CRS

Information for Manufacturers (MED)

The following are the information for manufacturers about the procedures for inspections, auditing and certification for products under the Council Directive 96/98/EC on marine equipment.

General

At the request of manufacturers, the Croatian Register of Shipping the Notified Body no. 2489 (hereinafter referred to as the “Notified Body”), may conduct the conformity assessments in accordance with the requirements of the Council Directive 96/98/EC on marine equipment for materials and equipment (hereinafter referred to as the “products”).
2489/yy

Upon satisfactory completion of these assessments, the manufacturers may affix the Wheel Mark to their products, issue an accompanying EC Declaration of Conformity and place their products on the market.

Conformity Assessment Procedures

The conformity assessment procedures for products under the Council Directive 96/98/EC on marine equipment are briefly explained in reference to the flow chart.


STEP 1
Manufacturer
Products on Annex A.1 List of Council Directive 96/98/EC

STEP 2
Manufacturer
Selection of Conformity Assessment Procedures e.g. Module B;
Module B + Module D, E or F; Module G

STEP 3
Manufacturer
Submission of Applications

STEP 4
CRS
Module B
Document review and Tests and Inspections Issue of EC Type Examination Certification
Module G
Unit verification
Module D
auditing of complete quality management system
Module E
auditing of quality management system for final inspection and testing
Module F
tests and inspections for every product

STEP 5
CRS
Completion of Conformity Assessment Procedures

STEP 6
Manufacturer
Affixing of Wheel Mark and Issue of Declaration of Conformity

STEP 1 - Products on Annex A.1 List of Council Directive 96/98/EC

A manufacturer is to ascertain that its products in questions are in the Annex A.1 List “Equipment for which detailed testing standards already exist in International Instruments” of the Council Directive 96/98/EC on marine equipment


STEP 2 - Selection of Conformity Assessment Procedures

Annex A.1 List specifies the conformity assessment procedures applicable to individual products.
The manufacturer is to choose the appropriate procedures for conformity assessment among those specified in Annex A.1 List, such as the assessment by means of inspections or auditing, or of the combination of inspections and auditing, bearing in mind the frequency of delivery / quantity of the products manufactured, and other factors. One example is either of combination for inspection and auditing as the conformity assessment procedures for lifejackets as accepted in Annex A.1 as follows:

  • EC Type-Examination (module B) + Production-Quality Assurance (Module D),
  • EC Type-Examination (module B) + Product-Quality Assurance (Module E) and
  • EC Type-Examination (module B) + Product Verification (Module F)

STEP 3 - Submission of Applications

The manufacturer is to submit an application for conformity assessment for its products to the Notified Body using CRS Application Form.


STEP 4 - Inspections and Auditing

(1) Initial Inspections and Auditing

It is to be noted that among the conformity assessment procedures is the EC Type-Examination (Module B) which is always required to be chosen except where the Unit Verification (Module G) is chosen. The manufacturer who has decided to choose the EC Type-Examination (Module B) is to submit an application for the EC Type-Examination (Module B) to the Notified Body. Once the EC Type-Examination (Module B) has been completed, the manufacturer may choose either the Production-Quality Assurance (Module D), the Product-Quality Assurance (Module E), or the Product Verification (Module F), (in accordance with permitted modules in the A.1 List), based on its quality system and the level of implementation, and submit the application for the procedures chosen. If the manufacturer has chosen the Unit Verification (Module G), no further procedures other than this need to be chosen additionally. The inspections and auditing under the EC Type-Examination (Module B), the Production-Quality Assurance (Module D), the Product-Quality Assurance (Module E), the Product Verification (Module F) and the Unit Verification (Module G) are briefly explained below:

EC Type-Examination (Module B)

The Notified Body is to conduct testing and inspections and review of the technical documentation for a specimen, representative of the production envisaged, and ascertain and attest that the type complies with the provisions of the international instruments that apply to it.
Once it has been ascertained that it complies with the provisions, the Notified Body is to issue an EC Type-Examination Certificate.

