The Transportable Pressure Vessels Regulations 2001

Type Statutory-Instrument
Publication 2001-04-09
Last updated 2004-05-10
State In force
Department King's Printer of Acts of Parliament
PDF Download
articles Not indexed
Reform history JSON API

Made: 9th April 2001

Laid before Parliament: 10th April 2001

Coming into force

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PART I — PRELIMINARY

Citation and Commencement

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Interpretation

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Application

3

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PART II — GENERAL REQUIREMENTS

Requirements relating to the placing on the market and use at work of transportable pressure vessels

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Transportable pressure vessels placed on the market or used at work exclusively in Great Britain

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Reassessment of conformity

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Periodic inspection and repeated use

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Notified bodies

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Approved bodies

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Appointment of notified bodies and approved bodies by the Executive

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Conformity marking

11

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PART III — MISCELLANEOUS

Fees

12

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Defence

13

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Amendments and saving

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SCHEDULE 1 — DISAPPLICATIONS TO THESE REGULATIONS

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SCHEDULE 2 — STANDARDS

The standards referred to in regulations 4 to 6 are—

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SCHEDULE 3 — CONFORMITY ASSESSMENT PROCEDURES

Module A—internal production control

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Module A1—internal manufacturing checks with monitoring of the final assessment

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Final assessment must be performed by the manufacturer and monitored by means of unexpected visits by a notified body chosen by the manufacturer.

During such visits, the notified body must:

  • ensure that the manufacturer actually performs final assessment,
  • take samples of the transportable pressure vessels at the manufacturing or storage premises in order to conduct checks. The notified body assesses the number of vessels to sample and whether it is necessary to perform, or have performed, all or part of the final assessment of the samples of vessels.

Should one or more of the transportable pressure vessels not conform, the notified body must take appropriate measures.

On the responsibility of the notified body, the manufacturer must affix that body’s identification number to each transportable pressure vessel.

Module B—EC type-examination

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4.1

examine the technical documentation, verify that the type has been manufactured in conformity with it and identify the components designed in accordance with the relevant requirements of these Regulations and in particular:

  • examine the technical documentation with respect to the design and the manufacturing procedures,
  • assess the materials used where these are not in conformity with the relevant provisions of these Regulations and check the certificate issued by the materials manufacturer,
  • approve the procedures for the permanent joining of transportable pressure vessel parts or check that they have been previously approved,
  • verify that the staff undertaking the permanent joining of transportable pressure vessel parts and the non-destructive tests are qualified or approved,

4.2

perform or have performed the appropriate examinations and necessary tests to establish whether the solutions adopted by the manufacturer meet the relevant requirements of these Regulations.

4.3

perform or have performed the appropriate examinations and necessary tests to establish whether the relevant provisions of these Regulations have been applied.

4.4

agree with the applicant the location where the examinations and necessary tests are to be carried out.

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Module B1—EC design examination

1

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2

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4.1

examine the technical documentation and identify the components which have been designed in accordance with the relevant provisions of these Regulations and in particular must:

  • assess the materials used where these are not in conformity with the relevant provisions of these Regulations,
  • approve the procedures for the permanent joining of transportable pressure vessel parts or check that they have been previously approved,
  • verify that the staff undertaking the permanent joining of transportable pressure vessel parts and the non-destructive tests are qualified or approved;

4.2

perform the necessary examinations to establish whether the solutions adopted by the manufacturer meet the relevant requirements of these Regulations;

4.3

perform the necessary examinations to establish whether the relevant provisions of these Regulations have actually been applied.

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Module C1—conformity to type

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Module D—production quality assurance

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3.1

The manufacturer must lodge an application for assessment of his quality system with a notified body of his choice and the application must include:

  • all relevant information on the transportable pressure vessels concerned,
  • the documentation concerning the quality system,
  • the technical documentation for the approved type and a copy of the EC type-examination certificate.

3.2

The quality system must ensure compliance of the transportable pressure vessels with the type described in the EC type-examination certificate and with the relevant requirements of these Regulations.

  • 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. The 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 transportable pressure vessels, the manufacturing, quality control and quality assurance techniques, processes and systematic measures that will be used, particularly the procedures used, 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, 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 paragraph 3.2.

