NPI Product Compliance Gate Checklist (Free)

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14 critical items still open - these are the highest-risk gaps.

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Scope and applicability

Target markets and ship-to countries are listed and approvedCRITICALApplicable laws and standards are identified for each marketCRITICALProduct functions such as wireless, battery, software and pressure are recordedIntended use and foreseeable misuse are documentedLegal manufacturer, importer and authorised representative are namedCRITICALProduct is classified for export control and customs tariffCRITICAL

Design and testing evidence

Safety, EMC and radio tests are done by a lab with suitable scopeCRITICALTest reports cover the final design and the exact model variantsRisk assessment is completed and linked to design controlsCRITICALHarmonised or recognised standards are listed with edition datesSoftware and firmware versions under test are recordedAny change since testing has been assessed for impact

Materials and substances

BOM is complete down to part level with manufacturer part numbersRoHS declarations are held for all components, exemptions listedCRITICALREACH SVHC screening against the current Candidate List is doneCRITICALConflict minerals and PFAS inquiries are sent to suppliersBattery chemistry and transport classification are confirmedPackaging materials are reviewed for restricted substances

Marking, labelling and documents

Rating plate shows model, ratings, serial or batch and manufacturer addressCRITICALRequired marks are applied only where certificates existCRITICALWEEE and battery symbols are on the product where requiredCountry of origin marking is decided and consistent with customs entryUser manual includes safety instructions in required languagesCRITICALDeclaration of conformity is signed by an authorised personCRITICALProp 65 or similar warning need is assessed for California sales

Records and post-market

Technical file is assembled and stored for the required retention periodCRITICALTraceability by lot or serial number is set up in the ERPProcedure for complaints, incidents and recalls is in placeCRITICALMarket registrations such as WEEE, batteries and packaging are filedOwner and review date are set for certificate renewalsSupplier change notification requirements are in the purchase agreements

Release should not proceed while any critical item is open. Non-critical gaps need an owner and a date.

Gate checks tied to ERP changes

Optional: we can discuss triggering this review from engineering change orders.

Optional. The tool and every export work without this. No spam.

How to use the checklist

Run it at the last design review before production release and again before first shipment to each new market. Tick each item only when evidence exists and is filed, such as a report number, a declaration or a signed form. Critical items are those where a gap normally blocks sale or exposes the company to enforcement. Export the completed list to PDF to keep with the release record.

Why a gate and not a final inspection

Most compliance work depends on decisions made early: component choices, enclosure, software and labelling. A gate that links to product lifecycle stages lets compliance veto a release without surprise. Tie the gate to your ERP engineering change process so that a revision to a certified product triggers a re-check automatically.

Evidence expectations

Auditors and market surveillance authorities ask to see evidence, not intentions. For each item keep a pointer to a controlled record, such as a document number, a lab report ID and date, or a supplier declaration reference. A declaration signed without supporting test reports and risk assessment is weak and exposes the signatory.

Common mistakes

Typical failures are testing a pre-production sample that differs from the released design, applying a mark before the certificate arrives, forgetting importer details on the label, and not planning for substance regulations that change yearly. Another is missing the link between customs classification, country of origin and the product marking, which creates trouble at import.

Frequently Asked Questions

Who should sign off the gate?

At minimum the compliance engineer and the product owner, with quality and engineering review for the evidence. The person who signs the declaration of conformity must have authority and access to the technical file.

How long must the technical file be kept?

It depends on the law. Many EU product laws require ten years after the product is placed on the market, while others differ. Check the retention period in each applicable act and apply the longest.

Does a small design change need a new gate?

Run a short impact assessment on every change. Changes that affect safety, EMC, radio, materials or software of a certified product usually need re-testing or at least a documented technical justification.

What counts as critical?

Items whose absence normally prevents lawful sale, such as missing declarations, uncertified required marks, absent safety instructions or unidentified responsible persons. Adjust the list to your products and risk appetite.

Netray can help connect release gates to ERP change orders so a compliance review is triggered automatically for certified items.

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