what is ISO Standards?
What is an ISO standard? ISO is the International Organization for Standardization, an independent, non-governmental international organization that develops and publishes International Standards. ISO standards provide common specifications, methods, terminology and frameworks for products, processes, services and management systems.
ISO is not limited to quality management. Its standards cover machinery safety, industrial robotics, testing, measurement, environmental management, occupational health and safety, information security, medical devices, materials, manufacturing, energy and thousands of other technical subjects.
“ISO standard” therefore does not describe one single type of document. Some ISO standards apply to company management systems, while others deal directly with machinery, mechanical interfaces, laboratory competence, risk reduction or industrial safety.
In Simple Terms: What Does ISO Do?
Imagine engineers in many different countries trying to build, test and describe things in the same way. One country might use one method, another country a different one, and manufacturers would constantly need to translate technical expectations. ISO brings experts together to agree on common rules and then publishes those rules as standards. In simple terms, ISO's main job is not to hand out certificates; it helps the world use a common technical language.
What Does ISO Actually Do?
ISO brings national standards bodies and technical experts together to develop International Standards through a consensus-based process.
Create a common technical language: Standards help manufacturers, users, engineers, laboratories and regulators use consistent terminology, methods and specifications.
Support compatibility and interoperability: Common dimensions, interfaces, methods and requirements can make products and systems easier to integrate.
Provide safety and performance methods: Depending on the subject, a standard may define risk-assessment principles, test methods, design criteria or performance requirements.
Facilitate international trade: Using internationally recognised technical requirements can reduce unnecessary differences between markets and make technical comparison easier.
Provide management-system frameworks: Standards such as ISO 9001, ISO 14001 and ISO 45001 provide requirements or frameworks for managing specific areas of an organization.
Who Develops ISO Standards?
ISO standards are not written by a few people working at ISO headquarters. Standards development takes place through technical committees, subcommittees and working groups.
Experts can represent industry, users, laboratories, academia, government bodies, consumers and other interested groups through their national standards organizations.
The process is based heavily on consensus. The objective is not to turn the opinion of one manufacturer or one country into an international rule, but to develop a technically agreed document that can be used internationally.
Who Can Become an ISO Member?
One common misunderstanding is that manufacturers, consultants or individuals can directly become ISO members.
ISO members are national standards bodies. There is one ISO member representing each country or territory within the ISO membership structure. Companies and individuals do not become direct ISO members, although they can contribute to standards development through their national standards organizations and technical committees.
ISO currently brings together 177 national standards bodies through this international network.
Does ISO Issue Certificates?
No. ISO does not perform certification and does not issue certificates.
For example, when a company says that it is “ISO 9001 certified,” the certificate is not issued by ISO itself. An independent certification body audits the organization's quality management system against ISO 9001 and, if the requirements are satisfied, that certification body issues the certificate.
ISO also does not permit its logo to be used as though ISO itself had certified a company or product.
ISO develops the standard; an independent conformity-assessment body can assess compliance with it.
Is an ISO Certificate the Same as Product Certification?
No. This distinction is especially important for management-system standards such as ISO 9001.
If a variable frequency drive manufacturer has an ISO 9001-certified quality management system, that does not automatically mean that every drive manufactured by that company has passed electrical-safety, EMC or functional-safety testing.
The company's management system, the product's technical standards and the legal conformity requirements of the target market are separate subjects.
For equipment-specific requirements, see our device standards section.
Are ISO Standards Mandatory?
ISO standards are generally voluntary International Standards. ISO itself is not a national legislature or regulator.
However, an ISO standard can become important or effectively mandatory through other mechanisms. Legislation may reference a standard, a customer specification may require compliance, or an engineering contract or procurement document may specify a particular ISO standard.
For this reason, “ISO standards are voluntary, so they can always be ignored” is also too simplistic. The application, contract, legislation and target market have to be considered together.
What Is the Difference Between ISO and IEC?
ISO and IEC are separate international standards organizations. ISO covers a very broad range of technologies, products, services and management subjects, while the IEC specializes primarily in electrical, electronic and related technologies.
Their fields frequently meet in industrial automation. Machinery safety, robotics, information technology and laboratory systems can involve standards developed by either organization or by both organizations together.
