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Seeing the Light?

Companies make personnel moves to emphasize quality

This year, many well-known companies had to deal with major recalls or delayed product launches due to failings in quality systems, processes and outcomes.

Three companies—Apple, Johnson & Johnson and Toyota—have created high-ranking positions focused on overseeing quality, safety and compliance issues. Representatives from all three talked about how these positions or promotions could help head off future problems.

These promotions and new positions could signal a renewed commitment to the value and importance of quality, according to quality consultants. At the same time, the companies know these personnel decisions are good public relations moves in helping reassure customers that the companies are committed to providing quality products customers should continue to buy.

"I think that there are basically two camps of senior executives," said Brien Palmer, an ASQ senior member and the managing principal at a management consulting firm. "One camp believes its company succeeds because of the good business decisions their management makes. Another camp believes that success comes from building organizational capability by developing their culture, their people and their work processes. The former are more egocentric and the latter are more system-centric."

Armand V. Feigenbaum, president and CEO of General Systems Co. and one of today’s leading quality thinkers, said companies that are committed to quality in every aspect of their business tend to be leaders in their industry in long-term financial and customer-satisfaction performance

"I certainly hope there is a trend toward more organizations ‘waking up’ to quality as a driver of business improvement results," he said. "By making these appointments, the involved companies have exposed themselves to a higher level of quality performance expectation in the future. Hopefully, the incentive for these appointments is not purely PR in nature. The proof will lie in the results."

The recent personnel moves include:

  • Apple appointed a new senior vice president of operations dedicated to ensuring the "company’s products meet the highest standards of quality." Jeff Williams, who has been with the company for 10 years, assumed this role after problems surrounding Apple’s new iPhone 4 launch came to light. Issues included a controversial antenna design and problematic Bluetooth performance.
  • Following eight separate recalls since September affecting several brands of its pain relievers, Johnson & Johnson created a new position to oversee companywide quality, manufacturing and compliance issues. Corporate Vice President Ajit Shetty will oversee the push for quality improvement in its pharmaceutical, consumer products, and medical device and diagnostics groups. In addition, Johnson & Johnson appointed chief quality officers for each of its three major business units.
  • Toyota Motor Corp. named Steve St. Angelo, the company’s top North American engineering and manufacturing official, to lead a quality improvement task force that will address the automaker’s well-documented safety lapses that have occurred during the last year. In addition to his role as the head of the North American Quality Task Force, St. Angelo will be a regional representative to a global quality committee headed by Toyota’s president.

If such high-profile quality positions are created simply because of recalls and other events that made headlines, Palmer said, "It’s like closing the barn door after the horse is out. You want it to be done because of the perceived benefits, not in the face of a calamity."

Bob Hayes, the president of a consulting firm, shared Palmer’s thoughts.

"While these quality programs are good for PR in the short term, their true value will be measured by the long-term impact they have on quality and business growth," Hayes said. "Quality programs are aimed at improving the business processes that are responsible for producing high-quality products and excellent service. Improvements in business processes will likely be reflected in improvements to the customer experience and, consequently, increases in customer loyalty."

Hayes’ advice for companies implementing new programs and creating these new quality positions? Improve the chances these quality programs will be effective and useful by properly implementing them. "How companies structure and embed the program into the company culture will impact their success," Hayes said.


—Nicole Adrian, contributing editor


ISO Approves New SR Standard

The new ISO 26000 social responsibility (SR) standard has been approved by the International Organization for Standardization (ISO) and will be available in early November.

ISO 26000 is a guidance standard that includes:

  • Global agreement on SR definitions, principles and core subjects.
  • Guidance on how to integrate SR throughout an organization.

Sixty-six of the 71 countries voted to approve the standard. Work to develop the standard began in 2005.

"Without question, there has been a tremendous amount of time and effort put into creating SR 26000," said Mary McKiel, U.S. EPA standards executive and chair of the U.S. technical advisory group to ISO 26000. "It should be read, evaluated and taken seriously by anyone interested in social responsibility."

ISO Secretary-General Rob Steele called the standard "a powerful tool to help organizations move from good intentions about SR to good actions."

The standard is scheduled to be released next month and will be be available through ASQ at www.asq.org/social-responsibility-standard/index.html.

SR conference

ASQ has also announced plans for a new SR conference June 16-17, 2011, in San Francisco. The event will feature speakers and sessions focused on SR research studies by IBM and Manpower, SR case studies and ISO 26000.

