AQRA TECHNIC d.o.o.

applies the conformity assessment provided by the "new approach" directives, in order for the interested companies get the possibility for CE marking of their products.

CE MARKING

CE Marking is safety symbol, which is implemented within the framework of “New Approach” constituted by European Union (EU) in 1985, to ensure free movement of goods.

CE Marking is the symbol of conformity with the EU New Approach Directives, which shows that the product on which it has been affixed is healthy and safe for the purposes of people, domestic animals and environment. It is not possible for a product within the scope of one or one or two New Approach Directives, to be put on the EU market without bearing CE Marking.

CE Marking is not a quality mark. Product with affixed CE mark meets all the requirements of the related directive, what ensure free movement of goods among the Member States of the EU.

CE Marking of conformity consists of the capital letters in the form of the figure below.
If CE Marking of conformity is minimised or enlarged it must be fit in with the ratios given above.

PRODUCTS WHICH MUST BEAR CE MARKING

  • Products within the scope of the directives involving CE Marking,
  • All new products which have been manufactured in the Member States and in third countries,
  • Second-hand products imported from third countries,
  • Products subject to the provisions of the directives as if new products
  • Products which have undergone a change significantly must bear CE Marking.

IMPROPER USE OF CE MARKING 

In case a situation in non-conformity with the directives is ascertained, the manufacturer or its authorised representative is obliged to ensure that the product is in conformity with the provisions involving CE Marking of conformity and bring the violation to a close. In case the non-conformity continues, the Ministry, in the framework of the authority given by Law, takes all the appropriate measures to restrict or prohibit those products being placed on the market or to withdraw them from the market.

PROCEDURES OF AFFIXING CE MARKING:

  • Directive(s) involving the product is/are determined.
  • (If exist) Harmonised Standards are identified.
  • Module or combination of modules is/are selected.
  • Whether Notified Body is required or not is determined.
  • Subsequent to conformity assessment, declaration of conformity and if required other documents are prepared.
  • Technical file is prepared and retained.
  • “CE” Marking is affixed to the product and/or on its package and on the accompanying certificate and the product is put on the market.

NEW APPROACH AND MODULAR SYSTEM

In the “New Approach”, directives don’t include too much technical detail, but they designate the general principles that the manufactured products must be in conformity with according to the product groups. Besides, the products meeting the “Essential Requirements” are ensured to be in free movement.

Directives are arranged not according to the products, but according to the intended use of the products. Consequently, the products functioning similarly are gathered together in groups and “minimum safety requirements” are determined by means of only one directive.

A modular conception has been implemented in CE Marking system since 1990. The main objective of the modular concept is to determine the conformity assessment procedures by taking the product characteristics and their risk level into consideration.

In the Construction Products Regulation there is an approach named as “Assessment and Verification of Constancy of Performance” instead of Modular approach.

Assessment And Verification Of Constancy Of Performance

SYSTEM 1+ / 1
Declaration of the performance of the essential characteristics of the construction product by the manufacturer on the basis of the following items:
(a) The manufacturer shall carry out:
1.Factory production control (FPC)
2.Further testing of samples taken at the factory in accordance with the prescribed test plan.

(b) The notified product certification body shall issue the certificate of constancy of performance of the product on the basis of:

1.determination of the product-type on the basis of type testing (including sampling), type calculation, tabulated values or descriptive documentation of the product;

2.initial inspection of the manufacturing plant and of factory production control;
3.continuous surveillance, assessment and evaluation of factory production control
4.audit-testing of samples taken before placing the product on the market (only for 1+)

SYSTEM 2+
Declaration of the performance of the essential characteristics of the construction product by the manufacturer on the basis of the following items:
(a) The manufacturer shall carry out:
1.Factory production control (FPC)
2.testing of samples taken at the factory in accordance with the prescribed test plan
3.determination of the product-type on the basis of type testing (including sampling),     type calculation, tabulated values or descriptive documentation of the product

(b) The notified production control certification body shall issue the certificate of conformity of the factory production control on the basis of :
1.initial inspection of the manufacturing plant and of factory production control
2.continuous surveillance, assessment and evaluation of factory production control

SYSTEM 3
Declaration of the performance of the essential characteristics of the construction product by the manufacturer on the basis of the following items
(a) The manufacturer shall carry out: Factory production control (FPC)

(b) The notified testing laboratory shall carry out determination of the product-type on the basis of type testing (based on sampling carried out by the manufacturer), type calculation, tabulated values or descriptive documentation of the product

SYSTEM 4
Declaration of the performance of the essential characteristics of the construction product by the manufacturer on the basis of the following items
(a) The manufacturer shall carry out:
1. factory production control (FPC)
2. determination of the product-type on the basis of type testing, type calculation, tabulated values or descriptive documentation of the product

(b) No tasks for the notified body

CONFORMITY ASSESSMENT MODULES

  1. Module A: Internal Production Control
    2. Module B:Type Examination
    3. Module C: Conformity to Type
    4. Module D: Production Quality Assurance
    5. Module E: Product Quality Assurance
    6. Module F: Product Verification
    7. Module G: Unit Verification
    8. Module H: Full Quality Assurance

Module A: Internal Production Control

This module covers internal design and production control. The manufacturer declares the conformity of the product with the relevant directives and prepares a technical file which explains the design, production and usage of the product. This module does not require a Notified Body to take action.

