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
(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 220.127.116.11.3.2;
(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
18.104.22.168.3.1 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
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 22.214.171.124.3.1.
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 126.96.36.199.4.2 to 188.8.131.52.4.6 and 184.108.40.206.4.9.
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 220.127.116.11.4.9. 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
(e) Details of any refusal of approval of a similar application by any other competent
(f) The identity of the inspection body for design type approval;
(g) Documentation on the manufacturing facility as specified under 18.104.22.168.3.1; 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 22.214.171.124.4.9.
An initial audit in accordance with 126.96.36.199.3.2 shall be performed to the satisfaction of the competent
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 188.8.131.52.4.3 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 184.108.40.206.4.8 and
220.127.116.11.4.9, provided a manufacturer is in the possession of an initial design type approval. In such a
case, the manufacturer's quality system according to 18.104.22.168.3 shall have been approved during the
initial design type approval and shall be applicable for the new design.
The application shall include:
(a) The name and address of the manufacturer and in addition, if the application is submitted
by an authorised representative, its name and address;
(b) Details of any refusal of approval of a similar application by any other competent
(c) Evidence that initial design type approval has been granted; and
(d) The technical documentation, as described in 22.214.171.124.4.3 (h).
Procedure for design type approval
The inspection body shall:
(a) Examine the technical documentation to verify that:
(i) the design is in accordance with the relevant provisions of the standard, and
(ii) the prototype lot has been manufactured in conformity with the technical
documentation and is representative of the design;
(b) Verify that the production inspections have been carried out as required in accordance with
(c) Select pressure receptacles from a prototype production lot and supervise the tests of these
pressure receptacles as required for design type approval;
(d) Perform or have performed the examinations and tests specified in the pressure receptacle
standard to determine that:
(i) the standard has been applied and fulfilled, and
(ii) the procedures adopted by the manufacturer meet the requirements of the standard;
(e) Ensure that the various type approval examinations and tests are correctly and competently
After prototype testing has been carried out with satisfactory results and all applicable requirements of
126.96.36.199.4 have been satisfied, a design type approval certificate shall be issued, which shall include the
name and address of the manufacturer, results and conclusions of the examination, and the necessary
data for identification of the design type.
If the manufacturer is denied a design type approval, the competent authority shall provide written
detailed reasons for such denial.
Modifications to approved design types
The manufacturer shall either:
(a) Inform the issuing competent authority of modifications to the approved design type, where
such modifications do not constitute a new design, as specified in the pressure receptacle
(b) Request a subsequent design type approval where such modifications constitute a new design
according to the relevant pressure receptacle standard. This additional approval shall be given
in the form of an amendment to the original design type approval certificate.