EN 45000 Series

Resume
Identification
EN 45000 Series
Source
CEN - European Committee for Standardization
Summary
The EN 45000 series:

cover accreditation for different types of of conformity assessment bodies:

certification bodies,
testing laboratories,
inspection bodies and
accreditation bodies.

basicaly, EN 45000 series assess:

the organisation and management of the body
the technical requirements relating to the operation of the body.

assessment of the competence of bodies seeking notification the essential standards are covered by EN 45001, 45004, EN 45011 and EN 45012 (107).

are voluntary standards.

Conformity to directive 93/465/EEC
Conformity to the relevant standard of the EN 45000 series (on the part of the notified body) constitutes an element of presumption of conformity to the requirements of the EU Decision 93/465/EEC, but is not always in itself sufficient without demonstration of technical capability within the scope of the directives.

Resume
Identification	EN 45000 Series
Source	CEN - European Committee for Standardization
Summary	The EN 45000 series: cover accreditation for different types of of conformity assessment bodies: certification bodies, testing laboratories, inspection bodies and accreditation bodies. basicaly, EN 45000 series assess: the organisation and management of the body the technical requirements relating to the operation of the body. assessment of the competence of bodies seeking notification the essential standards are covered by EN 45001, 45004, EN 45011 and EN 45012 (107). are voluntary standards.
Conformity to directive 93/465/EEC	Conformity to the relevant standard of the EN 45000 series (on the part of the notified body) constitutes an element of presumption of conformity to the requirements of the EU Decision 93/465/EEC, but is not always in itself sufficient without demonstration of technical capability within the scope of the directives.

The EN 45000 series of standards relevant for notified bodies

Scope Certification bodies Testing laboratories Inspection bodies
Criteria for accreditation bodies EN 45010 EN 45002
EN 45003 EN 45010
Accreditation and assessment criteria EN 45010 EN 45002
EN 45003 EN 45010
Operational criteria EN 45011
EN 45012
EN 45013 EN 45001 EN 45004

Simplified overview of relevant standards of the EN 45000 series for each module

Identification of the EN 45000 series standard for each module of the conformity assessment procedures defined in the New Approach.
(It is a simplified overview of the old New Approach scope. Now there is the New Legislative Framework!)

Module Conformity assesment module in the New Approach scope EN 45000 standard(s) applicable
A Internal control of production EN 45001 or EN 45004 or EN 45011
B EC type-examination EN 45004 or EN 45011
C Conformity to type EN 45001 or EN 45004 or EN 45011
D Production quality assurance EN 45012
E Product quality assurance EN 45012
F Product verification EN 45001 or EN 45004 or EN 45011
G Unit verification EN 45004 or EN 45011
H Full quality assurance EN45012 + EN 45004 or EN 45011

Scope	Certification bodies	Testing laboratories	Inspection bodies
Criteria for accreditation bodies	EN 45010	EN 45002 EN 45003	EN 45010
Accreditation and assessment criteria	EN 45010	EN 45002 EN 45003	EN 45010
Operational criteria	EN 45011 EN 45012 EN 45013	EN 45001	EN 45004

Module	Conformity assesment module in the New Approach scope	EN 45000 standard(s) applicable
A	Internal control of production	EN 45001 or EN 45004 or EN 45011
B	EC type-examination	EN 45004 or EN 45011
C	Conformity to type	EN 45001 or EN 45004 or EN 45011
D	Production quality assurance	EN 45012
E	Product quality assurance	EN 45012
F	Product verification	EN 45001 or EN 45004 or EN 45011
G	Unit verification	EN 45004 or EN 45011
H	Full quality assurance	EN45012 + EN 45004 or EN 45011