Standards and regulatory compliance are an essential component in commerce. Prior to the globalization of trade, this aspect of business was fairly static, making it well within the means of most businesses to comply. However, many businesses now buy and sell products around the world. Compliance with differing requirements, required by regulations in various jurisdictions, can be a real challenge for many organizations.
However, within the last 20 years, there has been a significant decrease in the understanding of standards and regulatory processes and documents. At the same time, it has become an increasingly more complex and challenging task to choose, monitor and meet the requirements necessary to trade.
We've have been selling standards for over 30 years now, and we notice that an increasing part of our business is educating our customers. In the past, it was not uncommon for there to be a standards specialist or a librarian at many of our customer’s facilities. The Internet and financial pressures have made this type of specialization a rarity. Yet, there is no good replacement for this expertise.
So, we find that employees who are being put in control of technical documentation are ill-equipped to handle the task. Often, they do not know what the documentation is, how it is numbered, how it is modified, how it should properly be used, and how revisions can affect the company. These caretakers do not understand the territorial implications of these documents and the hierarchy of jurisdictions that exist in the world today. They do not understand where the requirements for usage originate and the impact that non-compliance can have on their organizations.
If this type of information is your responsibility, this website will guide you through the maze of standards, regulations and other conformance documents. You will learn how to find them, choose them, retain them, monitor them, and disseminate them. You’ll learn to set up a methodology for identifying documentation critical to your organization’s success and how to ensure your organization is aware of on-going changes to this documentation. It will become your expert resource that you can turn to when in doubt (and you will have moments of doubt when dealing with standards!).
It must be my many years of working with standards, but I automatically want to organize my thoughts in the same way that standards are organized. And one of the first things that many standards address is definitions. I am going to give you some major concepts here.
Of course, the concept of a standard is not a foreign one. We know about dress codes at work and school. We refer to one’s standard of living and standard of care. But did you know that there are engineering documents that specify things like the odor and taste of exposed fish, the sound level of highway truck tires, and the abrasion resistance of shoelaces? If someone makes something, uses something and/or sells it, there’s a strong likelihood that there’s a standard for it too.
So for our purposes, our general definition is that a standard is a document that specifies a product, a material, a process or a test.
In general, a standard is a legally valid document providing the user with a set of guidelines. It is usually an engineering document and is often used in trade. It is normally created according to a protocol (set of rules) and may be modified, again usually by an agreed-upon process. And ideally it’s non-monopolistic, that is, in support of free and fair trade practices. It may be created by a government, by an alliance, or by a standards-developing organization. Its use (or lack thereof) may have legal implications.
Standards are usually recognizable by the alphabet soup of identifying number. If someone asks you to get them a document and gives you an identification number like MIL-STD-100 or ASTM-B633 or SAE-J1926/1, you’re looking at a standard. Remember, these numbers are created by engineers so you can bet that they are filled with information for those in the know (and very confusing for everyone else!).
Regulations are a lot like standards, but they are in response to legislation. When a legislative body creates a law, regulators are then tasked to create regulation to enforce that law. The critical thing about regulations is that non-compliance is not an option.
Standards are considered voluntary unless they are called out in laws or regulations. One difficulty we run into in these cases is that a physical document is mandatory for reference in most regulatory schemes. Therefore, a standard will not only be called out by number in legal documents, but also by the specific date of the document (revision level). Over the years, regulations can therefore reference documents that have been obsolete for some time (and may no longer be available as well).
One other type of documentation needs to be mentioned here: internal documentation. Many companies create their own internal specifications and standards as blueprints for their products. You may have company information to oversee that fits into the same management challenge as the external information we call standards and regulations. Certainly, all 3 types of information belong in the same system in any organization.
There are many sub-types of documents that fall into the heading of “standards.” Some of them are specifications, manuals, commercial item descriptions, drawings, handbooks, and recommendations.
Some things that are NOT standards are journal articles, books, interpretations, and guidelines. These are documents that will give you lots of information, but do not provide you with the kind of organized definition and process methodology that you will find in standards.
Also, technical information that is not a standard will normally have no legally binding impact on your actions. The exception is when an organization has used any external document to prove that its product or process meets “best practices” on a specific date.
A Brief History of Standards
Our earliest evidence of standardization is to be found in the work of metrologists, scientists who study weights and measures. It is believed that as agriculture became the main source of food supply, primarily in the area from Syria to Iran in about 6000 B.C., people needed a way to distribute crops, especially during times of famine. Metrologists surmise that the early standard of grain was the contents of two hands cupped together (1).
Other early standards were counting tokens, used to keep accounts of personal wealth. These counting tokens varied from place to place until the formation of the Akkadian Empire in Sumeria around 2200 B.C., an early consolidation of city-states by Sargon the Great. Sargon’s standard lasted as long as the Sumerian Empire did.
Evidence of the standardization of distance is linked to building. By the time of the pyramids, we find details of measuring devices in documents found in the tombs as well as pictures of some instruments on the tomb walls. We don’t have the standards documents, but the pyramids themselves are built with blocks that are regular, symmetric and aligned with the Earth’s axis. That means the use of standard units of measurement!