  • The auditing team must have at least one member with experience of assessing the transportable pressure vessels 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 paragraph 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.

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4.1

The purpose of surveillance is to ensure that the manufacturer duly fulfils the obligations arising out of the approved quality system.

4.2

The manufacturer must allow the notified body access for inspection purposes to the locations of manufacture, inspection, testing and storage and provide it with all necessary information, in particular:

  • the quality system documentation,
  • the quality records, such as inspection reports and test data, calibration data, reports concerning the qualifications of the personnel concerned, etc.

4.3

The notified body must carry out periodic audits to make sure that the manufacturer maintains and applies the quality system and provide the manufacturer with an audit report. The frequency of periodic audits must be such that a full reassessment is carried out every three years.

4.4

In addition, the notified body may pay unexpected visits to the manufacturer. The need for such additional visits, and the frequency thereof, will be determined on the basis of a visit control system operated by the notified body. In particular, the following factors must be considered in the visit control system:

  • the category of the vessels,
  • the results of previous surveillance visits,
  • the need to follow up corrective action,
  • where applicable, special conditions linked to the approval of the system,
  • significant changes in manufacturing organisation, policy or techniques.

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Module D1—production quality assurance

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4.1

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

4.2

The quality system must ensure compliance of the transportable pressure vessels with relevant requirements of these Regulations.

4.3

The notified body must assess the quality system to determine whether it satisfies the requirements referred to in paragraph 4.2.

4.4

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.

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5.1

The purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations arising out of the approved quality system.

5.2

The manufacturer must allow the notified body access for inspection purposes to the locations of manufacture, inspection, testing and storage and provide it with all necessary information, in particular:

  • the quality system documentation,
  • the quality records, such as inspection reports and test data, calibration data, reports concerning the qualifications of the personnel concerned, etc.

5.3

The notified body must carry out periodic audits to make sure that the manufacturer maintains and applies the quality system and provide the manufacturer with an audit report. The frequency of periodic audits must be such that a full reassessment is carried out every three years.

5.4

In addition, the notified body may pay unexpected visits to the manufacturer. The need for such additional visits, and the frequency thereof, will be determined on the basis of a visit control system operated by the notified body. In particular, the following factors must be considered in the visit control system:

  • the category of the vessels,
  • the results of previous surveillance visits,
  • the need to follow up corrective action,
  • where applicable, special conditions linked to the approval of the system,
  • significant changes in manufacturing organisation, policy or techniques.

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Module E—product quality assurance

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3.1

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

3.2

Under the quality system, each transportable pressure vessel must be examined and appropriate tests must be carried out in order to ensure its conformity with the relevant requirements of these Regulations. 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. The quality system documentation must permit a consistent interpretation of the quality programmes, plans, manuals and records.

3.3

The notified body must assess the quality system to determine whether it satisfies the requirements referred to in paragraph 3.2.

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.

4

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4.1

The purpose of surveillance is to ensure that the manufacturer duly fulfils the obligations arising out of the approved quality system.

4.2

The manufacturer must allow the notified body access for inspection purposes to the locations of manufacture, inspection, testing and storage and provide it with all necessary information, in particular:

  • the quality system documentation,
  • the technical documentation,
  • the quality records, such as inspection reports and test data, calibration data, reports concerning the qualifications of the personnel concerned, etc.

4.3

The notified body must carry out periodic audits to make sure that the manufacturer maintains and applies the quality system and provide the manufacturer with an audit report. The frequency of periodic audits must be such that a full reassessment is carried out every three years.

4.4

In addition, the notified body may pay unexpected visits to the manufacturer. The need for such additional visits, and the frequency thereof, will be determined on the basis of a visit control system operated by the notified body. In particular, the following factors must be considered in the visit control system:

  • the category of the vessel,
  • the results of previous surveillance visits,
  • the need to follow up corrective action,
  • where applicable, special conditions linked to the approval of the system,
  • significant changes in manufacturing organisation, policy or techniques.

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Module E1—production quality assurance

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4.1

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

4.2

Under the quality system, each transportable pressure vessel must be examined and appropriate tests must be carried out in order to ensure its conformity with the relevant requirements of these Regulations. 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. The quality system documentation must permit a consistent interpretation of the quality programmes, plans, manuals and records.

