Certificate of quality

Introduction of a certificate »Health-beneficial food supplier« with an established system of continuous monitoring of the quality of offered dishes and meals.

Whereas, under Article 2 (2) of the abovementioned Regulation, certificates can be issued only for products meeting minimum quality standards;

The quality system must ensure compliance with the type as described in the EC type-examination certificate and with the requirements of this Directive.

up to 100 % of the costs of the charges levied by recognised certifying bodies for the initial certification of quality assurance and similar systems;

The Member States shall ensure that all necessary information relating to the certificates and quality system approvals is made available to bodies they have notified.

The quality system must ensure compliance of the transportable pressure equipment with the type described in the EC type-examination certificate and with the requirements of the Directive which apply to it.

The quality system must ensure compliance of the interoperability constituents with the type as described in the EC type-examination certificate and with the requirements of Decision 96/48/EC and of the TSI that apply to them.

For the main contractor the quality system must ensure overall compliance of the subsystem with the type as described in the type-examination certificate and overall compliance of the subsystem with the requirements of the TSI.

Each notified body must communicate to the other notified bodies the relevant information concerning the quality system approvals and the design examination certificates which it has withdrawn or refused.

For other manufacturers (subsuppliers) the quality system has to ensure compliance of their relevant contribution to the subsystem with the type as described in the type-examination certificate and with the requirements of the TSI.

d) certificates issued by authorised bodies or other quality control organisations attesting conformity to specifications or standards of products or services with certain required specifications or standards in the contract documents,

If the conformity of the subsystem with the type as described in the EC type-examination certificate and the compliance of the subsystem with the requirements of the Directive 96/48/EC and the TSI is based on more than one quality system, it has to examine in particular:

(1) Contractors may ask candidates to produce certificates drawn up by independent bodies for attesting conformity of the supplier or service provider to certain quality assurance standards. The attestations shall refer to quality assurance systems based on the relevant EN 29 000 European standards series certified by bodies conforming to the EN 45 000 European standards series.

copies of the EC declarations of conformity and, where appropriate, of the EC declarations of suitability for use, which said constituents must be provided in accordance with Article 13 of the Directive, accompanied, where appropriate, by the corresponding documents (certificates, quality system approval and surveillance documents) issued by the notified bodies on the basis of the TSI,

(2) Contractors shall recognise equivalent certificates from bodies established in other countries where so laid down in an international treaty concluded by the Republic of Slovenia. Contractors shall also accept other evidence of equivalent quality assurance measures from service providers who have no access to such certificates or no possibility of obtaining them within the relevant time limits.

Where the subsystem meets the requirements of Directive 96/48/EC and the TSI, the notified body must then, based on the type-examination and the approval and surveillance of the quality system(s), draw up the certificate of EC verification intended for the adjudicating entity or its authorised representative established within the Community, which in turn draws up the EC declaration of verification intended for the supervisory authority in the Member State within which the subsystem is located and/or operates.

Where the subsystem meets the requirements of Directive 96/48/EC and the TSI, the notified body must then, based on the design examination and the approval and surveillance of the quality system(s), draw up the certificate of EC verification intended for the adjudicating entity or its authorised representative established within the Community, which in turn draws up the EC declaration of verification intended for the supervisory authority in the Member State within which the subsystem is located and/or operates.

In order to verify whether the data submitted in order to obtain a conformity certificate comply with the monographs of the European Pharmacopoeia, the standardisation body of the nomenclatures and the quality norms within the meaning of the Convention relating to the elaboration of the European Pharmacopoeia(15) (European Directorate for the quality of Medicinal Products) may ask the Commission or the Agency to request such an inspection when the starting material concerned is the subject of a European Pharmacopoeia monograph.

carrying out measures aimed at achieving mutual recognition of systems and quality certification,

When issuing this certificate, the manufacturer will take into account the provisions of the current WHO certification scheme on the quality of medicinal products/drugs moving in international commerce.

sampling, testing and issue of seed analysis certificates may be carried out by officially recognised seed testing laboratories according to the rules of the AOSA.

The quality system must ensure conformity of explosives with the type as described in the EC type-examination certificate and with the requirements of this Directive that apply to them.

"Sampled and analysed according to ISTA rules for orange or green certificates by..., (name or initials of the ISTA seed testing station)",

The quality system shall ensure compliance of the products with the type as described in the EC type-examination certificate and with the requirements of the Directive that apply to them.

The manufacturer shall give the assurance in writing to the applicant that the manufacturing process has not been modified since the granting of the certificate of suitability by the European Directorate for the Quality of Medicines.

Notified bodies shall, during the evaluation of the risk analysis and risk management in the framework of the conformity assessment procedure, take account of the TSE certificate of suitability issued by the European Directorate for the Quality of Medicines, hereinafter TSE certificate', for starting materials, where available.

Where the herbal substance or the herbal preparation is the subject of a monograph, the applicant can apply for a certificate of suitability that was granted by the European Directorate for the Quality of Medicines.

