1 Conformity based on full quality assurance is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2 and 5, and ensures and declares on its sole responsibility that the radio equipment concerned satisfies the requirements of this Ordinance that apply to it.
2 Manufacturing
2.1 The manufacturer shall operate an approved quality system for the design, manufacture, final radio equipment inspection and testing of the radio equipment concerned as specified in point 3 and shall be subject to monitoring as specified in point 4.
2.2 The manufacturer shall take appropriate account of changes to the design of the radio equipment or in its characteristics and changes in the harmonised standards or other technical specifications by reference to which conformity of radio equipment is declared.
3 Quality assurance system
3.1 The manufacturer shall apply to the conformity assessment body of its choice for the assessment of its quality system for the radio equipment concerned.
The application contains:
- a.
- the name and address of the manufacturer and, if the application is filed by the authorised representative, its name and address as well;
- b.
- the technical documentation for each radio equipment type intended to be manufactured;
- c.
- the documentation concerning the quality system;
- d.
- a written declaration that the same application has not been filed with any other conformity assessment body.
3.2 The quality system shall ensure compliance of the radio equipment with the requirements of this Ordinance that apply to it.
All the elements, requirements and provisions adopted by the manufacturer shall be documented in a systematic and orderly manner in the form of written policies, procedures and instructions. The quality system documentation shall permit a consistent interpretation of the quality programmes, plans, manuals and records.
It shall, in particular, contain an adequate description of:
- a.
- the quality objectives and the organisational structure, responsibilities and powers of the management with regard to design and product quality;
- b.
- the technical design specifications, including the standards that will be applied and, where the relevant technical standards designated by OFCOM (Art. 31 para. 2 let. a TCA) will not be applied in full, the means that will be used to ensure that the essential requirements of this Ordinance that apply to the radio equipment will be met;
- c.
- the design control and design verification techniques, processes and systematic actions that will be used when designing radio equipment pertaining to the radio equipment type covered;
- d.
- the corresponding manufacturing, quality control and quality assurance techniques, processes and systematic actions that will be used;
- e.
- the examinations and tests that will be carried out before, during and after manufacture, and the frequency with which they will be carried out;
- f.
- the quality records, such as inspection reports and test data, calibration data, reports concerning the qualifications of the personnel, etc.;
- g.
- the means of monitoring the achievement of the required design and product quality and the effective operation of the quality system.
3.3 The conformity assessment body shall assess the quality system to determine whether it satisfies the requirements referred to in point 3.2.
It shall presume conformity with those requirements in respect of the elements of the quality system that comply with the corresponding specifications of the relevant standard designated by SECO (Annex 2 AccDO61).
In addition to experience in quality management systems, the auditing team shall have at least one member experienced as an assessor in the relevant radio equipment field and radio equipment technology concerned, and knowledge of the applicable requirements of this Ordinance. The audit shall include an assessment visit to the manufacturer's premises. The auditing team shall review the technical documentation referred to in point 3.1 letter b to verify the manufacturer's ability to identify the applicable requirements of this Ordinance and to carry out the necessary examinations with a view to ensuring compliance of the radio equipment with those requirements.
The manufacturer or its authorised representative shall be notified of the decision.
The notification shall contain the conclusions of the audit and the reasoned assessment decision.
3.4 The manufacturer shall undertake to fulfil the obligations arising out of the quality system as approved and to maintain it so that it remains adequate and efficient.
3.5 The manufacturer shall keep the conformity assessment body that has approved the quality system informed of any intended change to the quality system.
The conformity assessment body shall evaluate any proposed changes and decide whether the modified quality system will continue to satisfy the requirements referred to in point 3.2 or whether a reassessment is necessary.
It shall notify the manufacturer of its decision. The notification shall contain the conclusions of the examination and the reasoned assessment decision.
4 Monitoring under the responsibility of the conformity assessment body
4.1 The purpose of monitoring is to make sure that the manufacturer duly fulfils the obligations arising out of the approved quality system.
4.2 The manufacturer shall, for assessment purposes, allow the conformity assessment body access to the design, manufacture, inspection, testing and storage sites, and shall provide it with all necessary information, in particular:
- a.
- the quality system documentation;
- b.
- the quality records as provided for by the design part of the quality system, such as results of analyses, calculations, tests, etc.;
- c.
- the quality records as provided for by the manufacturing part of the quality system, such as inspection reports and test data, calibration data, reports concerning the qualifications of the personnel, etc.
4.3 The conformity assessment body shall carry out periodic audits to make sure that the manufacturer maintains and applies the quality system and shall provide the manufacturer with an audit report.
4.4 Furthermore the conformity assessment body may pay unexpected visits to the manufacturer. During such visits, the conformity assessment body may, if necessary, carry out radio equipment tests, or have them carried out, in order to check the proper functioning of the quality system. It shall provide the manufacturer with a visit report and, if tests have been carried out, with a test report.
5 Conformity marking and declaration of conformity
5.1 The manufacturer shall affix the conformity marking in accordance with Article 18 and, under the responsibility of the conformity assessment body referred to in point 3.1, the latter's identification number to each item of radio equipment that satisfies the applicable requirements set out in this Ordinance.
5.2 The manufacturer shall draw up a written declaration of conformity for each radio equipment type in accordance with Annex 5.
6 The manufacturer shall, for a period ending 10 years after the radio equipment has been placed on the market, keep at the disposal of OFCOM:
- a.
- the technical documentation referred to in point 3.1;
- b.
- the documentation concerning the quality system referred to in point 3.1;
- c.
- the change referred to in point 3.5, as approved;
- d.
- the decisions and reports of the conformity assessment body referred to in points 3.5, 4.3 and 4.4.
7 Each conformity assessment body shall inform its OFCOM of quality system approvals issued or withdrawn, and shall, periodically or on request, make available to its notifying authority the list of quality system approvals refused, suspended or otherwise restricted.
Each conformity assessment body shall inform the other conformity assessment bodies of quality system approvals which it has refused, suspended or withdrawn, and, on request, of quality system approvals which it has issued.
8 Authorised representative
8.1 The manufacturer's obligations mentioned in points 3.1, 3.5, 5 and 6 may be fulfilled by its authorised representative on the manufacturer's behalf and under its responsibility provided such obligations are specified in a mandate.
8.2 The design and manufacture of radio equipment and drawing up the technical documentation may not be delegated to the authorised representative.