A technical file is the compiled set of design, manufacturing and test records that demonstrates a product's conformity to the requirements applying to it. It is the evidence a manufacturer must hold and produce on request, and its completeness determines whether a conformity claim can be sustained.
What Technical File delivers for your organisation.
The core requirements your organisation will need to meet.
General product description and identification
Design and manufacturing drawings and specifications
List of standards applied and the essential requirements met
Risk assessment and the results of design calculations
Test reports and conformity assessment evidence
Declaration of conformity and retention arrangements
Our structured approach from initial assessment through to completion.
We determine what the applicable legislation or scheme requires the file to contain.
We audit your existing records against that requirement and identify what is missing.
We compile the file, including risk assessment and the standards applied.
We establish how the file is updated as the product or applicable standards change.
Our expertise spans across diverse sectors, delivering tailored certification solutions.
Common questions answered by our consultants.
Others we support in Product Certification.
Empower your business today with Achievemax's expertise.