4.3

The notified body must assess the quality system to determine whether it satisfies the requirements referred to in paragraph 4.2.

4.4

The manufacturer must undertake to discharge the obligations arising from the quality system as approved and to ensure that it remains satisfactory and efficient.

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5.1

The purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations arising out of the approved quality system.

5.2

The manufacturer must allow the notified body access for inspection purposes to the locations of manufacture, inspection, testing and storage and provide it with all necessary information, in particular:

  • the quality system documentation,
  • the technical documentation,
  • the quality records, such as inspection reports and test data, calibration data, reports concerning the qualifications of the personnel concerned, etc.

5.3

The notified body must carry out periodic audits to make sure that the manufacturer maintains and applies the quality system and provide the manufacturer with an audit report. The frequency of periodic audits must be such that a full reassessment is carried out every three years.

5.4

In addition, the notified body may pay unexpected visits to the manufacturer: The need for such additional visits, and the frequency thereof, will be determined on the basis of a visit control system operated by the notified body. In particular, the following factors must be considered in the visit control system:

  • the category of the vessels,
  • the results of previous surveillance visits,
  • the need to follow up corrective action,
  • where applicable, special conditions linked to the approval of the system,
  • significant changes in manufacturing organisation, policy or techniques.

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Module F—product verification

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4.1

Each transportable pressure vessel must be individually examined and must undergo appropriate examinations and tests in order to verify that it conforms to the type and the relevant requirements of these Regulations.

4.2

The notified body must affix its identification number or have it affixed to each transportable pressure vessel and draw up a written certificate of conformity relating to the tests carried out.

4.3

The manufacturer, or his authorised representative established within the Community, must ensure that the certificates of conformity issued by the notified body can be made available on request.

Module G—EC unit verification

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4.1

The notified body must affix its identification number or have it affixed to each transportable pressure vessel and draw up a certificate of conformity for the tests carried out. This certificate must be kept for a period of 10 years.

4.2

The manufacturer, or his authorised representative established within the Community, must ensure that the declaration of conformity and certificate of conformity issued by the notified body can be made available on request.

Module H—full quality assurance

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3.1

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

3.2

The quality system must ensure compliance of the transportable pressure vessel with the relevant requirements of these Regulations.

3.3

The notified body must assess the quality system to determine whether it satisfies the requirements referred to in paragraph 3.2.

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.

4

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4.1

The purpose of this surveillance is to make sure that the manufacturer duly fulfils the obligations arising out of the approved quality system.

4.2

The manufacturer must allow the notified body access for inspection purposes to the locations of design, manufacture, inspection, testing and storage and provide it with all necessary information, in particular:

  • the quality system documentation,
  • the quality records provided for in the design part of the quality system, such as results of analyses, calculations, tests, etc.,
  • the quality records provided for in the manufacturing part of the quality system, such as inspection reports and test data, calibration data, reports concerning the qualifications of the staff concerned, etc.

4.3

The notified body must carry out periodic audits to make sure that the manufacturer maintains and applies the quality system and provide the manufacturer with an audit report. The frequency of periodic audits must be such that a full reassessment is carried out every three years.

4.4

In addition, the notified body may pay unexpected visits to the manufacturer. The need for such additional visits, and the frequency thereof, will be determined on the basis of a visit control system operated by the notified body. In particular the following factors must be considered in the visit control system:

  • the category of the vessel,
  • the results of previous surveillance visits,
  • the need to follow up corrective action,
  • where applicable, special conditions linked to the approval of the system,
  • significant changes in manufacturing organisation, policy or techniques.

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Module H1—full quality assurance with design examination and special surveillance of the final test

1

In addition to the requirements of Module H, the following apply:

  • (a) the manufacturer must lodge an application for examination of the design with the notified body,
  • (b) the application must enable the design, manufacture and operation of the transportable pressure vessel to be understood, and enable conformity with the relevant requirements of these Regulations to be assessed.