Module B: EC Type Examination

This module, covering only the design phase, is generally used together with a declaration of conformity. Within the framework of this module, for which CE Marking is not stipulated, Notified Body tests the product type to the relevant directive.

Module C: Conformity to Type

This module, covering the production phase, is unsufficient alone. It represents a phase after EC Type Examination Module (Module B). As a result of this module, which is used to show the conformity of the product with the requirements of the directive, the manufacturer affixes CE marking to the product and draws up a declaration of conformity.

Module D: Production Quality Assurance

This module covers the production phase and follows Module B. It involves testing and approval processes carried out by a Notified Body. The process it pursuits is similar to the production, foundation and after sales service scope of ISO 9000 (ex. ISO 9002). It envisages a quality assurance system to be established oriented to production. Final product inspection and testing are implemented by the manufacturer.

Module E: Product Quality Assurance

This module covers the production phase and follows Module B. It involves testing and approval processes carried out by a Notified Body. The process it pursuits is similar to the final check and tests, purchasing + packaging + after sales services (does not involve production) scope of ISO 9000 (ex. ISO 9003). It envisages a quality assurance system to be established oriented to production. Final product inspection and testing are implemented by the manufacturer.

Module F: Product Verification

This module is oriented to only production phase and is used together with Module B. A Notified Body controls the product’s conformity to type and technical documents. Within the framework of this module CE Marking is affixed accompanying a certificate of conformity.

Module G: Unit Verification

This module covers the design and production phases. Each individual product is examined by a Notified Body, which issues a certificate of conformity. As a result of this module CE Marking is affixed to the product.

Module H: Full Quality Assurance

This module, involving design and production phases, is implemented by a Notified Body’s control of quality management system (ISO 9000’s scope of design + development + production + foundation + after sales services). In case the design does not conform to the harmonised standards fully, it is controlled whether the design conforms to the provisions of the directive or not.

CE Marking does not have a direct relationship with the Quality Management Systems (EN ISO 9001). CE Marking symbolizes that a product has been designed and manufactured in conformity with the New Approach Directives of EU and relevant Harmonised European Standards. It is seen that in modular system Quality Management Systems are stipulated for some product groups.

RELEVANT EUROPEAN DIRECTIVES

AQRA TECHNIC d.o.o. can provide conformity assessment based on the following directives:
90/385/EEC Active implantable medical devices

92/42/EEC Hot-water boilers

93/42/EEC Medical devices

98/79/EC In vitro diagnostic medical devices

2000/14/EC Noise emission in the environment by equipment for use outdoors

2006/42/EC Machinery

2009/48/EC Safety of toys

2010/35/EU Transportable pressure equipment

Regulation (EU) No 305/2011 – Construction products

2013/29/EU Pyrotechnic articles

2013/53/EU Recreational craft and personal watercraft

2014/28/EU Explosives for civil uses

2014/29/EU Simple pressure vessels

2014/30/EU Electromagnetic compatibility

2014/31/EU Non-automatic weighing instruments

2014/32/EU Measuring Instruments Directive

2014/33/EU Lifts and safety components for lifts

2014/34/EU Equipment and protective systems intended for use in potentially explosive atmospheres (recast)

2014/53/EU Radio equipment

2014/68/EU Pressure equipment

2014/90/EU Marine equipment

2016/797 on the interoperability of the rail system

Regulation (EU) 2016/425 Personal protective equipment

Regulation (EU) 2017/746 on in vitro diagnostic medical devices

Regulation (EU) 2017/745 on medical devices

Regulation (EU) 2016/426 Appliances burning gaseous fuels

Regulation (EU) 2019/945 on unmanned aircraft systems and on third-country operators of unmanned aircraft systems

Regulation (EU) 2016/424 Cableway installations

Regulation (EC) No 552/2004 – Interoperability of the European Air Traffic Management network

Decision 2009/750/EC (implementing Directive 2004/52/EC) – Interoperability of Electronic Road Toll Systems

Regulation (EU) 2019/1009 on EU fertilising products