F1SCHEDULE 2United Kingdom Conformity Assessment Procedures
PART 3
Quality system20
1
A manufacturer must lodge an application for assessment of its quality system for the marine equipment concerned with an approved body of its choice.
2
The application must include —
a
the name and address of the manufacturer and if the application is lodged by the authorised representative, its name and address as well;
b
a written declaration that the same application has not been lodged with any other approved body;
c
all relevant information for the marine equipment category envisaged;
d
the documentation concerning the quality system;
e
the technical documentation of the approved type and a copy of the United Kingdom type-examination certificate.
3
The quality system must ensure compliance of the products with the type described in the United Kingdom type-examination certificate and with the applicable international standards.
4
The manufacturer must document in the form of written policies, procedures and instructions all the elements, requirements and provisions that it has adopted.
5
The quality system documentation must enable a consistent interpretation of the programmes, plans, manuals and records and must include an adequate description of—
a
the quality objectives and the organisational structure, responsibilities and powers of the management with regard to product quality;
b
the examinations and tests that will be carried out after manufacture;
c
the quality records, including inspection reports and test data, calibration data and qualification reports on the personnel concerned;
d
the means of monitoring the effective operation of the quality system.
6
The approved body must assess the quality system to determine whether it satisfies the requirements set out in sub-paragraphs (3), (4) and (5).
7
The auditing team of the approved body must include members with experience in quality management systems and must include at least one member with—
a
experience of evaluation in the relevant marine equipment field;
b
experience of the marine equipment technology concerned;
c
knowledge of the applicable international standards.
8
The audit carried out by the approved body must include—
a
an assessment visit to the manufacturer's premises, and
b
a review of the technical documentation of the approved type in order to verify the manufacturer's ability to identify the applicable international standards and to carry out the necessary examinations with a view to ensuring compliance of the product with those requirements.
9
The approved body must notify the manufacturer of its decision and that notification must contain the conclusions of the audit and the reasoned assessment decision.
10
The manufacturer must undertake to fulfil the obligations arising out of the quality system as approved and to maintain it so that it remains adequate and efficient.
11
The manufacturer must keep the approved body that has approved the quality system informed of any intended change to the quality system.
12
Where the manufacturer proposes changes to the quality system, the approved body must—
a
evaluate any proposed changes;
b
decide whether the modified quality system will continue to satisfy the requirements set out in sub-paragraphs (3), (4) and (5) or whether a re-assessment is necessary;
c
notify the manufacturer of its decision and that notification must contain the conclusions of the examination and the reasoned assessment decision.
Schs. 2-5 inserted (31.12.2020) by The Merchant Shipping (Marine Equipment) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/470), reg. 1(1), Sch. para. 27(2) (with regs. 5, 6) (as amended by S.I. 2020/1000, regs. 1, 7(2)); 2020 c. 1, Sch. 5 para. 1(1)