TÜV SÜD

TÜV SÜD

ISO 9001 Getting Maximum Value

Headline here in one or two linesSubhead here in one or two lines

2

Interior blue call outs should go here

TÜV SÜD America Inc. is an international certification organization providing professional management systems certification, product testing and certification services. As a Notified Body, the Medical Health Services unit at TÜV SÜD America offers Auditing, Testing, and review services to help ensure acceptance and success of your Medical Device products in global marketts.

As a Notified Body, we conduct the legally prescribed test and certification for you throughout the world – from disposable syringes to complex products in the fields

of cardio and neurosurgery to large machines for tumor radiation – no matter what risk class your product belongs to, TÜV SÜD America’s expertise is available during all development phases. Anywhere worldwide. More than 1,000 customers globally trust in our abilities and market reputation. The result: shorter cost-intensive development times with smooth test procedures.

ISO 9001 Certification Demonstrates Your Quality Commitment to International Markets - But Is That Enough?

Your organization is one of thousands of companies worldwide using ISO 9001 to help manage processes to become more efficient and cost-effective. As a result of your certification, you’ve probably realized some or all of the following:

Improved operational efficiency New access to national and international markets Immediate recognition of commitment to quality

and continuous improvement

Today’s global marketplace is placing relentless pressure upon your organization to lower your costs, improve your quality, and increase your speed to market. Your competitive advantage is dependent on finding the right balance of those three factors. You need your ISO certification to move beyond the minimal framework of the standard. It should help enhance your performance, leading to:

Increased profits Enhanced reputation Improved customer satisfaction Increased productivity as the correct data, equipment, and

documentation are integrated into the total process Decreased operating costs due to fewer problems and

reduced rework…not to mention fewer returns and lower after-sales support costs

Elevated confidence among sales force as quality improves

If this isn’t happening, consider rolling over your ISO 9001 and other applicable certifications to TÜV SÜD America.

Getting Maximum Value with Insight Auditing®

As the ISO 9001 auditing process has evolved over the years, so has TÜV SÜD America. We’ve taken the process to new heights with Insight Auditing®. It’s more

than a process, it’s an attitude.

Our auditors are experienced, well trained, and insightful. But above all, they’re passionate about their work. They come to your facility with a fresh eye and out-of-the-box thinking. They take the time to listen to you and understand your business, so they can add value beyond the auditing process. We “read between the lines” of the audit to uncover observations that can lead to higher efficiency, reduced costs, and increased speed to market.

An ISO 9001-based Quality Management System should be more than a checklist of requirements. Used properly, it is empowering and dynamic, providing information to drive organizational improvements. Over the years, TÜV SÜD America has refined its approach, helping companies maximize the value of ISO 9001 certification.

America

2

Headline here in one or two linesSubhead here in one or two lines

3

Interior blue call outs should go here

TÜV SÜD America Inc. is an international certification organization providing professional management systems certification, product testing and certification services. As a Notified Body, the Medical Health Services unit at TÜV SÜD America offers Auditing, Testing, and review services to help ensure acceptance and success of your Medical Device products in global marketts.

As a Notified Body, we conduct the legally prescribed test and certification for you throughout the world – from disposable syringes to complex products in the fields

of cardio and neurosurgery to large machines for tumor radiation – no matter what risk class your product belongs to, TÜV SÜD America’s expertise is available during all development phases. Anywhere worldwide. More than 1,000 customers globally trust in our abilities and market reputation. The result: shorter cost-intensive development times with smooth test procedures.

This is the IDEAL Process ™

Everything ISO and More

We are a leading global Certification Body, with 750 + experts in over two dozen locations across the U.S., Canada, and Mexico. Our international operations are in more than 30 additional countries.

Our ISO expertise covers: AS9100 EN 15038 Quality Management for Translation

Service Providers ESD S20.20 ISO 9001 ISO 13485 ISO 14001 ISO/TS 16949 OHSAS 18001 Supplier Auditing Services Telecom Services

TL 9000 Training ISO 22000

In addition, we are an internationally recognized testing, inspection, and certification organization offering the highest quality service for a wide range of industries.

We have the resources to help you create an integrated, global, comprehensive certification/testing/inspection strategy.