"This conference will provide an opportunity for business leaders to understand the modern views of SR, how the new ISO 26000 standard will provide a framework for developing SR objectives and programs, and how the concepts, techniques and tools of quality play a major role in implementation and measurement of SR success," said Paul Borawski, ASQ’s executive director and chief strategic officer.

Planners have issued a call for papers for the conference. For more on the event and the call for papers, visit www.asq.org/conferences/social-responsibility.


Survey Shows Manufacturers Down on Economy

Manufacturing leaders said they’re pessimistic about the U.S. economy, and only one-third said they expect it to improve in the next six months, according to a recent survey.

The quarterly survey, conducted by Grant Thornton LLP, an accounting and consulting firm, also reported that only 37% of manufacturing business leaders plan to increase hiring in the next six months.

The majority of business leaders, however, said they are upbeat about their own businesses: More than three-quarters—77%—said they feel optimistic about their companies’ growth potential during the next six months. 

"Manufacturers are very optimistic about the factors that they can control, such as their own productivity, quality of their products and ability to control internal costs. They are pessimistic on matters that they feel are beyond their control," said Walter Gruenes of Grant Thornton.

Visit www.grantthornton.com/boi for more details from the survey.


Quick Poll Results

Each month at www.qualityprogress.com, visitors can take an informal survey, and we post the results.

Here are the numbers from a recent Quick Poll:

"Which lean basic best ensures project success?"

  • Lean is a mind-set, not a toolset. 46.3%
  • Lean is a journey, not a destination. 41.4%
  • Lean is about people, not techniques. 12.2%

Visit www.qualityprogress.com for the most recent poll question:

"What’s the most important feature of a useful audit?"

  • Brevity.
  • Clarity.
  • Consistency.
  • Positivity.

Popularity Contest

QP regularly tallies the top clicks to www.qualityprogress.com. The five most-accessed articles in September were:

  1. "Root Cause Analysis for Beginners," by James J. Rooney and Lee N. Vanden Heuvel, July 2004, http://asq.org/pub/qualityprogress/past/0704/qp0704rooney.html.
  2. "Likert Scales and Data Analyses," by Elaine Allen and Christopher A. Seaman, Statistics Roundtable, July 2007, http://asq.org/quality-progress/2007/07/statistics/likert-scales-and-data-analyses.html.
  3. "Career Climb," by Diane G. Kulisek, Teresa Whitacre, Russell T. Westcott, Hank Lindborg and Greg Hutchins, January 2010, http://asq.org/quality-progress/2010/01/career-development/career-climb.html.
  4. "Test Run," by Govind Ramu, January 2010, http://asq.org/quality-progress/2010/01/certification-asq/test-run.html.
  5. "Leaning Toward Green," by Christopher D. Chapman and Newton B. Green II, March 2010, http://asq.org/quality-progress/2010/03/lean/leaning-toward-green.html.

ASQ News

NEW ENTERPRISE MEMBERS Intel, the world’s largest semiconductor-chip maker, the Abu Dhabi Water and Electricity Authority in the United Arab Emirates, and the Tata Group of Mumbai, India, have become the latest ASQ enterprise members. They join 30 other organizations at this membership level. Visit www.asq.org/membership/organizations/enterprise.html for more information about enterprise memberships.

QUALITY CONFERENCE—MEXICO ASQ Mexico will host its second quality conference Oct. 6-7 in Chihuahua, Mexico. ASQ President David Spong is scheduled to speak at the event. The society has partnered with five organizations and groups in presenting the conference: Instituto Tecnológico y de Estudios Superiores de Monterrey, Campus Chihuahua; Universidad de Chihuahua; Centro Chihuahuense para la Calidad y Productividad; Centro de Investigación de Materiales Avanzados; and ASQ Section 1429, Juárez. To request more information, e-mail ASQMexico@asq.org.

ASQ IN INDIA India’s Registrar of Companies has given ASQ the green light to move forward with plans to operate in the country. Last month, the registrar officially recognized and commissioned the American Society for Quality India Pvt. Ltd. to conduct business in the local currency. This step is a legal requirement for any company or organization that intends to conduct business in India. ASQ’s India office, which will be located in New Delhi, is expected to open this month.