It must include:

  • the technical design specifications, including standards, which have been applied,
  • the necessary supporting evidence for their adequacy. This supporting evidence must include the results of tests carried out by the appropriate laboratory of the manufacturer or on his behalf,
  • (c) the notified body must examine the application and where the design meets the relevant provisions of these Regulations issue an EC design-examination certificate to the applicant. The certificate must contain the conclusions of the examination, the conditions for its validity, the necessary data for identification of the approved design and, if relevant, a description of the functioning of the transportable pressure vessel,
  • (d) the applicant must inform the notified body that it has issued the EC design-examination certificate of all modifications to the approved design. Modifications to the approved design must receive additional approval from the notified body that issued the EC design-examination certificate where they may affect conformity with the relevant requirements of these Regulations or the prescribed conditions for use of the transportable pressure vessel. This additional approval must be given in the form of an addition to the original EC design-examination certificate,
  • (e) each notified body must also communicate to the other notified bodies the relevant information concerning the EC design-examination certificates it has withdrawn or refused.

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SCHEDULE 4 — MODULES TO BE FOLLOWED FOR CONFORMITY ASSESSMENT

(This Schedule substantially reproduces the provisions of Annex V to the Transportable Pressure Equipment Directive)

SCHEDULE 5 — CONFORMITY REASSESSMENT PROCEDURE

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SCHEDULE 6 — PERIODIC INSPECTION PROCEDURES

Module 1—periodic inspection of products

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2

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3.1

All transportable pressure vessels must be examined individually and appropriate tests, as set out in Chapter 6.2 of ADR, must be carried out in order to check that it meets the requirements of these Regulations.

3.2

The notified or approved body must affix, or have affixed, its identification number to each vessel periodically inspected immediately after the periodic inspection has taken place and draw up a written periodic-inspection certificate. That certificate may cover a number of vessels.

3.3

The owner or his authorised representative established in the Community must keep the periodic-inspection certificate required under paragraph 3.2 and the documents required under paragraph 2 at least until the next periodic inspection.

Module 2—periodic inspection through quality assurance

1

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2

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3

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3.1

The owner or his authorised representative established in the Community must lodge an application for assessment of his quality system for the transportable pressure vessels with a notified body of his choice.

3.2

Under the quality system, each transportable pressure vessel must be examined and appropriate tests must be carried out in order to ensure its conformity with the relevant requirements of these Regulations. 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.

3.3

The notified body must assess the quality system to determine whether it satisfies the requirements referred to in paragraph 3.2.

  • The auditing team must have at least one member with experience of assessing the transportable pressure vessels concerned. The assessment procedure must include an inspection visit to the premises of the owner or his authorised representative established in the Community.
  • The decision must be notified to the owner or his authorised representative established in the Community. The notification must contain the conclusions of the examination and the reasoned assessment decision.

3.4

The owner or his authorised representative established in the Community must undertake to discharge the obligations arising from the quality system as approved and to ensure that it remains satisfactory and efficient.

  • The owner or his authorised representative established in the Community must inform the notified body which 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 modified quality system will still satisfy the requirements referred to in paragraph 3.2 or whether a reassessment is required.
  • It must notify its decision to the owner or his authorised representative established in the Community. The notification must contain the conclusions of the examination and the reasoned assessment decision.

4

Surveillance under the responsibility of the notified body

4.1

The purpose of surveillance is to make sure that the owner or his authorised representative established in the Community duly fulfils the obligations arising out of the approved quality system.

4.2

The owner or his authorised representative established in the Community must allow the notified body access for inspection purposes to the locations of inspection, testing and storage and provide it with all necessary information, in particular:

  • the quality system documentation,
  • the technical documentation,
  • the quality records, such as inspection reports and test data, reports concerning the qualifications of the personnel concerned, etc.

4.3

The notified body must carry out periodic audits to make sure that the owner or his authorised representative established in the Community maintains and applies the quality system and provide the owner or his authorised representative established in the Community with an audit report.

4.4

In addition, the notified body may pay unannounced visits to the owner or his authorised representative established in the Community. During such visits, the notified body may if necessary perform tests or have tests performed to verify if necessary that the quality system is functioning correctly. The notified body must provide the owner or his authorised representative established in the Community with a visit report and, if a test has taken place, with a test report.

