Safety helmet or hard hat

Regimes engaged, per market

Standing when pasted with its name: mapped

What the file has to hold

• Technical file (5 of the 8 regimes, including PPE Reg, REACH, UK PPE)
  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 (PPE Reg, UK PPE, UKCA)
  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 (CPSC, PPE Reg, UK PPE)
  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 (5 of the 8 regimes, including CPSC, PPE Reg, UK PPE)
  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 (6 of the 8 regimes, including CPSC, PPE Reg, UK PPE)
  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 (CPSC)
  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 (PPE Reg, UK PPE, OSHA PPE / NIOSH)
  A type-examination certificate, notified or approved body certificate, or listing from a recognised laboratory, with the scope and the expiry.
• Substance declarations (REACH, UK REACH, Prop 65)
  Safety data sheets for mixtures and supplier material declarations for articles: the trail that shows what is in the product against the restricted lists.

Duties that continue after sale

• Market surveillance cooperation (CPSC)
  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: CPSC PM.4 · CPSC PM.3
• Incident reporting (CPSC)
  Notify the authority when a product has caused, or could cause, an accident, injury or serious incident, through the channel the regime names (the Safety Business Gateway, the MHRA, the FDA, SaferProducts.gov) and within its clock.
  Licensed controls: CPSC USCPSC 1 · CPSC PM.1
• Recall readiness (CPSC)
  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: CPSC USCPSC 3 · CPSC PM.2
• Security updates and vulnerability handling (CPSC)
  Provide security updates for the stated support period, run a coordinated vulnerability disclosure process, and report actively exploited vulnerabilities and severe incidents within the reporting clock.
  Licensed controls: CPSC CS.4 · CPSC SW.3
• Substance list watching (REACH, UK REACH, Prop 65)
  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

Check the type-examination certificate has not expired and names the shell material and sizes being shipped.

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.