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.

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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

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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

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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

[email protected]

www.pjr.com

18PERRY JOHNSON REGISTRARS, INC.