Conformity Assessment Procedures

GSO Board of Directors in its 10th meeting (Muscat, 24 May 2009) approved the Technical Regulation for Conformity Assessment Procedures.

Out of its desire to render its conformity procedures compliant with the recognized international practices and easy to fulfill , the GCC Member States intend to apply the modular approach. The modular approach deploys a set of modules for conformity assessment. This approach defines 8 basic modules and 8 additional modules as shown in the following. The technical regulation for each products category defines to manufacturer the available options out of those modules to be followed so as to be able of affixing the GCC Conformity Marking. Some of the modules require the intervention of a third party (notified body) to monitor and control or to perform some of its activities. In such case, the GCC Conformity Marking should be accompanied with the identification number of the concerned notified body.

Fundamentals of Conformity Assessment

1.     The conformity assessment procedures are carried out by the manufacturer (First Party) or by the means of a notified conformity assessment body (Third Party/ Notified Body).

2.     The conformity assessment activities are relevant to the product design phase or manufacturing phase or both.

3.     If the manufacturer is subcontracting design or manufacturing, the manufacturer is sill held responsible for the conformity assessment of his/her products.

4.     The conformity assessment activities are confined in a specific number of modules; 8 Basic  (A,B,C,D,E,F,G,H).

5.     To constitute a complete conformity assessment procedure, the basic and the additional modules are combined together as prescribed in the relevant technical regulation of the product category.

6.     The application of the conformity assessment modules according to the relevant technical regulation results in awarding the product the GCC Conformity Marking.

7.     All labs, whether those for calibration or testing, private or governmental, even those that are affiliated to the manufacturer should be a notified bodies in the scope of work they perform  for conformity assessment (unless otherwise stated in a regulation issued by GCC).

Modules of the Conformity Assessment

Basic Modules

Module A: Internal Production Control:

This module covers the internal design and production control. The module does not require the intervention of a notified third party (unless the manufacturer possesses a lab that is involved in design or production process. In such a case, the lab should be notified unless otherwise stated in a regulation issued by GCC). This is known as the Supplier Declaration of Conformity SDoC.

Module B: The GCC Type Examination:

This module covers the design process and it should be followed by another module that covers the production process. Type Examination certificates are issued by notified bodies.

Module C: Conformity to Type:

This module covers the production process. It follows always module B. It provides an evidence for Type Conformity as described in the GCC Type Examination Certificate issued by the notified body in accordance with the requirements of module B. This module does not entail the intervention of a notified third party (unless the manufacturer possesses a lab that is involved in production control process. In such a case, the lab should be notified unless otherwise stated in a regulation issued by GCC).

Module D:  Production Quality Assurance:

This module covers the production control process and it follows always module B. It is derived from ISO 9001, where a notified third party (Certification Body) should intervene to certify the compliance of manufacturer in the scope of the production, final inspection and product testing.

Module E: Product Quality Assurance:

This module covers the production control process and it follows always module B. It is derived from ISO 9001, where a notified third party (Certification Body) should intervene to certify compliance of manufacturers in the scope of the final inspection and products testing.

Module F: Products Verification:

This module covers the production control process and it follows always module B. It provides Type Conformity evidence as described in the GCC Type Examination Certificate issued in accordance with the requirements of module B. The module herein entails the intervention of a notified third party to issue the conformity certificate.

Module G: Unit Verification:

This module covers both of the design and production control processes. A notified body should test each produced item to issue a conformity certificate.

Module H:  Full Quality Assurance:

This module covers both of the design and production control  processes. It is derived from ISO 9001, where a notified body  (Certification Body) should intervene to certify the compliance of manufacturer quality system to it in the scope of design, production, final inspection and testing.