Conformity assessment system and approval for manufacture of pressure receptacles
For the purposes of this sub-section:
Conformity assessment system means a system for competent authority approval of a manufacturer, by
pressure receptacle design type approval, approval of manufacturer's quality system and approval of
Design type means a pressure receptacle design as specified by a particular pressure receptacle
Verify means confirm by examination or provision of objective evidence that specified requirements
have been fulfilled.
The competent authority that approves the pressure receptacle shall approve the conformity
assessment system for the purpose of ensuring that pressure receptacles conform to the requirements
of ADR. In instances where the competent authority that approves a pressure receptacle is not the
competent authority in the country of manufacture, the marks of the approval country and the country
of manufacture shall be indicated in the pressure receptacle marks (see 188.8.131.52 and 184.108.40.206).
The competent authority of the country of approval shall supply, upon request, evidence
demonstrating compliance to this conformity assessment system to its counterpart in a country of use.
The competent authority may delegate its functions in this conformity assessment system in whole or
The competent authority shall ensure that a current list of approved inspection bodies and their
identity marks and approved manufacturers and their identity marks is available.
The inspection body shall be approved by the competent authority for the inspection of pressure
receptacles and shall:
(a) Have a staff with an organizational structure, capable, trained, competent, and skilled, to
satisfactorily perform its technical functions;
(b) Have access to suitable and adequate facilities and equipment;
(c) Operate in an impartial manner and be free from any influence which could prevent it from
(d) Ensure commercial confidentiality of the commercial and proprietary activities of the
manufacturer and other bodies;
(e) Maintain clear demarcation between actual inspection body functions and unrelated
(f) Operate a documented quality system;
(g) Ensure that the tests and inspections specified in the relevant pressure receptacle standard and
ADR are performed; and
(h) Maintain an effective and appropriate report and record system in accordance with 220.127.116.11.6.
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 18.104.22.168.4 and 22.214.171.124.5).
The manufacturer shall:
(a) Operate a documented quality system in accordance with 126.96.36.199.3;
(b) Apply for design type approvals in accordance with 188.8.131.52.4;
(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 184.108.40.206.6.
The testing laboratory shall have:
(a) Staff with an organizational structure, sufficient in number, competence, and skill;
(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
(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.