Product documentation compliance
Compliance and documentation: What risks?
The European commission recently published the latest version of its guide “The Blue Guide on the implementation of EU product rules 2016”, covering product documentation, among other things.
An opportunity to revisit several issues, notably via section 4.3. TECHNICAL DOCUMENTATION, on European requirements regarding technical documentation...
What is the product manufacturer's responsibility?
First of all, we must remember that in all but a few very specific machines (pressure vessels, certain medical devices, measurement devices, etc.), it's a question of self-certification. The manufacturer may thus be held responsible if the product documentation does not follow the rules.
These basic rules are simple:
The manufacturer must develop technical documentation;
Technical documentation is designed to supply information on the design, manufacturing and use of the product.
What are the requirements for this product documentation?
According to the directive, the documentation must meet very precise criteria:
The documentation proves the conformance of the product with applicable requirements.
The documentation is available at the time the product is put on the market.
It must be available for 10 years after the last time the product is placed on the market.
It contains an analysis of the risks associated with the product and how these risks are taken into account to assure compliance with regulations.
An lastly, the various versions of the documentation for various versions of the product must remain available. In fact, during an inspection, the correct version of the product documentation must be presented!
The most demanding point in this list is, without a doubt, the analysis of risks and their coverage. A veritable methodology must be established (frequency, severity...) to list them and reassure the public of the steps taken to counter these risks.
Here again, common sense applies: the product documentation should be in a language accepted by the customer, and understandable by a possible control body.
Structured writing tools to the rescue
Luckily, structured writing tools are going to establish a methodology to minimize risks while standardizing production of this documentation for products that are increasingly complex and changing at a rapid pace.
Working collaboratively, so that everyone can take part depending on his skills in terms of conception, manufacturing or use;
Working collaboratively to determine risks and counter them;
Modification tracking and automatic logging;
The simple and effective solution developed by NeoDoc: Calenco
Structured writing tools exist, but remain reserved for elite computing developers, accustomed to languages such as XML, XSLT, etc..
With more than 12 years' experience in technical writing, NeoDoc developed Calenco, a simple-to-use solution, easy for non-computing experts to use.
Many of NeoDoc key account clients (EDF, SNCF, Bouygues, General Electric, etc.), as well as small to medium-sized manufacturers of equipment (Carrier, Tecnoma, Saint Gobain, etc.) quickly adopted the Calenco solution for writing technical documents.
The benefits of the Calenco solution
- Productivity Boosts: Industrialize document production by optimizing reusable content;
- customize the documentation according to a user profile, product, country of destination;
- Produce product documentation quickly: Time to market;
- Automatically update all documentation from a single source;
- Disseminate up-to-date product documentation on different media (Paper, PDF, Web, Tablets ..);
- ensure consistent quality in accordance with the company's graphic charter.
The Calenco solution is available in SaaS mode, and accessible to any type of company facing the complexity of technical writing whatever its size.
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