market access market access MAY/09/JUNE

market market access access maY/09/juNe 

www.us.tuv.com 

www.tuv.com 

Your KeYs to NatioNal aNd iNterNatioNal CompliaNCe 

ConneCting the global PV grid 

tUV leads entry into marketPlaCe 

The Inside View 2 

Overview from our Product Safety 

Division Manager 

Cover Story: 3 

Photovoltaic 

Photovoltaic Inverters Come Of Age 

Late Breaking News 6 

May is Electrical Safety Month 

Product Safety 7 

TÜVRheinland ® GS S1 Certificate Provides 

Passport to the European Market 

Medical 10 

What is the FDA’s Third Party Inspection 

Program and pMAP? 

UTS 15 

The Hunt Oil Refinery Doubling Capacity 

With Help Of Unified Testing 

Services, Industrial Services Group 

Quality 17 

Department Of Homeland Security (DHS) 

/ Private Sector Preparedness (PS-PREP) 

Certification Program 

NDT 19 

Fluoroscopy X-Ray: Not Just For 

Medical Use 

TUVdotCOM 21 

When Budgets Shrink, Technology 

Investments Pay Off 

Quality 23 

Announcing The Monthly Customer 

Feedback Survey Winners 

TÜVRheinland ® Resources 24 

Tradeshows/Seminars

market access 

The Inside View 

Dear Valued Customers, 

In this issue of Market Access, we will investigate 

alternative energy sources, a subject of increasing 

importance in today’s global landscape. Everyday, we 

hear of new technology and applications for generating 

electricity from sources other than fossil fuels, including 

solar, wind, tidal energy and geothermal energy. 

Today, two alternative sources are readily available and 

are in great demand – solar and wind energy. When most 

of us think of these energy sources we only think of the 

photovoltaic panels on a roof or a wind turbine in a field. 

This is only a small part of what makes up these alternate 

energy sources. Somewhere down the line you will have 

to convert the “raw” energy from a photovoltaic panel 

or wind turbine into a form of electricity that can operate 

everyday appliances and equipment. This is accomplished 

by an inverter. 

Inverters serve a very important role in the generation 

process. It not only safely connects the building wiring 

back to the solar or wind generation source, it also may 

connect to a utility grid for the utility company to provide 

for other sources of electrical demand. When a utility 

company harnesses this power to supply other electrical 

demands, it is extremely critical an inverter always operate 

safely in all modes of operation. 

The safety requirements for inverters vary substantially 

throughout the world. This is mainly due to each country or 

region having specific requirements for connection to the 

utility grid and building wiring. It can be a very difficult task 

to untangle the varying requirements, standards and codes 

country-by-country. In this issue of Market Access, we will 

explore and detail the safety requirements for inverters in 

some of the major countries of the world. 

Also in this issue of Market Access, we will explore a 

variety of subjects ranging from the use of x-rays outside 

of the medical field to a new certification program through 

the Department of Homeland Security, and we will dig 

deeper into the true and expansive market benefits of the 

TÜVRheinland ® GS Mark, including a detailed examination 

regarding the dual benefits to manufacturers of the 

TÜVRheinland ® GS S1 certification. This certification can 

be used for applying a TÜVRheinland ® GS Mark on 

your product, and it can also be used as a platform to 

demonstrate compliance to the EU Low Voltage Directive. 

maY/09/juNe 

Dan Sullivan 

Division Manager, Product Safety Division 

TUV Rheinland of North America, Inc. 

We will also check in on the latest Unified Testing Services 

project, discuss the FDA’s third party inspections and 

highlight the latest TUVdotCOM web platform to help with 

the compliance process and much more. 

Sincerely, 

Dan Sullivan 

Division Manager, Product Safety Division 

TUV Rheinland of North America, Inc.


Cover Story 

Photovoltaic 

Currently, issues about alternate energy sources 

dominate what we see and hear in the media, today. 

As the demand for energy increases, so does the 

need to find alternate, inexpensive and green energy 

sources, such as Wind Energy and Solar Energy. 

Additionally, Wave Energy, Tidal Energy, Geothermal 

and many others are also being further developed 

and utilized. 

In 2002, there was approximately 100MW of Solar 

Power Generation worldwide, which had grown to 

1,700 MW by 2006. In 2007, there was approximately 

120 GW of Wind Power Generation. 

A common aspect of these alternate power sources 

is that the electrical power is often produced as a 

DC voltage, which must then be converted to AC for 

domestic or industrial usage. Once converted to AC, 

this electrical power may then be used by a dedicated 

load, or may be exported to the power grid. When 

exported to the power grid, this is often referred to as 

Micro Generation, and more commonly referred to as 

a Grid Tied Inverter. 

This conversion from DC to AC voltage is achieved 

by a DC to AC Inverter (Inverter). The size of the 

Inverter can range from a few watts to many kilowatts, 

depending upon the application. The inverter 

may also have a charge controller to charge batteries 

for use when the energy source is not available (i.e., 

night time or a windless day). 

A simple block diagram of an inverter for powering 

a dedicated load is shown in Figure No. 1 and an 

example of a Grid Tied application in Figure No. 2. 


Photovoltaic Inverters Come Of Age 

Demand for Alternative Energy Sources Power New Opportunities & Challenges 

Authored by Paul Morton, Product Safety Engineer, TUV Rheinland Canada, Inc. 

ConTInUEd on PAgE 4


Cover Story 

Photovoltaic 

Photovoltaic Inverters Come Of Age (continued) 

DC Source 

DC Source 

Figure No. 1 

Figure No. 2 

In Figure No. 1, the DC input voltage is converted to 

AC voltage by the Inverter in order to power the dedicated 

load. Excess power from the DC Source is used 

to charge the batteries. When the DC source is not 

available, the batteries can then be used to provide 

the DC voltage for the DC to AC Inverter. The Charge 

Controller, which is often part of the inverter, manages 

the charging and discharging of the battery. 

In Figure No. 2, the DC Source is converted to AC and 

fed directly to the utility power grid. Connection to 

the grid must meet national and local codes within a 

country. 

Traditionally, electrical power has been produced in 

large power stations, with the power flow generally 

from the point of power generation to the point of 

utilization (or the customer). When Grid Tied inverters 

are used, we can now have the situation of power flow 

from the customer towards the power generators. 

ConTInUEd on PAgE 5 

Charge 

Controller 

Batteries 

DC to AC Inverter 

DC to AC 

Inverter 

DC to AC 

Inverter 

Utility 

Grid 

Dedicated 

Load 


This can create unique problems on the power grid. 