Joint standards are identified by the ISO/IEC prefix. ISO/IEC 17025 is a well-known example.
What Is the Difference Between ISO and EN?
ISO publishes standards at international level. EN standards are standards adopted within the European standardization system.
When an ISO standard is adopted as a European Standard, it can appear as an EN ISO document. A European country can then publish the same document nationally with another national prefix.
This is why machinery documentation may contain designations such as ISO, EN ISO or DIN EN ISO. These prefixes do not necessarily mean that three unrelated technical standards exist.
What Types of ISO Standards Exist?
ISO should not be reduced to a list of management-system standards. Several types of ISO documents are directly relevant to industrial engineering.
Management-system standards: ISO 9001 for quality management, ISO 14001 for environmental management, ISO 45001 for occupational health and safety and ISO/IEC 27001 for information security are well-known examples.
Machinery and safety standards: ISO 12100, ISO 13849, ISO 13850, ISO 14119 and ISO 14120 address subjects such as machinery risk assessment, safety-related control systems, emergency stopping, interlocking devices and guards.
Product and interface standards: ISO publishes standards defining mechanical interfaces, dimensions, technical characteristics and requirements for specific product groups.
Testing and laboratory standards: Standards can define laboratory competence, test methods, calibration principles and measurement practices.
Terminology and data standards: These help different manufacturers and industries describe technical information consistently.
What Is ISO 9001?
ISO 9001 specifies requirements for a quality management system and is one of the world's most widely recognised management-system standards.
It deals with subjects such as process management, understanding customer and applicable requirements, risk-based thinking, performance evaluation and continual improvement.
ISO 9001 is not a product-quality certificate. A manufacturer having an ISO 9001-certified management system does not automatically prove that every individual product it manufactures is safe, reliable or independently certified.
What Is ISO 14001?
ISO 14001 is an international standard for environmental management systems.
It provides a framework for identifying environmental aspects, managing obligations, monitoring environmental performance and continually improving the organization's environmental management system.
An ISO 14001-certified company does not automatically manufacture products that have independently received an “environmentally friendly product” certification.
What Is ISO 45001?
ISO 45001 specifies requirements for occupational health and safety management systems.
It helps organizations establish systematic processes for identifying workplace hazards, managing occupational health and safety risks and improving OH&S performance.
Older documents may refer to OHSAS 18001. OHSAS 18001 has been replaced by ISO 45001 and should not be presented as the current ISO occupational health and safety management-system standard.
What Is ISO/IEC 27001?
ISO/IEC 27001 specifies requirements for an information security management system.
It provides a management framework for protecting information in terms of confidentiality, integrity and availability.
This is increasingly relevant to industrial organizations as operational technology and information technology networks become more connected. However, ISO/IEC 27001 should not be treated as a PLC or SCADA product cybersecurity standard; its primary subject is the organization's information security management system.
What Is ISO 13485?
ISO 13485 is a quality management system standard specifically associated with medical devices.
It provides requirements relevant to organizations involved in the design, production, installation and servicing of medical devices, with particular emphasis on regulatory and quality-management needs.
For industrial automation, this can become relevant where automation equipment is used in medical-device manufacturing, testing or regulated production processes.
What Is ISO 9409?
ISO 9409 is associated with mechanical interfaces between industrial robots and end effectors.
When a gripper, welding tool, vacuum gripper or another end-of-arm tool is mounted to a robot, standardized mechanical interfaces can make integration between equipment from different manufacturers easier.
ISO 9409 is a useful example showing that ISO is not limited to management systems; it also develops standards directly related to industrial robotics and mechanical integration.
What Is ISO/IEC 17025?
ISO/IEC 17025 specifies general requirements for the competence of testing and calibration laboratories.
Having test equipment alone does not make a laboratory technically competent. Personnel competence, methods, metrological traceability, measurement uncertainty, equipment control and the validity of results are also important.
For this reason, when reviewing an EMC, electrical-safety or calibration report, it can be important to check whether the laboratory has relevant ISO/IEC 17025 accreditation for the actual test or calibration scope.
Why Is ISO 13849 Important in Industrial Automation?
ISO 13849 is highly relevant to machinery safety and the design of safety-related parts of control systems.
Safety relays, safety PLCs, safety sensors, contactors and drive safety functions can form part of machine safety functions assessed using the Performance Level (PL) approach.
