EN ISO 9000 AND EN 45000.pdf

8/17/2019 EN ISO 9000 AND EN 45000.pdf

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-

EUROPEAN COMMISSION

DIRECTORATE GENERAL Ill

INDUSTRY

Legislation and

standardization

nd

telematics

networks

Quality Polley, certification and conformity marking

Brussels,

12108/96

AM/GG 111/B/4

DOC. CERTIF. 95/2 rev

The

European Quality Assurance Standard

EN

ISO 9000 and

EN

45000

in

the

Community s

New pproach

legislat

8/17/2019 EN ISO 9000 AND EN 45000.pdf


-

PREFACE

The scope of this document is to give an overview

of

the use and im

European standards series EN ISO

9000

and EN 45000 in the Co

Approach legislation.

The document, which supersedes the document CERTIF 92/9 on th

has taken into consideration the different developments in Communi

in the quality standards fields, namely:

• the evolution of the

EN

ISO 9000-1994 former EN 29000} and E

standards series;

•

the

publication

of

New

Approach Directives and

of

Decision

conformity assessment procedures;

as well as the issues brought to light by

the

development and imple

conformity assessment process and the growing consideration acro

quality systems concepts and quality in general, both by econom

public administrations.

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\

TABLE OF CONtENTS

· tJr

.

p 1 - : ~ · , ~

·a

INTRODUCTION

1.

THE EN ISO 9000 FORMER EN 29000 SERIES

OF

STANDARDS

2. THE EN

45000

SERIES OF EUROPEAN STANDARDS

3. IMPLEMENTATION OF QUALITY STANDARDS BY ECONOMIC

OPERATORS UNDER NEW APPROACH DIRECTIVES

4. GENERAL CONSIDERATIONS ON QUALITY ASSURANCE STAND

APPLICATION

ANNEXES

ANNEX I - DEFINITIONS

ANNEX II - TABLE ISO/CEN QUALITY STANDARDS

ANNEX Ill - TABLE

OF

EN

45000

ND

RELATING ISO

REFERENCES

ANNEX IV - THE

EN

ISO 9000 STANDARDS IN THE MEMBER STAT

ANNEX V - THE NEW APPROACH DIRECTIVES

ANNEX VI - HARMONIZED STANDARDS BY NEW APPROACH

DIRECTIVE

ANNEX VII - THE CONFORMITY ASSESSMENT PROCEDURES

TO E USED IN THE TECHNICAL HARMONIZATION

· DIRECTIVES NEW APPROACH DIRECTIVES)

ANNEX Vll.l- FLOWCHARTS

OF

THE CONFORMITY ASSESSMENT

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I

t

I

.

.

0. INTRODUCTION

0 1 The evolution

of

Community legislation (from old

to

new approa

The free movement of products is at one and the same

time

one o

and one

of

the aims

of

the U Internal Market. The existence of

standards and technical regulations and of different conformi

procedures in the Member States leads to the raising

of

technical ba

the

effect

of

which

is

twofold:

• increased production costs in order to meet various national require

• increased conformity checking costs owing to the mushrooming

certification requirements.

The Community since the beginning

of the

1980s, in

the

field of

the

technical barriers to trade, passed through a silent revolution in

mechanisms

for

ensuring

that

only safe products get

to

the market,

come from, inside and outside the Community.

The Cassis de Dijon case in 1 981 gave the Community the key e

later were

to form the

basis

for the new

Community legislation, fixin

principles:

• products manufactured in a Member State should benefi t from

throughout

the

Community;

• it is up to the Member States to demonstrate

that

a product do

essential safety and health requirement and no longer to the m

demonstrate that it does;

• Member States can intervene only when a product does not respe

requirement,

that

means

that

in all other cases Member States m

products on their market.

Following these principles, the Council

of

the European Communiti

May

1

1985 a resolution

1

, the New Approach to technical harm

standardization, which combines

both

the harmonization of regulation

standards and the mutual recognition of the results of tests and of

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i

I

1

j

l

l

l

:

•

the

technical specifications governing the production and mark

meeting the essential requirements set out in

the

Directives

will

the European Standardization Bodies (CEN, C E N E L E ~ ET

Standards (EN, ETS); .

• implementation of the European Standards remains voluntary;

• the manufacture of products in line with the harmonized Eur

leads to a presumption

of conformity

with said essential r

normally leads

to

less burdensome certification process.

The groundwork for the

New

Approach formed only one part of

the

order to achieve the Internal Market. The existence of standards sp

requirements is a necessary but insufficient prerequisite. It is es

conditions whereby conformity assessment is carried

out

in

transparent, reliable procedures which guarantee the quality

of the

r

To date, seventeen

New

Approach Directives (considering the Dir

s

part

of

them) have already ·been approved on

this

basis, and

following areas:

• simple pressure vessels (87/404/EEC);

• . toys (88/378/EEC);

• construction products (89/1 06/EEC);

• electromagnetic compatibility (89/336/EEC);

• machinery (89/392/EEC);

• personal protective equipment (89/686/EEC); .

• non-automatic weighing instruments (90/384/EEC);

• active implantable medical devices (90/385/EEC);

• appliances burning gaseous fuels (90/396/EEC);

• telecommunications terminal equipment (91 /263/EEC);

• h ~ t

water

boilers fired

with

liquid or gaseous fuels (92/42/EEC).

• electrical ~ q u i p m e n t designed

for

use within certain voltage limi

• explosives for civil uses (93/15/EEC);

• medical devices (93/42/EEC);

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-

In its Resolution of 2 December 19 9 on the Global Approach to C

Testing

2,

the. Council stated its aim

of

providing,

within

the Inter

homogeneous, transparent and credible technical environment within

authorities, economic operators and users will be able to have confide

will ultimately lead

to

the existence on the market

of

higher quality pro

This confidence must be based on technical competence on

manufacturers, test laboratories, the bodies responsible for q

certification and inspection bodies, and on transparency in

th

assessment procedures whether subject

to

regulations or voluntary th

of the Internal Market).

Testing

and

Calibration

ACCREDITATION

Certification

and

Inspection

Quality

t

Auditing

. BASIC FUNCTIONS INVOLVED

IN

THE CONFORMITY ASSESSMENT PROCEDURES

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The resolution on the Global Approach fixes the guiding principles

policy as regards conformity assessment:

• . use

of

the modules concerning the different stages ·of

assessment procedures (modular approach) and of the criteria

fo

and notification of bodies under those procedures;

• generalized use of

the

European standards relating to quality as

9000

and

to

the requirements to be fulfilled by the above ment

45000 ,

and the setting up of accreditation systems;

• promotion

of

mutual recognition agreements concerning testing

in

the

non-regulatory sphere, under

the

aegis

of

the European

Testing and Certification (EOTC);

• reinforce.ment of the development

of

existing quality infrastruc

Community to minimize their differences; ·

• promotion

of

external Community relations

with

third countries b

• mutual recognition agreements;

• co-operation and technical assistance programmes.

Amongst the eight conformity assessment procedures retained

for

the Council decided to include the three models of quality assurance

EN ISO 9001,

9002

and 9003 (former EN 29001,

29002

and 29

alongside the more traditional product certification procedures such

and unit verification, and even

the

manufacturers declaration

of con

This approach was adopted by Decision 90/683/EEC

3

of

1 3 Dec

amended and brought up to date by Decision 93/465/EEC

4

, which

of basic principles on how the procedures should be used in Comm

such as

the

one

that the

Council should leave as

wide

.a choice a

manufacturers .and should avoid restricting it to only

product

c

quality system certification.

The decision

to

leave these

two

choices

was

oriented

to

manufacturers, in particular SMEs, to operate under the Directives a

the time to ~ o v over to quality system certification if and when

and according to their own economic interests.

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'

;

.

l

The importance

of

accreditation for conformity assessment bodies wh

in

the

regulated 'or non regulated area, in order

to

help

them

independently their technical competence and to ensure transpare

driven certi fication in Europe, was clearly set out by the Council.

One stop accreditation, which can lead to one stop certification and t

nowadays a main objective in

this

area

of

activity.

To achieve suc

mutual recognition can help in

the

regulated sector, where public

obliged

by

law to accept certificates issued on

the

territory ·of other M

to

increase the transparency and credibility

of

thei

activities, and

sector

to

guarantee a common level of competence of certificatio

eliminating the need for artificial multiple certifications.

To date, several accreditation bodies are members of the EAL

operation_

for

Accreditation of Laboratories) multilateral agreement

accreditation, while activities are ongoing

to

enlarge the participatio

accreditation of certification bodies

to

the EAC (European A

Certification) multilateral agreement.

It is appropriate, in this context, to define

5

the

notion of quality. S

the

meaning

of

quality (according to ISO

8402

-

1994)

is

th

characteristics of an entity (i.e. an

activity or

a process, a product, an

system or a person, or any combination thereof) that bear on its a

stated and implied needs

As part

of

Community legislation, quality has

thus

become

an

integ

essential requirements of

the

Directives whereby the quality of prod

the

market cannot be less than

the

level

of those

requirements and a

meeting those requirements is

thus, by

definition, banned.

The idea

of

quality includes within

its

overall meaning

its

three ins

standardization, certification and metrology, plus a management pillar

management and quality assurance.

0.2. The i n ~ e g r t i o n of quality s t ~ d r d s in the new

conform

system

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1989 provided support

for

the needs of economic operators in Eur

be considered

to

be one

of

the most significant planks in the

strategy.

Under the modular approach

to

conformity assessment

the

Counc

use

of

quality assurance

as set out

in

the N

ISO

9

se

standards as a means of demonstrating conformity of produc

Directives set out the safety levels and use of operational and as

set

out

in the N 45 series

of

European standards as the mea

to demonstrate the technical competence and operational transpare

assessment bodies.

Indeed the N ISO 9 series of standards identify those quality

that are needed to generate confidence in manufacturer capacity

providing products in line with pre-established requirements.

The N 45 series of standards defines the criteria needed in

confidence in

the

capacity transparency and technical compe

involved in the conformity assessment procedures.

Experience in

the use

of N 45

standards has revealed a numbe

the operation of the system over these years.

There is a general consensus throughout the public and private ope

that there is now sufficient practical experience for the developm

position

which

will bring clarity efficiency and improved cre

standards.

In particular there is a need to consider the question

of ttie ext

criteria

of

the N 45 series can be reorganised to reflect the

carried out rather than the structures of the bodies involved in the t

European Standardization Institutions have been involved in this

have been requested to make recommendations

for

action in this ar

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1.

THE

EN ISO 9000 FORMER EN 29000) SERIES

OF

STANDARD

On the current (European and international) market, manufacturers nee

guarantees concerning product quality.