FIRST MBB EXAM Nine people at nine different sites—including spots in Ireland and India—took ASQ’s first Master Black Belt (MBB) certification exam in late summer. The number of test takers who passed was not available at press time. The next MBB certification exam will be held March 5. Visit http://asq.org/certification/master-black-belt/index.html for more information.

SERVICE AWARDS The U.S. Technical Advisory Group (TAG) to ISO/Technical Committee (TC) 207 on Environmental Management recently honored members Dorothy Bowers and W. Gary Wilson with the Distinguished Service Award. Bowers and Wilson, former chairs of TAG 207, were recognized for their longtime commitment and dedication to the TAG. The awards were presented by current TAG 207 Chair Sue Briggs at the TAG’s August meeting in Washington, D.C.

Word to The Wise

To educate newcomers and refresh practitioners and professionals, QP features a quality term and definition each month.

Self-directed work team (SDWT)

A type of team structure in which much of the decision making regarding how to handle a team’s activities is controlled by the team members themselves.

Source: "Quality Glossary," Quality Progress, June 2007, www.asq.org/quality-progress/2007/06/quality-tools/quality-glossary.html.



The number of organizations that received Asia Pacific Quality Awards earlier this year. The Asia Pacific Quality Organization recognized the organizations for their world-class quality performances at recent ceremonies in Nepal.

The World Class award recipients are:

  • Large manufacturing: Larsen & Toubro Ltd., Maharashtra, India.
  • Large service: Dahanu Thermal Power Station, Reliance Infrastructure Ltd., Mumbai, India; and GTL Ltd., Mumbai, India.
  • Education: Universiti Tenaga Nasional, Malaysia.

The following organizations received the Best in Class award:

  • Large manufacturing: Viglacera Halong Joint Stock Co., Vietnam.
  • Large service: ICICI Prudential Life Insurance, Mumbai, India; and Phu Nhuan Jewellery Joint Stock Co., Vietnam.
  • Small service: Shanghai Electric Power Design Institute Co., Shanghai, China.
  • Education: Colombo International Nautical and Engineering College, Sri Lanka; and the Global Indian International School, Malaysia.
  • Not for profit: Gerencia de Centrales Nucleoelectricas, Mexico.

The following six organizations won the Quest for Excellence award:

  • Large manufacturing: Lanxess India, Thane, India; and Marico Ltd., Mumbai, India.
  • Small service: First Philippine Industrial Corp., Philippines; and Long Hau Corp., Vietnam.
  • Healthcare: Moolchand Medcity, New Delhi.
  • Education: Mepco Schlenk Engineering College, Sivakasi, Tamil Nadu, India.

For more information about the awards and the ceremony, visit www.apqo.org.


QP looks back on a person or event that made a difference in the history of quality.

Oct. 14, 1900

W. Edwards Deming was born on this date in Sioux City, IA. Revered as one of quality’s gurus, Deming is known as the father of the Japanese post-war industrial revival and regarded as one of the leading proponents of quality in the United States.

In 1950, the Union of Japanese Scientists and Engineers and the offices of the Supreme Commander of Allied Power invited Deming to Japan to present lectures and training courses. His impact on Japan continued through later visits during which he conducted courses, seminars and clinics. Evidence of his legacy in Japan includes the establishment of the Deming Award and the incorporation of his quality control course into many of today’s training activities in Japan.

In the United States, Deming was rediscovered in the early 1980s. Deming’s published works include Out of the Crisis and The New Economics for Industry, Government, Education, which explain his system of profound knowledge and 14 points for management.

Additional Resource


Study: Healthcare Groups Should Disclose Mistakes to All Patients

Healthcare organizations should disclose information about mistakes to all patients affected by an event—including patients not actually harmed by the mistake but who could have been, according to a recent study by the New England Journal of Medicine.

"It’s clear that healthcare organizations face a dilemma regarding disclosure of large-scale adverse events—whether these events lead to patient harm or not," said Carolyn M. Clancy, director of the U.S. Department of Health and Human Services’ Agency for Healthcare Research and Quality. "It’s not always clear how to do that in a way that minimizes risk to the patient and organization, but this research can help."

While disclosure policies for adverse events that affect patients are becoming more common among healthcare organizations, they often fail to address how to disclose large-scale adverse events (LSAE) that could have affected many patients.

For more information about the study, visit www.ahrq.gov/news/press/pr2010/nejmstudypr.htm.