With power being generated in many local areas this 

can affect the overall voltage regulation on the power 

grid. At present, Grid Tied Inverter’s usually do not 

provide any means of active voltage regulation, but 

rather, simply follow the voltage at the point where it 

is connected. 

If a fault occurs on the power grid, it is possible to have 

a situation of a local “island” of power caused by the 

Grid Tied Inverter. Because this “island” is not being 

powered by the grid, the power quality may no longer 

be within specifications. This can cause damage to 

equipment that is now being powered by the inverter 

alone. In addition, this situation can be dangerous for 

people working on the power grid, since power can 

now be flowing from the other direction. 

Consequently, there is a requirement that inverters 

stop exporting power to the grid when the grid voltage 

or frequency go out of specification or if it detects that 

there is a fault on the grid (i.e., blackout). This is often 

referred to as “automatic grid disconnection”. 

The standards that inverters are tested to and the 

conditions for them to stop exporting power vary 

from country to country. In North America, they 

must meet UL1741 “Inverters, Converters, Controllers 

and Interconnection System Equipment for Use with 

Distributed Energy Resources” for the United States and 

CSA 107.1 “General Use Power Supplies” for Canada. 

The latest edition of UL1741 now uses IEEE1547 “IEEE 

Standard for Interconnecting Distributed Resources 

with Electric Power Systems.”


Cover Story 

Photovoltaic 

Photovoltaic Inverters Come Of Age (continued) 

In Europe, the standard EN 50178:1997 “Electronic 

Equipment for use in Power Installations” covers the 

basic safety of the Inverter. At present, a new standard 

IEC 62109 “Safety of Power Converters for use 

in Photovoltaic Installations” is being used alongside 

EN50178. Each European country has different requirements 

for the grid interface. For example, in Germany 

it is VDE 0126-1 “Automatic Disconnection Device 

Between The Generator and The Public Low Voltage 

Grid,” while in Italy, compliance to the Enel standard, 

DK 5940 “Criteria for plant connections to the grid“ 

(translation), is required. Enel is Italy’s largest power 

company. The change provides clarification for the 

Document DK5940. Although similar in intent, each of 

these standards will have different limits of voltage 

and frequency variation under which the inverter must 

disconnect from the grid. 

Inverters are usually optimized for the type of DC 

Source in order to maximize the efficiency of the 

overall system. This is often referred to as Maximum 

Power Point Tracking. For example, the amount of 

power available from a photovoltaic system is a 

function of sunlight and temperature, and the output 

power is elevated with increased sunlight or in lower 

temperatures. The Maximum Power Point Tracking 

System will automatically adjust the inverter operating 

point to ensure maximum power transfer from the 

photovoltaic cells. 

TÜVRheinland ® has a worldwide network of offices 

that can test and evaluate inverters to provide initial 

design reviews or provide certification to national 


requirements. In North America, TÜVRheinland ® 

provides certification to UL1741 and CSA 107.1, and 

in Europe it provides certification to EN 50178 

and VDE 0126. TÜVRheinland ® is also a leading 

evaluator of PV Modules and DC to AC Inverters. 

This combination offers customers certification for 

complete PV Systems. 

For more information, please call toll-free at 

1-tUV-rheinland (1-888-743-4652) or visit 

www.us.tuv.com.


Late Breaking News 


May is Electrical Safety Month 

U.S. Consumer Product Safety Commission Offers Important Safety & Recall 

Information 

May is celebrated as National Electrical Safety Month. 

Electricity is used for so many things as part of our 

daily life, both in and outside of the home. 

The U.S. Consumer Product Safety Commission (CPSC) 

is charged with protecting the public from unreasonable 

risks of serious injury or death from more than 15,000 

types of consumer products. You can find information 

on over 4,000 product recalls and recall alerts using the 

various searches at http://www.cpsc.gov/cpscpub/ 

prerel/prerel.html. 

Electrical safety is often overlooked and taken for 

granted, TÜVRheinland ® would like to remind all Market 

Access subscribers to review the latest information. 



www.us.tuv.com. 

May is National 

Electrical Safety Month 

Each year, there are about 31,000 fires and 200 deaths involving home electrical 

systems. Additionally, 180 people died from electrocution relating to consumer 

products in 2002. 

Don’t use equipment or cords that are damaged. Inspect cords for excessive wear 

before plugging them in. Have a licensed electrician check your home’s electrical 

system for hazards if it’s been more than 10 years since your last inspection, or if you 

notice any of these . . . 

Electrical System Hazard 

Warning Signs: Dimming or Flickering Lights 

Sizzle or Buzzing Sounds 

Odor of Overheated Plastic 

Plugs that Pull Out of the Receptacle Easily 

Flashes or Showers of Sparks 

Hot Switch Plates and Outlet Covers 

Fuses Burn Out or Circuit Breakers Need 

Resetting Frequently 

�� 

�� 

�� 

Source: CSPC 

�� 

�� 

�� 

NSN–06–3


Product Safety 



TÜVRheinland ® GS S1 Certificate Provides Passport to the 

European Market 

Certificate Demonstrates Full Compliance with German Safety Law and Low Voltage 

Directive 

Authored by dan Sullivan, Product Safety division Manager, TUV Rheinland of north America, Inc. (newtown, CT) 

In today’s competitive global market, manufacturers 

must satisfy regulatory requirements while maintaining 

a competitive advantage. As it is well known, CE 

Marking is merely a symbol for trade to the European 

Union (EU), with an assumption of conformity as a safe 

product. But what do consumers really think of CE 

Marking? Does it help or hinder consumer purchasing 

decisions and does it fully protect manufacturers from 

product recalls or corporate liability? 

EU Commission data shows the number of dangerous 

and recalled products reported to the European 

Commission has continued the trend upward. The data 

also suggests that Europe is still the most demanding 

regulatory environment in the world and continues 

to lead the world in regulatory reform, which demonstrates 

the increasing demand for safe products in the 

EU by distributors, retailers and consumers. 

Manufacturers can gain a distinction in the EU market 

over the basic “assumptions“ a product with a CE 

marking. This can be obtained by using a third party 

certification mark, which are driven by distributors, 

insurers and consumers because of growing mistrust 

in CE marking. 1 

With the large number of third party certification 

marks existing in the EU, the European Free Trade 

Association (EFTA) recently published a study on 

Certification Marks in Europe. As the EFTA study 

notes, some manufacturers have been limiting themselves 

to only the CE Marking to reduce costs, and 

say the added cost for the third-party review and testing 

– including factory inspections and sampling from 

the production line – would cut into their profit margins. 

