Professional Documents
Culture Documents
Date __11/2/07__________
Return to Physio-Control
P.O. Box 97006
Redmond, WA 98073-9706
Attn: __________________________________
PHYSIO-CONTROL
COMPANY INFORMATION
Subsidiary of: NA
Name and title of person completing this survey. Jorry Lee, Quality Manager
Contact name and title of person responsible for corrective action issues.
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.
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__
-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?
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
Esterline Korry
Avtech
Siemens Medical
Arrow
Future Electronics
TTI
Benchmark
What percent of the market share does your company possess? 10%
What percentage of cost reduction on an annual basis do you commonly provide to your
customers? 5%
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
Other _AS9100___________________
Process controls (process control planning, acceptance, SPC) Process Risk analysis (PFMEA)
HARMONIZED STANDARDS
Check any industrial or other harmonized standards (please provide a copy)
QUALITY REQUIREMENTS
Check and list limits/goals