Unless you are an expert in manufacturing processes, the concept of ISO has probably never been relevant to you. The International Organization for Standardization (ISO) is an independent organization composed of representatives from member nations that cooperate to create standard codes and practices for businesses. The organization was founded to create international manufacturing standards.
What Is ISO?
In 1946, delegates from 25 different countries held a meeting at the Institute of Civil Engineers, located in London, England. The problem that these leaders were trying to solve was a lack of international manufacturing standards. Lack of standards was a problem that ran rampant, due to a general lack of safety regulations from countries around the globe, including the United States (President Richard Nixon did not sign the Williams-Steiger Occupational Safety and Health Act until Dec. 29, 1970).
On Feb. 23, 1947, the ISO officially began operations. A few years later, in 1951, the first ISO standard was published. At the time, standards were known instead as recommendations, so the language was slightly different than what is used today.
This first standard was known as ISO/R 1:1951 and discussed standard reference temperature for industrial length measurements. This standard is still in use today, though it has been updated numerous times and is now called ISO 1:2002 Geometrical Product Specification (GPS) - Standard reference temperature for geometrical product specification and verification.
The ISO Today
As the world’s largest developer of voluntary international standards, the ISO facilitates trade around the world by providing nations with common standards to adhere to. There are more than 20,000 standards active within the ISO. These standards cover a wide variety of different industries including healthcare, food safety and manufacturing. Though there are thousands of standards, they all are focused on one overarching issue: the creation of safe, reliable and high-quality products worldwide.
Why Is Standardization Important?
Enabling a direct comparison of products from different markets (like China vs. Canada) gives companies common ground to communicate on. This is more productive for the worldwide community as it raises standards in production. The ISO also facilitates companies that are entering global markets, and assists in the development of fair trade practices.
ISO standards are also a safety measure for consumers and other end-users of products and services. To gain an ISO certification, products must conform to the minimum safety standards that have been set internationally. Since its inception, the ISO has published over 22,663 International Standards that cover almost all aspects of manufacturing and technology.
Today, the ISO is composed of 164 member countries and it has 782 technical committees and subcommittees to deal with standards development. The organization boasts more than 135 full-time workers at its headquarters in Geneva, Switzerland.
How Do ISO Standards Work?
ISO standards are not laws and are non-enforceable. How, then, was it that the ISO became such a massive force for standardization in almost every industry? Teamwork is the simple answer to this question. The ISO’s vast membership is made up of countries that together strive for a more productive and inclusive global economy.
These nations, in turn, make laws to uphold these regulations. Many countries, such as Germany, Switzerland and New Zealand have laws that go above and beyond the regulations. These countries have healthier economies and markets as a result. They also are consistently rated as some of the best countries to live in worldwide.
Current ISO 9000 Series
The ISO 9000 is simply a series detailing fundamentals and vocabulary to be used in the ISO 9001 series of regulations. This means that the ISO 9000 is setting the groundwork for all further writings, reports and findings that will subsequently become the ISO 9001 set of standards. The reason why there is an entire standard dedicated to language ties into the greater goals of ISO as an organization — one of which is to ensure common ground for communication.
When trying to work out a mutually beneficial agreement between different companies in different countries, there are a variety of factors to deal with. These include different languages, customs, laws regarding trade, social norms and currency, just to name a few variables. Giving these companies a common language to speak via ISO standards goes a long way to fostering positive relationships and communication.
ISO 9001 Basics
ISO 9000 also contains the actionable requirements that an organization needs to comply with to gain the ISO 9001 registered status. These requirements provide the building blocks for implementing and maintaining a Quality Management System (QMS).
Since the ISO was developed to reach all industries, the requirements are applicable to any company within any industry. While the ISO 9001 provides the mandatory elements for a QMS, they do not outline how to incorporate these necessary elements into your QMS system.