A WORKSHOP TO REVIEW the standards that affect the accessibility of products, services and facilities—especially for people with disabilities—will be held next month in Geneva, Switzerland. The World Standards Cooperation, the International Electrotechnical Commission and the International Organization for Standardization have organized the Nov. 3-4 event. For more information about the workshop, visit www.iso.org/wsc-accessibility.

A NEW SPORTS EQUIPMENT standard developed by the American Society for Testing and Materials will address the stiffness and elasticity of baseballs and softballs relative to cylindrical collisions. The primary users of the new standard, ASTM F2845, will be test labs that certify balls and bats for regulating associations. For more details, visit www.astmnewsroom.org/default.aspx?pageid=2217.

TO MARK THE CONTRIBUTIONS and achievements of statistics and statisticians, the first World Statistics Day will be held Oct. 10. The international event is being organized by the United Nations Statistics Division. For more information, visit http://unstats.un.org/unsd/wsd/default.aspx.

THE POLYURETHANE MANUFACTURERS ASSOCIATION (PMA) is organizing its annual meeting April 10-12, 2011, in Jacksonville, FL. For more information about the event and topics to be covered, visit www.pmahome.org.

THE NUMERICAL ALGORITHMS GROUP (NAG) has added to the largest commercially available collection of numerical algorithms for C and C++, which are used for quality systems modeling application development. With the addition of more than 150 functions, the collection—also known as the NAG C Library—now has more than 1,300 user-callable functions for quality assurance engineering and research activities. For more information, visit www.nag.com/contact_us.asp.

THE INTERNATIONAL ORGANIZATION for Standardization (ISO) has released a new CD-ROM with 202 standards and documents related to the field of mechanical vibration, shock and the condition monitoring of machines, including vehicles, and structures, such as bridges and buildings. For more information, visit www.iso.org/iso/pressrelease?refid=Ref1322.

Who’s Who in Q

NAME: Alka Jarvis.



INTRODUCTION TO QUALITY: While she was working as an account manager at a small company that developed and sold general ledger software products, customers constantly complained about product quality. She relayed this fact to the manager. One day, he challenged her: "You are the only account manager who complains about quality. Why don’t you do something about it?" She started learning about software quality. Eventually, she became president of the Bay Area Quality Assurance Association (BAQAA), a group that met to discuss topics related to customer satisfaction, product and process quality, and software quality. Sixteen years later, her knowledge base includes total quality management, Six Sigma, the Malcolm Baldrige National Quality Award criteria, standards and other quality management systems. She started public speaking, wrote several books and articles, and taught at all the major Bay Area universities. 

CURRENT JOB: Senior quality manager at Cisco.

ASQ ACTIVITIES: Jarvis is in her second term as chair of the U.S. technical advisory group to the International Organization for Standardization’s (ISO) Technical Committee 176 and lead delegate for the United States to the ISO committee responsible for the ISO 9000 family of quality management standards. She was instrumental in the development of ISO 9001:2000 and ISO 9001:2008, and is involved in the next revision of the standards. She is also an ISO 9001 lead auditor, certified by the Registration Accreditation Board (RABQSA).

RECENT HONOR: Won Silicon Valley’s "Corporate Woman Advocate of the Year" award for her accomplishments in the software quality field and effectiveness in improving the environment for women in the workforce.

PUBLISHED: Books she has written include ISO 9000-3, Inroads to Software Quality, Dare to Be Excellent and two versions of TL 9000: A Guide to Measuring Excellence in Telecommunications. She is currently writing a book on the latest software quality culture. She has also had articles published in many quality-related periodicals and magazines.

QUALITY QUOTE: A good product with quality does not happen by chance. It is a result of commitment to excellence in exceeding customer expectations.


Marking a Milestone

ANSI-ASQ National Accreditation Board celebrates 20 years

EDITOR’S NOTE: To recognize its 20-year anniversary, ANSI-ASQ National Accreditation Board’s vice president, Randy Dougherty, provided a brief history of the organization, which assesses and accredits certification bodies. Sidebars on the company’s emergence and the development of the ISO 9000 series standards can be found at www.qualityprogress.com. More history on the company can be found at www.anab.org.

When the European Community announced it would form a single market by the end of 1992, other economies wondered how they would be able to sell their products in "fortress Europe." As 1992 neared, many had come to understand the ISO 9000 series of quality management standards would facilitate trade.

