US documentation standards and regulations
by George Lewis
by George Lewis
US documentation standards are very similar to the standards set out for EU documentation. Creating documentation that is compliant with EU standards goes a long way towards documentation compliance in US markets. However for full compliance in the US markets, you need to understand how standards are created and what the key elements you need consider.
So how do you make your products documentation compliant with US regulations?
In the US, initially laws are passed by the Senate. These laws are then acted upon by various government agencies. There is a different government agency for each industry or group of industries. Finally, local regulations and laws are set on a state-by-state level.
The largest government agency that provides a baseline for a lot of the other agencies and hence and good benchmark for documentation compliance, is the Consumer Product Safety Commission (CPSC).
The CPSC sets out documentation compliance using the same standards that are adopted in the EU, specifically the IEC 82079-1 Preparation of instructions for use standard. However there are additional standards that you need to be aware of, for example ISO/IEC Guide 37:2012 – Instructions for use of products by consumers and ANSI Z536.6 Product Safety Information in Product Manuals, Instructions, and Other Collateral Materials.
US documentation compliance standards are also defined by case law. This is where a legal action has taken place and as a result the documentation must be compliant with the outcome of that legal action.
The most obvious US documentation standard that is derived from legal action is ANSI Z536.6. This standard covers the use of warnings, cautions and notices in documentation.
As defined in ANSI Z536.6, the following elements make up a notice:
ANSI Safety notice examples
In product documentation there are three main places warnings, cautions and notices can be included:
US documentation regulations are set out by multiple federal agencies and through legal case law. This is different to the way that standards are defined in the EU, which uses a single European Commission and a single unified standard.
To ensure you have complete compliance for the US market you should review any relevant requirements for your product from each federal agency industry regulator and any relevant local state laws.
Does your current product documentation comply with the EU and US documentation directives? Use doc-department’s Documentation Audit Tool to help you do your own health-check on your documentation and documentation processes.
George works as 3di’s Service Delivery Director. Passionate about helping each individual team member reach their full potential. Outside of work George can be found cycling, reading books on business and psychology, as well as taking the odd trip to Spain or Germany.