How to build and keep a product compliance file

Start with the product, market and your role

Record the intended market, users, use, model, materials and accessories before requesting documents. More than one regulation can apply to a product. For Great Britain, build a requirements register showing each applicable rule, the assessment route and the evidence supporting it. Check Northern Ireland separately rather than treating the UK as a single compliance route.

Record whether you act as importer or manufacturer, especially for own-brand goods. Our markings and certification guide explains that distinction. Use the register to identify missing evidence and assign someone to resolve each gap.

Make the file an evidence map

Manufacturers remain responsible for assessing product risks and documenting how relevant requirements are addressed. Ask for a risk assessment that describes hazards, who could be harmed, foreseeable misuse, protective measures and remaining risks. Connect each protective measure to a drawing, material specification, test result or instruction.

Use an index with document titles, revisions, dates, owners and storage locations. Organise it around the technical file checklist, then add your purchase specification, approved configuration and unresolved questions. Mark missing documents explicitly so an empty folder cannot be mistaken for completed work.

Connect declarations and tests to the supplied goods

Save the manufacturer's signed declaration appropriate to the product and assessment route. Compare its product identification with the specification, label artwork and reports. Use our declaration checks for the detailed review rather than accepting a document solely because its heading looks right.

Keep complete reports, including sample descriptions, photographs, results and attachments. Record how the tested sample relates to the configuration being supplied and ask the laboratory about unclear scope. Our test report guide covers those checks. Keep inspection reports separately identifiable so they are not mistaken for laboratory evidence.

Archive the instructions actually supplied

For products covered by the government's Great Britain conformity-marking guidance, manufacturers must supply clear, legible instructions in easily understandable English. Keep the final instructions and safety information alongside approved product and packaging artwork.

Check the instructions against the risk assessment and supplied accessories. Read installation, use, cleaning and maintenance steps as the intended user would. Archive the released version, including any translation approval, and ask the factory to show which version will accompany production goods.

Secure access, retention and revision control

Record the retention requirement under each applicable product rule. Government guidance says documentation is typically retained for 10 years after each individual product is placed on the Great Britain market, rather than after the first item in a production run. Check the product-specific requirement before setting an archive deletion date.

If detailed drawings remain with the factory, agree who holds them, how they can be retrieved and how they reach the authorities. Test that arrangement before ordering. HSE guidance for work equipment requires importers to provide information and documentation following an enforcing authority's request. Treat confidentiality as an access-management issue, not a reason to leave retrieval unresolved.

Keep backed-up copies under your business's control and appoint a deputy file owner. Link released document sets to supplied batches, preserve superseded versions and log design, component and instruction changes. Review whether each change affects existing evidence before approving a repeat order.