Conveyor or packaging machine

Regimes engaged, per market

Standing when pasted with its name: mapped

What the file has to hold

• Technical file (9 of the 14 regimes, including Machinery Reg, EMC, RoHS)
  The technical documentation: design, drawings, bill of materials, the standards applied, the conformity assessment route, and the evidence that the requirements are met. Kept for the retention period the regime sets, typically ten years from the last unit placed on the market.
• Declaration of conformity (7 of the 14 regimes, including Machinery Reg, EMC, RoHS)
  The EU or UK declaration of conformity (or the food-contact declaration of compliance), signed by the manufacturer, naming the product, the legislation and the standards, and the notified or approved body where one was involved.
• Risk assessment (Machinery Reg, UK Machinery, OSHA/ANSI)
  The documented hazard identification and risk assessment for the product across its lifecycle, updated when the design, the use or the field data changes.
• Test reports (7 of the 14 regimes, including Machinery Reg, EMC, UK Machinery)
  Test reports from an accredited or accepted laboratory against the standards the technical file names, tied to the exact model and revision tested.
• Labelling and instructions (10 of the 14 regimes, including Machinery Reg, EMC, WEEE)
  Markings on the product and packaging (conformity mark, identification, warnings, manufacturer and importer details) and the instructions and safety information in the language of the market.
• Traceability records (Machinery Reg, UK Machinery)
  Batch, lot or serial identification on the product, the records that tie a unit to its production and supply chain, and UDI where the device rules require it.
• Third-party certificate (OSHA/ANSI, UL/NRTL)
  A type-examination certificate, notified or approved body certificate, or listing from a recognised laboratory, with the scope and the expiry.
• FCC authorisation (FCC Part 15)
  The FCC Supplier's Declaration of Conformity, or the grant of certification with the FCC ID, and the compliance statement in the manual.
• Substance declarations (RoHS, REACH, UK RoHS, UK REACH)
  Safety data sheets for mixtures and supplier material declarations for articles: the trail that shows what is in the product against the restricted lists.
• Registrations (WEEE, UK WEEE)
  Producer, establishment, device or product registrations in the databases the regime names (EUDAMED, EPREL, CPNP, the WEEE and battery registers, FDA registration and listing).

Duties that continue after sale

• Market surveillance cooperation (Machinery Reg, UK Machinery)
  Answer an authority's request for the technical file, the declaration and the supply chain within the time it sets, in a language it accepts, and cooperate with any corrective measure it requires.
  Licensed controls: Machinery Reg Art.10 · Machinery Reg Art.43, 44
• Recall readiness (Machinery Reg, UK Machinery)
  Be able to identify affected units, reach the customers who hold them, issue a notice in the required form, offer the remedy the rules require, and show the authority the effectiveness of the action.
  Licensed controls: Machinery Reg Art.45, 46
• Traceability records (Machinery Reg, UK Machinery)
  Keep the records that identify which batch went to which customer, and the identification on the product that lets a unit be traced back, for the retention period the regime sets.
  Licensed controls: Machinery Reg Art.17, 18, 19
• Producer responsibility for take-back (WEEE, UK WEEE)
  Keep producer registrations current in each market, report the quantities placed, and finance collection and treatment of the product and its batteries at end of life.
• Substance list watching (RoHS, REACH, UK RoHS, UK REACH)
  Track additions to the restricted and candidate substance lists, re-check supplier declarations against them, and update customer communication and labels when a substance in the product is added.

This week

Put in writing who is the manufacturer of the assembled line, because the machinery rules place the whole file on that party.

What holding one is evidence for

Requirement text and evidence artefacts from a human-verified corpus. Data licensed to Conformity Sheet by The Art of Service Pty Ltd, revocable, non-transferable.