This cost-influenced strategy might actually hurt 

those manufacturers in the end. 

the growing Popularity of the gs mark 

There is one mark, according to European Free Trade 

Association (EFTA), that has been growing in popularity 

among consumers and manufacturers alike and is the 

only mark in the EU that has been increasing in market 

presence: the GS Mark. 

As a way to demonstrate the GS Mark’s skyrocketing 

appeal, the study provides several eye-raising statistics. 

The number of GS Mark licenses from 2004 to 2008




TÜVRheinland ® GS S1 Certificate Provides Passport to the European Market (continued) 

has grown to 60,000 and about 80% of GS marked products 

carry CE marking, a trend in opposition to other 

marks in the EU. 

For those not familiar with the GS Mark, it is a voluntary 

test mark that proves an accredited third party has 

evaluated, tested and certified the product for electrical 

safety. In German, GS stands for “Geprüfte Sicherheit,” 

which in English stands for “safety-tested” and underscores 

the major draw of the GS Mark to a wide range 

of stakeholders throughout Western Europe. 

Introduced in 1977, the GS Mark is based on the 

“German Equipment Safety Law” (Geräte – und 

Produktsicherheitsgesetz), otherwise known as 

GPSG for short. The GS Mark was created to meet the 

demands of industries, importers, distributors, tradehouses, 

public insurance and consumer organizations 

in Germany. It verifies that a technical product 

complies with the safety requirements of the GPSG. 

To attain the GS Mark, many product attributes are 

examined including electrical safety, ergonomic 

correctness and chemical hazards from polymeric 

materials. To keep the GS mark, the law also demands 

frequent checks (usually annually or every two years, 

depending upon the certificate) to ensure the manufacturer 

has maintained a continuous control on 

production. 

the marketability of the gs mark 

Because it is a voluntary mark, the GS Mark provides 

a distinct marketing advantage to the manufacturer. 

Studies have shown that consumers make purchasing 

decisions based on the presence of the GS mark on the 

product’s label. 

Although the GS Mark was originated in Germany, it 

is in fact a mark that is accepted in multiple Western 

European countries. In the past decade, members of the 

European Union have become accustomed to seeing 


the mark on consumer products, and now this mark 

continues to appear on a large number of electronic 

products and machinery sold elsewhere in the world. 

In comparison to the CE Marking, one difference is 

startlingly clear: the safety characteristic of the GS 

Mark is well understood by consumers throughout 

Western Europe and has made it a primary selling point 

at the point of purchase. 

In today’s market, consumers are offered a dizzying array 

of product choices – often given little more than a price 

point or brand recognition to help make a purchasing 

decision. Because of this, many products can seem like 

“peas in a pod”. Undoubtedly, consumers want more 

criteria when making their final buying decision and 

without being the product’s design or manufacturing 

engineer, it is impossible for consumers to instinctively 

determine the “inner values” of a device.



Consumers recognize the GS Mark as a symbol of 

safety. The CE Mark is simply an EU requirement for 

sale across various markets and does not require 

third-party testing to prove safety or compliance. When 

making a purchase, consumers can use the GS Mark 

to help them weed through the choices before them. 

However, it is important to note that the CE Marking is 

not an approval, certification or quality mark, nor is it 

a marketing tool to increase consumer sales. The CE 

Mark is an identifier that is a declaration of the supplier’s 

own responsibility, grants a product access to the 

European Market and also permits the withdrawal of 

non-conforming products. Therefore, the CE Marking 

still holds value to ensure a product can be distributed 

on the market. But it is obvious that a product increases 

its success on the EU market if it also displays a GS 

Mark. 

The question still remains: How can a manufacturer 

improve a product’s marketability, influence purchase 

decisions and reduce corporate liability to product 

recalls? The answer is the TÜVRheinland ® GS S1 

Certificate. 

tÜVrheinland ® gs s1 Certificate = Comprehensive, 

Cost-effective Compliance 

Manufacturers can find a cost-effective way to attain 

both a CE and a GS Mark through the TÜVRheinland ® 

GS S1 Certificate. The GS Mark and the CE Marking 

are of course mutually exclusive. Yet, there is great 

value in combining the two marks to further expand a 

product’s marketability. The TÜVRheinland ® GS S1 certificate 

makes this ideal possible. 

Manufacturers are finding the TÜVRheinland ® GS S1 

certificate to be the de facto certificate for acceptance 

into Europe. The certificate demonstrates full 

compliance with the GPSG. It also shows compliance 

to the LVD (minimum EU requirement) with a statement 

that the product has complied with Annex I of the LVD 

(2009/95/EEC), which is supported by TÜVRheinland ® . 


TÜVRheinland ® GS S1 Certificate Provides Passport to the European Market (continued) 

Additionally, the certificate can be used in connection 

with the manufacturer’s EC declaration of conformity, 

according to Annex III of the LVD. 

As an internationally recognized leader, the 

TÜVRheinland ® GS S1 certificate can help a manufacturer 

gain consumer confidence through the knowledge 

the product has been evaluated by an independent 

third party for safety and compliance. Because of high 

consumer recognition, a TÜVRheinland ® GS Mark can 

equate to a better return on product investment. 

In the end, combining the TÜVRheinland ® GS Mark and 

third party support of compliance to the LVD into one 

certificate is a value-added cost benefit to the manufacturer, 

while boosting the product’s credibility and 

marketability across the European Union. 



www.unifiedtesting.com. 

1 Source: “Certifications and Marks in Europe – A Study 

Commissioned by EFTA”


Medical 

Reprinted with permission from Medical Device & 

Diagnostic Industry, “Wanted: More Participants for 

FDA’s Third-Party Inspection,” January 2009. Copyright 

© 2009 Canon Communications LLC. 

Many medical device manufacturers do not realize they 

can save time, money and resources while satisfying 

inspection requirements by the FDA and other conformity 

assessment providers. Under the Medical Device 

User Fee and Modernization Act of 2002 (MDUFMA), 

the FDA introduced the Inspection by Accredited 

Persons Program or Third Party Inspection Program. 

Under this program, eligible Class II and III medical 

device manufacturers can turn to an FDA-accredited 

third party to perform U.S. regulatory inspections. 