It

is no longer enough

to

pr

that conform and

it

is thus becoming necessary to demonstrate the

capability to provide continuously products that conform.

First of all, manufacturers need to set up quality systems enabling the

as

a

first

concern

that

the

required quality

will

be obtained

at the l

reasons of competitiveness and even survival on the market.

Secondly, customers (sometimes public authorities) need to

k

manufacturers quality system provides the necessary assurance conc

quality. This may have serious consequences for manufacturers in

may require different quality system specifications, and so giv

excessively cumbersome and bureaucratic system without any furthe

quality in order

to

meet those requirements.

It is precisely against this background that approval of the European

series of standards plays a very important part in enabling the most

system model to be selected in the light of

the

operational and

suitability of the company. The EN ISO 9000 series specifies the elem

order

to

set up and manage the quality system;

it

applies

to

the g

categories that encompass all the kinds of products supplied

by

hardware, software, processed materials and services.

The series is intended to

be

used

by

manufacturer's organization in fo

for internal purposes

a. guidance for quality management:

in this situation

it

provides a quality management approach to ins

system

that

will

enhance the manufacturer's quality achievement

1 and other applicable parts of EN ISO 9004 series).

for

external

purposes

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. ; · ; , · -

.·. -

···

. i

I

c. second party approval or registration:

in

this

situation

the

manufacturer s

quality

system

is

assessed

b

The manufacturer may be given formal recognition of conform

standard EN ISO 9001

EN

ISO 9002 and EN ISO 9003 .

d. third party certification or registration:

in this situation the manufacturer s quality system is evaluated b

body, and

the

manufacturer agrees

to

maintain

the

quality

customers unless otherwise specified in an individual contract E

ISO

9002

and

EN

ISO

9003 .

In all situations (a, b, c and d),

the

setting up of the quality

organization is

the

result

of

a

commitment by

its management to

competitiveness and to achieve the quality required

by

the

economically efficient manner.

The three distinct quality system models suitable for the purpose

o

demonstrating

their

capabilities and

for

assessment

of

such manufa

by

external parties are:

• Standard EN ISO 9001 which covers the most complete qua

elements

of

which cover all aspects from product design

to

production;

• Standard EN ISO 9002

which

covers aspects from production to

• Standard EN ISO 9003 which covers final

i n s p ~ t i o n

and testing.

DEFINITIONS

-EN ISO 8402

-EN

45 2

- GLOSSARY

EOQ

INTERNAL PURPOSES

SELECTION

EXTERNAL P

EN

ISO 9000-1

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;·

.

A table showing the correspondence between the ISO and EN qu

either in existence

or

in preparation is set

out

in Annex II.

1 . 1. Standard EN ISO 9000-1 : Quality management and qu

standards. Part 1 : guidelines for selection and use

Standard EN ISO 9000 1 can be considered as the road map to

series and others ISO

9000

standards, since

it

deals

with

the. gen

underlying quality system standards by establishing relationships

principal concepts in approaching quality and the criteria of selection

entire series.

These basic concepts have been expanded significantly in

the 199

now includes:

• the five key objectives and responsibilities

for

quality,

with

stron

quality improvements in products and operation system. This build

objectives in the 1987 version that focused on achieving and su

quality;

• the concept of manufacturer's stakeholders (customers,. employee

suppliers and society) and their expectations;

• the distinction between quality system requirements and pro

requirements. The subject

of

EN ISO 9000 standards is the quali

This crucial distinction was

not

clear in

the

1987

version,

misunderstandings;

• the four facets that are key contributors to product quality:

definition

of

needs

for

the product,

product

design, c9nforma

design and quali ty due

to

product support. Articulation of these

in international standardization;

• the concept of a process and the need

for

an organization to id

and manage

its network

of

processes and interfaces (new aspec

version); ·

•

the

three areas to be addressed

for

. every process being e

assessing ·a . qual ity system: process definition and documen

deployment and process e f f e c t i v e n ~ s s

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party certification,

the

selection,of the quality assurance. standard s

by

the

manufacturer and

the

certifier,

taking

into

account

custo

. manufacturer objectives.

It sets

out the

responsibilities and

the typical

means

of

de

conformance to the selected model and explicit additional co

contractual situations.

1.2.

Standard EN ISO

9004-1

Quality management and quality

Part 1 : Guidelines

Standard EN ISO 9004-1 (former EN 29004 is designed to assist

designing, developing and setting up

the

quality system

that

is

most

The standard is not intended

for

contractual, regulatory, or certificatio

It

defines

the

broad approaches involving

the

human, technical an

factors concerning product quality

throughout

the life cycle from us

of

needs up to customer satisfaction. The standard describes all of

enabling a quality system to be set up within an organization in o

competitiveness and achieve the required quality in

an

econo

manner. The factors involved are:

• the organization s aims;

• customer and organization needs and interests;

• benefits, costs and risks;

• management responsibilities;

• principles, documentation and qual ity system audits;

• the financial aspects of quality systen: activities;

• marketing;

• design, supplies, production, product ion control, product ch

checking of measuring and testing equipment;

• non-conformity and remedial actions;

• handling, storage, delivery, packaging, installation and servicing;

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The 1994 revision contains, in addition to changes in wording for cl

consistency

with

the

revised

N

'SO

9000

series, changes relating

to:

• structure of

the

quality system, requiring documented pr

configuration management to

the extent

appropriate. Configuration

is a management discipline that applies technical and administrati

the design, development, production and use

of

the product, a

visibility of the state of documentation and product during its life-tim

• quality

syst_em

elements, requiring the organization's management

the

system facilitates and promotes continuous quality improvemen

• financial considerations, enlarging the selection of approaches

presenting and analysing

the

elements of financial data reporting,

th

• quality-cost approac;h;

• process-cost approach;

• quality-loss approach;

and identifying

the

aims

of

financial reporting

of

quality activities.

1.3. Standards

N

ISO 9001/2/3 Quality systems- Models for_ quali

Standards N ISO 9001 N ISO 9002 and N

ISO

9003

specify

quality system requirements

that

can

be

used

for

external qua

purposes. They represent three

distinct

models suitable

for ,th

manufacturers demonstrating their capabilities and for assessm

manufacturer capability

by

external parties.

The requirements concerning the elements of the quality system s

three standards are complementary (not alternative)·

to

the (prod

requirements and they apply independently

of

any specific industry

sector.

The standards are intended

for contractual (second or

third

party c

regulatory use.

The 1994 revision, while moving

towards

a general harmonization

and definitions of the quality system requirements, incorpor

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Resources, expanded to include management, work performa

activities;

• Quality system, clearly requiring a quality manual that defines th

structure of the quality system and stating the extent of documen

• Quality system procedures, enhanced

to

clarify

the

degree o

required

for the

quality system;

• Qual ity planning, added

to

. cover quali ty system planning and

plans;

•.

Contract review, expanded to include precontract tender arr

contract and ordering requirements;

• Process control, expanded to include additional requirements

process equipment;

• Corrective and preventive actions, addressed by separat

corrective action directed towards eliminating the cau

nonconformities, and the preventive action directed

towards

causes

of

potential nonconformities.

1.

3 1

Standard EN ISO

9001

- Quality systems - model for qua

design, development, production, installation and servicing

This standard is

to

be used when the need is to demonstrate the

capability

to

design and supply conforming products.

The requirements specified are aimed primarily at achieving custome

preventing non conformities at all stages from design through to ser

Standard

EN

ISO

9 1

applies in situations where:

a design is required and the requirements placed upon the pro

couc.hed in terms of product performance or where

it

is necess

such requirements;

b

confidence in obtaining a product in line with the requirements la

obtained py demonstrating the manufacturer s abilities

as

development. product ion. installation and servicing. ·

The 1994 specific modification, apart from those ones identifted a

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• design review, previously considered

an

option of the design ve

requires, at appropriate stages

of

design, the planning and execu

documented design ~ e v i e w s

• design verification, requires

that, at

appropriate stages of d

verification is performed to ensure that the desjgn stage outpu

desjgn stage jnput requirements:

• design validation, not previously included, requires that design

performed to ensure

that

products (normally final product) confor

user needs and/or requirements.

The module Decision (cf.

Section 3.) sets out, amongst others, ·th

assurance conformity procedure (module H based on

EN

ISO 9001

mean of assessing product conformity

to

New Approach Directives

The module H procedure provides for supplementary requirements bas

design verification

by

Notif ied Bodies. The mentioned changes in

apart from the effective improvement of manufacturers' design pr

should lead, when required

by

Directive,

to

the facilitation

of

p

verification activities by those notified Bodies

as

well.

1.3.2.Standard EN ISO 9002 - Quality systems - Model for qual

production, installation and servicing

This standard is to

be used when the need is to demonstrate the m

capability to supply conforming products to

an

established design.

The requirements specified are aimed primarily at achieving customer

preventing non conformities at all stages from production through to s

Standard EN ISO

9002

applies in situations where:

a

the specified requirements

for

products are stated in terms

of

design or specification;

b confidence in obtaining a product in line with specific requirem

obtained by demonstrating the manufacturer's ability as regar

installation and servicing.

The 1994 specific modification, apart from those ones identified ab

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1 3 3 Standard N ISO 9003 - Quality systems - Model for quality

inspection- and

test

This standard is

to

be used when the need is

to

demonstrate

th

capability

to

detect product non conformity and

to

control th

regarding final inspection and test.

Standard

N ISO 9003

is applicable in situations where confid

conformity is adequate if manufacturer s capacity is satisfactorily de

regard

to

the

final inspections and checks carried

out

on

the

finished

The 1994 standard version, apart from modifications identified abo

requirements. They relate

to

contract review, control

of

customer-

corrective actions and internal quality audits requirements.

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-

..

2.

THE EN 45000

SERIES

OF

EUROPEAN STANDARDS

It may be said in general terms

that

the

EN

45000 series of Euro

represents for the bodies operating in

the conformity

assessment fr

the EN ISO 9000 series represents for companies. The EN 45000

organizational, technical competence and operational criteria for those

The EN 45000 series (broadly based on

the

ISO Guides) is the serie

essential in

conformity

assessment

by

third

parties, in general, and

f

accreditation systems in particular. It covers the three types

assessment body (certification bodies, test laboratories and inspecti

sets out the criteria for the accreditation bodies, for the asses

operation of conformity assessment bodies.

