Search Legislation

The Pressure Equipment Regulations 1999

 Help about what version

What Version

  • Latest available (Revised)
  • Original (As made)

More Resources


This is the original version (as it was originally made). This item of legislation is currently only available in its original format.

Module D (production quality assurance)

3.  Quality system

3.1. The manufacturer must lodge an application for assessment of his quality system with a notified body of his choice.

  • The application must include:

    • all relevant information on the pressure equipment concerned,

    • the documentation concerning the quality system,

    • the technical documentation for the approved type and a copy of the EC type-examination certificate or EC design-examination certificate.

3.2. The quality system must ensure compliance of the pressure equipment with the type described in the EC type-examination certificate or EC design-examination certificate and with the requirements of the Directive which apply to it.

  • All the elements, requirements and provisions adopted by the manufacturer must be documented in a systematic and orderly manner in the form of written policies, procedures and instructions. This quality system documentation must permit a consistent interpretation of the quality programmes, plans, manuals and records.

  • It must contain in particular an adequate description of:

    • the quality objectives and the organisational structure, responsibilities and powers of the management with regard to the quality of the pressure equipment,

    • the manufacturing, quality control and quality assurance techniques, processes and systematic measures that will be used, particularly the procedures used for the permanent joining of parts as approved in accordance with section 3.1.2 of Annex I,

    • the examinations and tests that will be carried out before, during and after manufacture, and the frequency with which they will be carried out,

    • the quality records, such as inspection reports and test data, calibration data, reports concerning the qualifications or approvals of the personnel concerned, particularly those of the personnel undertaking the joining of parts and the non-destructive tests in accordance with sections 3.1.2. and 3.1.3 of Annex I,

    • the means of monitoring the achievement of the required quality and the effective operation of the quality system.

3.3. The notified body must assess the quality system to determine whether it satisfies the requirements referred to in 3.2. The elements of the quality system which conform to the relevant harmonised standard are presumed to comply with the corresponding requirements referred to in 3.2.

  • The auditing team must have at least one member with experience of assessing the pressure equipment technology concerned. The assessment procedure must include an inspection visit to the manufacturer’s premises.

  • The decision must be notified to the manufacturer. The notification must contain the conclusions of the examination and the reasoned assessment decision. Provision must be made for an appeals procedure.

3.4. The manufacturer must undertake to fulfil the obligations arising out of the quality system as approved and to ensure that it remains satisfactory and efficient.

  • The manufacturer, or his authorised representative established within the Community, must inform the notified body that has approved the quality system of any intended adjustment to the quality system.

  • The notified body must assess the proposed changes and decide whether the amended quality system will still satisfy the requirements referred to in 3.2 or whether a reassessment is required.

  • It must notify its decision to the manufacturer. The notification must contain the conclusions of the examination and the reasoned assessment decision.

Back to top


Print Options


Legislation is available in different versions:

Latest Available (revised):The latest available updated version of the legislation incorporating changes made by subsequent legislation and applied by our editorial team. Changes we have not yet applied to the text, can be found in the ‘Changes to Legislation’ area.

Original (As Enacted or Made): The original version of the legislation as it stood when it was enacted or made. No changes have been applied to the text.


Opening Options

Different options to open legislation in order to view more content on screen at once


More Resources

Access essential accompanying documents and information for this legislation item from this tab. Dependent on the legislation item being viewed this may include:

  • the original print PDF of the as enacted version that was used for the print copy
  • lists of changes made by and/or affecting this legislation item
  • confers power and blanket amendment details
  • all formats of all associated documents
  • correction slips
  • links to related legislation and further information resources