Additionally, Babylon, Egypt and the city states of Greece all had standards so they could regulate commercial measuring devices (2). By 500 B.C., Athens had instituted the Tholos, an official depository of weights and measures, much as we have NIST, the National Institute of Science and Technology, here in the U.S.today.
The oldest standards-developing organization in the United States is the Pharmacopeial Convention, formed in 1820 to adopt uniform standards for drugs. Other early examples of standards include the development of a uniform gauge standard for railways to propel national commerce and the development of our industrialized society. The Association of American Railways’ recommended practice B19 gage specification originally released in 1895 remains the oldest active standard in the U.S.
Safety was an early driver of standardization as well. The Baltimore fire of 1904 resulted in the development of fire codes by the NFPA (National Fire Protection Association). In this case, an incompatibility of the hoses of the Washington DC fire brigade with the Baltimore fire plugs left the volunteers who had come to help sitting helplessly by as the city burned.
International Standardization began with the formation of the ITU, International Telegraph Union (now the International Telecommunications Union). The ITU was founded in 1865 making it the oldest international organization in the UN family. The IEC (International Electrotechnical Commission) came into being in June of 1906 in London, UK, focused on the requirements for the world's electrotechnical industries.
The development of ISO followed in 1926, originally founded as the International Federation of the National Standardizing Associations (ISA). This organization focused heavily on mechanical engineering. It was disbanded in 1942 during the second World War but was re-organized under the current name, ISO, in 1946. Now ISO covers all standardization efforts except for electrotechnical and telecommunication standards, each of which have their own particular requirements.
(1) A History of Measure, Livio C. Stecchini, 1971, www.metrum.org/measures/index.htm
(2) Canada Science and Tecyhnology Museum, 2009, “Early Measurements and Standards.” www.sciencetech.technomuses.ca/english/collection/measurement2.cfm
The Standards Process
As we have discussed, standards are one way to provide a uniform, consistent product or policy that enhances quality, reliability, and trade.
We will be discussing a number of different methodologies of creating standards in this section.
First of all, we see two distinct types of standards development – one rooted in government organizations (most locations) and the other a voluntary system (the United States). This means that other than in the U.S., most standards developing activities take place in a governmental agency, like the British Standards Institute (BSI) or the Japanese Standards Association (JSA).
The other primary consideration for understanding different processes is the jurisdiction under which the standard is being developed (national, regional or international). As we move up the ladder to larger and larger geographic impact, the political considerations play a greater and greater role.
So we’ll discuss the basic format of most standardization work, and then take a look at a number of examples at a number of different jurisdictional levels. This should provide us with the background to handle most queries that will come our way.
1) Someone has to suggest the need for a standard, or the need for reviewing an existing standard. This is getting the work project into the standard organization’s pipeline. Usually there is a methodology in any given standards-developing organization for suggesting and getting approval for a new standards project. In a perfect world, this methodology should consider if there is already a standard on the topic, if standardization is appropriate for the topic, and if there will be a market for the standard once developed (will the standard be used?). Good standards practice suggests the need for a formal review of existing standards on a scheduled timeline (the American National Standards Institute requires a 5 year review for standards that are ANSI-approved, for example). This means that existing standards should flow back into the pipeline on a regular basis as well.
2) The work project needs to be assigned to a particular committee or administrator. If it is unclear that an existing committee has the right balance of input for the topic, it may be necessary to recruit participants for this task. Again, the goal for good standards development is to have a balanced mix of committee members. They should reflect both the creator and the user of the subject matter, as well as possibly regulators and other members of the supply chain. For example, if we were working on a parachute standard, we might want participation from parachute manufacturers, silk fabric manufacturers, the Air Force, skydivers themselves and the FAA (Federal Aviation Administration).
3) The committee (authors) work out a tentative document (the Committee Draft). This will involve a number of meetings, either online or face-to-face. They may start from a straw man document, an existing standard, or from scratch. Certainly, there will be an amount of give and take as the needs of each participant must be brought into balance. Normally, there are strict protocols on how drafts are accepted, so we would expect a number of draft attempts prior to a result that satisfies the committee.
4) The tentative document is labeled as a draft for public comment (sometimes called a Draft Standard) and handed out to interested parties not involved with the committee work. Comments are solicited in an attempt to improve the standard and to avoid difficulties which could cause a standard to either be inferior technically or not acceptable for widespread usage. It is normal for there to be a specific time period for distribution of a draft like this, with a deadline for public comment.
5) The committee meets and addresses each public comment one by one. The draft may be modified or not. But for each comment, there usually is a formal response as to why it is or is not implemented. If the draft undergoes significant changes, it may go back into the public comment cycle until it meets general approval.
6) When finalized, the document may go into a formal approval process, such as being voted on by an association’s membership at the Annual General Meeting. When a standard passes such an approval, but prior to printing, it is labeled a Final Draft. At this point, it is not published but has been approved in its final form.
7) At the point where the document is released from the printers, it becomes a Standard. With technology’s impact, this may be a very short time after approval or sometimes not. Normally, it is only when the document is released for public distribution that it is considered to be in force and will continue to be in force until a replacement document is actually released for public distribution.