Is the process under which an economic operator such as a manufacturer, importer or distributor ultimately claims compliance with the UK Statutory Instrument, and marks their product with the PPE conformity marks for Great Britain and Northern Ireland respectively.  And thus declares to the Union Market that their product is safe and legal.

Currently, this process mirrors that of the EU PPE Regulation as described on the CE Marking page. For products such as personal protective equipment (PPE), this process may require third-party intervention through examination and surveillance.

The UK Statutory Instrument describes the types of PPE which may be placed on the market under UKCA/UKNI marking provisions, and what preparatory steps a manufacturer must submit to, to evidence their declaration.

The general approach is as described here:

UKCA / UKNI marking requirements

Category I

Category II

Category III

Comply with the Health and Safety Requirements

√ 

Compile technical documents

 

Type-examination

Product / Quality system control

Write Declaration of Conformity

Apply UKCA / UKNI mark

Type-Examination

In the context of PPE, type-examination is the process by which products are independently assessed against the Essential Health and Safety Requirements (EHSRs) of the PPE Regulations – this frames the end use of the PPE in terms of its ability to offer protection and limit any introduction of hazards presenting a risk to the user, and outline the information which must be communicated to an end user so that such PPE may be used safely.

PPE may satisfy these Requirements by way of:

  • Meeting a, or set of, designated standard(s).
  • Meeting a technical specification designed to addresses each of the Requirements relevant to the product.

For Categories II and III, technical documentation must be submitted to an approved body such as INSPEC, which must evidence compliance with the Requirements of the Statutory Instrument (SI) 2018/390. In-short, this documentation is the blue-print of the PPE, describing its construction, constituents, function and bounds of use.

It is the approved bodies task to evaluate this documentation, and examine the PPE through comparison to design principles and testing to verify the applicants claim. Where the PPE does satisfy requirements, a Type-examination certificate will be issued for the PPE. For Category II this will mean the manufacturer can proceed with the mark and their statements. For Category III, the manufacturer must submit to further independent processes. 


Internal Production Control & Supervised Product Checks

This is an option for Category III PPE.

In the context of PPE, internal production control is the ongoing activity of a manufacturer to control production outcomes in conformity with the PPE as described by a type-examination certificate through applying their documented quality system. The outputs are assessed independently by testing to the designated Standard(s) or technical specification.

Production PPE would be sampled by an approved body such as INSPEC, with testing conducted to validate conformity to type and verify homogeneity. This independent step is repeated annually, and constitutes the product checks.


Quality Assurance of Production Process

This is an option for Category III PPE.

In the context of PPE, quality assurance of the production process is the independent assessment of the documented quality system controlling the production of PPE by means of auditing.

The manufacturer establishes a quality system, for instance based upon ISO 9001, which is then sampled annually by INSPEC under audit to verify that controls effectively allow for the production of PPE to type. For INSPEC, this independent step is conducted over a three-year cycle, with the certificate issued valid for a maximum of three years.

Download:

Statutory Instrument SI 2018/390
 

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