To date,

as

evidenced by the table below,

the

EN

45000

series is inc

it does not set out the assessment procedures and operating c

accreditation bodies carrying

out the

accreditation

of

certification

inspection bodies a proposal of standard is in process). This is im

notification of "notified bodies"

within the

context of the New Approa

CERTIFICATION TESTING

BODIES

LABORATORIES

CRITERIA

FOR

ACCREDITATION

p r ~ 45010

EN4SOOJ

BODIES

ACCREDITATION

ASSESSMENT

prEN 45010 EN450 03

CRITERIA

OPERATIONAL

EN

45011

-

PRODU fS

CRITERIA

+

pr EN 45011)

EN 45012- QUALITY SYSTEMS

EN 45001

+

pr EN

45011)

EN 45013 - PERSONNEL

The real life implementation

of

the conformity assessment standards

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· This re-direction

of

the series should facilitate the solution

of

t

function, very often carried

out

either by testing laboratories

or

bodies, covering

the

issue

of

the

professional

judgement

which

inspection .

Integration of concepts and criteria of N 30011 series of standard

ISO 1

0011

series), which relates to the qualification of au

management of audit programmes and

the

execution of quality aud

45000 series is,

amongst

others, one of

the

question to be ana

standards restructuring activities.

A table showing the correspondence between the N and ISO/IEC

existence or in preparation is

set

out in Annex Ill.

2.1.

Testing and calibration laboratory standards

2.1.1.

Standard N

45001

1989) general criteria for

the

op

laboratories

Standard N 45001 lays down the general criteria governing technic

the

operation of

testing

laboratories, including calibration laboratori

account of

the

sector concerned. In particular

the

standard iden

criteria:

- organization and management;

- legal

identity;

- impartial ity;

- independence and integrity;

- technical competence;

• quality system;

• staff;

• premis.es and equ ipment ;

•

working

procedures;

• subcontracting;

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-

The approach to quaiity in laboratories has significantly advanced ove

150/IEC Guide

25

has in the meantime reflected

the

developments in

t

The existing leapfrogging problem between the two -documents will b

ongoing joint revision of 150/IEC Guide

25

and N 45001 standard th

and -European Standardization bodies co-ordinated efforts and

adoption of common requirements should result in considerable progr

mutual acceptance

of

test results and international trade.

2.1.2.St41ndard N 45002 1989), general criteria for

the

asses

laboratories

This standard sets out the general criteria to be used by the accredi

assessing the testing laboratories including calibration laboratories

their accreditation.

To date these criteria in line

with

the content

and

the

structure

Guide 58 1993), have been integrated into

the

N

45003 standa

covers both the accreditation assessment and

the

accreditation bo

criteria.

N 45002 1

989

has therefore

to

be considered as replaced

by

the

1995).

2.1 .3.Standard N 45003 1995), General criteria

for

laborator

bodies

Standard

N 45003

sets out

the

general requirements the operati

for accreditation

of

calibration and/or testing laboratories. In particul

identifies the following criteria:

- accreditation body:

• organization;

• quali ty system components;

• means for granting maintaining extending suspending an

accreditation;

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• application and assessment;

· • sub-contracting

of

assessment;

• report;

• decision, grant, surveillance and reassessment;

• proficiency testing;

• certificates

or

reports issued by accredited laboratories;

- relationship between accreditation

body

and laboratory.

2.2.

Standards

for

certification bodies

Presently, the EN 45000 series covers

only

the operating criteria o

bodies involved in the certification

of

products, quality systems and

The standardization activities

both at

European and internat

significantly advanced over these years. ISO/IEC Guides 61

assessment and accreditation of

certification bodies, is on the

way

and it

will

be later adopted as new European standard EN

45010.

The three existing standards 1989) lay

down

in detail the operatin

certification bodies in order that these

may

be recognised as comp

, in implementing certification systems. They identify, in particular:

the

components

of

the

administrative and organization structure;

- staff qualifications;

-certification

procedures;

- the

required facilities;

- the quality manual;

-

the

c ~ n f i d e n t i l i t y criteria;

-

the.

procedures

for

complaints and

for withdrawal

and cancell

certificates and conformity marks.

The application

of

those standards

to

specific sectors sometimes

criteria defined are · supplemented

by

interpretations specific

to

question.

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2.2.2.Standard

EN 45012 1989), General criteria for certifi

operating quality system certification

This standard sets

out

in detail the general organizational and ope

which must be applied by the certification bodies. in the implementa

and transparent management of the certification of company quality sy

2.2.3. Standard EN 45013 1989), General criteria for certifi

operating certification

of

personnel

This standard lays down the general criteria for the organization and

need to be applied by_ certification bodies when implementing and ma

and transparent

staff

certification systems.

2.3. Standards

for

inspection bodies

The European standardization bodies CEN/CENELEC have in 199

European standard dealing with the operation

of

inspection bodies

EN

the criteria for their assessment and accreditation will be integrated

European standard EN 45010.

2.3.1.,Standard

EN

45004

1995),

General criteria

for the

opera

performing inspections

The standard EN 45004 specifies the general criteria governing

competence·, organization and operation

that

the inspection bodies

their departments are to be recognized as competent.

This standard defines three types

of

inspection body on the base of

of independence) under

which they

perform their services· . In

standard identifies the

following

criteria:

-administration;

- independence, impartiality and integrity;

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-inspection reports and inspection certificates;

- sub-contracting, complaints and appeals, co-operation.

2.4. Standards for auditing

The standard series

N

30011 (ISO 10011 deals

with

quality

qualification

of

quality system auditors and audit

programm_e

manage

2.4.2. Standard N 30011-1 (ISO

1

0011-1 , Guidelines for qualit

Part 1 :

Audit

The

first

part

of

the

N

30011 series sets

out

in detail the basic p

and quality system audit practices and provides guidelines

for the

planning and performance

of

quality systems audits.

The standard identifies, in particular:

-audit

aims;

- role and responsibilities

of

auditors and audits;

-principles

governing the performance

of

the various stages

of

the q

2.4.3. Standard N 30011-2 (ISO

1

0011-2 , Guidelines for quali

Part

:

Qualification criteria for quality s y s t ~ auditors

The second part

of

the

N

30011 series lays

down

qualification and

as well

as

criteria for the maintenance

of

quality system auditors

identifies, in particular, the principles governing education, experien

characteris.tics

of

auditors and the characteristics of programmes for

2.4.4; Standard N 30011-3 (ISO 10011-3 , Guidelines for quali

Part

3:. Audit

programme management

The third part

of

the N 30011 series lays

down the

basic princi

''

' '1'

'

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''

:·;

I

3. IMPLEMENTATION

OF

QUALITY STANDARDS

BY

ECONOMIC

UNDER

NEW APPROACH DIRECTIVES

The explicit reference

to

quality standards (EN ISO 9000 and EN 45

Community legisiation, which does not confer any mandatory na

standards,

was made for the first time in

1989

in

the

Resolution of

which approves the Global Approach.

Aware as it is

of

the importance

of

quality standards in order

to

put in

co'mmunity policy stated under

the

Global Approach, the Counc.il boos

those quality standards in its Decision of 1 3 December 1990

8

(amende

up to date by

the

Council on 22 July 1993

9

,

which approves t

framework dealing with the

conformity

assessment procedures (cf. A

Indeed,· that Decision points

out

that the setting up of quality

manufacturers in compliance with EN ISO 9000 European standa

presumption

of

conformity

with

the requirements of the Directives

quality systems and

that

compliance

with

the

EN

45000

series

standards confers a presumption of conformity with the require

Directives related to the notified bodies (for conformity assessment pu

Several New Approach Directives draw upon different procedures to

authorities to ensure

that

products placed on the market conform

(health and safety) requirements as expressed in the Directives.

Those procedures use basic

conformity

assessment structures, either

(manufacturers)

or by

a third party (certification bodies, inspection

laboratories), which relate to the design phC:tse of products and to th

phase .

The modules give the legislator, in relation with the type of prod

involved, the means for setting up the appropriate procedures for m

order to demonstrate their product conformity.

We may say, in ·general terms, that four ~ ~ o n f o r m i t y assessment route

up' by the following combinations of possible procedures:

• manufacturer's declaration (self-certification) (module A);

• product certification (modules B

+

C, B

+

F, module G);

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I

;

Simplified flowchart of conformity assessment procedures

set out in the

New

Approach Directives

The Decision referred

to

above sets out, amongst other basic guide

in

the

technical harmonization (New Approach) Directives,

the follow

• as a general rule a

product

should be subject to

both

phases bef

on

the

market;

• the Directives should

set

a range of possible choices among

the

d

which

cover

the

two

phases in order

to

guarantee a high level

given

product

or

product

sector. In setting

the

range of poss

Directives will take

into

consideration the appropriateness .o

relation to the

type

of products, risks involved, etc.;

• whenever Directives provide

the

manufacturer with

the

pos

modules based on

quality

assurance techniques,

the

manufacture

able to have recourse to a combination of modules not using

q

and

vice versa

To date, twelve

of

the seventeen

New

Approach Directives

~ d o p t e

refer directly

to

quality system

procedures as a

way of

demonstra

conformity.

· :

.'"

· · 1

. . >-·

• I . ' -

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· I

{

3.1.

The

New

Approach Directives

3. 1.

1.

Directive

87/404/EEC

(and related amendments) relating to si

vessels

The Directives (cf. Annex V) apply to simple pressure vessels, ma

series, subjected to an internal gauge pressure greater than

0,5

bar

exceeding 30 bar,

that

are intended to contain air or nitrogen and

intended

to

be fired. • ·

Before placing his product on the market, the manufacturer or h

representative established in tf )e Community shall,

for

vessels where

PS

and V

e x c e ~ d s 50

bar.litre, demonstrate

conformity

with the es

requirements

by

means of the

conformity

assessment procedures s

Directive 87/404/EEC. These vessels shall bear

the

CE marking.

At

vessel design stage the manufacturer shall:

•

for

products complying

with

standards,

submit

his product

to:

c either

the

EC type examination

by

a notified body; or

c the certification of adequacy by a notified body stating that t

manufacturing schedule are satisfactory.

•

for

products

not

or partially complying

with

standards,

submit

his p

c EC type examinati9n

by

a notified body;

At vessel manufacturing stage the manufacturer

may

choose also

different types of

conformity

p r o c ~ d u r e s

• where

the

product of PS and V exceeds 3000 bar.litre,

the

EC ve

11); -

• where the product of

PS

and V does

not

exceed

3000

bar.litre

b

bar.litre:

c

either the EC declaration

of

conformity

(art. 12); or

c the EC verification (art. 11

).

A manufacturer

who follows

the EC declaration

of conformity

proce

subject

to EC

surveillance

by

a notified body where the

p r o d ~ c t

of

PS

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l I

from the manufacturer a document describing the manufacturing p

the pre-determined systematic provisions taken

to

ensure

the

co

pressure vessels

with

the

Directive.

Member States shall apply the criteria for the assessment of the no

have been provided for in Annex Ill

of

the Directive. Bodies meeting

criteria provided for in the relevant harmonised standards EN 4500

to

meet the said criteria

3.1.2.

