Module: Legal Requirements for Technical Documentation (Including International Standards)
About the topic
Technical communication is
subject to certain legal requirements because the information
given, such as instructions for use, is essential for the safe
and satisfactory use of the given product. The user has the
right, based on legal regulations, to receive all information
necessary to enable him or her to use the product properly and to
avoid any kind of damage that might result from improper use.
Persons in charge of technical communication in a company, such
as technical communicators, managers, and vendors offering
technical writing services, are all obliged to comply with
regulatory law related to technical writing.
Compliance with these regulations requires that those in charge must be knowledgeable on the govering law. A lack of knowledge will not be accepted as an excuse if a manufacturer or any other organization is found liable for not providing sufficient information for the proper use of a product.
Any technical communication that does not comply with the applicable law could cause legal consequences for the manufacturer or any other organization dealing with the product. One possible consequence is that a customer can claim their rights under the warranty or terminate the purchase contract. In the case of damages or of personal injury or fatalities resulting from the improper use of a product the customer can make a claim for compensation. As an additional consequence, market surveillance authorities may prohibit the further distribution or sale of the relevant product. In cases involving personal injury or fatality, authorities may also initiate a criminal investigation.
The obligation to comply with legal requirements goes beyond the laws and other regulations of a company’s domestic market. In the age of globalization manufacturers have to comply with the applicable laws and regulations in each market they target. The principles of Contract Law and Product Liability Law are more or less similar in most countries. In contrast, Health and Safety Regulations differ significantly (except under the multinational legal framework of the European Community – “New Approach Framework”).
Unfortunately, the legal requirements regarding the content, structure, and design of technical documentation are usually not explicitly defined. More detailed requirements may be found in national or international standards, which describe the state of the art regarding product design including the technical documentation.
In some case the legal requirements refer directly to industry standards. This method of additionally referring to technical standards is often used in the EU-Health and Safety Regulations. For example, the requirements for the documentation of machines as defined in the EU-Machine Directive 2006/42 is set forth in the European standard EN 12100:2.
Despite the key role played by such international standards, it is important to know that they are not equal to statutory law. Unlike laws or other regulations, standards are not legally binding. Their legal implications and effects, however, must be carefully examined and analyzed, and Technical Communicators need to be aware of this issue.
In the light of the complex system employed in this area of law, it is necessary for manufacturers as well as service vendors to implement a proper management structure for compliance with both applicable laws and the corresponding standards. Compliance management should comprise proper up-to-date research and the interpretation of the retrieved requirements. Furthermore, the role of technical communicators should be clearly defined. It is important for them to know their responsibilities with regard to legal regulation.
For compliance with legal requirements dealing with product safety, it is mandatory to conduct a risk analysis for each individual product as a first step. This in turn may result in the implementation of changes within the manufacturing or design process. Technical communicators should be involved in this process because they must be able to draft any safety related information like warning messages or safety signs for product users.
The general learning target of Module 1 is to enable technical communicators and their employers (manufacturers and service vendors) to minimize the risk of claims based on technical documentation that does not comply with the applicable legal requirements and international standards. In addition, the acquired background knowledge about prevailing legal requirements and applicable standards will support the production of high quality technical documentation, including user friendly instructions for use.