Pjr Short Ce Presentation
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Transcript of Pjr Short Ce Presentation
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MARKCERTIFICATION PROGRAM
PERRY JOHNSON REGISTRARS, INC.
PERRY JOHNSON REGISTRARS, INC.
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CE stands for Conformité Européene, which
is French for "European Conformity."
A product in one of the controlled product
categories cannot legally be sold in the EU
unless it has passed the tests for CE marking.
PERRY JOHNSON REGISTRARS, INC.
3
CE Marking continued…
All products placed on the European market
must be safe!
• The European Union established a group of regulations (called
“Directives”) in order to simplify commerce throughout the European
Economic Union (EEU) and the European Free Trade Area (EFTA).
• Before these regulations, countries had their own individual laws
governing product safety.
• With introduction of the Directives, safety requirements were
significantly harmonized throughout Europe.
• Imported products are now assessed according to the Directives, and if
necessary also tested according to Harmonized Standards that ensure
compliance with the intent of each Directive.
PERRY JOHNSON REGISTRARS, INC.
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The Road to
CE Certification
• Are you ready to expand your sales efforts to Europe?
• Do you know which EU Directives apply to YOUR product?
• Do you know what testing is required?
• Do you need Annual Surveillance Audits?
PJR is ready to show you the way!
Do you know which direction to go?
PERRY JOHNSON REGISTRARS, INC.
History of Perry Johnson Registrars
• Perry Johnson Registrars, Inc. is the #1 Reporting Registrar in
North America.
• Since 1994, PJR is an industry leader in the Management
Systems certification market.
• PJR has offices in more than seven countries including: the U.S.,
Japan, Italy, Mexico, China, Thailand and India.
• PJR maintains accreditations from ANAB, UKAS, EMA,
INMETRO, JAB, RvA, and SINCERT.
• PJR has a large and diverse client base that includes many
globally recognized companies.
• PJR now offers CE Mark Product Certification through it’s
partnership with SZUtest, a European Notified Body.
5PERRY JOHNSON REGISTRARS, INC.
PJR and SZUtest– Strategic Partners –
• SZUtest was established as the official representative of the
largest Czech Republic Testing Body (SZU) and one of the
European Notified Bodies with the largest scopes of accreditation.
• SZUtest and its team of young and dynamic engineers now
provide assessment and testing services as an accredited
European Notified Body (N.B. #2195).
• SZUtest’s specialists have provided services as an accredited test
and calibration laboratory for more than 53 years.
• SZUtest has certified leading companies around the world.
6PERRY JOHNSON REGISTRARS, INC.
The PJR Advantage
• The Manufacturer is assigned a personal project
manager from A-Z throughout the CE Marking process
• Clients benefit from PJR’s EU technical experience
through our European partners
• Businesses rely on PJR’s proven track record of
customer satisfaction, responsiveness, and excellence
7PERRY JOHNSON REGISTRARS, INC.
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The Basics – How to Navigate
• European Directives
• Technical Files
• Declaration of Conformity
PERRY JOHNSON REGISTRARS, INC.
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• 90/396/EEC Appliances burning gaseous fuels
• 2000/9/EC Cableway installations designed to carry persons
• 89/106/EEC Construction products
• 2004/108/EC Electromagnetic compatibility
• 94/9/EC Equipment & protective systems in potentially
explosive atmospheres
• 93/15/EEC Explosives for civil use
• 95/16/EC Lifts
• 2006/95/EC Low voltage equipment
• 98/37/EC Machinery safety
• 2004/22/EEC Measuring instruments
Just a few of the Directives…
http://www.newapproach.org/Directives/Default.asp
PERRY JOHNSON REGISTRARS, INC.
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• 90/385/EEC Medical devices; active implantable
• 93/42/EEC Medical devices; general
• 98/79/EC Medical devices; in vitro diagnostic
• 92/42/EEC New hot-water boilers fired with liquid or gaseous fluids
• 90/384/EEC Non-automatic weighing instruments
• 94/62/EC Packaging and packaging waste
• 89/686/EEC Personal protective equipment
• 97/23/EC Pressure equipment
• 1999/5/EC Radio and telecom terminal equipment
• 94/25/EC Recreational craft
• 87/404/EEC Simple pressure vessels
• 88/378/EEC Toys safety
. . . and more Directives
Products can fall under one or more Directives –
Contact your project manager for your free quote today!PERRY JOHNSON REGISTRARS, INC.
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What’s a
Technical Documentation File?
• A Technical File (TF) is a document that the
manufacturer’s representative must produce if they are
challenged in the European union
• Any EU customs authority can challenge a manufacturer
at any time
• The Manufacturer (or representative) must be able to
produce this document and present it to the European
Authorities. …and in hard copy
PERRY JOHNSON REGISTRARS, INC.
Consequences of an Incorrect TF…
• Shipments Stopped at Port
• Fines [$29,000 USD]
• Products Removed From the Markets
• No Further Sales Within the EU
• Imprisonment
“I did it myself before”
“Why do I need help now?”
12PERRY JOHNSON REGISTRARS, INC.
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What’s aDeclaration of Conformity (DoC)?
• A Legally Binding Document – A sworn statement
of fact
• Contains a legal statement that the product complies
with the requirements of the applicable Directives
(Laws) and Standards (test methods)
• Must be signed by a responsible person
representing the Manufacturer. Someone who is
accountable for the product design, testing, and
validity of the DoC
PERRY JOHNSON REGISTRARS, INC.
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How does the Manufacturer
Prepare for Audit & Testing?
• Provide adequate documentation to test the
product
• Ensure that the product functions as close
as possible to normal operation for a
continuous period of time
• Provide a knowledgeable technician during
the onsite audit
PERRY JOHNSON REGISTRARS, INC.
The Application Process
1. Fill out your free application with your Project Manager
2. PJR’s technical advisors review and assess your
unique product to determine which Directive(s),
Standard(s), and testing protocols will apply
3. Project Manager delivers and reviews your customized
product quote with you
4. Client provides deposit to initiate the CE Marking
process
15PERRY JOHNSON REGISTRARS, INC.
Cycle Of Continuous Service
PJR’s
CE MARK
ASSESSMENT
AND
PROCESS
CE MARK
CERTIFICATION
INCREASED
PRODUCT
SALES
$$
EASY
APPLICATION
16PERRY JOHNSON REGISTRARS, INC.
The PJR Advantage
• Competitive Pricing
• PJR’s strong 25+ years as a global quality leader
• Fully walking customers through step-by-step protocols
• Providing guidance in technical file preparation
• Identifying applied Directives, Standards and Testing
Protocols
• Technical expertise to readily complete your projects with
quick turnover time
• Total Project Management – customer service, scheduling
and follow-up
• US-based servicing with Corporate Headquarters in
Michigan
17PERRY JOHNSON REGISTRARS, INC.
Thank you!
Get started today –
contact us here at Perry Johnson Registrars
and we’ll be glad to help you fill out our
FREE application for the CE Mark!
Scott Grossman
561.429.2164
www.pjr.com
18PERRY JOHNSON REGISTRARS, INC.