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Physio-Control, Inc

11811 Willows Road Northeast


PO Box 97006
Redmond, WA 98073-9706 USA
Company Confidential

Date __11/2/07__________

Company Name: __Qualitel Corporation________


ATTN. : __Jorry Lee ___________
ADDRESS: __4608 150 AVE NE__________
__Redmond, WA 98052 ______

Dear Potential Supplier to Physio-Control:

Enclosed is a written survey. This survey is a basic requirement of


the Physio-Control Supplier Selection process. It is also a requirement
of the regulatory agencies that control the distribution of Medical
Devices in various regions around the world including the US FDAs QSR
(21 CFR 820) and the European Union Directive 93/42/EEC (ISO
13485:2003). The appropriate commodity team will review the results
of this survey. The answers provided could result in an audit of your
quality systems. If your systems do not fully agree with the preprinted
statements, please explain your system with an attachment. Your
timely attention to this matter is appreciated.

Return to Physio-Control
P.O. Box 97006
Redmond, WA 98073-9706

Attn: __________________________________

Supplier Written Survey Form: 7000131.J attachment Page 1 of 9


Physio-Control, Inc
11811 Willows Road Northeast
PO Box 97006
Redmond, WA 98073-9706 USA
Company Confidential

PHYSIO-CONTROL

SUPPLIER WRITTEN SURVEY

SECTION 1: GENERAL INFORMATION

COMPANY INFORMATION

Company name: Qualitel Corporation

Address of office: 4608-150 AVE NE, Redmond, WA 98052

Address of plant: 4608-150 AVE NE, Redmond, WA 98052

Subsidiary of: NA

Phone: 425-702-8887 Fax: 425-702-8885

Name and title of person completing this survey. Jorry Lee, Quality Manager

Date of completion. 11/5/07

Contact name and title of person responsible for corrective action issues.

Jorry Lee, Quality Manager Phone 425-702-88887 ext238

Company Internet address: www.qualitelcorp.com

How long has the company been in this location? 11 years

Are there any other manufacturing locations? Please describe: No

Primary product or service: EMS, SMT, TH, HLA SIC#: 3672, 3679

How long has the company been in the business of manufacturing this product? 21 yrs

Has your company ever been stopped from shipping product due to regulatory or Agency
compliance issues? NO
If Yes – Please provide a summary of the dates, problem, and corrective action.

Supplier Written Survey Form: 7000131.J attachment Page 2 of 9


Physio-Control, Inc
11811 Willows Road Northeast
PO Box 97006
Redmond, WA 98073-9706 USA
Company Confidential

Supplier Written Survey Form: 7000131.J attachment Page 3 of 9


Physio-Control, Inc
11811 Willows Road Northeast
PO Box 97006
Redmond, WA 98073-9706 USA
Company Confidential

Number of employees:
Department Number of Responsible Person/Title
Employees
Quality 11 Jorry Lee/Quality Manager
Production 47 Rodger Nelson/VP Operations
Mfg. Eng. 5 Hoa Hoang/Engineering Manager
Design Eng. NA
All Others 20 Rodger Nelson/VP Operations
Total Number of 82
Employees in Company

Number of shifts being worked: 2 Shifts Hours per shift: 8, 2nd Shift SMT Only

Does your quality system meet any of the following quality specifications? (check all that
apply)

ISO9001:2000_X__, USA FDAs QSR _X__ , ISO 13485:2003 _X__, Other _AS9100__

Please provide an uncontrolled copy of your quality system manual.

-If you are registered to one of the above listed quality systems, please provide a copy of your
registration.
See attached
-If you are not registered, but are working toward registration, please complete the following:

Quality System
Expected registration date:
Have you ever been audited or surveyed for compliance to the requirements of the current Good
Manufacturing Practices for Medical Devices by the Food and Drug Administration or a
customer? If so, when and by whom?

Supplier Written Survey Form: 7000131.J attachment Page 4 of 9


Physio-Control, Inc
11811 Willows Road Northeast
PO Box 97006
Redmond, WA 98073-9706 USA
Company Confidential

FINANCE

Is the company privately or publicly owned? Privately What is your Stock Symbol? NA
For the last 3 years, what were annual revenues? (Can you provide an annual report or financial
statements from the previous 3 years.) $7.5M (2004) , $7.4M(2005), $9.5M(2006)
What was net income for the last 3 years? Profitable 1.5-6%
Is there any history of bankruptcy, tax seizure, or similar difficulties? If yes, please describe:
No

Is the company involved in any current or pending litigation? If yes, please describe:
No

Name your top five customers:


Astronics

Esterline Korry

Lucent Medical (Medtronic & Bard)

Avtech

Siemens Medical

Name your top 3 suppliers:

Arrow

Future Electronics

TTI

Name your top 3 competitors:

Applied Technical Services

Technical Services Inc.

