Conformity assessment procedures

Resume
Identification
Conformity assessment procedures
Source
New Approach
Foreword
A smooth introduction:

The idea is that the conformity assessment does not only occurs when the product is ready for delivery but before, during its production.

Since it is not possible to define only one straight forward assessment procedure to cover all possible production processes and products in Europe, the procedures were grouped into 8 modules.

The combination of modules to be employed depends on the sort of product being assessed.

Official Definition

Conformity assessment is subdivided into modules, which comprise a limited number of different procedures applicable to the widest range of products

The modules relate to the design phase of products, their production phase or both. The eight basic modules and their eight possible variants can be combined with each other in a variety of ways in order to establish complete conformity assessment procedures.

As a general rule, a product is subject to conformity assessment according to a module during the design as well as the production phase.

Each New Approach directive describes the range and contents of possible conformity assessment procedures, which are considered to give the necessary level of protection. The directives also set out the criteria governing the conditions under which the manufacturer can make a choice, if more than one option is provided for.

Resume
Identification	Conformity assessment procedures
Source	New Approach
Foreword	A smooth introduction: The idea is that the conformity assessment does not only occurs when the product is ready for delivery but before, during its production. Since it is not possible to define only one straight forward assessment procedure to cover all possible production processes and products in Europe, the procedures were grouped into 8 modules. The combination of modules to be employed depends on the sort of product being assessed.
Official Definition	Conformity assessment is subdivided into modules, which comprise a limited number of different procedures applicable to the widest range of products The modules relate to the design phase of products, their production phase or both. The eight basic modules and their eight possible variants can be combined with each other in a variety of ways in order to establish complete conformity assessment procedures. As a general rule, a product is subject to conformity assessment according to a module during the design as well as the production phase. Each New Approach directive describes the range and contents of possible conformity assessment procedures, which are considered to give the necessary level of protection. The directives also set out the criteria governing the conditions under which the manufacturer can make a choice, if more than one option is provided for.

Flowchart of conformity assessment modules by product manufacturing phases

Simplified flow chart of conformity assessment procedures

Conformity assessment basic modules

Module Title Description Quality
Assurance
Standard Notified Body
A Internal control of production Covers internal design and production control. --- ---
B EC type-examination Covers the design phase, and must be followed up by a module providing for assessment in the production phase. --- Issues a EC type-examination certificate
C Conformity to type Covers the production phase and follows module B. Provides for conformity with the type as described in the EC type-examination certificate issued according to module B. --- ---
D Production quality assurance Covers the production phase and follows module B. EN ISO 9002 Approves and controlls the quality system for production, final product inspection and testing
E Product quality assurance Covers the production phase and follows module B. EN ISO 9003 Approves and controlls the quality system for production for final product inspection and testing
F Product verification Covers the production phase and follows module B. --- Controls conformity to the type as described in the EC type-examination certificate issued according to module B, and issues a certificate of conformity.
G Unit verification Covers the design and production phases. --- Issues a certificate of conformity after examining each individual product
H Full quality assurance Covers the design and production phases. EN ISO 9001 Approves and controlls the quality system for design, manufacture, final product inspection and testing.

Module	Title	Description	Quality Assurance Standard	Notified Body
A	Internal control of production	Covers internal design and production control.	---	---
B	EC type-examination	Covers the design phase, and must be followed up by a module providing for assessment in the production phase.	---	Issues a EC type-examination certificate
C	Conformity to type	Covers the production phase and follows module B. Provides for conformity with the type as described in the EC type-examination certificate issued according to module B.	---	---
D	Production quality assurance	Covers the production phase and follows module B.	EN ISO 9002	Approves and controlls the quality system for production, final product inspection and testing
E	Product quality assurance	Covers the production phase and follows module B.	EN ISO 9003	Approves and controlls the quality system for production for final product inspection and testing
F	Product verification	Covers the production phase and follows module B.	---	Controls conformity to the type as described in the EC type-examination certificate issued according to module B, and issues a certificate of conformity.
G	Unit verification	Covers the design and production phases.	---	Issues a certificate of conformity after examining each individual product
H	Full quality assurance	Covers the design and production phases.	EN ISO 9001	Approves and controlls the quality system for design, manufacture, final product inspection and testing.