5

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SCHEDULE 7 — CONFORMITY MARKING

(This Schedule substantially reproduces the provisions of Annex VII to the Transportable Pressure Equipment Directive)

If the marking is reduced or enlarged, the proportions of the drawing must be respected.

The various components of the marking must have substantially the same vertical dimensions, which may not be less than 5 mm.

This minimum dimension may be waived for small vessels.

SCHEDULE 8 — AMENDMENTS TO THE CDGCPL REGULATIONS

1

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2

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3

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4

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5

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6

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7

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8

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9

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10

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11

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Signed

Signed by authority of the Secretary of State

Larry Whitty — Parliamentary Under Secretary of State, — Department of the Environment, Transport and the Regions — 9th April 2001

Explanatory note

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Footnotes

[^f00001]: 1974 c. 37; sections 11(2), 15(1) and 50(3) were amended by the Employment Protection Act 1975 (c. 71), Schedule 15, paragraphs 4, 6 and 16(3) respectively.

[^f00002]: Current edition (2001): ISBN 92 1 139069 9.

[^f00003]: S.I. 1996/2092, as amended by S.I.s 1998/2885, 1999/257, 1999/303 and 2000/128.

[^f00004]: S.I. 1999/2001.

[^f00005]: Cmnd 5897.

[^f00006]: OJ No. L262, 27.9.1976, p.153.

[^f00007]: OJ No. L300, 19.11.1984, pp.1, 20 and 48, respectively.

[^f00008]: OJ No. L138, 1.6.1999, p.20.

[^f00009]: S.I. 1999/2001.

[^f00010]: S.R. & O. 1919/809, to which there are amendments not relevant to these Regulations.

[^f00011]: S.R. & O. 1937/54, to which there are amendments not relevant to these Regulations.

[^f00012]: S.I. 1978/1723, to which there are amendments not relevant to these Regulations.

[^f00013]: S.I. 1996/2089, relevant amending instrument is S.I. 1998/2885.

[^f00014]: S.I. 1996/2095, relevant amending instrument is S.I. 1998/2885.

[^f00015]: S.I. 2000/128.

[^f00016]: Current edition: Volumes I to IV ISBN 92 801 5090 1; Supplement ISBN 92 801 5093 6.

[^f00017]: Current edition and supplement (2001-2002): Doc 9284-AN/905.

[^f00018]: OJ No. L300, 19.11.1984, p.1.

[^f00019]: OJ No. L300, 19.11.1984, p.20.

[^f00020]: OJ No. L300, 19.11.1984, p.48.

[^f00021]: S.I. 1999/2001.

The standards referred to in regulations 4 to 6 are—

(This Schedule substantially reproduces the provisions of Part 1 of Annex IV to the Transportable Pressure Equipment Directive)

Module A1—internal manufacturing checks with monitoring of the final assessment

In addition to the requirements of module A, the following applies.

Final assessment must be performed by the manufacturer and monitored by means of unexpected visits by a notified body chosen by the manufacturer.

During such visits, the notified body must:

  • — ensure that the manufacturer actually performs final assessment,
  • — take samples of the transportable pressure vessels at the manufacturing or storage premises in order to conduct checks. The notified body assesses the number of vessels to sample and whether it is necessary to perform, or have performed, all or part of the final assessment of the samples of vessels.

Should one or more of the transportable pressure vessels not conform, the notified body must take appropriate measures.

On the responsibility of the notified body, the manufacturer must affix that body’s identification number to each transportable pressure vessel.

Module B—EC type-examination

The application must include:

  • — the name and address of the manufacturer and, if the application is lodged by the authorised representative established within the Community, his name and address as well,
  • — a written declaration that the same application has not been lodged with any other notified body,
  • — the technical documentation described in paragraph 3.

The applicant must place at the disposal of the notified body a representative example of the production envisaged, hereinafter called “type”. The notified body may request further examples should the test programme so require.

A type may cover several versions of the transportable pressure vessels provided that the differences between the versions do not affect the level of safety.

A list of the relevant parts of the technical documentation must be annexed to the certificate and a copy kept by the notified body.

If the notified body refuses to issue an EC type-examination certificate to the manufacturer or to his authorised representative established within the Community, that body must provide detailed reasons for such refusal. Provision must be made for an appeals procedure.

