TERUMO CARDIOVASCULAR SYSTEMS TITLE: Supplier Questionnaire Request ************************************************************************************* Company Name Supplier Contact: Name Company Website Email Phone Manufacturing/ Service Location Other facilities used by Terumo CVS? (e.g. shipping) Remit N/A Street Address City, State Postal Code, Country Phone Yes No If yes, please explain: Street Address City, State Postal Code, Country Phone How long in operation? Total number of employees at this site? Number in Quality: Manufacturing: Engineering: Temporary: Is your company registered with the FDA? FDA registration number, if applicable Percentage of customers in medical device industry? Size of Facility in square feet: Scope and overall summary of primary products / services provided at this facility: Does your company have a quality policy? Yes No If yes, please state or attach policy Does your company rely on third party contract manufacturers? Yes No N/A If yes, please explain: Does your company provide sterilization services or contract a 3rd sterilization service provider? Yes No N/A If yes, please explain: Does your company rely on third party design/engineering providers? Yes No N/A If yes, please explain: Does your facility have a clean room with established environmental controls? Yes No N/A If yes, please explain:
10 Does your company have work instructions that are used to control manufacturing (or service) processes, inspection operations and product/equipment release testing? 5: Work Instructions established 3: Informal process exists 1: No Work Instructions established 11 Does your company have an Inspection and Testing Policy/Procedure? 5: Policy/ Procedure established 3: Informal system exists 1: No Policy/ Procedure established 12 Does your company have a Training Policy/ Procedure? 5: Policy/ Procedure established 3: Informal system exists 1: No Policy/ Procedure established 13 Does your company have Calibration Policy/Procedure? N/A 5: Policy/ Procedure established 3: Informal system exists 1: No Policy/ Procedure established 14 Does your company have a Control of Nonconforming Material/Product/Service (NCR) Policy/Procedure? 5: Policy/ Procedure established 3: Informal system exists 1: No Policy/ Procedure established 15 Does your company have a Corrective and Preventive Action (CAPA) and Complaint Handling Policy/Procedure? 5: Policy/ Procedure established 3: Informal system exists 1: No Policy/ Procedure established 16 Does your company have a Handling, Storage, Packaging, and Delivery Policy/Procedure? N/A 5: Policy/ Procedure established 3: Informal system exists 1: No Policy/ Procedure established 17 Does your company have a Statistical Techniques and Sampling Plan Policy/Procedure? N/A 5: Policy/ Procedure established 3: Informal system exists 1: No Policy/ Procedure established 18 Does your company have a Process Validation Policy/Procedure? N/A 5: Policy/ Procedure established 3: Informal system exists 1: No Policy/ Procedure established 19 Does your company have a Risk Management Policy/Procedure? 5: Policy/ Procedure established 3: Informal system exists 1: No Policy/ Procedure established 20 Does your company have an independent quality organization/department? 5: Independent Quality Department 3: Quality Department is not independent 1: No Quality Department Supplier Questionnaire Completion (To be completed by Supplier) Supplier’s Representative Sign: Print: Date: Title: Questionnaire Return Instructions Please return completed Supplier Questionnaire Request via e-mail E-mail: Attn: Supplier Quality Engineering