"Some U.S. industry leaders feared that potential European customers and partners would be reluctant to accept American products without a shared set of quality standards," said Connie Conboy, board chair of the ANSI-ASQ National Accreditation Board. "Appropriate oversight of the certification quality process was needed to provide assurance to customers on both sides of the Atlantic."

ASQ recognized there would be a need for independent third parties to determine conformance to the standards and initially considered forming such an organization. Ultimately, ASQ decided to establish a body to provide oversight of third-party certifiers.

ASQ announced formation of a subsidiary for accreditation of quality system certification bodies—originally known as the Registrar Accreditation Board (RAB)—and named George Lofgren as its director Jan. 29, 1990.

Launching RAB

Lofgren said he felt excitement and trepidation about forming the new organization. "I had never had the opportunity to do something like this, but neither had anyone else in the United States. I felt confident I could do it," he said.

Lofgren assembled a board of directors, and volunteers were recruited to provide technical help. Ed Barabas, Norm Siefert, John Stratton and Jack Wyler met with Lofgren monthly, dividing tasks to complete between meetings and critiquing each other’s work at the next meeting.

The volunteers conducted initial assessments of the certification bodies that participated in RAB’s pilot program. Lofgren witnessed—but did not participate in—the assessments. RAB’s board of directors made the initial accreditation decisions.

On March 3, 1991, RAB announced its first accreditation of a quality system certification body to Quality Systems Registrars Inc. Less than four years later, RAB had accredited 25 certification bodies.

The ANSI connection

RAB’s board of directors believed cooperation with the American National Standards Institute (ANSI), the international standards community and the federal government would enhance the global credibility of the U.S. system. The government declined to be involved and, in essence, gave its blessing to a private-sector activity.

On Dec. 13, 1991, RAB and ANSI agreed to operate the American National Accreditation Program for Registrars of Quality Systems. Twelve certification bodies accredited by RAB prior to the agreement were subsequently converted to accreditation under the ANSI-RAB program.

After RAB introduced its second accreditation program in May 1996, a second agreement was negotiated with ANSI. The ANSI-RAB National Accreditation Program (NAP) covered ISO 9000 quality management systems (QMS) and ISO 14000 environmental management systems (EMS).

Learning from others

An early priority for Lofgren was to connect with the few who had experience operating a national accreditation body. He spent time in the United Kingdom with the National Accreditation Council for Certification Bodies (NACCB) and NACCB-accredited certification bodies to learn how they operated and to compare evaluation methods.

Some registrars that RAB was evaluating were already accredited by the Netherlands’ Raad voor de Certificatie (RvC), and RAB was able to schedule audits at the same time RvC was conducting its audits.

The assessment teams discovered differences of style and substance, a cause for concern. "We wanted to eliminate barriers by developing confidence in each others’ operations, and you can’t do that if you’re working to different requirements," Lofgren said.

Casual, independent efforts to harmonize were followed by more formal arrangements. In October 1992, RAB and ANSI signed a memorandum of understanding (MOU) with RvC that detailed a shared recognition of the desirability of doing things similarly. RAB later signed MOUs with other national accreditation bodies.

Expanded offerings

As RAB gained experience in evaluating certification bodies, it became clear there was a large variation among certification body auditors’ abilities. RAB created a certification program for quality auditors and issued its first quality system auditor certifications in June 1992.

RAB then introduced a program to accredit quality system auditor training course providers in October 1992. Again, the driver was the perceived need for such a program to ensure consistent auditing practices.

RAB added staff as its lines of business grew, and the management systems business expanded following publication of the ISO 14000 standards. In December 1995, Joseph Dunbeck was hired as CEO to provide overall leadership to the organization. Lofgren would remain as QMS president until his retirement in August 2000.

Dunbeck negotiated the agreement with ANSI that led to formation of the ANSI-RAB NAP, which covered accreditation for QMSs and EMSs. The ANSI-RAB NAP accredited its first five ISO 14000 certification bodies in March 1997.

Accreditation for the AS9000 aerospace standards and the telecommunications industry’s TL 9000 were added during Dunbeck’s tenure. Dunbeck also made the RAB mark available to certification bodies regardless of where they were based and where they conducted business.

Robert H. King Jr. became RAB’s president in January 2002. He oversaw the splitting of RAB into two businesses and, as president of RAB’s successor organization, oversaw expanding company activities.

