From 1970 onward, countless quality standards emergeQuality assurance systems were born from customers' need to confirm that suppliers were meeting specifications. This made it possible to choose more confidently who would supply raw materials and components to companies. Over time, many standards were created around the world.In the USA, suppliers to the Department of Defense had to keep their quality systems in line with the MIL-Q-9858A and MIL-I-45208A standards.In 1979 the United Kingdom created BS 5750, also for quality systems. Many others appeared in other countries and sectors, such as NQA-1 (Quality Assurance Requirements for Nuclear Facility Applications), from the American ASME, for nuclear plants; GMP (Good Manufacturing Practices), in the pharmaceutical, medical device and food sectors; API Q1, from the American Petroleum Institute, in the oil industry; the Canadian CSA Z299; and AQAP-1 and AQAP-13 (Allied Quality Assurance Publications), from NATO (the North Atlantic Treaty Organization).To prevent the proliferation of standards, ISO (the International Organization for Standardization) set up a technical committee in 1979, ISO/TC 176, to evaluate the existing standards. In 1987 it released the ISO 9000 series of quality system standards: ISO 9000:1987, ISO 9001:1987, ISO 9002:1987, ISO 9003:1987 and ISO 9004:1987. In essence, these standards took over most of the elements of the UK's BS 5750:1979. Also in 1987, the European Community adopted the ISO 9000 series under the name EN 29000 series.In Brazil, the body that represents the country in ISO is ABNT (Associação Brasileira de Normas Técnicas, the Brazilian national standards body), a founding member of the organization. ABNT publishes the Brazilian versions of the standards, labeled ABNT NBR ISO, through its Brazilian Quality Committee, ABNT/CB-25. Inmetro (Instituto Nacional de Metrologia, Qualidade e Tecnologia, Brazil's national metrology and quality institute) has a different role: through its General Coordination for Accreditation (Cgcre), it accredits certification bodies, that is, it recognizes the certification companies qualified to audit and certify organizations seeking the "ISO 9001 seal".A Brazilian factory wants to know who publishes the official Portuguese text of ISO 9001 and who recognizes the certification body that will audit it. What is the correct answer?Answer: ABNT publishes the standard and Inmetro (Cgcre) accredits the certification body — ABNT is Brazil's member of ISO and publishes ABNT NBR ISO 9001. Inmetro's Cgcre accredits certification bodies. ISO does not certify anyone: it only writes the standards.The ISO 9000 seriesThe creation of the ISO 9000 family of standards coincides with the peak of the Japanese economy, which came to threaten American dominance. Since the 1970s, thousands of Japanese cars of undeniable quality had been arriving at US ports at competitive prices, even after freight costs and import duties. Western industry reacted, and one of its responses was to standardize what was required of a quality system.ISO standards spread around the world very quickly. In Brazil, this happened most intensely in the 1990s, shortly after the government launched the Brazilian Quality and Productivity Program (PBQP) in 1990. Although they are seen, for marketing reasons, as a guarantee or even a "synonym" of quality, these standards only propose that production or service processes follow established, documented criteria that can be audited by third parties. In theory, even a poor product can be made by a certified company, as long as it does what the standard requires: controlled processes, records and the handling of nonconformities. Certification attests to the management system, not to the product.A type of seal usually displayed by certified companiesAt first, the standards of ISO (founded in 1947) had very limited use, and the organization was practically unknown outside technical circles linked to product engineering. In practice, the general public only became aware of ISO when the ISO 9000 series was released in 1987, since its implementation involves the effective participation of every hierarchical level of an organization.The first ISO 9000 series had five standards, from ISO 9000 to ISO 9004, originally designed for industry. Thanks to its flexibility, during the 1990s it also came to be applied in other sectors, such as construction, services, health care, hospitality and education. The standards were of two types:Contractual standards (ISO 9001, ISO 9002 and ISO 9003): models for the relationship between the supplier (the company in question) and the customer, and the only ones against which a company could be certified. They use the verb "shall" ("the supplier shall..."), which indicates a mandatory requirement. ISO 9001 was the most complete: it covered design, development, production, installation and servicing, with 20 quality system elements. ISO 9002 left design out, and ISO 9003 covered only final inspection and testing. That is why ISO 9001 is said to include ISO 9002, which in turn included ISO 9003.Guidelines (ISO 9000 and ISO 9004): ISO 9000 guided the selection and use of the other standards in the series, and ISO 9004 guided the implementation of a quality management system. Being recommendations, they use "should" ("the quality system should..."), not "shall".From ISO 9000 to ISO 9004: the five standards of the first seriesIn 1995, a screw factory produced to drawings sent by its customers and did no design of its own. Against which standard of the time would it normally seek certification?Answer: ISO 9002, because it covers production, installation and servicing, without design — with no design activity, ISO 9001 would require something the factory does not do. ISO 9000 and ISO 9004 were guidelines, and no one was certified against them.ISO 9001 revisions: from 1987 to 2026ISO reviews its standards periodically. ISO 9001 has gone through the following editions:EditionWhat changedISO 9001:1987First edition, based on BS 5750; certification to 9001, 9002 or 9003ISO 9001:1994Minor revision, with emphasis on preventive action; kept the three certifiable standards and the 20 elementsISO 9001:2000Major revision: ISO 9002 and ISO 9003 were withdrawn and merged into ISO 9001, which became the only certifiable standard in the family; the process approach was