The inspection body shall perform design type approval, pressure receptacle production testing and
inspection, and certification to verify conformity with the relevant pressure receptacle standard
(see 6.2.2.5.4 and 6.2.2.5.5).
Manufacturer
The manufacturer shall:
(a) Operate a documented quality system in accordance with 6.2.2.5.3;
(b) Apply for design type approvals in accordance with 6.2.2.5.4;
(c) Select an inspection body from the list of approved inspection bodies maintained by the
competent authority in the country of approval; and
(d) Maintain records in accordance with 6.2.2.5.6.
Testing laboratory
The testing laboratory shall have:
(a) Staff with an organizational structure, sufficient in number, competence, and skill;
and
(b) Suitable and adequate facilities and equipment to perform the tests required by the
manufacturing standard to the satisfaction of the inspection body.
Manufacturer's quality system
The quality system shall contain all the elements, requirements, and provisions adopted by the
manufacturer. It shall be documented in a systematic and orderly manner in the form of written
policies, procedures and instructions.
The contents shall in particular include adequate descriptions of:
(a) The organizational structure and responsibilities of personnel with regard to design and
product quality;
(b) The design control and design verification techniques, processes, and procedures that will be
used when designing the pressure receptacles;
(c) The relevant pressure receptacle manufacturing, quality control, quality assurance and
process operation instructions that will be used;
(d) Quality records, such as inspection reports, test data and calibration data;
(e) Management reviews to ensure the effective operation of the quality system arising from the
audits in accordance with 6.2.2.5.3.2;
(f) The process describing how customer requirements are met;
(g) The process for control of documents and their revision;
(h) The means for control of non-conforming pressure receptacles, purchased components, inprocess
and final materials; and
(i) Training programmes and qualification procedures for relevant personnel.
Audit of the quality system
The quality system shall be initially assessed to determine whether it meets the requirements in
6.2.2.5.3.1 to the satisfaction of the competent authority.
The manufacturer shall be notified of the results of the audit. The notification shall contain the
conclusions of the audit and any corrective actions required.
Periodic audits shall be carried out, to the satisfaction of the competent authority, to ensure that the
manufacturer maintains and applies the quality system. Reports of the periodic audits shall be
provided to the manufacturer.
Maintenance of the quality system
The manufacturer shall maintain the quality system as approved in order that it remains adequate and
efficient.
The manufacturer shall notify the competent authority that approved the quality system, of any
intended changes. The proposed changes shall be evaluated in order to determine whether the
amended quality system will still satisfy the requirements in 6.2.2.5.3.1.
Approval process
Initial design type approval
The initial design type approval shall consist of approval of the manufacturer's quality system and
approval of the pressure receptacle design to be produced. An application for an initial design type
approval shall meet the requirements of 6.2.2.5.4.2 to 6.2.2.5.4.6 and 6.2.2.5.4.9.
A manufacturer desiring to produce pressure receptacles in accordance with a pressure receptacle
standard and ADR shall apply for, obtain, and retain a design type approval certificate issued by the
competent authority in the country of approval for at least one pressure receptacle design type in
accordance with the procedure given in 6.2.2.5.4.9. This certificate shall, on request, be submitted to
the competent authority of the country of use.
An application shall be made for each manufacturing facility and shall include:
(a) The name and registered address of the manufacturer and in addition, if the application is
submitted by an authorised representative, its name and address;
(b) The address of the manufacturing facility (if different from the above);
(c) The name and title of the person(s) responsible for the quality system;
(d) The designation of the pressure receptacle and the relevant pressure receptacle
standard;
(e) Details of any refusal of approval of a similar application by any other competent
authority;
(f) The identity of the inspection body for design type approval;
(g) Documentation on the manufacturing facility as specified under 6.2.2.5.3.1; and
(h) The technical documentation required for design type approval, which shall enable
verification of the conformity of the pressure receptacles with the requirements of the relevant
pressure receptacle design standard. The technical documentation shall cover the design and method
of manufacture and shall contain, as far as is relevant for assessment, at least the following:
(i) pressure receptacle design standard, design and manufacturing drawings, showing components and
subassemblies, if any;
(ii) descriptions and explanations necessary for the understanding of the drawings and intended use
of the pressure receptacles;
(iii) a list of the standards necessary to fully define the manufacturing process;
(iv) design calculations and material specifications; and
(v) design type approval test reports, describing the results of examinations and tests carried
out in accordance with 6.2.2.5.4.9.
An initial audit in accordance with 6.2.2.5.3.2 shall be performed to the satisfaction of the competent
authority.
If the manufacturer is denied approval, the competent authority shall provide written detailed reasons
for such denial.
Following approval, changes to the information submitted under 6.2.2.5.4.3 relating to the initial
approval shall be provided to the competent authority.
Subsequent design type approvals
An application for a subsequent design type approval shall meet the requirements of 6.2.2.5.4.8 and
6.2.2.5.4.9, provided a manufacturer is in the possession of an initial design type approval. In such a
case, the manufacturer's quality system according to 6.2.2.5.3 shall have been approved during the
initial design type approval and shall be applicable for the new design.
Previous Matter
Next Matter