Traditionally, the FDA handled all inspections of manufacturing 

facilities. But as U.S. manufacturers began to 

expand nationally and globally, the increasing numbers 

made it difficult for the limited number of FDA inspectors 

on hand to visit every facility on the list. Allowing 

a qualified third-party, such as TÜVRheinland ® , to 

handle the inspection as an FDA proxy loosened the 

load while ensuring U.S. regulatory requirements were 

being met. 

maY/09/juNe 10 

What is the FDA’s Third Party Inspection Program and pMAP? 

pMAP Reduces Number of Audits/Inspections; Provides More Control Over Timing 

and Planning of Audits/Inspections 

Authored by gregor dzialas, Third-Party Inspection Program Manager (Boxborough, MA) 


On the upside, the FDA’s AP Program offers a tremendous 

benefit to participating manufacturers. Manufacturers 

can combine FDA inspections with other conformity 

assessment inspections, e.g., MDD/ISO 13485/CMDCAS. 

Combining these usually separate inspections into one, 

allows the manufacturer to uncover once lost time, 

money and resources. 

a Closer look at mdUFma 

When the MDUFMA of 2002 was passed, it established 

a new subsection of the U.S. Food, Drug and Cosmetics 

Act, which required the FDA to accredit qualified 

third parties to perform inspections of eligible device 

manufacturers. Through this program, an Accredited 

Person (AP) is a third party recognized by FDA to: 

• Assess the quality system of eligible manufacturers 

of Class II and III devices under 21 CFR Part 820. 

• Determine compliance with other device requirements 

in the act and regulations. 

• Prepare and submit reports to FDA, which makes the 

final compliance assessment. 

By law, the FDA must inspect Class II and III device 

manufacturers every two years. But the FDA’s internal 

resources dwindled as the medical device industry 

expanded globally. As a result, actually completed 

inspections (especially for lower risk device manufacturers 

and foreign manufacturers) were much lower 

than the biannual inspection requirement.


Medical 

In January 2008, the U.S. Government Accountability 

Office (GAO) issued a report about the FDA’s ability to 

complete required inspections. In the report, the FDA 

estimated that facilities for medium risk devices had 

been inspected every five years in the U.S. and every 

27 years abroad. The wide variance underscored the 

need to start the AP inspection program. Through it, 

the FDA can focus on higher-risk inspections as well 

as those outside the scope of the program, such as 

“for cause,” pre-market approval, and bioresearch 

monitoring inspections. 

In spite of the FDA’s struggle to hold biennial inspections, 

global manufacturers have been faced with a 

growing number of regulatory requirements and conformity 

assessments in other countries. To maintain 

their market presence in other countries, they must 

undergo numerous separate inspections each year to 

demonstrate compliance with requirements that are 

largely harmonized. Overall, participation in the AP 

Inspection Program reduces the number of inspections 

needed to meet FDA and other countries’ regulations, 

and to control the scheduling of inspections. 

two for one: the Pilot multi-Purpose audit Program 

The U.S. is not the first country to turn to third-party 

compliance experts as a resource. Health Canada 

originally launched CMDCAS several years before the 

FDA started the AP Inspection Program. However, the 

FDA’s program touted the ability to perform joint audits 

for both U.S. and Canadian regulations. To validate the 

combined audit approach, Health Canada launched a 

pilot Multi-Purpose Audit Program in cooperation with 

the FDA in September 2006. 

pMAP focuses on the common ground shared by both 

the FDA’s AP Program and Health Canada’s CMDCAS 

program. Its purpose is to review the effectiveness of 

a single third-party inspection/audit of a quality management 

system to satisfy both the U.S. and Canada’s 

regulatory requirements. Both of these regulatory 


What is the FDA’s Third Party Inspection Program and pMAP? (continued) 


programs already involve third-party quality system 

auditing organizations. As a result, the FDA and Health 

Canada intend to use pMAP as an opportunity to learn 

how auditing/inspection approaches can support 

several regulatory objectives at once. 

It is important to note that at the current time, the 

pMAP is mandatory for manufacturers who are seeking 

a single inspection/audit under the CMDCAS and 

AP program. pMAP does not alter or eliminate any 

previously established procedures, guidance and 

regulations. Ultimately, it is a program in itself, with its 

own set of rules and requirements. 

Progress and status of the aP and pmaP Programs 

According to a GAO report, both the AP Inspection 

Program and pMAP have had low participation among 

medical device manufacturers. From March 11, 2004 

(the date the FDA first cleared accredited organizations 

to conduct independent inspections) through January 

2008, only five inspections were conducted under the 

AP program and two audits under the pMAP. These 

numbers suggest a limited interest in these programs


Medical 

but a closer look at the program’s history and rules 

might reveal other reasons for the small numbers. 

By October 2003, the FDA met its objective to initially 

accredit 15 third-party inspection services. In the following 

years, another inspection service was added 

to that list. Yet, slow progress was made to qualify 

individual inspectors/auditors. Today, only eight of the 

16 accredited third parties are operational and offer 

independent inspections. Of those eight APs, four are 

located in the United States. 

Apparently, each auditor must follow current program 

rules by participating in three joint inspections with the 

FDA. The demand for joint inspections far exceeds the 

number of inspections offered. In fact, the FDA assigns 

the inspections to AP’s by a random draw, which can 

decrease the odds of fulfilling the required number of 

joint inspections. 

Also working against the third parties was the availability 

of training opportunities. Joint inspections are 

dependent on whether device manufacturers volunteer 

to host one. Ultimately, few manufacturers chose to do 

so. Additionally, training was limited by the availability 

of FDA performance inspectors who must monitor AP 

auditors during joint inspections. The limited availability 

of training inspections made it difficult for AP’s to plan 

auditor qualifications, which subsequently affected the 

FDA’s ability to offer third-party inspection services. 




Another reason for the low participation in the program 

might be the restrictive eligibility requirements. To 

begin with, certain device manufacturers are excluded 

from participating: 

• Those who have not been inspected by the FDA 

(baseline inspection). 

• The last inspection has been qualified as OAI (Official 

Action Indicated). 

On top of this, the AP must be accredited or recognized 

by the country where the manufacturer must or intends 

to market a device. A quick view of the FDA’s website 

shows that some AP’s appear to be recognized in just 

a few countries. In one example, an AP listed on the 

FDA’s website is recognized only in Norway. 

Further, the pMAP program has outlined an even narrower 

list of eligibility requirements for manufacturers. 

Audits not accepted for the pMAP program include: 

• Initial ISO 13485:2003 registration audits under 

CMDCAS. 

• Transfer of registration from one audit organization/ 

registrar to another. 

• Audits to support an extension to the existing scope 

of registration. 

• Special “for-cause” audits (e.g., re-audits to followup 

on major non-conformities). 