Benchmark

Supplier Written Survey Form: 7000131.J attachment Page 5 of 9


Physio-Control, Inc
11811 Willows Road Northeast
PO Box 97006
Redmond, WA 98073-9706 USA
Company Confidential

What percent of the market share does your company possess? 10%

Do you have offshore manufacturing operations? No

List areas of core competency and/or technical expertise.


High-reliability SMT/TH/PCBA/BGA Electronics Manufacturing and Box-build/test.

What percentage of cost reduction on an annual basis do you commonly provide to your
customers? 5%

What is your Financial Rating (D&B)? NA


Can you sign a long term contract (minimum of 3 years)? Yes

Can you provide dedicated Key Account Support staff to our account? Yes
What level of support can you provide in obtaining regulatory approval of the products you
commonly provide? Quality Manager support in completing forms and document

Please provide the following;


• An organization chart (attach contact names and phone numbers).
• A copy of your facility layout

USA Federal Debarment


Is your company or are any of your employees, representatives, consultants, or
contractors on the USA Federal Debarment list per sections 306(a) and (b) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 335(a) and (b)) as published in the FEDERAL
REGISTER? No

Targeted Business Concerns


Identify if your company is qualified to any of the following business
concerns;

o Small Business Concern


Small Disadvantaged Business Concern
o Women-Owned Business concern
o Large Business Concern
o Veteran Owned Business Concern
o Service-Disabled Veteran Small Business Concern
o Non-Profit Business Concern
o Foreign Business Concern
o Historical Black Colleges & Universities/Minority Institutions
o HUB Zone Small business Concern

Supplier Written Survey Form: 7000131.J attachment Page 6 of 9


Physio-Control, Inc
11811 Willows Road Northeast
PO Box 97006
Redmond, WA 98073-9706 USA
Company Confidential

SECTION II: QUALITY SYSTEM INFORMATION

Please indicate all that apply using check marks.


Attach additional information or objective evidence as appropriate (including
US FDA Registration Number, European MDD Facility CE Certification & expiration date,
Australia TGA Certificate & date, Canadian TPD License & date, Japan Overseas Manufacturer
Accreditation Certificate, etc.)

QUALITY SYSTEM CERTIFICATIONS or REGISTRATION


Identify the Quality System compliance or certification (please include a copy)

Quality Systems Regulation (21CFR820) ISO 9001:2000

ISO 13485:2003  TS 16949

Other _AS9100___________________

QUALITY SYSTEM (QS)


Identify specific QS elements (parentheses implies including)

Management review Quality audit program (internal)

Training programs  Design Verification

 Design Validation  Design Transfer

Design Changes (change control)  Design Risk & Hazard analysis

Document & data control Software validation

Supplier Selection and Management Supplier audit program

Process capability (characterization and verification) Process change control

Process controls (process control planning, acceptance, SPC)  Process Risk analysis (PFMEA)

Process Validation (IQ, OQ, PQ) Equipment Qualification (IQ/PM)

Test method (validation) Calibration program

Acceptance activities (IQA, in-process, final) Control of non-conforming product

CAPA (improvement, CA, PA, effectiveness) Failure analysis

Product ID Quality records

Complaint management  Customer IP protection

Traceability Service (returns)

Statistical methods Other ________________________

Supplier Written Survey Form: 7000131.J attachment Page 7 of 9


Physio-Control, Inc
11811 Willows Road Northeast
PO Box 97006
Redmond, WA 98073-9706 USA
Company Confidential

Supplier Written Survey Form: 7000131.J attachment Page 8 of 9


Physio-Control, Inc
11811 Willows Road Northeast
PO Box 97006
Redmond, WA 98073-9706 USA
Company Confidential

HARMONIZED STANDARDS
Check any industrial or other harmonized standards (please provide a copy)

 QS 9000  ISO 14001

 ISO 17025  ISO 14971:2000

List any FAA standards___AS9100__________  List any AAMI standards_____________

 List any IEC standards _______________________  List any ME standards


__________________________

 List any EE standard_________________________ Attach workmanship


Standards___________________ J-STD-001, IPC-A-610-D

 List any FMEA standard______________________  List general standards (i.e. Boeing)


________________

 Other (specify) ________________________

QUALITY REQUIREMENTS
Check and list limits/goals

 Reliability threshold: < _______________________  Process Capability Cpk > ______________

 Defect Goal: < ____________________PPM  Trending/Triggering Thresholds ____________

Other (specify) _100% Inspection___________________

Supplier Written Survey Form: 7000131.J attachment Page 9 of 9