In response to European concerns about RAB’s providing accreditation and certification, RAB signed an agreement in June 2004 to merge its auditor certification business with the Quality Society of Australasia (QSA International). King also worked with ANSI on an operating agreement to form a new legal entity to carry on RAB’s original business. In October 2004, RAB’s board of directors voted to recommend that ANSI and ASQ move the business of the ANSI-RAB NAP to a new partnership.

Effective Jan. 1, 2005, the ANSI-RAB NAP became a legal entity jointly owned by ANSI and ASQ, and it was renamed the ANSI-ASQ National Accreditation Board. The ANAB mark replaced the ANSI-RAB NAP mark for accredited certification bodies. Auditor certification and training provider accreditation were taken over by another new unit, RABQSA International.

Under King’s leadership, the ANAB brand encompassed accreditation covering additional standards, including the chemical industry’s RC14001, ISO 22000 for food safety management systems, the Sustainable Forestry Initiative standard, ISO 13485 for medical devices and ISO 27001 for information security management systems.

In October 2007, the company acquired Assured Calibration and Laboratory Accreditation Select Services (ACLASS). The ACLASS brand was retained for the accreditation of ISO/International Electrotechnical Commission (IEC) 17025 testing and calibration labs, ISO/IEC 17020 inspection bodies, ISO Guide 34 reference material producers and ISO/IEC 17043 proficiency test providers.

The company today

King’s successor, John Knappenberger, had been treasurer of ASQ and was a strong advocate for establishing RAB when Lofgren was hired. Knappenberger joined the RAB board of directors in 1994 and served as chair from April 1996 through 2005.

Since Knappenberger became president and CEO in November 2007, the company has added programs for the American Tree Farm System, ISO 28000 for supply chain security management, ISO/IEC 20000-1 for IT service management, the Recycling Industry Operating Standard, the e-Stewards standards, Responsible Recycling, IEQC QC 080000 for hazardous substance process management and the Department of Homeland Security’s PS-Prep business continuity and preparedness voluntary certification program.

State of management systems

Since publishing the first ISO quality management standards in 1987, there has been tremendous growth in implementing management system standards, with corresponding benefits.

"Before there was a credible system of accredited third-party certification to ISO standards, organizations spent excessive time on redundant audits," Conboy said. "Now, companies with ANAB-accredited certification offer customers assurance of independently verified, internationally recognized processes, without the need for numerous customer visits to each facility."

In serving the needs of its customers, the company has benefited from longstanding relationships. Lofgren continues to serve on the board of directors, as does the person who hired Lofgren, Paul Borawski, ASQ’s executive director and chief strategic officer. Barabas and Stratton, who were among the first RAB assessors, still work as contract assessors for the company. Many others have contributed to the its success.

"We can each be proud of our contributions; each of us met a different set of challenges" Dunbeck said. "The organization has grown much larger, more complex and more respected than we could have dreamed."

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How the U.S. National Accreditation Body Emerged

How the ANSI-ASQ National Accreditation Board—originally the Registrar Accreditation Board (RAB)—came to exist dates back to 1957 when the European Economic Community was formed to increase economic cooperation and decrease the likelihood of war. The community had a great vision, but initially there was little meaningful cooperation.

The next significant event happened in 1970 when the International Organization for Standardization (ISO) recognized that mechanisms for evaluating compliance with standards were needed. ISO ’s Certification Committee (CERTICO) was formed to establish a process to determine whether products were being manufactured in conformance with standards.

Nine years later, ISO Technical Committee 176 on Quality Management and Quality Assurance was established. In addition, BS 5750 and Z2999, similar series of quality assurance standards, were published in the U.K. and Canada and the quality management system (QMS) standard ANSI-ASQ Z1.15 was published in the United States.

Despite publication of these standards, product quality continued to fall short. A white paper published by Great Britain ’s Department of Trade in 1982, Standards, Quality, and International Competitiveness, said the U.K. needed better products and systems in place to ensure their success. A national quality campaign the following year also addressed issues raised in the paper.

Also in 1983, CERTICO published ISO/IEC Guide 40, General Requirements for the Acceptance of Certification Bodies, a precursor to guidance that would be used in quality management.

Two years later, ISO, recognizing that conformity assessment dealt with more than product certification, replaced CERTICO with the Conformity Assessment Committee (CASCO).

