Regulations 38 and 41
1. This module describes the procedure whereby the owner, or his authorised representative established within the Community, ensures that the transportable pressure equipment subject to paragraph 3 continues to meet the relevant requirements of Part 4 of these Regulations.
2. To meet the requirements referred to in paragraph 1 the owner, or his authorised representative established in the Community, must take all measures necessary to ensure that the conditions of use and of maintenance ensure the continued conformity of the transportable pressure equipment to the relevant requirements of Part 4 of these Regulations, in particular so that:
the transportable pressure equipment is used as intended,
it is filled in appropriate filling centres,
any maintenance work or repairs are carried out,
the periodic inspections necessary are carried out.
The measures carried out must be recorded in documents and held at the disposal of the competent authority by the owner or his authorised representative established in the Community.
3. The notified body or approved body must perform the appropriate examinations and tests in order to check the conformity of the transportable pressure equipment with the relevant requirements of Part 4 of these Regulations by examining and testing every product.
3.1. All transportable pressure equipment must be examined individually and appropriate tests as required pursuant to Part 4 of these Regulations, must be carried out in order to check that it meets the relevant requirements of that Part of these Regulations.
3.2. The notified body or approved body must affix, or have affixed, its identification number to each product being periodically inspected immediately after the date of the periodic inspection and draw up a written periodic inspection certificate. That certificate may cover a number of items of equipment.
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.
1. This module describes the following procedures:
the procedure whereby the owner or his authorised representative established in the Community, who satisfies the obligations of paragraph 2, ensures and declares that the transportable pressure equipment continues to meet the relevant requirements of Part 4 of these Regulations. The owner or his authorised representative established in the Community must affix the date of the periodic inspection to all transportable pressure equipment and draw up a written declaration of conformity. The date of the periodic inspection must be accompanied by the identification number of the notified body responsible for surveillance as specified in paragraph 4.
the procedure whereby, in the case of the periodic inspection of tanks performed by the approved body in accordance with regulation 43(1)(iii), the approved body which satisfies the obligations of the last sub-paragraph of paragraph 2, certifies that the transportable pressure equipment continues to meet the relevant requirements of Part 4 of these Regulations. The approved body must affix the date of the periodic inspection to all transportable pressure equipment and draw up a periodic inspection certificate.
The date of periodic inspection must be accompanied by the identification number of the approved body.
2. The owner or his authorised representative established within the Community must take all steps necessary to ensure that the conditions of use and of maintenance are such as to enable the transportable pressure equipment to comply permanently with the relevant requirements of Part 4 of these Regulations and in particular that:
the transportable pressure equipment is used as intended,
it is filled in appropriate filling centres,
any maintenance work or repairs are carried out,
the periodic inspections necessary are carried out.
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 competent authority.
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 equipment as specified in paragraph 3, and be subject to surveillance as specified in paragraph 4.
3. Quality system
3.1. The owner or his authorised representative established in the Community or the approved body must lodge an application for assessment of his quality system for the transportable pressure equipment with a notified body of his choice.
The application must include:
all relevant information on the transportable pressure equipment being submitted for periodic inspection,
the documentation regarding the quality system.
3.2. Under the quality system, each item of transportable pressure equipment must be examined and appropriate tests must be carried out in order to ensure its conformity with the relevant requirements referred to in Part 4 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.
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 equipment,
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.
3.3. 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 equipment concerned. The assessment procedure must include an inspection visit to the premises of the owner or of his authorised representative established in the Community or the approved body.
The decision must be notified to the owner or his authorised representative established in the Community or the approved body. 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 or the approved body 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 or the approved body 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 or the approved body. 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 or the approved body duly fulfils the obligations arising out of the approved quality system.
4.2. The owner or his authorised representative established in the Community or the approved body 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 or the approved body maintains and applies the quality system and provides the owner or his authorised representative established in the Community or the approved body 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 or the approved body. 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 or the approved body with a visit report and, if a test has taken place, with a test report.
5. The owner or his authorised representative established in the Community or the approved body must, for a period of 10 years from the date of the last periodic inspection of the transportable pressure equipment, hold at the disposal of the competent authority:
the documentation referred to in the second indent of the second sub-paragraph of paragraph 3.1,
the adjustments referred to in the second sub-paragraph of paragraph 3.4,
the decisions and reports from the notified body which are referred to in the last paragraph of 3.3, in the last paragraph of 3.4 and in paragraphs 4.3 and 4.4.