Directive 88/378/EEC (and related amendment) relating

to

saf

The Directives (cf. Annex V) apply to toys, defined as any pro

designed or clearly intended for use in play by children of less than

1

Before placing his product on the market, the manufacturer o

representative established in the· Community shall, in order to affix

submit

it

to the conformity assessment procedures set out in Direc

It provides manufacturers with two means of demonstrating con

essential requirements based on whether the toy conforms to

standards or

it

does not conform in whole or in part to them:

• if

toys

are manufactured in accordance

with

harmonized

manufacturer shall keep available, for inspection, a technical

report) describing, amongst other items, the means ensuring th

production with the standards and detailed information on the pr

manufacturing process. ·

• if toys do not conform in whole or in part

to

the harmonize

manufacturer shall submit

the

product

to

an EC

type

exarr)inatio

a notified body _that certifies conformity of the product with the

· requirements. The manufacturer or his authorized representativ

the

Community shall

confirm

the conformity

of

the product

model and keep available for inspection all the relevant technical

The

i r ~ c t i v e

makes no requirements in terms of quality system to

manufacturer as a means

of

ensuring product conformity.

Member States shall apply the criteria for the assessment of the no

have been provided for in Annex Ill of the Directive. Bodies meeting

criteria provided for in the relevant harmonized standards EN. 4500

to

meet the said criteria.

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-

j .

.1

3.1.3. Directive ·

89/1 06/EEC

(and related amendmentl relating to

products

The Directives (cf. annex V) apply to construction products which are

products manufactured

with

a

view to

their incorporation in a perma

construction works.

The performance

of

these products, evaluated against the essentia

applicable

to

the works, are

laid

down in technical specifications,

standards elaborated

by

CEN/CENELEC

or

European Technical Appro

both, under EC mandates.

A step-by-step procedure has been adopted

to

elaborate th

specifications. Draft provisional mandates were delivered

to

CEN/CE

'92

and finalised after consultations

with

Member States, via

Committee

of

the Directive,

to

consider further characteristics which

by present national legislation on works.

A mandate for certain families (40) of products has been given

to

CEN

Before being placed on the market, the manufacturer or his authorized

established in

the

Union shall, in order

to

affix the CE marking, submi

the conformity assessment procedures set

out

in the Directive.

The Manufacturer or his authorized representative shall be respo

attestation

of

conformity that products are in conformity

with the

the relevant technical specifications.

This attestation, as provided in art.

13.3,

presupposes

that

the

ma

within his factory, a control system (quality system) providing

production meets the relevant technical specifications. For ce

provisions have been made for the involvement .

of an

approved certi

orde;r to

assess and monitor the factory production control. .

As stated in art 13.4, the attestation procedure shall be specified by t

in the mandates, after consultation

of the

Standing Commit1:ee.

.

It

is, therefore, necessary

to

proceed, in parallel,

with

the

elaboratio

and the decision on the attestation, adopting the same definition

families of products.

Since the- system

of

conformity shall be deter.mined according

the

in art. 13.4 (a), (b), (c) and

d)

(that is

to

say, mainly

to the

essentia

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The Directive does not

lay down in

detail

the eAements

of

the qual

set up (factory

production

control system} and· does

not

explici

standard concerning quality systems,

although

the interpretative

explicitly to

the

EN

ISO

9000

standardsA

The advantages to be gained from setting up a quality system in

continue

to be very clear, above all, in view of the obligations under

in respect

of public procurement

which, as a

result of

the referenc

European standards, adds significant weight to

the EN ISO 9000

sta

Member

States shall apply the criteria provided for in Annex

IV

of

the assessment of

the

bodies involved in

the

conformity process.

the assessment criteria provided

for

in the relevant harmonized

45000)

are presumed

to meet the

said criteria.

3.1.4. Directive 89/336/EEC and related amendments) relating

to

ele

compatibility

The Directives cf. Annex V) apply

to

any apparatus, equipm

installations containing electrical and/or electronic components,

electromagnetic disturbance

or

whose functioning is liable

to

be a

disturbance.

Before being placed on the

Community market,

a

product

has

to c

essential requirements stated in art. 4 of the Directive. The man

authorized representative within the

territory

of the Community has

the

conformity

assessment procedures

set out

in art.

10 of

the Direc

• as regards products other than radio transmitters, the

directive

manufacturer s

declaration

of

conformity according

to

the

followi

o if the manufacturer has

followed the

relevant harmonized stan

draw up a declaration

of

conformity self-certification route);

o

if the

manufacturer

has

not

applied the relevant harmonized

has chosen

not to

apply

them,

or

they

do

not

exist,

or

he h

only in part, then he has

to draw

up a Technical Construction

this

to

a Competent Body in order

to

obtain a certificate or a t

• as regards radio transmitters, the manufacturer has to sub

representative

of

his

production to

a

notified

body for

the EC

t

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3.1.5. Directive 89/392/EEC (and related amendments) relating to mach

The Directives (cf.

Annex

V) apply to machinery, generally defined as a

linked parts or components, at least one of.

which

moves, with th

actuators, control and power circuits, etc., joined together for a speci

in particular for

the

processing, treatment, moving or packaging

of

a m

safety components not bearing

CE

marking) placed on the market sepa

Before placing his product on the market,

the

manufacturer or

representative established in the Community shall submit

it

to

th

assessment procedures set

out

in Directive 89/392/EEC,

that

is:

\

• for all machinery and safety components, apart from those referre

IV, he will prepare a technical construction file and a declaration

with the essential requirements of

the

Directive according

requirements;

• for machinery and

safety

components referred to in Annex IV m

accordance with the standards referred to in art. 5(2), he

w

manufacturer's declaration

of

conformity:

c after

forwarding

the technical file to a notified body,

which

ac

receipt

of

the file; or

c on the basis of

the

certification of adequacy of the technical fil

body; or

c

following the EC type-examination by a notified body.

•

for

the

machinery and safety components referred

to

in Annex IV

in whole

or

in part, with the s t a n ~ a r d s referred to in art. 5(2) or

such standards, he

will

draw up

the

manufacturer's declaration

with

the

type

following EC type-examination by a notified body.

The notified body involved in the EC type-examination of

safety

com

verify the suitability

of

such components

for

fulfilling the safety func

by

the

manufacturer.

Each machine

must

bear

the

CE

marking and be accompanied

by

an

of conformity. Safety components are not allowed to bear the CE mar

be 'accompanied

by

an

EC

declaration

of

conformity. ·

No reference ·is made to a quality system,

which

continues

to

be the

the ·responsibility

of the

manufacturer.

j

_:.- .,

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·

I

I

3.1.6. Directive

89/686/EEC

(and related amendments) relatin

protective equipment

The Directives (cf. Annex V) apply

to

personal protective equipmen

shall mean any device or appliance to be worn

or

held

by

an individu

against one or more safety and health hazards.

Before placing his product on the market, the manufacturer · or

representative established in the Community shall, in order to

affix

submit

it

to

the

conformity

assessment procedures set out in ·oirectiv

It requires that the manufacturer draws up for all PPE a technical fi

relevant data on the means used

to

ensure that they comply

requirements related

to

them. The manufacturer must also, acco

category:

• either issue a manufacturer's declaration

of

conformity

for PPE

as described in art.

8 3;

•

or

issue a declaration

of conformity after the

model

was

subm

type examination by a notified body;

• or, for

PPE of

complex design as described in art. 8,4a, issue

conformity after submission

of

the model

to

an EC type exa

notified body, followed by:

o either the assessment of the production quality system

by

(system for ensuring

EC

quality

of

production

by

means

of

mo

o

the

set

up

of

the

manufacturing

quality

control system

for t

complemented by random checks

of

the manufactured produ

body EC quality control system for the final product).

The Directive does not specify any quality system standard, but

t

provided for setting up

the

production quality system are in line w

ISO

9002.

.

The Member States shall apply the minimum criteria set out in

Directive in order

to

designate

the

bodies

to

be notified. Bodies me

laid down for the relevant harmonized standards that apply

presumed to ~ e e t the criteria set out in Annex V to the Directive.

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shall, in order to

affix the

CE marking, submit his product to t


out

in

the

Directive.

It

provides ,for:

• either the EC type examination (for certain instruments

it

compulsory - art. 8.1

a)

accompanied

by

a technical file concernin

manufacturing and operation of

the

product followed by:

c either an EC declaration

of type conformity

after asses

production quality system

by

a notified body;

c or

the

EC verification of

the

products

by

a notified body

attesting their

conformity

to

the

type;

• or the EC

unit

verification

by

a notified body certifying the con

instrument with the directive's requirements.

Instruments intended for applications other than those defined in art. 1

bear the CE marking.

The Directive_ does not identify any standard for the quality sys

requirements provided

for

setting up the production quality system a

standard EN ·ISO 9002.

Member States shall apply

the

minimum criteria defined in Annex V o

when designating the bodies to be notified. The bodies meeting t

down by

the relevant harmonized standards EN

45000)

are presume

criteria defined in Annex V

to the

Directive.

3.1.8.

Directive 90/385/EEC (and related amendments) relatin

implantable medical devices·

The Directives (cf. Annex V) apply

to

active i m p l n t ~ b l e medical d

means to any active medical device (that is to say to any device in

manufacturer to be used for human beings in the diagnosis, preventi

treatment or alleviation

of

a disease or injury, in the investigation, r

modification

of

the

anatomy or

of

a physiological process, and in

conception, and

which

does not achieve its principal intend

pharmacological, chemical, immunological or metabolic means),

functioning on a source

of

electrical energy (or any source

of

power

o

directly generated

by the

human

body

or gravity), intended to be tota

··.

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• either

to follow

the procedure relating

to

the EC declaration

(approval and monitoring of complete quality system by a

complemented by the examination of the design of

the

product;

• or to submit a model to EC

type

examination

by

a notified bod

with:

a

either the EC verification of devices by a notified body;

a

or the EC declaration

of conformity

(approval and monitorin

quality system

by

a notified body).

The EC type examination and the EC verification may be follow

authorised representative of

the

manufacturer established in the Com

The manufacturer of his authorised representative established in

shall affix the CE marking before

the

placing on the market of the de

The manufacturer

must

d.raw up a specific declaration

for

custom-m

for

those intended

for

clinical investigations. These devices shall

marking.