introduced, with a focus on the customer and continual improvementISO 9001:2008Clarifications to the text, no new requirementsISO 9001:2015Common structure for management system standards (clauses 4 to 10), risk-based thinking, context of the organization and interested parties; the mandatory quality manual and documented procedures gave way to "documented information"ISO 9001:2015/Amd 1:2024Amendment of February 2024: the organization must determine whether climate change is a relevant issue for its system, and interested parties may have climate-related requirementsISO 9001:2026Sixth edition, published in September 2026: incorporates the climate amendment, aligns the text with the new common structure of ISO standards and strengthens quality culture and ethical behavior of leadership; according to certification bodies, the transition of 2015 certificates is expected to take about three yearsIn the 2000 edition the whole family was reorganized: ISO 9000 (fundamentals and vocabulary), ISO 9001 (requirements, the only one used for certification) and ISO 9004 (guidance for sustained success). In the versions up to 2008, the standard required a four-level documentation system: the quality manual, procedures, work instructions and quality records. Since 2015, the company decides which documents it needs to keep, as long as it has the documented information required by the standard and whatever is needed for the system to be effective. What ISO seeks is for this information to be available in an accessible, quick and easy-to-understand way, and for the means of work to be suitable for meeting the requirements. One example is keeping equipment clean and in good working order.One of the most important aspects of obtaining and maintaining certification is the internal audit. The company must regularly audit its own system to identify failures, take the necessary actions to correct them and prevent future problems. This keeps the documentation alive and everyone committed to quality.ISO has no enforcement power: it is up to each country, customer or company to decide whether to follow or require its standards. In practice, ISO 9001 certification is often required in supply contracts, in public tenders and by customers who want assurance that the supplier has a working quality management system.Meeting product specifications also depends on other factors that must be standardized and well managed, such as design, development, planning, post-production, installation, technical support and marketing. The quality management system requirements set out in ISO 9001 complement the technical requirements specified for products and services; they do not replace them.How to obtain ISO 9001 certificationA clarification first: a company is certified to ISO 9001, which is the requirements standard. There is no ISO 9000 certificate; that is the name of the family of standards and of the vocabulary standard. Many people say "ISO 9000 certificate" out of habit.The final step in obtaining the certificate is the certification audit, and it does not always result in approval. Once hired, the certification body (which, in Brazil, must be accredited by Cgcre/Inmetro to issue accredited certificates) sends at least one auditor, and the assessment is carried out in two stages.In the first stage, the auditor checks whether the company's documentation and preparation are in line with what the standard requires. He issues a report approving the move to the next stage or pointing out adjustments.Once the adjustments are made, the second stage begins. In it, the auditor asks for access to the various areas and management processes, checks whether the system works in practice, reviews the results of the internal audit and the management review, and checks whether the requested corrections were actually implemented.The certification audit usually takes two to three days, but it all depends on the scope and size of the company.If everything is in order, the auditor recommends issuing the ISO 9001 certificate. If there are major nonconformities, the certificate is not issued until they are addressed: the company is given a deadline, usually up to 90 days, to present and implement the corrections, and the certification body verifies them, sometimes with a new visit, before deciding.Costs vary widely with company size, number of sites and scope; figures starting at R$ 6,000 (Brazilian reais) for small companies and above R$ 40,000 for larger ones have been cited in the Brazilian market as a reference. Certification is not for life: the certificate is valid for three years, with surveillance audits at least once a year. At the end of the three years, a recertification audit renews the certificate or asks for adjustments. To keep it indefinitely, the company must maintain good management practices and adapt them to new versions of the standard.A company received its ISO 9001 certificate in March 2027. What is the normal schedule of external audits until renewal?Answer: Surveillance audits around March 2028 and March 2029, and recertification before March 2030 — the cycle is three years, with surveillance at least annually. The option with no audit until 2030 is the most tempting, but without the annual audits the certificate is suspended.Link to the ISO 9001 standard in PDFHere you can download the text of the ISO 9001 standard in PDF, in Portuguese. Note: the document contains the standard, not a certificate; the certificate is issued to each company by the certification body.Inmetro material on ISO 9001What ISO 9001 means for buyers: leaflet by ABNT/CB-25 with comments from Inmetro, in Portuguese.Survey of buyers' perception of suppliers with ISO 9001 certification, in Portuguese. This survey shows how companies look for suppliers, what they look at when placing a purchase order, how they check the quality of the product supplied and whether, in their view, having ISO certification really helps to get better-quality supply.Survey on the credibility of ISO 9000 certifications, in Portuguese. This survey looked at the difficulties in obtaining the certificate and the main reasons for seeking it.These materials were published between 2005 and 2013, before the 2015 version of the standard, but their conclusions about how certification is perceived and how credible it is remain useful.
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