The ISO 9001 set of standards is separated into eight sections, which they call clauses. Of these, five contain mandatory requirements for quality management systems. Other clauses involve management responsibility, resource management, product realization and measurement, analysis and improvement. Clauses 1 through 3 do not include any requirements and speak solely to the scope of the document and its application.
Combining ISO Standards
In the year 2000, three ISO standards (9001:1994, ISO 9002:1994, and ISO 9003:1994) were combined into ISO 9001. This revision is known as ISO 9001:2000, to follow the naming convention of ISO 900X:YEAR. If you are searching for a standard from before 2000, you can go to the ISO website to search revision history of ISO standards.
ISO 9002 vs. 9001
This section guides companies as to the intent of the ISO 9001 requirements. While this may look redundant at first glance, it is a separate set of requirements for a purpose, since ISO 9002 was, according to the ISO website, last revised in 1994. At that time, it was titled Model for quality assurance in production, installation, and servicing. In essence, it contained much of the same material as the standard; thus, there is no need for ISO 9002:1994 any longer because they now use the new 9001 standard.
ISO 9002 Definition
ISO 9002 is the umbrella term referring to a standard that was developed and published by the ISO. The latest version of the ISO 9002 standard is ISO 9002:2016, and any organization that refers to themselves as being ISO 9002 certified will refer to the current version of this standard. Any certification should give the specific date if they are not currently compliant on all standards. The ISO 9002 series has been revised by the related ISO 9001.
Describing ISO 9002
The ISO 9002 level of certification follows a standard that has been published by the ISO. These specific guidelines are maintained for quality assurance in their installation, production and service provision. ISO 9002 has gone through many changes and was eventually replaced by the ISO 9001:200 and later ISO 9001:2008.
All aspects of ISO 9002 are very similar to ISO 9001. That said, the former does not deal with requirements for product development. ISO 9002 is also not industry-specific. Instead, it was designed broadly for any company that deals in processing or production, but not patenting.
What Does ISO 9002 Certified Mean?
The ISO 9002 is a non-industry specific certification. All ISO certifications are issued by third-party certifying bodies, ensuring an extra layer of eyes in an attempt to avoid biases and to guarantee fairness.
ISO 9002 has gone through many different versions, the most recent being the ISO 9002:2016. All of the ISO 9002 guidelines are made to provide guidance regarding the ISO 9001 series of standards requirements. Along with helping clarifying the finer points of the 2001 regulations, the 9002 also provides concrete examples of possible steps that an organization can take to meet the requirements of the 9001 standard.
ISO 9002 does not modify or change the content of the ISO 9001 in any way. It also does not provide any templates or assistance when a company is implementing the ISO 9001 standards in its organization.
ISO 9002 Quality Assurance Systems
The British government was one of the main sponsors of the ISO 9000 series of standards. This effort started after the U.K. experienced several disasters, such as explosions in weapons factories as a result of munitions defects. After these disasters, it became evident that an independent quality control system would be imperative if the U.K. wanted to protect its workers.
When the ISO standards were originally created, they were not supposed to be generalized to all fields. For example, the ISO 9001 standards were originally formatted to be relevant to the design field. ISO 9003 was designed for firms that handle testing and inspection. Lastly, ISO 9002 was designed for companies that were responsible for production.
Per the ISO, ISO 9002 was instrumental in bringing quality assurance in production, service, and installation to the 21st century by ensuring through its nine sets of system requirements. At the time, this standard was not applicable to the service industry and was solely focused on processing and manufacturing.
Updates to ISO 9002
The last amendment of ISO 9002 was in 2016, originally created in 1994. This is now considered a benchmark for production quality, servicing and installation. At the time of its creation, ISO 9002:1994 was extremely relevant to contract manufacturing. Currently, however, companies use ISO 9001, rendering ISO 9002:1994 practically obsolete.
ISO 9002’s elements have at least 20 clauses that detail different aspects of quality assurance that are required for production and installation processes. Clause 4.14, for example, handles both preventive and corrective actions that a company can take. It also provides the appropriate time frame for documentation concerning any of the corrective actions taken.