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A Session On Ce Mark Requirements at

The document discusses the requirements for CE marking in the European Union. It explains that CE marking indicates a product's compliance with EU safety, health and environmental protection standards and allows for free movement of goods throughout the European Economic Area. It outlines the key directives and regulations regarding CE marking and conformity assessments. It also discusses the role of standards organizations like ISO in developing technical standards to facilitate harmonization.

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ALOKE GANGULY
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45 views18 pages

A Session On Ce Mark Requirements at

The document discusses the requirements for CE marking in the European Union. It explains that CE marking indicates a product's compliance with EU safety, health and environmental protection standards and allows for free movement of goods throughout the European Economic Area. It outlines the key directives and regulations regarding CE marking and conformity assessments. It also discusses the role of standards organizations like ISO in developing technical standards to facilitate harmonization.

Uploaded by

ALOKE GANGULY
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Download as PPT, PDF, TXT or read online on Scribd
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A SESSION ON CE MARK

REQUIREMENTS AT

INDO WEBAL SURGICAL


PVT. LTD.
Presented By
aloke ganguly
AG
WHAT IS CE???
 Existing in its present form since 1995, CE marking
indicates compliance with EU legislation of a product.
 Allowing free movement of the product throughout the
European Economic Area (EEA)
 Irrespective of which country the product has been
manufactured.
 CE mark is a self certification scheme. Self declaration is
required by the manufacturer that the product meets all EU
Directives or EU legislations related to the product.
 All products do not need CE mark, only product categories
subject to relevant directives or regulations are required to
bear CE marking.

MR PRESENTED BY MR
AG
Countries requiring CE Mark
 Mandatory for certain product groups within the EEA and 27
member states of the EU plus EFTA(European Free Trade
Agreement) like Iceland, Norway, Switzeland and Turkey.
 The Manufacturer of products made within the EEA and importers
of goods made in other countries must ensure that they bear CE
mark.
 Till 2013, it was tot required by countries of the Central European
Free Trade Agreement (CEFTA), but since members like
Macedonia, Serbia and Montenegro had applied for membership of
EU, now it has become mandatosy for all. The European Union
(EU) includes the following 27 Member States: Austria, Belgium,
Bulgaria,Cyprus, Czech Republic, Denmark, Estonia, Finland,
France, Germany, Greece, Hungary, Ireland,Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Poland, Portugal, Romania,
Slovakia,Slovenia, Spain, Sweden and United Kingdom

MR PRESENTED BY MR
Rules underlying CE marking MR

 Responsibility lies with whoever markets in the EU, an


EU based manufacturer, importer or distributor made
outside the EU.
 Products subject to certain EU directives, manufacturer
has to check which EU legislation it needs to apply for
the products.
 If stipulated in the directive, an authorised third
party(Notified Body) must be involved in the conformity
assessment.
 A technical file alongwith a manual in line with ISO 9001
has to be prepared.

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MR
Identify the applicable directive(s)

 First step is to identify whether the product needs CE


mark at all.
 More than 20 sectoral products needing CE mark like
Electrical equipment, medical devices, toys, PPE,
wireless devices etc.
 Identify which directive is applicable (ex. Low
voltage directive is 2006/95/EC)
 Identify an appropriate route to conformity which is a
self declaration process.
 Prepare a technical file for each product

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MR

Standardization
 Standardization is the process of agreeing on
technical standards. The standards are prepared
by National/International bodies to ensure
mutually convenient

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Who makes the standards
 National Bodies, in India, it is Bureau of Indian
Standards (BIS), in UK, it is British Standard
Institute (BSI), in Japan, it is Japanese Institute of
Standardization (JIS)….and so on
 Above all, ISO makes standards.

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WHO/WHAT IS ISO?
 International Organization for Standardization.
Established in 1947 with Head Office in Geneva,
Switzerland and having 154 member countries.

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Why ISO was formed
 Facilitate harmonization of standards
 Single set of standards that people
everywhere would recognize and respect.

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MR

ISO 9OOO SERIES


EVOLUTION
OF THE STANDARD
THE REASON BEHIND.

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ISO 9OOO SERIES
 QC – Inspection quality onto the product.
 QA – Building quality into the product.
 QS – Overall quality of the system.

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ISO 9OOO SERIES.
 Technical Committee TC 176 made a study of
Industries world wide and published 3 standards in
the year 1987
 ISO 9001 – Quality System requirements for design,
manufacture and supply.
 ISO 9002 - Quality System requirements for
manufacture and supply.
 ISO 9003 - Quality System requirements for final
inspection and testing.

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MR

ISO 9OOO SERIES.


 The principle of ISO
9000 series
 Establish
 Document

 Maintain

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BASED ON…
 US DEF-STAN MIL-1-Q9858-1969
 UK DEF STAN 05/21,05/24 – 1971
 BS 5750 PART 1,2, & 3

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WHAT IS IN ISO 9001/2/3
 There are 20 clauses giving guidelines as to how an
Organization should executes its activities.
 Reference to what documents need to be prepared.

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WHAT DOCUMENTS ARE
TO BE MADE?
 Four tier documentation
 A Quality manual having Organization’s policy,
objectives, responsibilities of different personnel
etc.
 20 documented procedures for each clause of the
standard.
 Work Instructions.
 Forms and formats for maintaining records

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HOW TO CHECK THE MR

SYSTEM?
 Through Internal audit carried out at defined
intervals to ensure whether the documented
system is being maintained or not.

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MR

What are the benefits? Internal?


 Better management of core business
processes for improving efficiency .
 Increased awareness of quality among staff.
 Improved productivity and quality.
 Improved internal communications.
 Reduced costs of quality.

MR PRESENTED BY MR

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