Each notified body must also communicate to the other notified bodies the relevant information concerning the EC type-examination certificates it has withdrawn or refused.

Where neither the manufacturer nor his authorised representative is established within the Community, the obligation to keep the technical documentation available is the responsibility of the person who places the product on the market.

Module B1—EC design examination

and may cover several versions of the transportable pressure vessel provided that the differences between the versions do not affect the level of safety.

A list of the relevant parts of the technical documentation must be annexed to the certificate and a copy kept by the notified body.

If the notified body refuses to issue an EC type-examination certificate to the manufacturer or to his authorised representative established within the Community, that body must provide detailed reasons for such refusal. Provision must be made for an appeals procedure.

Each notified body must also communicate to the other notified bodies the relevant information concerning the EC type-examination certificates it has withdrawn or refused.

Where neither the manufacturer nor his authorised representative is established within the Community, the obligation to keep the technical documentation available is the responsibility of the person who places the product on the market.

Module C1—conformity to type

Where neither the manufacturer nor his authorised representative is established within the Community, the obligation to keep the technical documentation available is the responsibility of the person who places the transportable pressure vessels on the market.

During such visits, the notified body must:

  • — ensure that the manufacturer actually performs the final assessment,
  • — take samples of transportable pressure vessels at the manufacturing or storage premises in order to conduct checks. The notified body assesses the number of items to sample and whether it is necessary to perform, or have performed, all or part of the final assessment of the samples.

Should one or more of the transportable pressure vessels not conform, the notified body must take appropriate measures.

On the responsibility of the notified body, the manufacturer must affix that body’s identification number to each transportable pressure vessel.

Module D—production quality assurance

Quality system

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. The 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 transportable pressure vessels,
  • — the manufacturing, quality control and quality assurance techniques, processes and systematic measures that will be used, particularly the procedures used,
  • — 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,
  • — the means of monitoring the achievement of the required quality and the effective operation of the quality system.

The auditing team must have at least one member with experience of assessing the transportable pressure vessels 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.

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 paragraph 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.

Surveillance under the responsibility of the notified body

4

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4

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4

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4

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4

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During such visits the notified body may, if necessary, carry out tests, or have them carried out, to verify that the quality system is functioning correctly. The notified body must provide the manufacturer with a visit report and, if a test has taken place, with a test report.

Each notified body must also communicate to the other notified bodies the relevant information concerning the quality system approvals it has withdrawn or refused.

Module D1—production quality assurance

Quality system

4

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4

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The application must include:

  • — all relevant information on the transportable pressure vessels concerned,
  • — the documentation concerning the quality system.

4

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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. The 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 transportable pressure vessels,
  • — the manufacturing, quality control and quality assurance techniques, processes and systematic measures that will be used,
  • — 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,
  • — the means of monitoring the achievement of the required quality and the effective operation of the quality system.

4

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The auditing team must have at least one member with experience of assessing the transportable pressure vessels 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.

4

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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 paragraph 4.2 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.

Surveillance under the responsibility of the notified body

5

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During such visits the notified body may, if necessary, carry out tests, or have them carried out, to verify that the quality system is functioning correctly. The notified body must provide the manufacturer with a visit report and, if a test has taken place, with a test report.

Each notified body must communicate to the other notified bodies the relevant information concerning the quality system approvals it has withdrawn or refused.

Module E—product quality assurance

Quality system

3

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The application must include:

  • — all relevant information on the transportable pressure vessels concerned,
  • — the documentation concerning the quality system,
  • — the technical documentation for the approval type and a copy of the EC type-examination certificate.

3

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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 transportable pressure vessels,
  • — the examinations and tests to be carried out after manufacture,
  • — the means of monitoring the effective operation of the quality system,
  • — the quality records, such as inspection reports and test data, calibration data, reports concerning the qualifications or approvals of the personnel concerned.

3

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The auditing team must have at least one member with experience of assessing the transportable pressure vessels 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

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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 paragraph 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.

Surveillance under the responsibility of the notified body

4

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4

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4

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4

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4

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During such visits the notified body may, if necessary, carry out tests, or have them carried out, to verify that the quality system is functioning correctly. The notified body must provide the manufacturer with a visit report and, if a test has taken place, with a test report.

