Legal compliance and standards
»Standards and laws are rarely unambiguous: they require research, interpretation, discourse, organization and - not least - decisions.«
Roland Schmeling; CEO
Build up know-how: Our expertise for your company
Technical information that meets requirements - instructions, warning signs, online help, training documents, catalogs, product information on the Internet - is correct, up-to-date, consistent, clear, unambiguous and comprehensible. This is required not only by directives, regulations and standards, but also by product liability and, not least, by the customers themselves.
Particularly in the US market, consistent information is highly relevant under liability law. Managing and meeting these legal requirements requires experience and structured approaches.
Different knowledge requirements among employees and unclear responsibilities are often the cause of unclear information processes. As a result, the legal conformity of technical information is not ensured. Liability cases and trade barriers are only the tip of an iceberg of customer complaints, costs due to rework, goodwill and contractual penalties.
Our trainings: Achieving common understanding
A common understanding of the legal requirements, clarified responsibilities and clear rules are the essential prerequisites for legally compliant action.
In workshops or in-house training, we introduce the topic, sensitize employees and provide the necessary overview and confidence in dealing with international technology law.
With targeted workshop elements in the training courses, we develop clear measures that get everyone pulling in the same direction.
Standards research and requirements catalogs
Which standards are important? What do these standards require? How are the requirements to be implemented?
Technical writing departments must meet hundreds of individual requirements. Many requirements are product-specific, market-specific and change. Without structured requirements management, the complexity can no longer be mastered.
For important standards we offer "out of the box" requirement catalogs maintained by us.
We also break down complex standards into digestible portions structured and classified at the requirements level according to our requirements engineering guide.
Testing of instructions according to relevant standards such as IEC/IEEE 82079-1, ANSI Z535, ISO 20607
Only those who understand the standards can test reliably. Our basis for the correct interpretation of standards is our many years of experience in the testing and certification of technical documentation, consulting in many industries and active participation in international standardization and legislation.
We have comprehensive, up-to-date and proven catalogs of requirements for the central documentation standards. In this way, we ensure a high level of reproducibility of results, design reliability and high efficiency during testing.
If required, we supplement the catalogs of requirements with product-specific standards, for example on machinery and equipment, medical products, vehicles, construction products or electrical products.
"Safety chapters" in instructions have the unpleasant property of growing out of control. The idea of legal protection alone, however, leads to long, barely comprehensible instructions. Instead of decreasing, liability risks may even increase. The way out: consistently structured and user-oriented safety instructions.
Safety instructions are often legalistic hedging texts. These texts are often complex and hardly user-oriented. Didactic preparation is essential for safety instructions in order to promote the retention rate of users.
We define rules for the structure, design and wording of safety instructions based on relevant standards such as ANSI Z535.6 and IEC/IEEE 82079-1. The development of the rules is in line with the Funktionsdesign® standardization method and fits seamlessly into corresponding standardization projects.
Steps to safe and understandable hints
- An analysis of existing safety instructions, the existence of a meaningful risk assessment, clear target group descriptions and a legal and standards research are important prerequisites for the optimization of safety instructions.
- In workshops with appropriately commissioned editors and, if required, with the product safety officers, we develop rules, structures and texts as part of a guideline. Building up the corresponding competence in the company is a central concern here.
- After editorial fine-tuning and approval, the result is not only safety-compliant texts, but also the formulated underlying rules and principles.
Our approach is tried and tested in many sectors: in medical technology and the automotive industry as well as for construction products and machinery. Together with the VDMA (Verband Deutscher Maschinen- und Anlagenbau e.V. - German Engineering Federation), for example, we have developed a guide and corresponding text templates for safety instructions in the area of agricultural technology.
Product Liability USA
Instruction errors are the most important error group for German companies operating in the USA, behind design and production errors.
The US market is characterized by high product liability risks LINK to the article US construction liability. Liability risks can be significantly reduced through a suitable set of measures. The measures include:
- Clear standards for safety-compliant instructions, the responsibility of which lies with suitable specialist personnel
- Consideration of standards for instructions such as IEC/IEEE 82079-1 and ANSI Z535 with their defined requirements for safety instructions and warnings, comprehensible texts, clear structure, minimalism or consistency
- Consistent and effective processes with clear responsibilities, including for legal and standards research, requirements management, risk assessment, and quality assurance
- Practiced safety orientation from marketing and sales to design, product monitoring and recall organization
- Comprehensive quality management, with good internal communication, exchange in the editorial team and with users, training and field tests
We complement our many years of experience in developing information concepts for globally active companies with coordination and targeted cooperation with specialist departments, law firms, engineering offices and testing houses. In this way, we create the solid knowledge base that matches the challenges.
Making safe products available on the market means knowing, mitigating and controlling the risks. With systematic risk assessment and optimal dovetailing with the information management process of technical writing. Risk assessment is a building block of efficient product development and not just a chore.
Our goal is a risk assessment that is not a chore, but a productive building block of efficient product development.
Risk assessment considers the hazards posed by a product and identifies measures to mitigate these hazards. It is not only a central step in the CE conformity assessment procedure, but is also fundamentally required from the point of view of product liability. The state of the art is to consider the functions of the product and the activities of users, as recommended, for example, by ISO TR 14121-2 ("machine-based risk assessment" and "task-based risk assessment").
Minimizing the design risks of products is a familiar area of product development. Little known, however, are the methods for determining and assessing the risks of user-side product use and the "human factors". A particular challenge are the risks that can arise from the foreseeable behavior of users (§3 ProdSG).
Risk assessment is teamwork and therefore requires a clear and simple method, also with regard to the so-called indicative safety: On the one hand, a technical editor has the responsibility for the instruction, on the other hand, the measures must be defined in the risk assessment. This is why dovetailing the risk assessment with the creation of warning signs, instructions and other instructions plays a central role.
Prerequisites for a successful risk assessment are:
- Clear definition of product boundaries and life cycle
- Clear definition of the limits of use, including a target group and activity analysis
- Carefully determined legal and normative requirements
Results-oriented workshop with know-how transfer
We agree on the procedure and introduce all participants to the method. In a joint workshop with your experts from development, application, and editorial departments, we methodically guide you through the risk assessment based on a concrete, current project. In doing so, we name and evaluate the risks and formulate the concrete measures for risk reduction. Not only a first risk assessment is created: practice- and result-oriented we build up the necessary methodical knowledge in the company.
Where does your company stand with regard to compliance with legal and normative requirements? In day-to-day business, it is not uncommon for compliance with legal requirements to fall behind. There is often a lack of the necessary diligence in quality assurance. The experienced view from the outside helps to uncover deficiencies in the process and to close gaps.
The assessment includes, for example, the analysis of instructions, internal documentation and process interviews in the sense of an audit. We prepare the results in a clear and comprehensible manner. We present and discuss the results and our recommendations.