurance Ltd. in New York City or the National Standards Authority of Ireland in Merrimack, New Hampshire) or they can obtain certification from U.S. registrars that have been accredited by a European body. The key is to determine what is acceptable to the client or company requiring certification.

Another issue that companies may want to consider before choosing a registrar is industry expertise. Accredited registrars usually are authorized to audit quality systems only in certain industries.

ISO AUDITOR CERTIFICATION REQUIREMENTS

CPAs can expand their services to their companies or clients by obtaining certification to perform I SO 9000 quality system audits. Certification is available through the national certification body, such as the RAB in the United States. There are three progressive grades of auditor certification: q uality systems provisional auditor, quality systems auditor and quality systems lead auditor. Each has education, training and workplace experience requirements that candidates must satisfy. An initial application fee of $100 is required along with annual renewal fees of $150 to $200.

WHAT ISO 9001 200 DOES NOT DO

ISO 9001 2000 certification does not guarantee that a company produces quality products. It certifies only that a system of policies and procedures is in place to make the manufacture of quality products possible. A company can produce ISO 9001 2000 certified products that no one wants or needs. As Richard C. Buetow, director of corporate quality at Motorola, explains: "With ISO 9000 you can still have terrible processes and products. You can certify a manufacturer that makes life jackets from concrete, as long as those jackets are made according to the documented procedures and the company provides the next of kin with instructions on how to complain about defects."

This Article was Provided by a Driso Consultant.

Driso provide ISO 9001 2000 consultancy, auditing, software, and training Services.
They also supply Easy ISO 9001 2000® software for initially setting up an ISO 9001 2000 compliant Quality Management System or improving upon an existing one.
Click here to contact Driso Consultancy Services. See what they can do for you and your business.

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