The Directive does not identify any standard for quality sys

requirements provided

for

setting up the quality systems are in li

9001, for the

complete quality assurance system, and

EN

ISO

production quality assurance system, supplemented respectively

by

EN

46002 (additional quality system requirements in respect

of

this

Member States shall apply the minimum criteria set out in Annex 8

90/385/EEC for

the

designation

of

the

conformity assessment

bodies). Bodies meeting the requirements laid

down

in

the

harmonized standards (EN 45000) are presumed to meet

the

said cri

3.1.9.Directive 90/396/EEC (and related amendment) relating to ap

gaseous fuel

The Directives (cf. Annex V) apply to appliances burning. gaseou

cooking, heating,

hot water

production, refrigeration, lighting or was

where applicable, a normal

water

temperature

not

exceeding

105 °C

burners and heating bodies to be equipped with such burners are al

gas appliances. · ·

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. .

demonstrate conformity with .the essential requirements by means of t


out

in

the

Directive.

·The means

of

certification

of

conformity

of

series-manufactured applian

• the EC type examination by a notified body; and

• prior

to

placing them on the market, at the choice

of

the manufactur

c either the EC declaration of conformity to type by a notified bo

c or ,the EC declaratiQn of

conformity

to

type

after the ap

production quality system

by

a notified body;

c or the EC declaration

of

conformity

to

type after the approv

product quality system by a notified body;

c or EC verification by the notified body.

These procedures shall be applied also in respect of fittings with the ex

affixing the CE marking and, where appropriate, the drawing-up of the

conformity. A certificate shall be issued declaring

the conformity of th

the

provisions

of

the Directive.

In the case of production of an appliance as a single unit or in small q

verification by single

unit

may be chosen by

the

manufacturer.

The Directive does

not identify any quality system standard, but

the

provided for setting up

the

quality system are in line with EN ISO 900

the

production quality system, and

EN

ISO

9003,

for

the

final p

system.

In order to assess the technical competence of the notified bodies

States must apply

the

minimum criteria set out in Annex V of the Di

assessment bodies meeting the assessment criteria laid down by

harmonized standards EN

45000)

are presumed to meet the criteria s

Annex.

3.1.10.

Directive 91/263/EEC (and related amendment) relating

munications terminal equipment and Directive 93/97/EEC relat

earth station equipment ·

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• either EC type examination by a notified body accompanied by:

c

an EC declaration

of

conformity'ft

with

the

type

with

th

implementing product checks at random intervals; or

c an EC declaration

of

conformity with the type, after the

production quality assurance system

by

a notified body;

• or

to

the EC declaration

of

conformity , after approval of

assurance system

by

a notified body.

Directive 93/97/EEC extends the field

of

application

of

Directive

satellite earth station equipment, defined as equipment capable of b

for transmission only, or for transmission and reception, or for re

radio-communications signals by means

of

satellites or other space-b

Satellite earth terminal equipments are subject to the same confor

provisions referred

to

in Directive 91/263/EEC. Manufacturers, fo

equipment elements (art. 9 and art. 10) may opt, as an alterna

procedures,

for

the Community internal production control procedur

the

preparation

of

a technical file enabling

the

assessment

of

the

manufacturing and product operation details) and of a manufacturer

conformity

with the technical documentation.

Annexes Ill and

IV

of Directive 91/263/EEC clearly refer

to

Europe

29001 (now

EN

ISO 9001 ), for the complete quality assurance

29002

(now

EN ISO 9002),

for the

production quality assurance sy

provide a presumption of conformity with the Directive.

1n

order

to

designate

the

bodies

that

must

carry

out the conform

activities provided for by these Directives,

e m b ~ r

States shall ap

criteria laid down in Annex V

of

Dir. 91/263/EEC. Bodies meeting th

from the relevant harmonized standards EN

45000)

are presumed

criteria. This is reinforced by attempts being made· to cla

implementation of the EN 45000

to

IT T sectors via

the

preparatio

guides.

3.1 . 1 1 Directive 92/42/EEC concerning effic iency requirements fo

boilers fired with liquid or gaseous fuels

-

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Member States may decide to apply a specific system of labels enabli

performance

of

boilers

to

be clearly ascertained. The system shall ap

the efficiency of

which

is superior to the requirements set out in

according to the following:

•

if

efficiencies at rated

output

and at part load are equal or gre

relevant values

for

standard boilers, a boiler shall be awarded

an

in Annex I, section 2;

• if efficiencies at rated output and at part load are three or more

than

the

relevant values

for

standard boilers, a boiler shall be awarde

• every extra step of efficiency of three points at rated output and at

allow the attribution of an extra * .

Boilers in conformity with the efficiency requirements stipulated in ar

bear the CE marking and be accompanied by the EC declaration of conf

The conformity of series-produced liquid fired boilers shall be certified b

• the EC type examination (module 8); and followed, according to

manufacturer, by:

c

the

conformity to type

procedure (module C); or

c the

production quali ty assurance procedure (module D); or

c

the product

quality assurance procedure (module

E).

The procedures

for

assessing the conformity of gas fired boiler efficie

used in order

to

assess.the

conformity

to essential requirements set

o

90/396/EEC.

I

The Directive does not identify any quality system standard, but the

provided for setting up the quality system are in line

with EN ISO

9002

the production quality system, and EN ISO 9003, in respect

of

the

quality system.

In order to assess the technical competence of the notified bodies

States

must

apply the criteria set out in Annex V of the Directive. T

assessment bodies meeting

the

assessment requirements· laid d.own

b

har.monized standards EN.

45000)

are presun1ed

to conform with

the s

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· · ~ : ~ . , ~ ; . . ~ ~ , ,

' j

I

i

Before placing his product on the market,

th

manufacturer shall

conformity

of the

equipment

with

technical standards, as they are de

and 7.

Where goods conform

with

the technical standards,

the

presum

conform

to

them is:

• either certified

by the

conformity mark or certificate:

of confor

a body notified in accordance

with

procedure laid down in art. 11

• or

by

the manufacturer's declaration

of

conformity .

Where goods do

not

conform

with

the technical standards,

it

may

that they do conform

with

the safety requirements (art. 2) b

conformity report drawn up by a notified body.

The Directive, drawn up in 1973, has been aligned,

to

some ex

Approach Directives by Directive 93/68/EEC (CE marking Directive).

It integrates within Directive 73/23/EEC the new provisions rela

marking and,

as

a consequence, the reference

to conformity

m

eliminated. The affixing on equipment

of

any marking liable

to

dece

as

to

the meaning and form

of

the

CE

marking is prohibited. Any oth

be affixed, provided

that the

visibility and legibility

of

the

CE

markin

reduced.

It now requires that, before being placed on the market, the man

authorized

r e p r e s e n t t i v ~

established in the Community, in order

marking, shall:

• establish technical documentation covering the design, m

operation

of

the electrical equipment; and

• draw up an EC declaration of conformity, ensuring and dec

electrical equipment satisfies the requirements of the Directive.

Article 14

of

Directive 93/68/EEC states also

that

until 1 Jan.

1997

shall allow the· placing on the market and bringing into service

of

comply

with

the marking arrangements in force before 1 Jan. 1995.

This means

that

until 1 Jan.

1997,

tt:le manufacturer, or

representative established in the Community, will have the choice

market:

• either a product complying

with

the provisions of

the

actual

-

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Article 8(2), unchanged by Dir. 93/68/EEC, states that in the event

the

m n u f ~ c t u r e r

or

importer may

submit

a report,

drawn up the

auth

body, on

the conformity of

the electrical equipment with

the

safety obj

The Directive makes no requirements in terms

of

quality system to be

manufacturer as a means

of

ensuring product conformity.

3.1. 13. Directive

93/16/EEC

relating

to

explosives for civil uses

The Directive (ref. Annex V) applies

to

explosives, defined as those

articles considered

to

be such in the United Nations recommend

transport of dangerous goods and falling within Class 1

of

those recom

Before placing his product on the market,· the manufacturer or

representative established in the Community shall, in order to affix th

submit it to the conformity assessment procedures set out in the Direc

The manufacturer

may

opt

for

submitting his

product to:

• either EC

type

examination

by

a notified body followed, acc

choice, by:

either the

conformity

to

type

(module C), with the notified

randomly the products;

or the production. quality assurance procedure (module D)

body;

or the product quality assurance procedure (module

E)

by a n

or the product verification (module F) by the notified body;

• or the unit verification (module G) by a notified body.

The Directive does not identify any quality system standard,

but

the

provided

for

setting up

the

quality systems are in line with EN ISO

90

the production quality system, and EN ISO 9003, for

the

final p

system.

In order to assess the technical competence

of

.the notified bodie

States

must

apply

the

criteria set out in Annex Ill of the Directive. Tho

bodies meeting the assessment criteria laid

down

by the releva

standards EN 45000) are' presumed to meet the criteria set out in tha

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· ·

I

An

accessory

means

an

article which,

whilst

not being a dev

specifically

by

its

m n u f c t u r e ~

to

be used together

with

a devic

accessory to be used in accordance

with

the use of the device

manufacturer of the device.

Devices are divided into classes according

to

classification rules set

of the Directive. The application of those rules are governed by the i

of the device.

Before devices are produced and marketed, the manufacturer or

representative established in

the

Community depending on

classification, shall, 'in order to affix the E marking, submit his prod

tor class I

devices

•

for sten1ized devices and devices

with

measuring function, the "E

conformity and, according to his choice, either:

c the "EC verification" by a notified body or

c the approval of the "production quality system

by

a notified b

c the approval of the product quality system by a notified bod

N Qte: by derogation, the

E

declaration of conformity in conju

declarations referred to in the three alternative procedures

declaration.

• for other

devices,

the "internal production control ,

that

mean

technical documentation allowing assessment of the conformity

with

Directives requirements.

for class /Ia devices

at

manufacturer's choice:

,

• either the "EC declaration

of

conformity and, according to his ch

c the "EC verification"

by

a notified body,

or

c the approval of the "production quality system by a notified b

c the approval

of

the product quality system by a notified bod

N Qte: these alternative procedures are mandatory

for

the st

y

derogation,

the

E declaration of

conformity

in c o n

declarations r e f ~ r r e d

to

in the three alternative procedure

•

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I

1

:

;'

I

f .

: . * f l . ~

. I

·c

the EC verification by a notified body, or

c the approval of the production quality system by a notified bo

c

the approval

of

the product quality system by a notified body.

• or the approval of the full quality assurance system by· a

(annex II),

with

the exception of the application of the exam

design of the product;

tor class i devices.

at manufacturer's choice:

• either the EC

type

examination followed, according to his choice,

c


c the approval

of

the production quality system by a notified bo

• or

the

approval

of the

full quality assurance system by a notifie

II), including the application of

the

examination of the design of

th

notified body.

For devices intended

for

clinical investigations and custom-made

manufacturer must draw up a statement according to Annex VIII

devices shall not bear the CE marking

For devices, bearing the

CE

marking, marketed as syst ms or proced

which an complementary

CE

marking is not needed, the manufacturer

•

draw

up a declaration according

to

article

12

(2) criteria.