Production-Quality Assurance (Module D)

The Notified Body is to conduct the auditing of the quality system for production, final-product inspection and testing for the products concerned of the manufacturer. Upon satisfactory completion of the auditing, the Notified Body is to issue an EC Certificate of Conformity.
Then, the manufacturer can affix the Wheel Mark to each product and issue a Declaration of Conformity.
If the manufacturer has its quality management system certified by and registered with the Society with the applicable standard of ISO 9001 and with the audit scope covering the products concerned, it may be having an advantage when applying for the Production-Quality Assurance (module D), as it can demonstrate that it has an effective certified quality system.

Product-Quality Assurance (Module E)

The Notified Body is to conduct the auditing of the quality system for final inspection and testing for the products concerned of the manufacturer. Upon satisfactory completion of the auditing, the Notified Body is to issue an EC Certificate of Conformity.
Then, the manufacturer can affix the Wheel Mark to each product and issue a Declaration of Conformity.
If the manufacturer has its quality management system certified by and registered with the Society with the applicable standard of ISO 9001 and with the audit scope covering the products concerned, it may be having an advantage when applying for the Product-Quality Assurance (Module E), as it can demonstrate that it has an effective certified quality system.

Product Verification (Module F)

The Notified Body is to conduct the appropriate tests and examinations for every product and ascertain that they comply with the requirements of the international instruments. Upon satisfactory completion of the tests and examinations, the Notified Body is to issue an EC Certificate of Conformity.
Then, the manufacturer can affix the Wheel Mark to each product and issue a Declaration of Conformity.

Unit Verification (Module G)

For products to which the EC Type-Examination (module B) is not appropriate to be applied, the conformity assessment procedures may be the Unit Verification (module G).
The Notified Body is to conduct the tests and examinations for the individual products and ascertain that they comply with the relevant requirements of the international instruments. Upon satisfactory completion of the tests and examinations, the Notified Body is to issue an EC Certificate of Conformity.
Then, the manufacturer is to affix the Wheel Mark to the individual products and issue a Declaration of Conformity.

(2) Periodical Inspections and Surveillance Auditing

EC Type-Examination (Module B)

An EC Type-Examination Certificate has a validity of four years.
At the request of the manufacturer, the Certificate may be renewed for another 4 years after conducting tests and examinations as necessary.

Production-Quality Assurance (module D) and Product-Quality Assurance (Module E)

Periodical surveillance is to be carried out to ascertain that the quality management system implemented by the manufacturer is maintained.
If the manufacturer has its quality management system certified by and registered with the Society with the applicable standard of ISO 9001 and with the audit scope covering the products concerned, it may be having an advantage when applying for the Production-Quality Assurance (Module D) or the Product-Quality Assurance (Module E) , as it can demonstrate that it has an effective certified quality system.
These audits are conducted concurrently with the annual audits and renewal audits under ISO 9001.


STEP 5 - Completion of the Conformity Assessment Procedures

After satisfactory completion of the inspections and auditing, the Notified Body is to issue the following certificates:


STEP 6 - Affixing of Wheel Mark and Issue of Declaration of Conformity

After satisfactory completion of the inspections and auditing, the manufacturer can issue the following certificates/statements:

  • Declaration of Conformity after completion either of the Production-Quality Assurance (Module D), Product-Quality Assurance (Module E), Product Verification (Module F) or Unit Verification (Module G)

Any Inquiries


For further information and/or for any inquiries including the procedures for inspections, auditing and certification, please contact:

Croatian Register of Shipping
Marasovica 67
21000 Split

REPUBLIC OF CROATIA

Person in charge:
Marinko Popović

Phone: +385 (0) 21 408 190
Facsimile: +385 (0) 21 358 159 
e-mail: marinko.popovic@crs.hr
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