Finally, these programs are designed so that device 

manufacturers can clearly see the benefits and advantages 

to taking part. However, participation appears to 

require a “mind-set” adjustment regarding how to deal 

with FDA inspection and procedures.


Medical 

As an explanation, manufacturers wanting to market 

their products in Canada and the EU must “invite” 

CMDCAS registrars and Notified Bodies for an initial 

certification audit and surveillance audits at an annual 

interval. In the U.S., this proactive approach has not 

been the standard. Pre-market approval or pre-market 

notification clearance is all that is needed to market a 

product in the U.S. The FDA decides which manufacturers 

to inspect, and at what frequency. The FDA has 

been using a risk-based approach for these decisions. 

Now, the AP Inspection Program asks the manufacturer 

to assume a stronger role in keeping its 

facilities in compliance. The manufacturer can request 

its registrar, once qualified by the FDA, to handle the 

inspection. Taking this new approach further ensures 

the manufacturer stays in compliance and any potential 

failures in the facility are revealed early. There are 

other benefits to this approach including a reduced 

workload and costs as well as more control over the 

planning of the audit itself. 

After realizing the challenges of the AP program, the 

FDA and HC have worked on improving manufacturer 

participation. The Medical Device User Fee 

and Modernization Act (MDUFMA II) – Legislative 

Recommendations (April 30, 2007) includes proposals 

for the following changes: 

• streamline administrative burdens. 

Firms must provide the FDA 30 days notice of their 

intent to use an AP. This is a change from petitioning 

the FDA for clearance to use an AP. 

• expand participation. 

Firms may use an AP for an unlimited number of 

consecutive inspections without seeking a waiver. 

This is a change from previously using an AP for only 

two consecutive inspections. 

The FDA will continue to conduct “for cause” or follow-up 

inspections at its discretion. Additionally, the 

industry will be encouraged to provide the FDA with 

more data about the products and the facilities. 




• offer the option of submitting recent iso report. 

Firms may voluntarily submit third-party ISO reports 

that already confirm conformance with appropriate 

international quality systems standards. The FDA 

will consider information from this report while 

setting inspectional priorities. However, there is a 

caveat in that this option is still in an early stage 

and the FDA is working on guidance for this piece 

of legislation. 

In addition, Health Canada and the FDA worked 

together to identify all U.S. device manufacturers due 

for an inspection in 2008. They also reviewed which 

of these manufacturers are registered to ISO 13485 

under the CMDCAS program. Manufacturers who met 

both criteria received information in the mail about the 

pMAP program and were encouraged to participate. 

Most recently, there has been a surge of interest 

and participation in the program. In a Health Canada 

CMDCAS RBF (Registration Body Forum) meeting in 

May 2008, it was announced that five companies had 

already been successfully assessed under the pMAP 

process. Both Health Canada and the FDA (also at the


Medical 

meeting) expressed their continued commitment to 

the program. They decided that 10 successful pMAP 

audits would be “sufficient experience” to assess the 

results of the pilot. Ultimately, some of the restrictions 

might be eliminated if the assessment shows that 

multi-purpose audits are: 

• Valid. 

• Fulfill the requirements under the CMDCAS program. 

Another very promising objective arose from this meeting 

– the development of a common audit/inspection 

report format. A common report format would significantly 

reduce the time needed by the AP/Registrar to 

prepare the two submissions. This time reduction on 

the AP/Registrar’s part would reduce the additional 

service fees associated with AP/pMAP audits. 

Who should Participate and Why? 

Manufacturers who are likely to be inspected by the 

FDA and who market products in foreign countries will 

benefit from participation in the AP and pMAP program 

because they will reduce the overall number of audits/ 

inspections conducted at their establishment and they 

will gain more control over the timing and planning of 

the audit/inspection. 

Manufacturers who in the past have not been inspected 

at two-year intervals might want to consider an AP 

inspection for another reason: historic data shows that 

regularly inspected establishments are more likely to 

be found in compliance with the regulations. Regularly 

requesting an AP inspection can increase confidence 

in the manufacturer’s quality management system as 

well as its conformance to U.S. regulations. 

Finally, manufacturers not currently eligible under or 

participating in the program are encouraged to voluntarily 

host joint inspections by the FDA and a Third 

Party. In particular, manufacturers who have received 

FDA notification that they are due for an inspection 

can greatly help to advance this program by allowing a 

third party auditor to join on their next FDA inspection. 



Manufacturers who decide to volunteer for joint 

inspections should contact the FDA to request that the 

joint inspection will be conducted by an auditor from 

their own Registrar/Notified Body. This will assure this 

specific Notified Body/Registrar will advance their 

auditors through the training program and will be able 

to offer independent inspections to their clients in the 

near future. 

help keep these Programs going 

Both the Inspection by Accredited Person Program 

and the pilot Multi-Purpose Audit Program are active 

and operational. Successful audits/inspections have 

been conducted under both programs and plans have 

been made to continue expanding these numbers. 

FDA and Health Canada remain committed and have 

proposed changes and initiatives to promote and 

advance both programs. However, more participation 

is required to keep these programs alive. Consider 

the overall savings to the bottom line and it will be an 

easy decision to proactively seek involvement in these 

worthy ventures. 



www.us.tuv.com.


UTS 

The Industrial Services Group of Unified Testing 

Services (UTS) plays a major role in the ongoing, 

expansion of The Hunt Oil Refinery in Tuscaloosa, 

Alabama. 

In 2007 Hunt Refining Co. announced plans for an 

expansion of its Tuscaloosa refinery that would cost 

$450 to $500 million and double the refinery’s gasoline 

and diesel production. Hunt reported that the decision 

to expand was simply to seize an opportunity in their 

markets. Over the past couple of years, there has been 

an increase in the demand of gasoline and diesel, both 

in the United States and abroad. Although the demand 

has been rising, the capacity has stayed the same. 

The current expansion is the first for the Tuscaloosa 

refinery in more than 20 years, and it will include three 

major units: two, 2 million pound hydrocrackers, which 

produce diesel fuel and gasoline; and a $200 million, 

expanded delayed coker, which allows the refinery 

to process more and different kinds of crude oils. 

Production on the first units would begin in January 

2009, with the remaining units on line by July 2010. 

