Regulation 7
SCHEDULE 6PERIODIC INSPECTION PROCEDURES
(This Schedule substantially reproduces the provisions of Part III of Annex IV to the Transportable Pressure Equipment Directive.)
Module 1—periodic inspection of products
1. This module describes the procedure whereby the owner or his authorised representative established within the Community ensures that transportable pressure vessels subject to paragraph 3 continue to meet the relevant requirements 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 vessels to the relevant requirements of these Regulations, in particular so that:
the transportable pressure vessels are used as intended,
the transportable pressure vessels are 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 Executive by the owner or his authorised representative established in the Community.
3. The notified or approved body must perform the appropriate examinations and tests in order to check the conformity of the transportable pressure vessels with the relevant requirements of these Regulations by examining and testing every product.
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. This module describes 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 vessels continue to meet the relevant requirements of these Regulations. The owner or his authorised representative established in the Community must affix the date of periodic inspection to all such transportable pressure vessels and draw up a written declaration of conformity. The date of periodic inspection must be accompanied by the identification number of the notified body responsible for surveillance as specified in paragraph 4.
2. The owner or his authorised representative established in 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 vessels to comply permanently with the requirements of these Regulations and in particular that:
the transportable pressure vessels are used as intended,
the transportable pressure vessels are 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 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
3.1 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.
The application must include:
– all relevant information on the transportable pressure vessels being submitted for periodic inspection,
– the documentation regarding the quality system.
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.
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.
3.3 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.
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. The owner or his authorised representative established in the Community must, for a period of 10 years from the date of the last periodic inspection of the transportable pressure vessels, hold at the disposal of the Executive:
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 sub-paragraph of paragraph 3.3, in the last sub-paragraph of paragraph 3.4 and in paragraphs 4.3 and 4.4.