Getting regulatory standards for free

How do you get a copy of a standard?

Let's say you need one for work. You want to check what ISO 14001 says about management review, to make sure you are doing it right. Or you want to know what the American Welding Society says in Z49.1 about "Safety in Welding and Cutting." Where do you find the document?

You could try the organization's website. Some standards (such as Z49.1, in fact) are available for free. But many of them are for sale. So someone—you, or the organization you work for—has to pony up cash to get a copy. 

That's the normal expectation. And the assumption has always been that if you don't want to pay for the standard, no one is forcing you. There's no law that you have to hold management review, after all. If your customers expect it from you—because your customers expect ISO 14001 certification—that's a cost of doing business. And you are free to choose whether it is better to pay for the certification (which includes paying for the standard) or to forego the chance to hang that diploma in your lobby.

But there's a catch. Sometimes there is a legal requirement to comply with one of these standards. And that complicates the calculation.

In what follows, I explain how this came about, and then I tell you how to get the documents you need for FREE. 

How can you be required to follow a "voluntary" standard?

Let's back up a minute. In the United States, many industries operate within guidelines defined by federal regulations. In some industries—the design and manufacture of medical devices is a prime example—those regulations became so numerous that they ended up covering the same scope as the relevant "voluntary" quality standards (in this case, ISO 13485, "Medical devices — Quality management systems — Requirements for regulatory purposes"). 

For a while, medical device companies had to comply to two complete sets of rules, those from the Food and Drug Administration (FDA) and those from ISO. This mandate was awkward, because there is no way that two different sets of rules can ever completely coincide. Finally, the FDA repealed those detailed individual regulations which duplicated the terms of the ISO standard, and replaced them all with a general regulation that medical device companies must comply to ISO 13485. Technically this means that Title 21 of the Code of Federal Regulations now "incorporates ISO 13485 by reference." (The same thing happens in other industries.)

Did that solve the problem?

Yes and no. It clarified the rules for medical device manufacturers. But ISO 13485 is a document sold by the International Organization for Standardization (ISO) for CHF196. On the other hand, it's a basic principle of American law that Federal regulations are made available for free. The idea is that it's not fair to hold someone accountable to a law and then charge him a fee to find out what the law says!

But if 21CFR Part 820 now incorporates ISO 13485 by reference, doesn't that mean that medical device companies should have access to the standard for free? And likewise for other industries whose regulations incorporate standards by reference?

What's the answer?       

In the end, the regulatory agency has to come to some kind of agreement with the standards-developing organization to make the standard "reasonably available" to persons who are affected by the law. For standards written by a dozen major organizations—including ISO and IEC (International Electrotechnical Commission)—there is a one-stop shop hosted online by the American National Standards Institute (ANSI) where you can download for free read-only copies of those standards which have been incorporated by reference into legislation or regulation.

Start here: https://ibr.ansi.org/Default.aspx 

Now to be clear, none of these organizations have relinquished their copyrights on the documents in question. And in order to respect those copyrights, ANSI's access is not exactly convenient. 

• You cannot print the documents you download from this site. 
• You cannot select text and copy it. 
• You cannot highlight it or add notes. 
• Before you can open any of these documents, you have to download a special plug-in for the Acrobat Reader, and then you have to open them in Acrobat (not in your browser). 
• You have to register with your name and address for each document you download, each time you download it. 
• There is a Frequently Asked Questions page with more information at https://ibr.ansi.org/Faq/Default.aspx. 

If you want access that doesn't suffer from all these limitations, you have to pay for the document like a regular customer.

But strictly speaking, you can get access to these standards for free—just like any other federal regulation.