UTS’s Industrial Services Group has the capability 

of deploying a number of NDT technicians on an 

extended basis. This characteristic made the partnership 

between UTS and the Hunt Oil expansion project a 

perfect fit. Because of the duration of the project and 

the daily need for a variety of inspection techniques 

and personnel, UTS decided to place a construction 

trailer onsite, complete with darkroom capabilities 

for radiography film development and work-stations 

adequate for numerous technicians to produce multiple 

inspection reports daily. As a result of our on-site 


The Hunt Oil Refinery Doubling Capacity With Help Of Unified 

Testing Services, Industrial Services Group 

Onsite Staff Provides Continuity and Reduces Delays 

Authored by Blake Whiteside, UTS Sales Manager (Woodstock, AL) 


office, we have been able to immediately provide 

non-destructive testing and inspections to a number of 

mechanical contractors and construction companies 

working on the site without the delay or costs of travel 

time.


UTS 

The types of inspection services that UTS is providing 

on this project cover a relatively broad range, including: 

industrial radiography (RT) of welded joints in 

pressure piping systems; ultrasonic inspections (UT) to 

establish baseline thickness readings; positive material 

identification (PMI) of raw materials; liquid Penetrant 

(PT); magnetic particle (MT) testing of various welded 

components; and, visual inspections (VT) from our 

certified welding inspectors. 

This project and the model that we are using to 

execute our inspection activities are relatively new for 

our Industrial Services Group. Traditionally, we arrive 

on the scene of extended outages at power plants, 

paper mills and/or chemical plants for weeks or maybe 

even a month at a time. Having a staff onsite at The 

Hunt Refinery throughout the duration of the expansion 

has allowed us to maintain continuity and continual 

contact with our clients. As a result, we believe this 

greatly elevates our level of service to our customers. 

We plan to apply this same model to other projects in 

the future. 

Hunt Refining Company started operations in 

Tuscaloosa, Alabama in 1946. Shortly after legendary 

oilman H. L. Hunt discovered heavy, asphaltic 

crude oil near Gilbertown, Alabama, he built a small 

3,500-barrel per day asphalt refinery in Tuscaloosa to 

process the crude. Over the years, the original plant 

has been replaced and today it has a capacity of 52,000 

barrels per day. 



www.unifiedtesting.com. 


The Hunt Oil Refinery Doubling Capacity With Help Of Unified Testing Services, 

Industrial Services Group (continued)


Quality 



Department Of Homeland Security (DHS) / Private Sector 

Preparedness (PS-PREP) Certification Program 

Authored by Ken Puls, Contractor Auditor for Quality Registration Services (West Springfield, MA) 

Directed by Public Law 110-53 for implementing the 

recommendations of the 9/11 Commission Act of 2007, 

the Federal Emergency Management Administration 

(FEMA) is coordinating with the DHS toward 

establishing a common set criteria to assure business 

continuity in the private sector in their response 

to emergency or disastrous events. The voluntary 

program, known as PS-Prep, is being driven by a lack 

of comprehensive standards to support businesses in 

reducing their risk of catastrophic losses from such 

events. 

There have been six (6) core tasks delegated. Two (2) 

are completed and two (2) are in-place on an ongoing 

basis: 

• A program management structure has been established 

• An accrediting body has been selected 

• Providing program information and promotion of the 

business case (ongoing) 

• Monitoring of program effectiveness (ongoing) 

The two (2) remaining core tasks, for the designation of 

standards and for submitting a report to Congress, are 

open and continue in development. 

ANSI-ASQ National Accreditation Board (ANAB) has 

been selected as the third-party accrediting body for 

the program. Under the program, businesses will be 

able to earn ANAB-accredited management systems 

certifications for disaster preparedness, emergency 

management and business continuity. 

Relative to the designation of standards, under consideration 

are preparedness business continuity and best 

practices established under other provisions of Federal 

law and regulations, and as established by sectorspecific 

agencies. To date, this author’s research has 

surfaced several standards that have been offered by 

various agencies as models for adoption for the DHS 

PS-Prep program: 

• ISO 22399 

• ISO 22301 

• NFPA 1600 (USA) 

• BS 25999 (UK) 

• CSA Z1600 (Canada) 

• RAMCAP Plus (ASME-ITI)


Quality 


Department Of Homeland Security (DHS) / Private Sector Preparedness (PS-PREP) 

Certification Program (continued) 

Of recent note, on March 11, 2009, in a “Statement 

For the Record” to the U.S. House of Representatives 

Committee on Homeland Security Subcommittee on 

Transportation Security and Infrastructure Protection, 

William G. Raisch, Director, The International Center 

for Enterprise Preparedness (InterCEP), New York 

University, summarizes the need, proposes how-to/ 

why-to, presents the key elements of the DHS PS-Prep 

program and outlines next steps. 

As this program grows, U.S. Companies will be looking 

for this new standard in the near future. TÜVRheinland ® 

will proceed to monitor developments on this new service. 

For more details, please refer to the links below. 

reference sources for this article: 

http://www.fema.gov/business/certification/index.htm 

http://www.flaggmgmt.com/bc/presentations09/Session03-BCCS.ppt#1 

http://homeland.house.gov/SiteDocuments/20090311141136-44026.pdf 

http://www.anab.org/HTMLFiles/docs/Preparedness.pdf 



www.us.tuv.com.


NDT 

Fluoroscopy X-Ray: Not Just For Medical Use 

X-ray Plays Important Role in Non-Destructive Testing 

Authored by Stacey Bills, Sales & Marketing Representative at ndT (Caledonia, MI) 

When you think of x-ray most people would assume you 

are referring to the health industry. Not many people 

know just how important x-ray testing is to determine 

structural integrity on many everyday materials. Non 

destructive testing can be defined as applying test 

methods used to examine an object, material or system 

without impairing its function or usefulness. This terminology 

can apply to the human body, natural materials 

or any type of man-made product. Fluoroscopy testing, 

a form of x-ray, is highly recognized in the medical 

field, but most people don’t know just how beneficial 

this type of testing is in the industrial non destructive 

testing field. 

Fluoroscopy examination, often called “real-time xray” 

is applied the same way in the industrial setting 

as it is in the medical. An x-ray beam is passed through 

an object and the image is captured on an image intensifier, 

which is then read by a closed circuit camera. 

From the camera, an image is transmitted and projected 

on a screen just like a television or computer 

screen. 



It is most often used to look for internal flaws in parts 

and components. An example of a defect you can 

determine by using fluoroscopy testing is finding voids 

in castings. Another cost-effective application is to 

look inside assembled systems to determine if there 

are missing pieces, out of place components or even 

unwanted extra parts, such as washers or fasteners. 

Examples include: missing bearings in a pump assembly; 

missing needles in needle bearing for automotive 

lifters; shock absorbers for missing internal seal retainers; 

and, even mixed nuts and face cleanser for chards 

of metal or plastic from the processing and packaging 

equipment. 