By 1985, the group then known as the European Community (EC) was frustrated about the lack of cooperation. The group drew up a list of hundreds of actions to remove barriers to trade that would need to be completed before there could be an internal EC market. Each action was checked off as it was completed.

CASCO published ISO/IEC Guide 48, Guidelines for Third-Party Assessment and Registration of a Supplier’s Quality System in 1986.

In 1987, the ISO 9000 series standards were published. Before the year ended, they were adopted as national standards in the United States, the U.K. and other European countries.

That same year, the EC made a commitment to form a single internal market by the end of 1992. There had to be free movement of goods, capital and people among the member states. It was agreed that standards were needed that would define requirements for health, safety and the environment that would be acceptable for use anywhere within the EC.

The EC established a ranking of methods by which products could be considered to be acceptable from a manufacturer ’s self-declaration of conformity through 100% product testing. This included demonstrating that the design of a product met specifications, and the manufacturing system gave assurance that it would be produced according to requirements. One method for demonstrating the latter was whether the system met the appropriate ISO 9000 standard.

Some ASQ (then ASQC) members were confident there were methods to evaluate and officially recognize U.S. organizations so they could deal with Fortress Europe after 1992.

A study was conducted to determine the feasibility of ASQ becoming an evaluation organization to certify that a company meets requirements. Published in February 1988, this study stimulated much discussion and correspondence. A counterproposal emerged: Instead of operating as a certification body for QMSs, ASQ should oversee the certification system in the United States.

It was agreed that an oversight body was needed and ASQ should play a role. To avoid potential liability, it was proposed that ASQ form a legally separate subsidiary. The board approved the proposal in late 1988, and in January 1990 ASQ announced RAB ’s formation, a subsidiary for accreditation of quality system certification bodies.  —R.D.

Development of the ISO 9000 Series Standards

When Technical Committee 176 (TC 176) of the International Organization for Standardization (ISO) was about to publish its first standard in 1987, ISO realized the standards would have a significant impact and gave the series the designation 9000 because round figures are more memorable.

In the years that followed, the ISO 9000 standards have proved memorable indeed, becoming among the best known ISO offering.

ISO formed TC 176 in 1979 and invited all interested countries to send participants to write standards. ASQ (then ASQC) members Richard Freund, Donald Marquardt and Robert Peach were among the founding members of the U.S. Technical Advisory Group (TAG) to TC 176. Both Freund and Marquardt served as TAG chair.

Within TC 176, various national committees exerted pressure to have their national standards adopted as international standards. The Canadian and British standards were similar prescriptive quality assurance standards. The primary difference was that Canada had a set of four standards, and the U.K. had a set of three. The United States put forward a different approach, based on ASQC Z1.15, a quality management standard.

Eventually, the ISO 9000 series had both elements—quality assurance and quality management—in different parts of the standard. ISO 9001, ISO 9002 and ISO 9003 were intended for various types of activities to be included in the manufacturing system, while ISO 9004 was a quality management system (QMS) that specified the elements needed regardless of product. ISO 9000 gave background and guidance on how to use the rest of the standard.

Freund, Marquardt and Peach recognized the ISO 9000 standards would provide a means to facilitate global trade. They also recognized there would be a need in the United States—as elsewhere—for an evaluation organization to certify that a company meets requirements. This type of organization is now known as a certification body or registrar. ASQ considered operating such an organization, but ultimately it decided to form an independent organization to accredit management systems certification bodies. The Registrar Accreditation Board (RAB), which would later to evolve into the current ANSI-ASQ National Accreditation Board, was established in 1989 with George Lofgren as its first president.

When the ISO 9000 series was first published, Lofgren was very disappointed that almost nobody read ISO 9000. "The standard now, after multiple revisions, is finally getting to what it could have had at the outset," he said.

The ISO 9000 series today represents an international consensus on good quality management practices. ISO 9001:2008 provides standardized requirements for a QMS and is intended for any size or type of organizations. The other standards in the series cover specifics such as fundamentals and vocabulary, performance improvements, documentation, training, and financial and economic aspects.

ISO 9001 is the only standard in the family to which organizations can be certified. According to the latest ISO Survey of Certifications, by December 2008 there were at least 982,832 ISO 9001 certificates issued in 176 countries and economies.  —R.D.

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