Market Segments Implementing ISO 9001

TÜV SÜD America is your one stop for all your management system certification needs. Discover how ISO 9001 and our Insight Auditing® process can help your organization save time, reduce cost, and improve market access.

Aerospace Automotive Consumer Products Food Furniture General Manufacturing Medical Equipments Power Telecom Service/Call Center

Visit www.tuv-sud-america.com or call 800-TUV-0123.

3| 2

013

© T

ÜV S

ÜD A

mer

ica

Inc.

| US-

MKG

| PO

S 40

01

Call to action in one or two lines depending on lengthwww.tuvamerica.com

info@tuvam.com

www.tuv-sud-america.com

info@tuvam.com

Your Contacts for ISO 9001Services

Our global officesUSA

TÜV SÜD America Inc. 10 Centennial Drive Peabody, MA 01960 Tel. + 978-573-2500

TÜV SÜD America Inc. 1775 Old Highway 8 NW, Suite 104 New Brighton, MN 55112 Tel. +651-631-2487

TÜV SÜD America Inc. 10040 Mesa Rim Road San Diego, CA 92121 Tel. +1 858 -678-1400

Europe

Germany TÜV SÜD Product Service GmbH Ridlerstrasse 65 80339 Munich Tel. +49 (0) 89 - 50 08 - 43 58

Italy TÜV Italy SrI Via Isonzo, 61 40033 Casalecchio di Reno (BO) Tel. +39 (0) 051- 298 74 11

Turkey TÜV SÜD Teknik Güvenlik ve Kalite Denetim Ticaret Ltd. Sti Yildiz Posta Caddesi No: 17 Kat: 5 34394 Esentepe-Istanbul Tel. +90 (0) 212 347 98 10 (262)

United Kingdom TÜV Product Service Ltd. Octagon House, Concorde Way Segensworth North Fareham – Hampshire PO15 5RL Tel. +44 (0) 1489 -55 82 17

Asia-Pacific

China TÜV SÜD China No. 88 Heng Tong Road 200070 Shanghai Tel. +86 21 6141 0123

Hong Kong TÜV SÜD Hong Kong 3/F, West Wing Lakeside 2 10 Science Park West Avenue, Shatin Tel. +852-2776-1323

India TÜV SÜD South Asia Pte. Ltd. Off Saki Vihar Road, Saki Naka, Andheri (East) Mumbai - 400072 Tel. +91 22 30829797

Indonesia TÜV SÜD PSB Indonesia, PT. PSB Building JI. Pesanggrahan Raya Meruya Utara, Kembangan Jakarta Barat 11620 Tel. +62 (21) 5890 5633

Japan TÜV SÜD Japan Sumitomo Fudosan 3-Bldg. 7F 4-15-3 Nishi-Shinjuku Shinjuku-ku 160-0023 Tokyo Tel. +81 3 33724281

Korea TÜV SÜD Korea 12F, KLI63 Bldg., #60 Yoido-Dong, Youngdeungpo-Gu Seoul, 150-763 Tel. +82 2 3215 1100

MalaysiaTÜV SÜD PSB Malaysia Unit 842 & 846 Block A, Kelana Centre Point Jalan SS7/19, Kelana Jaya 47301 Petaling Jaya Selangor Darul Ehsan Tel. +60 3 7880 1995

PhilippinesTÜV SÜD PSB Philippines Unit 1808, The Orient Square Bldg. F. Ortigas Jr. Ave Ortigas Center, Pasig City Metro Manila 1605 Tel. +632 687 5673

SingaporeTÜV SÜD PSB 1 Science Park Drive Singapore 118221 Tel. +65 6885 1270

Taiwan TÜV SÜD Taiwan 7F., No.37, Sec. 2 Zhongyang S. Rd. Beitou District Taipei City 11270 Tel. +886 2 2898 6818

Thailand TÜV SÜD PSB (Thailand) Co. Ltd. Thailand Science Park 111 Moo 9 Paholyothin Rd. Klong 1, Klong Luang Pathumthani 12120 Tel. +66 2 564 8041

VietnamTÜV SÜD PSB Vietnam 6th Floor, 151 Bis Vo Thi Sau Street Ward 6, District 3 Ho Chi Minh City Tel. +84 8 820 8831