PRODUCT QUALITY ASSURANCE (Module E)
1. Product Quality Assurance means that the elevators installed by the elevator company that meets the conditions in Article 2 of this Annex meet the rules of the applicable regulation and are of the type defined in the EC type examination certificate.
It is the process of ensuring and declaring that it is appropriate.
The elevator company must attach the CE conformity mark to each lift and issue the EC Declaration of Conformity. CE conformity mark means the identity of the notified body responsible for surveillance as defined in Article 4 of this Annex.
It should be used with the number.
2. The elevator company must implement an approved quality assurance system for the final inspection of the elevator and the tests described in item 3 of this Annex and must be subject to the supervision described in item 4 of this Annex.
3. Quality Assurance System
3.1. The elevator company should apply to a notified body of its choice for the evaluation of the quality assurance system of the respective elevators.
This application should include:
- All information about elevators,
- Document on the quality assurance system,
- Technical document on approved elevators and a copy of the EC type-examination document.
3.2. Under the Quality Assurance System, in order to examine each elevator and ensure compliance with the relevant rules of the regulation, experiments in accordance with the relevant standards specified in Article 6 of this Regulation or
equivalent experiments must be carried out.
All elements, rules and provisions accepted by the elevator company must be documented systematically and regularly, in the form of written measures, procedures and instructions. Said quality assurance system certificate
A common understanding of quality programs, plans, manuals and quality records should be provided.
The document should in particular contain sufficient definitions of:
(a) Quality objectives;
(b) Establishment structure, responsibility and management power regarding elevator quality,
(c) Examinations and tests to be carried out before they are placed on the market, including at least the tests specified in Annex-VI article 4 (b),
(d) Tools to verify the efficient functioning of quality assurance.
(e) Quality records, such as inspection reports, test data and calibration data, and the qualifications of personnel involved in this job.
3.3. The notified body should assess whether the quality assurance system meets the rules set out in point 3.2 of this Annex. Quality assurance systems that implement the relevant harmonized standard
will accept compliance with these rules.
The audit team should have at least one person with assessment experience in the relevant elevator technologies.
The evaluation process should also include a visit to the assembly site and the installer´s work center.
The decision must be reported to the installer. The notification must include the results of the review and the justification for the evaluation.
3.4. The elevator company must fulfill its obligations arising from the approved quality assurance system and ensure that this is maintained effectively and appropriately.
The elevator company should inform the notified body that has approved the quality assurance system about the updates planned for the quality assurance system.
The Notified Body should evaluate the proposed updates and whether the updated quality assurance system still satisfies the rules in item 3.2 of this Annex or whether a new assessment is required.
should decide whether it is not.
The Notified Body must notify its decision to the elevator company.
The notification must include the results of the review and the justification for the evaluation.
4. Supervision under the responsibility of the Notified Body
4.1. The purpose of surveillance; be sure that the lift company has fully fulfilled its obligations outside the approved quality assurance system.
4.2. It should allow the elevator company to enter the inspection and test areas of the notified body for inspection purposes, and with this permission, all available information, especially on the following issues,
- Quality assurance system document,
- Technical document,
- Quality records, such as inspection reports, test and calibration data, and qualifications of personnel involved in this job.
4.3. The notified body should conduct inspections periodically to ensure that the elevator company maintains and implements the quality assurance system and provides an audit report to the elevator company.
It should give.
4.4. In addition, the notified body may make unexpected visits to the elevator assembly area.
During such visits, the notified body may carry out or have tests carried out to check the proper functioning of the quality assurance system and elevator, if necessary. Visit to the elevator company and
if the experiment has been carried out, it must report the experiment.
5. The elevator company must keep the following documents under the authority of the Ministry for 10 years from the date of manufacture of the last elevator.
- the document specified in the third paragraph of the second paragraph of article 3.1 of this Annex,
- This Supplement is 3.4 ´