If

th

marketed n sterile condition the declaration must be followed, at

either:

c


c

the approval of the production quality system

by

a notified bo

c the approval

of

the product quality s y ~ t e m by a notified body.

~

the application

of

these procedures and the intervention

body

are limited to

the

aspects relating

to

the obtaining of sterilit

The Directive· does not identify any quality system standard,

but

th

provided

for

setting up the quality systems are in line 'with

' .. '

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I

j ,

3.

1.15.

Directive 94/9/EC relating to equipment and

protective

syste

use

in

potentially exl)losive atmospheres

The Directive (cf. Annex V) applies to

equipment

and

protective

s

for use in potentially explosive atmospheres. Safety devices, control

regulating devices intended for use outside potentially explosive a

required for, or contributing to, the safe functioning of equipmen

systems

with

respect to

the

risks

of

explosion are also covered

by

· Directive.

Equipments are classified

into

equipment-groups I and II,

for whic

definitions apply:

• equipment-group

/,

applies to equipment intended for use in unde

mines, and to those parts

of

surface installations

of

such min

endangered by firedamp and/or combustible dust;

• equipment-group II applies to equipment intended for use in othe

be endangered by explosive atmospheres.

Equipment-groups are classified into categories (M1 and M2 for grou

group

II

defining the required level

of

protection. The classification

out

in Annex 1 of the Directive.

Before placing equipments on the market, the manufacturer or

representative established in the Community, may, in order to affix

submit, at his choice, his products to:

• either

the

unit verification by a notified body;

·or, depending on the equipment-group and category classifications,

procedures:

• the internal control

of

production , that means preparatio

documentation allowing assessment of the

conformity

of th

Directives requirements;

• the EC type examination by a notified body followed, accordin

·

by

either the EC verification

by

a

notified

body, or the

production quality system by a notified body;

• the EC type examination by a notified body followed, accordin

by either:

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The Directive does not identify any quality system standard, but the

provided for setting up the quality systems are in line with

EN

ISO

90

the

production quality system, and

EN

ISO

9003, for

the product

quali

In order to assess the technical competence, of the notified bodies

States n1ust apply the criteria set out in Annex XI of the Directive. Tho

assessment bodies meeting the assessment criteria laid down by th

standards EN 45000) are presumed

to

meet

those

criteria.

3 1 16

Directive 94 25 EC relating

to

recreational craft

The Directive (cf. Annex V) applies to recreational craft, partly c·omple

components referred to in Annex

II

of the Directive when separa

installed.

Recreational craft shall mean any boat

of

any type, regardless of

propulsion, from

2.5m

to

24m

hull length, measured according

to

th

harmonized standards intended

for

sports and leisure purposes.

Devices are divided into classes according to classification rules set ou

the Directive. The application of those rules is governed

by

the intend

the device.

Before products are produced and placed on the market, the manu

authorized representative established in the Community, shall apply

procedures

for

boat design categories

A,

B,

C and D

as

referred

to

in

Directive.

for

categories A

and

8

1J

for

boats of less than 12 m

hull

length

• the internal production control plus testing (module Aa);

2 for boats from

12m

to 24m hull length at manufacturer's choice

• either the EC type examination (module

B)

by a notified b

according to his choice, by either:

c the· EC declaration of conformity ·to type (module C), or

c the approval

of

the production quality system (module D)

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for

category C

1

for boats f rom 2. 5 m to 12 m

hull

length:

•

where the harmonized standards sections 3. 2 and 3. 3

o

complied with the ~ i n t e r n l production control (module A);

•

where the harmonized standards sections 3. 2

ard

3. 3

of A

complied

with: the internal pr.oduction control plus testing (

2) for boats

from

12 t;n to

24

m hull length, at manufacturer's choic

• either the EC type examination (module B) by a notified

according

to

his choice,

by

either:

o

the EC declaration

of

conformity to type (module C), or

o the

approval

of

the p r o ~ u c t i o n quality system (module

body, or

· o the

product

verification (module F) by a notified body;

• or the unit verification (module G) by a n o t i f i ~ d body;

• or

the

approval

of

the full

quali ty assurance system (module

body.

for

category D

1 for boats from 2. 5 m to

24

m hull length, the internal pro

(module A);

2)

for

components referred to in

Annex

II of the Directive, at m a n u f a

• either

the

EC

type

examination (module

B)

by

a notified

according

to

his choice, by either:

c the EC declaration of conformity to type (module C), or

o

the approval of the production quality system (module

body, .or

o the

product

verification {module

F)

by a notified body;

• or the

unit

verification (module

G)

by a notified body;

• or

the ~ p p r o v a l of the

full quality assurance system (module

body.

The Directive does not identify any quality system standard,

b

. :

l

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: l ~ ~ ~ J 4

I

l

,.

...

~ · ·

~ . : , ~ ~ ; ~

' .

j

. j

l

3 1 17 Directive 95/16/EC relating to lifts

The Directive (cf.

Anne?<

V) applies

to lifts

permanently serving

constructions and

to

certain safety components (cf. Annex IV)

far u s

For

the

purpose of this Directive, ·lift means an appliance serving s

having a car moving along guides which are rigid and inclined at an

·than

15

degrees

to· the

horizontal and intended

for the

transport.

of

pe

and goods, goods alone if the car is accessible,

that

is

to

say, a perso

without

difficulty,

and fitted

with

controls situated . nside the car. or wi

person inside.

Before safety components

are·

placed on the market, the manuf

authorized representative established in

the

Community,

must

either:

• submit the model

of

the safety component. for

EC

type examinatio

body (module

B

and for production checks by a notified body (mod

• or, submit the model of the safety component for EC type exa

notified body (module

B

and operate a product quality assurance s

E

assessed and surveyed by a notified body;

• or, operate a full quality assurance system (module

H

assessed an

a notified body.

and affix the

CE

marking on each safety .component and draw up an

of conformity.

Before being placed on the market, a

lift

must either:

, '

• 'if

it

was

designed in accordance

with

a

lift

having undergon

examination by a notified body, it shall be cohstructed, installed

implementing either:

o

the

final inspection, by

which

a notified

body

performs approp

checks defined by the applicable standard(s)

f

equivalent te

conformity of the

lift with

the relevant requirements

of the

Dire

o

the product quality assurance system (module

E

assessed and

notified body; or

o the production quality assurance system (module D assessed

by a nQtified body.

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o ~ - ; . ; y ~ : ~ A ( ~ j i l

i

i

.

the production quality assurance system (module D) assessed

by a notified body.

• or,

if it

was designed in accordance

with

a lift for which an

surveyed full quality assurance system was

put

in place, suppl

examination

of

the design if the latter is not

wholly

in ac

harmonized standards, it shall be constructed, installed a

implementing in addition either:

the final inspection,

by which

a notified body performs approp

checks defined

by

the applicable standard(s) or equivalent t

conformity

of

the

lift

with

the

relevant requirements

of

the

Dire

the product quality assurance system (module E) assessed and

notified body; or

the production quality assurance system (module D) assesse

by a notified body.

• or, having undergone the unit verification procedure (module G

notified body examines

the

technical dossier and performs appro

checks defined by the applicable standard(s), or equivalent te

conformity of the lift with the relevant requirements of the Directiv

• or, having been subject to the full quality assurance system

supplemented by an examination of the design

if

the latter is

accordance with, the harmonized standarqs.

The installer, in all cases referred above, shall

affix the

CE

marking

draw up

·an EC

declaration of o n f o r m i t y ~ ·

The Directive explicitly refer to European standards EN 29001 now

for the. complete quality assurance system, EN 29002 now

EN

ISO

production quality assurance system, and EN

29003 now

EN ISO

product quality assurance system, in order to provide a presumptio

with the. Directive.

In order to designate the bodies that

must

carry

out

the conform

activities provided for by this Directive, Member States shall appl

criteria laid down in Annex VII. Bodies meeting the criteria arising

fr

harmonized standards

EN 45000)

are presumed to meet the said _crit

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3 2 Summary table of conformity assessment procedures provided

New

Approach Directives.

DESIGN + PRODUCTION

MODULES

A B+C B+D

B+E

B+F G H

Directives +

87/404/EEC

x +)

X

X

Simple pressure vessels

881378/EEC

X X

Toys

89/106/EEC

X X

Construction products

89/336/EEC

X X

Electromagnetic compatib.

X +)

89/392/EEC

X

X

Machinery

89/686/EEC X

X

X

Personal protective equip.

X +)

90/384/EEC X

X

X

Non aut omatic weighing

instruments

90/385/EEC

X

X

X +)

Active implantable medical

devices

901396/EEC x +)

X

X X X

Appliances burning

gaseous fuels

911263/EEC

X (1)

X +).

X

X

Telecommunications

terminal equipment

92/42/EEC X +)

X

X

Hot-water boilers fired

with liquid or gas fuel

73123/EEC

~ ~

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J

I

I

i

DESIGN + PRODUCTION

Odules A

B+C

Directives

9419/EC

X X

Equip.

and

protect. systems

intended for use in potent.

explosive atmospheres

94/lS/EC

X

X

Recreational craft

x +)

95/16/EC

x(+).

Lifts

U enda:

x

=

procedure provided for

by

the Directive

tf

=

echnical file

(+) = with supplementary requirements

t:lQm

MODULES

B+D

B+E B+F

X

X X

X

X

X

X

X

G H

X

X

X

X X

x(+)

<

1

> Applicable

to

specific equipment elements defined in art. 9 and

1

of

which

supplements Directive 91/263/EEC.

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4.

GENER L

CONSIDERATIONS ON QUALITY ASSURANCE

APPUCATION

Although the EN ISO 9000 series of European. standards and EN 450

. l are not mandatory under Community law, the setting up of quality sys

the

requirements

of the

directives is so, unless the directives leave

another system. Compliance with those standards yields obvious a

economic operators

not

only in terms

of the

internal management

of th

or

organizations

but

also in

terms of

presumption of

conformity wit

directives, and, moreover, the probability

of

answering the appr

procurement requirements.

It must be made clear that the EN ISO 9000 standards are not prod

and

thus do

not specify

the

final characteristics

of

products. The

various components

of the

quality system

to

be set up

by

compani

demonstrate their capacity to provide products that

conform

and

situation, may be applied to any product regardless.

One

of the

most frequently made criticisms is that the setting up of a

may be highly (or even too) expensive for SMEs.

In

order to analyse

it is first

of

all necessary to try to answer another question:

Why

sh

system be set up?

There are

two

basic reasons:

• firstly, in order

to

assure

that

products continuously meet the

quality specifications or in order to meet CU$tomer requirements;

• secondly, in order to obtain those results at the lowest cost.