The manufacturer shall apply a quality system that ensures conformity of the appliances with the type as described in the EC type-examination certificate and with the essential requirements of this Directive which apply to them.

They shall also accept other evidence of equivalent quality assurance measures from service providers who have no access to such certificates or no possibility of obtaining them within the relevant time limits.

other parameters to be determined by Member States, in particular whether producer organisations are involved in a quality approach officially recognised by the Member States or by independent certifying bodies.

If the conformity of the subsystem with the type as described in the EC type-examination certificate and the compliance of the subsystem with the requirements of Directive 96/48/EC and the TSI is based on more than one quality system, it has to examine in particular,

Whereas these national provisions are often very detailed as regards the requirements relating to the design, manufacture, quality level, testing and certification of personal protective equipment with a view to the protection of individuals against injury and illness;

For notifications including a certificate of suitability from the European pharmacopoeia and when the variation concerns the dossier submitted for the certificate, the documentation required for this change is to be submitted to the European Directorate for the Quality of Medicines (EDQM).

Each batch exported will be accompanied by a batch certificate issued by the manufacturer ('self certification') after a full qualitative and quantitative analysis of all active constituents to ensure that the quality of the products complies with the requirements of the marketing authorisation/product approval.

Demonstration of compliance with the said Note for Guidance can be done by submitting either, preferably a certificate of suitability to the relevant monograph of the European Pharmacopoeia that has been granted by the European Directorate for the Quality of Medicines or by the supply of scientific data to substantiate this compliance.

Should contracting entities require the production of certificates drawn up by independent bodies for attesting conformity of the service provider to certain quality assurance standards, they shall refer to quality assurance systems based on the relevant EN 29 000 European standards series certified by bodies conforming to the EN 45 000 European standards series.

(7) Where the active substance and/or a raw and starting material or excipient(s) are the subject of a monograph of the European Pharmacopoeia, the applicant can apply for a certificate of suitability that, where granted by the European Directorate for the Quality of Medicines, shall be presented in the relevant section of this Module.

The EC declaration of type conformity (guarantee of product quality) is that part of the procedure whereby a manufacturer who fulfils the obligations in point 4.2 declares that the appliances concerned are in conformity with the type as described in the EC type-examination certificate and satisfy the essential requirements of this Directive which apply to them.

The EC declaration of conformity to type (guarantee of production quality) is the procedure whereby a manufacturer who fulfils the obligations in point 3.2 declares that the appliances concerned are in conformity with the type as described in the EC type-examination certificate and satisfy the essential requirements of this Directive which applies to them.

In the event of disruptions which severely impede a supply of goods free at port of landing or free at destination for reasons which are not attributable to the supplier, the Commission may decide that the monitor shall issue a final certificate of conformity before the supply has been carried out, on the basis of an appropriate check on the quantity and quality of the goods.

Contact points are identified in order to permit regulatory authorities and manufacturers to inform the regulatory authorities of the other Party with the appropriate speed in case of quality defects, recalls, and adverse incidents, which could necessitate additional controls or, suspension of the distribution of the product or, suspension or cancellation of a certificate of compliance.

Unless otherwise stated, use only reagents of a purity greater than 97 %, purchased from an ISO-accredited supplier with a certificate of purity, free from other congeners at test dilution (this may be confirmed by injection of individual congener standards at the test dilution using GC conditions as in 6.4) and only water of at least grade 3 as defined in ISO 3696. Acetal and acetaldehyde must be stored in the dark at < 5 °C, all other reagents may be stored at room temperature.

Unless otherwise stated, use only reagents of a purity greater than 97 %, purchased from an ISO-accredited supplier with a certificate of purity, free from other congeners at test dilution (this may be confirmed by injection of individual congener standards at the test dilution using GC conditions as in 6.4) and only water of at least grade 3 as defined in ISO 3696. Acetal and acetaldehyde must be stored in the dark at < 5 °C, all other reagents may be stored at room temperature.

Where the subsystem meets the requirements of Directive 96/48/EC and of the TSI, the notified body must then - based on the design examination and the approval and surveillance of the quality system(s) - draw up the certificate of EC verification intended for the adjudicating entity or its authorised representative established within the Community, which in turn draws up the EC declaration of verification intended for the supervisory authority in the Member State within which the subsystem is located and/or operates.

for quality management - the recognition of one Party's quality management certificates in accordance with the regulatory requirements of the other Party.

The certificate may be issued only for products having the minimum quality characteristics appropriate to a specific stage of marketing.

The quality system must ensure compliance of the pressure equipment with the type described in the EC type-examination certificate or EC design-examination certificate and with the requirements of the Directive which apply to it.

Application of the quality system must ensure that the devices conform to the type described in the EC type-examination certificate.

up to 100 % of the costs of the charges levied by recognised certifying bodies for the initial certification of quality assurance and similar systems;