Generally, inspections are driven by the cost of 

replacement, human safety, or critical application. In 

high volume manufacturing such as the automotive 

industry, inspections can help determine the costs to 

scrap an entire production lot versus segregating the 

bad components or assemblies. In the high volume, 

just-in-time manufacturing environment, scrapping 

production lots may cause a shut down up stream and 

eventually a high cost for lost time and productivity. 

Some of the more interesting fluoroscopy testing 

performed by Non-Destructive Testing Services is in 

the food industry. Some of these jobs include testing 

holiday jars of mixed nuts, salad dressings and frozen 

breadsticks for foreign non-eatable objects. In all three 

of these cases, the production company had reason to 

believe some of the batches were contaminated with 

parts that came up missing from machinery during


NDT 

Fluoroscopy X-Ray: Not Just For Medical Use (continued) 

product processing and packaging. These companies 

had three options: they could toss out the entire batch 

and incur the expenses; they could take the chance 

of selling the product as normal, risking human injury, 

potential lawsuits and unethical behavior; or, they 

could x-ray the products to determine what batches 

were contaminated and handle it accordingly. 

The end result in all three cases was that Fluoroscopy 

(real-time x-ray) was used, which saved the companies 

money and eliminated the risk of human injury. 

For more information, call TÜVRheinland ® Non- 

Destructive Testing Services toll-free at 1-800-748-0208 

or visit www.nondestructivetesting.com. 

Inspector Viewing Screen 

Aluminum Castings 

maY/09/juNe 0


TUVdotCOM 


When Budgets Shrink, Technology Investments Pay Off 

TÜVRheinland’s Business Tools Offers Security, Savings and Competitive Advantage 

Authored by Jessica Vitolo, TUVdotCoM Program Manager (newtown, CT) 

TÜVRheinland’s web platform, TUVdotCOM, offers 

security and savings for those looking to simplify the 

compliance process and give their products the competitive 

advantage. 

With a changing economy, and stringent budgets, it’s 

critical that companies demand the most out of their 

compliance dollars and employ solutions that promise 

efficiency. At the early stages of a product’s development, 

a compliance folder is created. When a product 

branches into product families, and markets span the 

globe, companies quickly realize the importance of 

competent tools to sustain growth and development. 

Often times the cost of software licenses and man 

hours necessary to keep organized and accomplish 

the corporate initiative can be grossly underestimated. 

Thankfully, a low cost solution is available. 

Keeping compliance documentation organized is not 

a simple task. Many do not consider the opportunity 

costs of using an inept filing system. Much is involved 

with structuring regulatory documents in an organized 

fashion, especially when dealing with multiple product 

lines and international regulations. Even with expensive 

computer programs, employees are needed to supervise, 

support and monitor the reliability of servers. 

The TUVdotCOM service, offered exclusively by 

TÜVRheinland ® , is an affordable option that targets 

the marketing of quality products and services as well 

as the data storage of regulatory documents. This 

internet platform offers the communication of product 

properties and informs the public of tested quality and 

safety. Users can gain or disperse compliance information 

anytime - 24/7 - in over a dozen languages, in 

real time. 


A giant in the semi-conductor industry sought an inexpensive 

solution to gain efficiency in their file storage 

and sharing software. It is with TUVdotCOM that this 

company was able to create a consolidated view of a 

product’s regulatory DNA. This central repository feature 

offers more flexibility for engineers who otherwise 

would have to organize a large amount of data and 

communicate them between OEMs, ODMs, internal 

colleagues and external customers. TUVdotCOM acts 

as a virtual assistant, sharing data with designated 

parties over secure lines, harmonizing efforts between 

Engineering, Regulatory, Marketing and Sales. 

Business owners are turning to TUVdotCOM versus 

expensive marketing channels and data housing companies. 

A small business, located in the West Coast, 

emerged on the scene with an innovative new product


TUVdotCOM 

When Budgets Shrink, Technology Investments Pay Off (continued) 

to serve the energy industry. Because the product was 

evaluated to specific standards, it became qualified to 

join the likes of other quality goods and services on the 

TUVdotCOM site. (www.tuvdotcom.com). 

TUVdotCOM affords companies, large and small, the 

opportunity to position themselves as a global player 

in this competitive market place. TÜVRheinland’s test 

marks in conjunction with TUVdotCOM delivers a 

heightened message around the world which showcases 

a commitment to third party testing from an 

industry leader. In a time where counterfeiting is at an 

all time high, TUVdotCOM is a way to protect brands 

and prove functionality. 

Various industries are enjoying the umbrella coverage 

TUVdotCOM can provide. Information stored 

goes beyond that which is issued by TÜVRheinland ® , 

a feature useful when multiple test labs are utilized. 

Online content can include non-TÜVRheinland ® issued 

safety certification in addition to documents from any 

TÜVRheinland ® office located around the world. This 

type of content is maintained by local TUVdotCOM 

experts, therefore eliminating the expense a missing 

report or certificate can cause. Information posted to 

TUVdotCOM can be secured at various tiers or made 

available for general audiences. 

Summary of Services 

• Tiered service menu 

• Affordable and timely administrative alternative 

• Usage of the TUVdotCOM Mark 

• Unique identifiers for product families, services and 

professionals 

• A marketing source from a neutral third party 

• Levels of secure, time-sensitive, access for users 

and content 

• Real time information exchange 

• Customized web page 

• Translation services 

• Document portfolio includes non-TÜVRheinland ® 

compliance documentation 


• Keywords to clearly spotlight product attributes at 

point of sale 

• Virtually unlimited amount of registered users 

• Ongoing support & maintenance 

• Generous storage capacity for relevant documents 

• Organization of critical documents: 

- Pictures 

- User manuals 

- Certificates 

- Test Reports 

- CDFs 

- International Approvals 

- Marketing brochures 

- Warrantees 

- Press Releases 

- And more… 



www.us.tuv.com.


Quality 

Congratulations to Ann Matthews, ACData Solutions 

(March) and Peter Maxon, Casey products (April) as 

the monthly winners of the TÜVRheinland ® customer 

feedback survey drawings for the Management 

System Certification (MSC) Division. Ann and Peter 

are proud winners of an elegant TÜVRheinland ® 

clock, which was recently sent to them compliments 

of TÜVRheinland ® . 

