contents
EU RO-MR
※ Documents to be submitted The English Languages shall be used for all submitted documents.
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(1) Data for approval
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- (A) Type test program(including standard of technical requirement) in accordance with the requirements of the applicable Technical Requirement for the product.
- (B) Relevant drawings (fully detailed sectional assembly, drawings for main component parts) and documents as below, if applicable.
- (a) Product specifications
- (b) All product details, catalogues, data sheets, calculations and functional descriptions, parts list, etc,(if any)
- (c) Application and operational limitation
- (d) Drawings showing the interaction between the main component(if any)
- (e) PCB(Printed Circuit Board) Lay-out/circuit diagram(if any)
- (f) Wiring diagram, connection diagram(if any)
- (g) System block diagram(control logic)(if any)
- (h) Name and version No of software to be installed and Quality Assurance Plan(if any)
- (i) Installation and operation manual(if necessary)
- (j) Marking methods
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(2) Data for reference, if necessary
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- (A) Particulars and specifications of products
- (B) Outline of company
- (a) Data on history, outline and layout of manufacturing plants
- (b) Organisation and management structure, including subsidiaries to be included in the approval/certification
- (c) Data on major manufacturing facilities
- (d) Data on manufacturing process
- (e) Data of in-house standards or codes
- (f) Data of quality control system
- (g) Data on major inspection and testing facilities
- (h) Service records
- (i) List of subcontractors and their products
- (j) For a newly developed product, documents related to tests and their results for its development
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- (C) The documentation concerning the quality management system
- (a) The quality management system certificate issued by the certifying body
- (b) The manufacturing, quality-control and quality-assurance techniques, processes and systematic actions that will be used
- (c) The examinations and tests that will be carried out before, during and after manufacture,
- (d) The quality records, such as inspection reports and test data, calibration data, damage and claim records,
qualification reports of the personnel concerned, etc
- (e) The means of monitoring the achievement of the required product quality and the effective operation of the quality system and
the frequency with which they will be carried out