While a product may fulfill all the technical requirements, the absence of a suitable documentation system can still complicate the demonstration of conformity. In other words, technical documentation is a key element in explaining how a product has been designed, produced, tested, and assessed. For this reason, documentation is not merely administrative paperwork; it is a crucial component of the certification process.
What Is Technical Documentation?
Technical documentation is a set of documents containing information about a product, which is used to demonstrate the characteristics and conformity of the product. The exact documents required for a particular product depends on the product, the applicable requirements, and the certification framework. The documentation may include:
Product specifications
Technical drawings
Information about the materials used
Information about the design
Reports on tests performed
Inspection reports
Manufacturing information
Assessments of risks or safety
The Importance of Technical Documentation
Certification means demonstrating that a product fulfills a set of requirements. Technical documentation is used to show how a product meets the requirements. It can be challenging to demonstrate conformity without proper documentation. The documentation should allow you to link the requirements to the evidence that demonstrates compliance.
For example, if a requirement relates to a certain product characteristic, the documentation should enable you to show how that characteristic was achieved or measured. Documentation can greatly simplify the certification process by making it easier to evaluate whether a product complies with the requirements.
Technical Documentation Is Created During Product Development
It is a common mistake to assume that technical documentation is created only after a product is ready for certification. The truth is that many important documents are created during the product development process. The design of a product, the choice of materials, calculations, tests, changes made to the product, and manufacturing information may all be relevant for certification at a later stage. Therefore, it is beneficial to keep track of the documentation from the start of the product development process. Doing so may save you a lot of time when you later need to demonstrate compliance.
Accurate Product Information
The documentation must be accurate and describe the product that is being certified. If the documentation describes a previous version of the product, but the product has been modified, and the tests were performed on the modified product, there is a risk that the documentation will be inconsistent. It is important to update the documentation as changes are made to the product. This includes changes to the design, materials, components, or manufacturing process.
Test Reports as Evidence
Tests are often an important part of certification, and test reports can provide important evidence. A good test report contains information about what was tested, how the test was performed, the test conditions, and the results. The test report should also make it clear which requirements are addressed by the test. Having many test reports is not always the same as having evidence that a product meets the requirements. You must show that the tests you have performed are relevant for the requirements you need to demonstrate compliance with.
How to Structure Technical Documentation
The documentation should be structured in such a way that you can find the information you need quickly. You could organize your documentation by categories, such as:
Product description
Design information
Materials
Tests
Inspections
Manufacturing
Evidence of conformity
You could also use consistent naming conventions and version control. This makes it easier to maintain the documentation and ensures that different teams can work together using the same documentation.
Common Documentation Errors
There are several errors that you should avoid when preparing technical documentation for certification:
Missing documentation: Key technical details were never documented or cannot be found when needed.
Inconsistent documentation: Different documents contain conflicting information about product specifications, dimensions, materials, or model information.
Outdated documentation: A document refers to a previous version of the product and is no longer up to date.
Inadequate test documentation: Test reports are available but do not clearly state which requirements are satisfied.
These errors can often be avoided by taking good care of the documentation during the product development process.
Relationship Between Technical Documentation and Quality Management
Technical documentation is closely related to quality management. If you have accurate and traceable product documentation, you will be able to track changes, analyze problems, and ensure consistency in production. Therefore, documentation is not only important for certification. Documentation can also be used to manage manufacturing, quality control, maintenance, and product development.
Digital Documentation for Product Certification
Today, digital solutions are changing the way we create and manage documentation. Companies can use digital document management systems, automated data collection, electronic test documentation, and quality systems that integrate the supply chain. As products and production processes become more complex, it is likely that digital documentation will play an even greater role in ensuring that the documentation is accurate and easily accessible for certification purposes.
Summary
Technical documentation forms the basis of how you demonstrate that a product conforms to the requirements. The documentation links the requirements to the product design, test results, manufacturing, and other types of evidence. Good documentation is not necessarily comprehensive; it is accurate, well-structured, traceable, and relevant. For anyone involved in product certification, it is just as important to master the documentation as it is to know the technical requirements. At CertifyPeak, we teach you how to handle documentation so that you understand how it contributes to the certification process.