5

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Each notified body must also communicate to the other notified bodies the relevant information concerning the quality system approvals it has withdrawn or refused.

Module E1—production quality assurance

The technical documentation must enable an assessment to be made of the conformity of the transportable pressure vessels with the relevant requirements of these Regulations. It must, as far as is relevant for such assessment, cover the design, manufacture and operation of the transportable pressure vessels and contain:

  • — a general description of the vessels in question,
  • — conceptual design and manufacturing drawings and diagrams of components, sub-assemblies, circuits, etc.,
  • — descriptions and explanations necessary for an understanding of the said drawings and diagrams and the operation of the vessels,
  • — a description of the solutions adopted to meet the requirements of these Regulations,
  • — results of the design calculations made, examinations carried out, etc.,
  • — test reports.

3

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Quality system

4

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4

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The application must include:

  • — all relevant information on the transportable pressure vessels concerned,
  • — the documentation concerning the quality system.

4

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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 transportable pressure vessels,
  • — the procedures used for the joining of parts,
  • — the examinations and tests to be carried out after manufacture,
  • — the means of monitoring the effective operation of the quality system,
  • — the quality records, such as inspection reports and test data, calibration data, reports concerning the qualifications or approvals of the staff concerned.

4

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The auditing team must have at least one member with experience of assessing the transportable pressure vessels 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.

4

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The manufacturer, or his authorised representative established within the Community, must inform the notified body which 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 modified quality system will still satisfy the requirements referred to in paragraph 4.2 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.

Surveillance under the responsibility of the notified body

5

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5

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5

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5

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5

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During such visits the notified body may, if necessary, carry out tests, or have them carried out, to verify that the quality system is functioning correctly. The notified body must provide the manufacturer with a visit report and, if a test has taken place, with a test report.

Each notified body must communicate to the other notified bodies the relevant information concerning the quality system approvals it has withdrawn or refused

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Module F—product verification

The manufacturer

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3

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The manufacturer, or his authorised representative established within the Community, must keep a copy of the declaration of conformity for a period of 10 years after the last of the transportable pressure vessels have been manufactured.

Verification by examination and testing of each transportable pressure vessel

4

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4

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In particular, the notified body must:

  • — verify that the personnel undertaking the permanent joining of parts and the non-destructive tests are qualified or approved,
  • — check the certificate issued by the materials manufacturer,
  • — carry out the final inspection and proof test or have them carried out and, where appropriate, examine the safety devices.

4

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4

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Module G—EC unit verification

3

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The technical documentation must contain:

  • — a general description of the vessels in question,
  • — conceptual design and manufacturing drawings and diagrams of components, sub-assemblies, circuits, etc.,
  • — descriptions and explanations necessary for an understanding of the said drawings and diagrams and the operation of the vessels,
  • — results of design calculations made, examinations carried out, etc.,
  • — test reports,
  • — appropriate details relating to the approval of the manufacturing and test procedures and of the qualifications or approvals of the staff concerned.

4

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4

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4

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In particular, the notified body must:

  • — examine the technical documentation with respect to the design and the manufacturing procedures,
  • — assess the materials used where these are not in conformity with the relevant provisions of these Regulations and check the certificate issued by the materials manufacturer,
  • — approve the procedures for the permanent joining of pressure vessel parts,
  • — verify the qualifications or approvals required,
  • — perform the final inspection, perform the proof test or have it performed and examine the safety devices if applicable.

Module H—full quality assurance

Quality system

3

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3

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The application must include:

  • — all relevant information concerning the transportable pressure vessels in question,
  • — the documentation concerning the quality system.

3

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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. The quality system documentation must permit a consistent interpretation of the procedural and quality measures such as 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 design and to product quality,
  • — the technical design specifications, including standards, that will be applied,
  • — the design control and design verification techniques, processes and systematic measures that will be used when designing the transportable pressure vessels,
  • — the corresponding manufacturing, quality control and quality assurance techniques, processes and systematic measures that will be used,
  • — the examinations and tests to 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,
  • — the means of monitoring the achievement of the required transportable pressure vessel design and quality and the effective operation of the quality system.