This is why ISO standards are closely connected with SIL and functional safety. Depending on the application and standard, machinery safety may use SIL- or PL-based methods.
What Is ISO 12100?
ISO 12100 provides fundamental principles for machinery risk assessment and risk reduction.
Its general approach includes identifying hazards, estimating and evaluating risks and applying risk-reduction measures through inherently safe design, safeguarding and information for use.
For the wider subject, see our machinery safety standards section.
Where Do ISO Standards Appear in Industrial Automation?
Industrial automation can interact with ISO standards in many different ways.
Machine design: Risk assessment and risk reduction.
Safety PLC and safety circuits: Safety-related control-system performance.
Robotics: Robot safety and mechanical tool interfaces.
Manufacturing organizations: Quality, environmental and occupational health and safety management systems.
Testing and calibration: Laboratory competence and confidence in measurement results.
When “ISO” appears in the datasheet or documentation of a PLC, drive, robot or machine, the first question should therefore be which ISO standard is being referenced?
Does Compliance With an ISO Standard Prove That a Product Is Safe?
Not by itself. The actual ISO standard being referenced matters.
ISO 9001 provides information about an organization's quality management system. ISO 9409 concerns robot mechanical interfaces. ISO 13849 concerns safety-related parts of machine control systems.
The statement “ISO compliant” provides very little technical information unless the standard number and scope are specified.
How Can You Check Whether an ISO Standard Is Current?
ISO standards do not remain unchanged forever. They are periodically reviewed and may be confirmed, revised, amended or withdrawn.
An ISO number found in an old machine manual should therefore not automatically be copied into a new specification. The current edition and status should be checked in the official ISO catalogue or through the relevant national standards body.
The standard number can remain the same while its edition, publication year or amendments change.
How Many ISO Standards Are There?
The number continually changes as new standards are published and existing documents are revised or withdrawn. ISO has published more than 25,000 International Standards and related documents.
Older web pages sometimes quote figures such as 21,000 or 22,000 standards. These numbers become outdated as the ISO portfolio grows.
ISO also publishes different types of technical documents, including International Standards, Technical Specifications and Technical Reports, so a single fixed number should always be treated as time-sensitive.
What Is the Correct Path From an ISO Standard to Certification?
For a management-system standard, the process can be simplified as:
Identify the relevant ISO standard → implement its requirements → establish processes and records → perform internal review and audits → if certification is required, engage an independent certification body → complete the external audit → receive certification if conformity is demonstrated.
ISO's role in this chain is to develop and publish the standard. ISO itself does not issue the certificate.
Common ISO Mistakes
“ISO issues certificates.” Incorrect. ISO does not perform certification or issue certificates.
“Companies can become ISO members.” Incorrect. ISO members are national standards bodies.
“An ISO 9001-certified company automatically makes certified high-quality products.” Incorrect. ISO 9001 concerns the organization's quality management system.
“All ISO standards are legally mandatory.” Incorrect. They are generally voluntary, although legislation, contracts or market requirements can make a particular standard necessary.
“ISO is only about quality management.” Incorrect. ISO covers subjects ranging from robotics and machinery safety to laboratories, information security and medical devices.
“ISO 27001 is the correct name.” The formal designation is ISO/IEC 27001, because it is jointly published by ISO and IEC.
“An old publication year means the ISO standard is obsolete.” Not necessarily. Current status must be checked in the official catalogue.
Where Should Evaluation of an ISO Standard Start?
Identify the standard number → check its official title and scope → verify the current edition and status → determine whether it concerns a product, management system, test method or safety process → identify which requirements actually apply → if certification is required, evaluate the conformity-assessment process separately.
“ISO compliant” is not a complete technical statement. You need to know which ISO standard, which edition and which scope are being claimed.
Important: ISO develops International Standards but does not act as a certification body. Compliance with an ISO standard, management-system certification, product certification and legal market conformity are different concepts and should not be treated as interchangeable.
ISO Topic Guide
ISO 9001 • ISO 14001 • ISO 13485 • ISO 9409 • ISO/IEC 17025
Related Standards and Automation Guides
Industrial Standards • IEC Standards • EN Standards • Machinery Safety • Device Standards
Related Automation Guides