Providing customer service is critical to the MSC 

Division of TÜVRheinland ® . A customer feedback 

survey is given to all customers at the completion of 

their audit and is used to identify the following key 

points in providing good customer service: 

• Response time of services 

• Quality of services 

• Communications with staff 

• Technical competence 

• Level of knowledge 

• Level of courtesy 

• Overall impression 

• Professionalism of auditor 

If you are a quality customer, please take a few 

moments to respond to our survey and qualify as the 

winner of a TÜVRheinland ® monthly prize. Your satisfaction 

is important to us. Other response vehicles 

are available to TÜVRheinland ® customers through an 

online feedback form available at www.us.tuv.com. 

For any certification, testing or compliance questions, 

please call toll-free at 1-tUV-rheinland (1-888-743- 

4652) or visit www.us.tuv.com. 


Announcing The Monthly Customer Feedback Survey Winners 

Management System Certification Response Yields Valuable Prize For 

Lucky Contestants


TÜVRheinland ® Resources 

Tradeshows 

Windpower 2009 

McCormick Place 

Chicago, IL 

May 4-7 | Booth #2885 

del mar electronics show 2009 

Del Mar Fairgrounds 

San Diego, CA 

May 6-7 | Booth # 224 

md&m east 2009 

Medical Design & Manufacturing 

New York, NY 

June 9-11 | Booth #736 

semicon West 2009 

North Hall/Moscone Center 

San Francisco, CA 

July 14-16 | Booth #6361 

ieee emC symposium 

Austin Convention Center 

Austin, TX 

August 17-21 | Booth #505 


To view other tradeshows that TÜVRheinland ® will be exhibiting at, please visit http://www.us.tuv.com/news/tradeshows.aspx. 

Seminars 

raPs 2009 

Regulatory Affairs Professional Society 

Philadelphia Convention Center 

Philadelphia, PA 

September 13-16 | Booth #403 

arema 2009 

American Railway Engineering and 

Maintenance-of-Way Association 

Hilton Chicago 

Chicago, IL 


Quality expo 2009 

Donald E. Stephens Convention Center 

Rosemont, IL 


Pack expo 2009 

Las Vegas Convention Center 

Las Vegas, NV 

October 5-7 | Booth #S-7217 

isa expo 2009 

Reliant Center 

Houston, TX 

October 6-8 | Booth #2848 

solar Power international 2009 

Anaheim Convention Center 

Anaheim, CA 

October 27-29 | Booth #2454 

sae aerotech Congress & exhibition 2009 

Washington State Convention & Trade Center 

Seattle, WA 

November 10-12 | Booth #419 

To view the many other seminars that TÜVRheinland ® will be exhibiting at, please go to www.us.tuv.com. 

Functional safety training event 

June 8-10 | Metro Boston Area 

siemens safety/ innovation tours 

June 17 | Perrysburg, OH 

June 19 | Cleveland, OH 

To register, please go to: 

http://www.mysiemensevents.com/lists/applicationPages/cpeventlist.aspx?filterid=seid&seid=51 

U.s. Commercial service along with tÜVrheinland ® will offer a seminar: 

Challenges of exporting to the european Union: eU directives 

June 21 | San Bernardino, CA 

For more information, place call 1-tUV-rheinland (1-888-743-4652).


News 


Functional Safety Training Event 

TÜVRheinland’s Functional Safety 

Training Event 

June 8 – 10, 2009 in the Greater Boston Area 

� Learn all about functional safety 

� Avoid worldwide acceptance barriers for your products 

� Enhance your credentials 

If IEC 61508 hardware/software design is important to you, 

this Boston-area three-day seminar could be perfect. 

For more information log on to 

www.tuv.com/us/en/functional_safety_training_event.html 

or call 1-TUV-RHEINLAND (1-888-743-4652) 

TÜVRheinland ® | North American Headquarters | 12 Commerce Road | Newtown CT 06470, USA 

Aliquippa | Austin | Boston | Birmingham | Caledonia | Chicago | Detroit | Flint | Houston | Orlando 

Portland | Raleigh | Rochester | San Diego | San Francisco | Tempe | Canada | Mexico 

Copyright 2009 TÜVRheinland®. All Rights Reserved.


traci Conroy • managing editor 

TÜVRheinland ® 

12 Commerce Road, Newtown, CT 06470 USA 

Tel 203-426-0888 

Fax 203-426-4009 

Email tconroy@us.tuv.com 

www.us.tuv.com 

Market Access is published six times a year by TÜVRheinland ® . 

Subscriptions are free. This newsletter is published for the 

convenience of our customers, clients and professional 

associates. Although it is intended to provide accurate and 

authoritative information with respect to the subject matter 

covered, the information and opinions contained in this 

publication are those of the authors and not of the editor or 

publisher. The authors, editor and publisher disclaim any liability 

for any inaccuracies contained herein. Before any action is 

taken based upon the published information, it is essential that 

competent and individual professional advice is obtained. 

TÜVRheinland ® , Inc. is an equal-opportunity/affirmative 

action employer. 

mission statement 

Employees and Leadership 

our employees are the most important success factor for the TÜVRheinland ® 

group. Their engagement, competence, neutrality and performance are key. 

Services and Products 

demonstrable quality marks our services and products. This creates and 

secures competitive advantages. 

Technology and Safety 

We represent responsibly designed technology and set safety standard for 

the future. 

Customers and Markets 

Customers safeguard our existence. The customer must be convinced of the 

quality of our services in order for us to achieve success in the marketplace. 

Economic Success and a Secure Future 

Market-oriented thinking and efficient action secure the strength and 

independence of the TÜVRheinland ® group. 

Environment 

In our work, we demonstrate that environmental protection, technology and 

economics can be combined in a sustainable manner. This applies to both our 

services and our own product. 

The Public 

openness, competence, presence and neutrality as an independent third 

party determine our actions and shape our public image 

TÜVRheinland ® delivers premier independent testing, assessment, and certification services to help companies gain access 

into global markets. Boasting an international network across six continents, the company’s in-country experts ease the path to 

compliance with cost-effective pricing and quick turnaround times. The $1.5 billion corporation is compromised of an international 

network of more than 12,500 employees in 62 countries and serves most industry sectors and markets worldwide. For more 

information visit www.us.tuv.com. 

United states Canada 

Aliquippa, PA Houston, TX 

Toronto 

Austin, TX Orlando, FL 

Birmingham, AL Portland, OR 

Boston, MA Raleigh, NC 

Caldonia, MI Rochester, NY 

Chicago, IL San Diego, CA 

Detroit, MI San Francisco, CA 

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mexico 

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market access market access MAY/09/JUNE

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