FREQUENTLY ASKED QUESTIONS ABOUT ISO 9000
(If you only have time to read one of these, read the last one)

The International Organization for Standardization (ISO) is a worldwide federation of national standards bodies from over 100 countries, one from each country.

ISO is a non-governmental organization established in 1947. The mission of ISO is to promote the development of standardization and related activities in the world with a view to facilitating the international exchange of goods and services, and to developing cooperation in the spheres of intellectual, scientific, technological and economic activity.

ISO's work results in international agreements, which are published as International Standards.  In addition to quality and environmental management systems, ISO also publishes standards that set criteria for film speed, data stored on ATM and credit cards, wine glasses for use in competitions, crayons, and more.

How it all started

International standardization began in the electrotechnical field : the International Electrotechnical Commission (IEC) was created in 1906. Pioneering work in other fields was carried out by the International Federation of the National Standardizing Associations (ISA), which was set up in 1926. The emphasis within ISA was laid heavily on mechanical engineering.

ISA's activities ceased in 1942, owing to the Second World War. Following a meeting in London in 1946, delegates from 25 countries decided to create a new international organization "the object of which would be to facilitate the international coordination and unification of industrial standards". The new organization, ISO, began to function officially on 23 February 1947.

The first ISO standard was published in 1951 with the title, " Standard reference temperature for industrial length measurement ".

ISO's name : a user's guide

Many people will have noticed a seeming lack of correspondence between the official title when used in full, International Organization for Standardization, and the short form, ISO. Shouldn't the acronym be " IOS " ? Yes, if it were an acronym - which it is not.

In fact, "ISO" is a word, derived from the Greek isos, meaning "equal ", which is the root of the prefix " iso-" that occurs in a host of terms, such as " isometric " (of equal measure or dimensions - Shorter Oxford English Dictionary) and " isonomy " (equality of laws, or of people before the law - ibid.).

From "equal" to "standard", the line of thinking that led to the choice of "ISO" as the name of the organization is easy to follow.

In addition, the name has the advantage of being valid in each of the organization's three official languages - English, French and Russian. The confusion that would arise through the use of an acronym is thus avoided, e.g. "IOS" would not correspond to the official title of the organization in French - Organisation internationale de normalisation.

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Some 70 countries have adopted and published ISO 9000 standards as their own national standards. The national standards usually have a different name, but they contain exactly the same text as the original ISO 9000 standards. In the United States the ISO 9000 standards have been adopted and published by ANSI and ASQC and are known as ANSI/ISO/ASQC Q9000 series.

ISO 9000 standards were been initially published in 1987. Since the initial publication the ISO 9000 standards have been revised in 1994 and most recently in December 2000.

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Companies may have their quality systems assessed and registered by a third party registrar. The assessment is conducted in the form of an on-site audit.

When successful, the company is awarded an ISO 9001 registration certificate. The 1994 revision allowed for certification to the less comprehensive standards, ISO 9002 or ISO 9003; these certifications do not exist with the 2000 revision but accommodations are made for these system types in the ISO 9001:2000 standard. A company that previously held an ISO 9002 or 9003 certificate would become certified to ISO  9001:2000 with exclusions.

The certificate is usually valid for a period of three years, and it must be confirmed every 6 to 12 months by a surveillance audit.

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Registrars are organizations that assess conformance of quality systems to ISO 9000 requirements and maintain a register of companies that operate and maintain conforming ISO 9000 quality systems. Typically, ISO 9000 registrars are companies of international certification bureaus, inspection services and laboratories. There are currently over 100 ISO 9000 registrars operating in the United States.

In order to be recognized, ISO 9000 registrars must be accredited. About 80 countries in the world operate their national accreditation schemes. In the United States the national accreditor is the Registrar Accreditation Board (RAB).

ISO 9000 accreditation schemes of most European countries, USA, and other highly industrialized countries are recognized internationally. Many registrars have multiple accreditations form different countries.

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The basic requirement is that the registrar be accredited to issue ISO 9000 registration certificates in a given industry. Otherwise, the most important criteria for selecting an ISO 9000 registrar is the market recognition and reputation of the registrar. An ISO 9000 registration certificate carries the registrar's logo and the prestige associated with this logo. Different industries, countries and regions favor different registrars. Find out which ISO 9000 registrars are most active in your industry and which are favored by your customers.

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The first step in the ISO 9000 registration process is review of documentation.  The review is either carried out at the registrar's offices prior to scheduling of the actual ISO 9000 audit, or on site as part of the audit. ISO 9000 documentation review usually results in some comments and observations, which must be resolved before the on-site audit. The next step is the ISO 9000 audit itself. The objective of the audit is to verify whether the quality system conforms with requirements of the ISO 9000 standard. The result of the audit is communicated by auditors at the closing meeting. If the company is recommended for ISO 9001 certification, it will receive the ISO 9001 certificate within a couple of weeks. If there are major nonconformances, the ISO 9001 certification is delayed. The company must implement corrective actions to deal with the nonconformances and the registrar would usually want to come back for a follow up audit.

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ISO 9000 registration audit starts with a brief opening meeting conducted by the Lead Auditor. The audited company is represented by executive managers and those responsible for implementing and operating the ISO 9000 quality system. At the meeting auditors explain the ISO 9000 audit process, confirm the audit schedule, and deal with other administrative matters. For the actual audit the auditors split up, each going to a different department or area. Each auditor is assisted at all times by an escort. The escorting personnel are usually those responsible for establishing, implementing and operating the ISO 9000 quality system. Typically it is the Quality Assurance Manager and his or her senior staff. In smaller companies, other management personnel may be assigned to escort the ISO 9000 auditors. The audit is concluded with the closing meeting where auditors communicate and explain results of the audit.

The closing meeting is usually attended by the executive management, the QA Manager and staff responsible for operating the ISO 9000 quality system, and by departmental managers.

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To pass the ISO 9000 registration audit there may be no major nonconformances and only a limited number of minor nonconformances scattered around different elements of the ISO 9000 system. When a couple of minor nonconformances pertain to the same ISO 9000 quality system element, they can be upgraded to a major.

ISO 9000 registrars may have slightly different definitions of a major and minor nonconformance. Typically, a nonconformance is classified as major when there is a breakdown of an ISO 9000 system element, or when the actual conformance to quality requirements of the shipped product is seriously at risk.

Minor nonconformance is an isolated lapse in implementing, or following any requirement of the ISO 9000 system.

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For any ISO 9000 nonconformance identified by the audit the company receives a corrective action request, which must be closed out within two to three months. Closeout of a minor CAR is usually verified at the next regularly scheduled ISO 9000 surveillance visit. Major CARs must be closed out before the company can be ISO 9000 registered. Closeout of major Cars requires a special follow up audit. Typically, companies take about two months to close out a major CAR and get back on track with the ISO 9000 certification process.

No. With enough time, resources, and top management commitment, you can do it yourself.  But the right consultant will shorten your learning curve and help you create a quality management system that is right for your company. The wrong consultant will create a system your employees hate, that does not save you money and leaves you no better off than when you started, only poorer.

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