When

the

setting up of a quality system by companies is driven by

strategic reasons

it

will fulfil those

two

basic aims and thus improve pr

customer satisfaction and company c o m p e t i t i ~ e n e s s

If the quality system is set up in order solely to meet the certifica

company's o.rganization

may

be reluctan.t to adopt and opera

prescriptions, as they may perceive them as being imposed arbitraril

qualjty and economic benefit to the company. In such circumstanc

. •

' . : •, / '

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itself, but is

an

excellent

instrument

in order to guarantee a

product quality.

However,

when

a quality system is

set

up

account

must be taken

characteristics of products and also of

the manufacturing

process

used. These specific needs, depending on the

sector or type of

ind

process of spawning a body of

other

supplementary standards wh

aspects that are specific to each ·sector of economic activity to th

9000 standards. For example:

•

•

•

N

29004-2, Quality Management and

quality system

componen

guidelines for services;

N

29000-3, Quality management and quality' assurance sta

Guides for

the

application of Standard ISO·

9001

to

the

develop

and

maintenance

of software.

N

46001

and

N

46002,

Specific requirements concerning

the

respectively

of N

ISO 9001 and

N

ISO 9002 in

the

industr

medical devices;

For

the N 45000

series, ECITC (European

Committee

for IT&T

Tes

Sector Committee

of

EOTC) and EAL (European co-operation

for

Laboratories) are currently finalizing a guide for the application o

series

for the

IT T sector.

Finally,

the N

ISO 9000 and N

45000

series

of

standards are st

the

quality

management of companies and conformity assessment

can

thus

be used with advantage

by the

public authorities in all s

and in particular protection

of

the

environment, energy,

foodstuffs

the

tradit ional industrial sector .where

they

were

devised. This us

economically essential once it enables duplication

to

be avoided o

and activities

that

are intended

to

check

company conformity

provisions

by

means

of

reliable, transparent and credible procedure

of the

various. aspects

of

the

company as a

whole.

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ANNEX I

DEFINITIONS

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·j

~ : ~ ; ~

.•.

Only those conforrr:-ity assessment terms considered to be the most

overall comprehension

of the text

are set

out

here. The defin itions c

which provide

the

greatest coherence among

the

various concepts.

For

other

definitions use may be made of either N 45020 (equivale

2), and

N

ISO 8402 (equivalent to ISO 8402 .

Product

Result of activities or processes.

N m: A product may include hardware, software, processed mater

combination

thereof.

Quality

Totality of characteristics of

an

entity that bear on

its

ability to

sa

implied needs.

Quality management

All activities

of the

overall management

function that

determine

th

objectives and responsibilities, and implement

them by

means

planning,

quality

control, quality assurance and quality improvem

quality system.

Quality

system

Organizational structure, procedures, processes and resources need

quality management.

N m: The quality

system

should be as comprehensive as needed to

o6jecti.ves.

Quality assurance

All the planned and systematic activities implemented within

the

qua

demonstrated- as needed,

to

provide adequate confidence

that

an

requirements for quality.

Quality

audit

8/17/2019 EN ISO 9000 AND EN 45000.pdf


Test

Technical operation

th t

consists

of the

determination

of

one

or

more

of

·

given product, process or given service according to. a specified p

Inspection

Evaluation for conformity by measuring, observing, testing or gaugi

. characteristics.

Accreditation

Procedure by which

n

authoritative body gives formal recognition

person is competent to carry out specific tasks.

GIVES CONFIDENCE

ASSURES CONFORMiTY

CERTIFICATION

CERTIFICATION

BODY

Third Party)

US

Secon

8/17/2019 EN ISO 9000 AND EN 45000.pdf


Notification

The act by means of which a public authority in a Member St

· Commission and

other Member

States

that

a

ody

or

bodies are

assessing conformity under a Community directive.

Notification may be divided into

two

acts:

• the act of identifying the body deriving from the political resp

national authorities;

. • the act of recognizing technical competence, thus enabl

transparency and a meeting

of

the criteria to

be

assured.

Member

State authorities

may

check

the

technical competence

of

assessment bodies that is needed for notification either on th

authorities own means (the authorities have their own inspectors or

or on the basis of any national accreditation system.

The conformity assessment bodies notified by the Member St

Community directives are generally identified as Notified Bodies.

Sub-contracting (by

the notified

bodies)

Sub-contracting within the terms of this document only

subcontracting, by notified bodies, of certain technical tasks

that

ha

by a detailed, strictly confined description: e.g., testing, examinati

quality auditing. These activities

must

be carried

out

on the basis o

technical specifications that are based on objective criteria in order

transparency.

The sub contracting

body must

be technically competent and be able

independence and objectivity on the basis of the ·same criteria and

conditions as

the

notified bodies. Compliance with

N 45000

stan

presumption to be made that those conditions are met.

In any case, the notified body will ensure that sub contracted tasks a

monitored

i n

line with the requirements imposed, and

r e m i n ~

resp

the

activity

covered by the

notification.

The notified body

cannot

undef any circumstances subcontract all

of

that would m ~ k e the notification

meaningless.

It

cannot

subcontract

appraisal activities, which are the essential tasks for which it was no

•

i

• •

1

8/17/2019 EN ISO 9000 AND EN 45000.pdf


ANNEX

· · · · · ~ n .

TABLE ISO CEN QUALITY STANDARDS

8/17/2019 EN ISO 9000 AND EN 45000.pdf


ISO

ISO STANDARD

STAGE

DATE

REVISION

ISO

8402: Quality

Management and

IS 1994

quality auurance standards - Vocabulary.

ISO

9000-1:

Quality

managemant and IS

1994

quality

assurance

standards. Part

1:

Guidelines for selection and use.

ISO 9000-2:

Quality management and

IS 1993

quality

assurance standards.

Part 2:

Generic guidelines for the application of

ISO 9001.1SO 9002. ISO

9003.

ISO

9000-3:

Quality

management and IS

1991

quality

assurance

standards. Part

3:

Guidelines

for the

application

of

ISO 9001

to

the

development,

supply and

maintenance

of

software.

ISO

9000-4/IEC

300.1: Quality

IS

1993

management and

quality assurance

standards.· Part 4: Guide to dependability

programme management.

ISO

9001:

Quality systems - Model for

IS 1994

quality assurance in design, development,

production, installation and servicing.

ISO 9002: Quality system - Model

for IS

1994

quality

assurance in

production,

installation and servicing.

ISO

9003: Quality systems - Model for

IS

1994

quality assurance final inspection and

test.

ISO

9004-1:

Quality

manageltlent and IS 1994

quality system elements. Guidelines.

ISO

9004-2: Quality management and IS

1991

quality

system elements. Part

2:

Guidelines

for

services.

8/17/2019 EN ISO 9000 AND EN 45000.pdf


ISO

ISO STANDARD STAGE

DATE

REVISION

ISO

9004 4:.

Quality I IUII18getn8nt and

IS

1993

quality

system

elements. Part

3:

Guidelines for quality improvement.

ISO 10005:

Quality management.

IS

1995

Guidelines

for quality

plans.

10006:

Quarrty

management. Guidelines CD 1996

on

quality

assurance

for

project

management.

ISO

10007:

Quality management. IS

1995

Guidelines

for

configuration management.

9004-8: Quality management and quality

NP

1997

system elements. Part

8:

Guidelines

on

quality principles and

their

application

to

management practices.

ISO 10011-1: Guidelines

for auditing IS 1990

quality systems. Part

1:

Auditing.

ISO

10011-2: Guidelines

for auditing IS 1991

quality systems. Part

2:

Qualification

criteria for quality systems auditors.

ISO

10011-3:

Guidelines

for

auditing IS

1991

quality systems. Part 3: Management

of

audit programmes.

,

ISO

. 10012-1:

Quality assurance

IS

1992

requirements

for

measuring

equipment.

Part 1 : Metrological

confirmation

system

for

measuring equipment.

10012-2: Quality assurance requirements

DIS

1996

for

measuring eqt.iipment Part

2:

Measurement assurance.

ISO

10013:

Guidelines

for

developing

IS 1995

quality manuals.

10014:

Guide to

the

economics

of

quality

CD

1996

j

-

,.

1

i

8/17/2019 EN ISO 9000 AND EN 45000.pdf


·· :

. ;

.

8/17/2019 EN ISO 9000 AND EN 45000.pdf


ANNEX Ill

TABLE OF

EN

45 STANDARDS

AND

RELATING ISO REFEREN ES

8/17/2019 EN ISO 9000 AND EN 45000.pdf


EN

STANDARD DOC. BASE STAGE

DATE

EN

46001

.

General criteria for the ISO/IEC Guides 25

EN

Standard

9 8 ~

IS

operation

of

testing laboratories

1982). 38

(1983)

2

. .d

43

1984)

EN 45002

.

General

criteria

for

the ISO/IEC Guide

38 EN

Standard

1989

assessment

of

testing laboratories

1983)

EN

45003

- General criteria

for

laboratory ISO/IEC Guide

58 EN

Standard

1995

IS

accreditation bodies

1993)

1

EN 45004

General

criteria

for

the

EN

Standard 1995

operation various

types

of bodies

performing inspection

prEN

45010

- General requirements

for

ISO/CASCO

226

EN Proposal

IS

assessment

and

accreditation of

i

certification/registration bodies a

6

EN

45011

-

General criteria

for

ISO/IEC Guide

28

EN

Standard

1989

IS

certification

bodies operating product

1982),

40

1983)

1

certification

pr

EN

45011

-

General criteria

for ISO/CASCO

228

EN

Proposal IS

certification

bodies operating product i

certification a

G

EN 45012

-

General criteria

for

ISO/IEC Guides 40 EN Standard

1989

IS

certification

bodies operating quality

1983).

48 (1986)

system certification

prEN

45012

- General requirements

for

ISO/CASCO

227

EN

Proposal IS

bodies operating

assessment and

certification/registration of quality system

a

6

EN 45013

General

criteria

for

ISO/IEC

Guide 40 EN Standard 1989

certification bodies operating certification

1983)

of

personnel

EN

4501

4 - General criteria

for

suppliers

ISO/IEC Guide

22

EN

Standard 1989

IS

declaration

of

conformity

1982)

\

(u

EN 45020

- General terms and their

ISO/IEC

Guide 2

EN

Standard

1993

IS

definitions

concerning

standardization

1991)

and related activities

prEN 45ASS - General requirements

for EN

Proposal

IS

op8ration and recognition: assesSment

procedures

.

1

8/17/2019 EN ISO 9000 AND EN 45000.pdf


ANNEX IV

THE

EN

ISO 9000

former EN

29000) STANDARDS

IN THE MEMBER STATES

8/17/2019 EN ISO 9000 AND EN 45000.pdf


Quality

Qual it y systems - Qua li ty system -

Quality syStems -

management and

Model for quality Model for quality

Model for quality

quality assurance

assurance in assurance in

assurance in

final

standards

design.

production. inspection and

Part 1 Guidelines

development.

installation and

test.

for selection and

production.

servidng

use.

installation and

servicing.