3

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

The auditing team must have at least one member with experience of assessing the transportable pressure vessels 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

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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 modified quality system will still satisfy the requirements referred to in paragraph 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.

Surveillance under the responsibility of the notified body

4

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

4

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4

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4

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4

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

During such visits the notified body may, if necessary, carry out tests, or have them carried out, to verify that the quality system is functioning correctly. The notified body must provide the manufacturer with a visit report and, if a test has taken place, with a test report.

5

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Each notified body must also communicate to the other notified bodies the relevant information concerning the quality system approvals it has withdrawn or refused.

Module H1—full quality assurance with design examination and special surveillance of the final test

The following table indicates which modules are to be followed when undertaking conformity assessment procedures.

Category of transportable pressure vessel Modules
Vessels for which the product of the test pressure and the capacity is no more than 30 Mpay litre (300 barylitre) A1,D1, orE1
Vessels for which the product of the test pressure and the capacity is more than 30 and no more than 150 Mpay litre (300 and 1500 bary litre respectively) H,B in combination with E,B in combination with C1,B1 in combination with F, orB1 in combination with D
Vessels for which the product of the test pressure and the capacity exceeds 150 Mpay litre (1500 bary litre) G,H1,B in combination with D, orB in combination with F

1

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2

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(This Schedule substantially reproduces the provisions of Part II of Annex IV to the Transportable Pressure Equipment Directive)

The notified body must also check that valves and other accessories having a direct safety function ensure a level of safety in accordance with the requirements of regulation 6(3) and (4).

(This Schedule substantially reproduces the provisions of Part III of Annex IV to the Transportable Pressure Equipment Directive)

The measures carried out must be recorded in documents and held at the disposal of the Executive by the owner or his authorised representative established in the Community.

3

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3

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Module 2—periodic inspection through quality assurance

The measures carried out must be recorded in documents and held by the owner or his authorised representative established in the Community at the disposal of the Executive.

The owner or his authorised representative established within the Community must ensure that the qualified staff and necessary facilities are available for the purpose of the periodic inspections.

The owner or his authorised representative established in the Community must operate an approved quality system for the periodic inspection and tests of the vessels as specified in paragraph 3, and be subject to surveillance as specified in paragraph 4.

Quality system

3

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3

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The application must include:

  • — all relevant information on the transportable pressure vessels being submitted for periodic inspection,
  • — the documentation regarding the quality system.

3

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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 transportable pressure vessels,
  • — the examinations and tests to be carried out for the periodic inspection,
  • — the means of monitoring the effective operation of the quality system,
  • — the quality records such as inspection reports and test data, calibration data, reports concerning the qualifications or approvals of the staff concerned.

3

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The auditing team must have at least one member with experience of assessing the transportable pressure vessels concerned. The assessment procedure must include an inspection visit to the premises of the owner or his authorised representative established in the Community.

The decision must be notified to the owner or his authorised representative established in the Community. The notification must contain the conclusions of the examination and the reasoned assessment decision.

3

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The owner or his authorised representative established in the Community must inform the notified body which 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 modified quality system will still satisfy the requirements referred to in paragraph 3.2 or whether a reassessment is required.

It must notify its decision to the owner or his authorised representative established in the Community. The notification must contain the conclusions of the examination and the reasoned assessment decision.

Surveillance under the responsibility of the notified body

4

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4

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4

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4

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4

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The conformity marking shall take the following form—

If the marking is reduced or enlarged, the proportions of the drawing must be respected.

The various components of the marking must have substantially the same vertical dimensions, which may not be less than 5 mm.

This minimum dimension may be waived for small vessels.

Editorial notes

[^key-e37ed1a8864b7d6de74d63ee0912f906]: Regulations revoked (10.5.2004) by The Carriage of Dangerous Goods and Use of Transportable Pressure Equipment Regulations 2004 (S.I. 2004/568), reg. 1, Sch. 14 (with reg. 63(5)) [Editorial note: No historical revised versions have been created for amendments to this S.I. made prior to its final revocation. Revised versions of how the S.I. stood at its first commencement are available and, to see the document content as it originally stood when it was made, select the 'Original (As Made)' version. For further details of the amendments see the List of All Changes available in 'More Resources']

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