ISO 9000-1 C 994)

ISO 9001 1994) ISO 9002 1994) ISO

9003

1994)

EN ISO

9000- EN

ISO

EN ISO 9002

EN

ISO 9003

1 1994)

9001 1994)

1994) 1994)

Austria

ONORM EN 29000

ONORM EN 29001 ONORM EN

29002

ONORM

EN 29003

Belgium

NBN EN ISO 9000-1

NBN

EN

ISO 9001 NBN

EN

ISO

9002

NBN

EN

ISO

9003

Denmark

OS

EN

ISO 9000-1

OS EN

ISO

9001 OS EN

ISO

9002

OS EN

ISO

9003

Finland

SFS

EN ISO 9000-1

SFS EN ISO 9001 SFS EN ISO

9002

SFS EN ISO

9003

France

NF EN ISO

9000-1

NF

EN ISO 900,

NF EN ISO

9002 NF

EN ISO 9003

Germany

DIN EN ISO 9000-1

DIN EN ISO 9001 DIN EN ISO

9002

DIN

EN ISO

9003

Greece

ELOT EN ISO 9000-1

ELOT EN ISO 9001

ELOT

EN

ISO

9002

ELOT EN ISO

9003

Ireland

IS EN

ISO 9000-1 IS

EN

ISO

9001

IS

EN

ISO

9002

IS

EN

ISO

9003

Italy

UNI

EN

ISO 9000-1 UNI

EN

ISO 9001

UNI

EN

ISO

9002

UNI

EN

ISO

9003

Luxembourg

TIM

EN

ISO 9000-1 TIM EN ISO 9001

TIM EN ISO 9002

t iM

EN

ISO

9003

Netherlands

NEN

EN ISO 9000-1 NEN

EN

ISO 9001

NEN EN ISO 9002 NEN EN ISO

9003

Portugal

NP

EN ISO

9000-1 NP EN

ISO

9001

NP EN ISO 9002 NP EN

ISO

9003

Spain

UNE

EN ISO 9000-1

UNE

EN

ISO 9001 UNE EN ISO

9002

UNE EN ISO 9003

Sweden

SS

EN

ISO 9000-1

SS EN

ISO

9001

SS EN ISO

9002

SS

EN

ISO

9003

United

BS EN ISO 9000-1 BS EN ISO 9001

BS

EN ISO

9002

BS EN

ISO

9003

8/17/2019 EN ISO 9000 AND EN 45000.pdf


ANNEX V

;

. ··

THE NEW APPROACH DIRECTIVES

:.,,,,

l

1

·j

8/17/2019 EN ISO 9000 AND EN 45000.pdf


NEW

APPROACH

DIRECI1VES

Simple

pressure

vessels

Dir. 87/404/EEC

Dir. 90/488/EEC amend. Dir. 87/404/EEC)

Safety of toys

Dir. 88/378/EEC

Construction products

Dir. 89/106/EEC

Electromagnetic compatibility

Dir. 89/336/EEC


Machinery

Dir. 89/392/EEC

Dir. 911368/EEC amend. Dir. 89/392/EEC)


Personal

protective

equipment

Dir. 89/686/EEC


Non automatic weighing instruments

Dir. 90/384/EEC

Active implantabl e medical devices

Dir. 90/385/EEC


Appliances

burning

gaseous fuels

Dir. 90/396/EEC

Telecommunications

terminal

equipment

Dir. 911263/EEC

Dir. 93/97/EEC suppl. Dir. 91/263/EEC).

New

hot water

boilers fired with liquid or

gaseous fuel

Dir. 92/42/EEC

Electrical equipment designed for use

.

within

certain

voltage limits

Dir. 73/23/EEC

OJE

L 220/48/87

L 270/25/90

L 187/01/88

L 40/12/89

L 139/19/89

L 126/11/92

L 183/09/89

L 198/16/91

L 175/12/93

L 399/18/89

L 276/11193

L 189/01190

L 189/17/90

L 169/01/93

L 196/15/90

L 128/01/91

L 290/01/93

L 167/17/92

L 77/29173

Adoption

Application

date

date

01/01/90

01i01190

01/07/91

01/07/91

30/06/89 01/01/90

27/06/91

27/06/91

01/07/91 01/01/92

28/07/92 28/10/92

01101/92

01/01/930) 3

11 1192

01/01/93

01/07/94

11 1195<

3

>

31/12/91

01/07/92

3

29/01/94 29/01/94

01/07/92 01101/93 0

01/07/92 01/01/93

01/07/94 01/01/95

01/07/91

01/01/92

06/11/92

06/11/92

01/05/92 01/05/92

01101/93

11 1194 2

19/08174 19/08/14

8/17/2019 EN ISO 9000 AND EN 45000.pdf


.

NEW APPROACH

OJE

Adoption

Application

DIRECTIVES

date date

Explosives for civil uses Cal

Dir. 93/15/EEC

L121120/93

30/06/94 01/01/95

Medical e v i ~ e s

Dir.

93/42/EEC

L

169/01193

01/07/94 01/01/95

Equipment nd protect. systems intended

for use in potentially explosive atmospheres

Dir. 94/9/EC

L 100/1/94 01/09/95 01103/96

Recreational craft

Dir. 94125/EC

L 164/15/94 16/12/95

16/06/96

Lifts

Dir.

95/16/EC

L 213/1/95 01/01197 01/07/97

NOTES:

l I July 1995 shall apply for the equipment referred to

in

Directives

861295/EEC, 861296/E

2) 31 December

1995

shall apply

as

end date for the equipment referred to

in

Directives 86/

861296/EEC

and 86/663/EEC.

3)

1 July 1994 shall apply for art. 1 10) excluding a,b,c; art 1 11 a,b;

art.

1 12 c,d,e,f.

8/17/2019 EN ISO 9000 AND EN 45000.pdf


-

. -

1

.

1

i

8/17/2019 EN ISO 9000 AND EN 45000.pdf


i

I

l

1

.,

.

ANNEX V

THE HARMONIZED STANDARDS

BY NEW APPROACH DIRECTIVE

J

.

8/17/2019 EN ISO 9000 AND EN 45000.pdf


NEW APPROACH

DIRECTIVES

Simple pressure vessels

Dir. 87/404/EEC

Safety

of

toys

Dir. 88/378/EEC

Construction products .

Dir. 89/1 06/EEC

Electromagnetic com p

atibility

Dir. 89/336/EEC

Machinery

Dir. 89/392/EEC

e r ~ o n a l protective equipment

Dir. 89/686/EEC

Harmonized

Standards

published in the Official

Journal

of

European Community

EN

286-1

EN 286-2

EN

286-3

EN

EN 71-1 EN 71-2

EN 71-3 HD2

Ami to HD

271

S 1 Am2 to HD271 S l

EN

71-4 Am3 to HD

271

S 1 EN 71-5

EN

71-3 (rev.)

No

standards published

in

the Official Journal

EN

50065-1

EN

55011 · EN 55013 EN

EN

55015 (86)

EN

55020 (87) EN 55022 EN

EN 60555-3

EN 50081-1 EN 50082-1

Ami to EN 50065-1 EN 50081-2 Am11 to EN

EN 55014 (93)

EN

55015 (92) EN 55020 (93)

Am 1 to EN 60269-l EN60282-1

EN

60687

Ami to

EN

60945 EN 61036 EN 61037

EN 50082-2 AmA12 to EN 55013 AmA2 to

AmA 1 to

EN

55015 AmA 1 to 60555-3 EN 55

EN 55104 EN 60601-1-2

EN

60945

EN

6

EN

61000-3-3

EN

292-1 EN 292-2

EN294

EN349

EN418

EN

457

E

EN 23741 EN 23742

EN 289 EN 60204-l

EN 474-1

EN563

EN608 EN 25136

EN

28662-1

EN

31252

EN

31253

EN

ll52 EN69 EN 115

EN 132 EN 133

EN

134

ENI35

EN

140

EN

141

EN

142

EN 148 1

EN 143 EN

144 1

EN

146 EN 147

EN

136-10

EN 137

EN 145-2 EN 148-3

EN

170 EN

171

EN25 EN 341

EN 345

EN346

EN 347 EN 348

EN

352-2

EN 353-1 EN 353-2 .EN 354

EN

358

EN36

EN

361

EN

362

EN364

EN

365

EN 367 EN 368

EN 371

EN372 EN

373 EN 381-1

EN401

EN4 3 EN405

EN·412

EN

138

EN

145

EN207

EN208

EN34 EN366 EN

374 1 EN 374-2

8/17/2019 EN ISO 9000 AND EN 45000.pdf


NEW

APPROACH

Harmonized Standards

DIRECT VES

published in the Official

Journal o

European Community

Active implantable medical devices

EN550 EN

552

EN 554

EN 3

Dir. 90/385/EEC

EN 30993 4 EN 30993 5 EN 46001

EN

Appliances burning gaseous tuels EN291

EN298

EN 377 EN437

Dir. 90/396/EEC

EN 549 EN 126 EN 203 2

Telecommunications terminal TBR3

TBR4 TBR5 TBR6 TBR7

T

equipment

TBR9 TBRlO TBR12

TBR14

Dir. 911263/EEC

New hot water boilers fired with

No standards published in the Official Journal

liquid or gaseous fuel

Dir. 92/42/EEC

Electrical equipment designed for

Standards published in the following Official Jour

use within certain voltage limits

92/C 210/12 93/C 18/04 93/C 319/

Dir. 73/23/EEC

94/C 169/04 94/C 199/03

Explosives for civil uses


Dir. 93/1 5/EEC

Medical devices

EN 550

EN 552 EN 554

EN 3

Dir. 93/42/EEC

EN

30993 4 EN 30993 5 EN 46001 EN

EN 60601 1 2

Equipment and protective systems

No standar:ds published

in

the Official Journal

intended for use in potentially

explosive

~ t m o s p h r s

Dir. 94/9/EC

Recreational

craft

EN 28846 EN 28847 EN 28848 EN

Dir 94/25/EC

EN 29775

Lifts


Dir. 95/16/EC

8/17/2019 EN ISO 9000 AND EN 45000.pdf


ANNEX

V

8/17/2019 EN ISO 9000 AND EN 45000.pdf


THE CONFORMITY ASSESSMENT PROCEDURES

TO

E

USED IN THE TECHNICAL HARMONIZATION DIRECT

NEW APPROACH DIRECTVES)

u

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8/17/2019 EN ISO 9000 AND EN 45000.pdf


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Documents

EN ISO 9000 AND EN 45000.pdf