Scale Rating Established: Informal System: Not Established: Defined, May have procedure Process is not documented (in but not documented defined, writing or or may be documented (in electronically), documented but no writing or and implemented formal procedure electronically), and # Question exists implemented Does your company’s Quality 5: QMS is 3: QMS exist but 1: No documented Management System (QMS) currently certified to ISO not certified to ISO QMS 1 meet national or international standard standard standards (i.e. ISO 9001)? Does your company have a Quality 5: Quality 3: Quality Manual 1: No Quality Manual that describes the systems and Manual documented but not Manual established 2 controls to assure the quality of its established rev controlled products and/or services? Does your company have a Contract 5: Policy/ 3: Informal system 1: No Policy/ Review Policy/Procedure? Procedure exists Procedure 3 established established Does your company utilize a 5: Policy/ 3: Informal system 1: No Policy/ documented engineering change Procedure exists Procedure 4 control system (EC/ECO) established established Policy/Procedure? Does your company have a Document 5: Policy/ 3: Informal system 1: No Policy/ 5 and Quality Records Control and Procedure exists Procedure Retention Policy/Procedure? established established Does your company have a Purchasing 5: Policy/ 3: Informal system 1: No Policy/ Policy/Procedure that includes Procedure exists Procedure requirements for maintaining an established established 6 Approved Supplier List (ASL) for product and service providers with product and/or quality system impact? Does your company use Good 5: Policy/ 3: Informal system 1: No Policy/ 7 Documentation Practices (GDP’s)? Procedure exists Procedure established established Does your company utilize controlled 5: Documentation 3: Informal system 1: No 8 travelers, work orders, bill of established exists documentation materials, or job routers? established Does your company have an 5: Policy/ 3: Informal system 1: No Policy/ Identification and Traceability Procedure exists Procedure Policy/Procedure that can be utilized established established 9 to determine date of manufacture/service and product/equipment status?
# Question Scale Rating Established: Defined, documented (in writing or electronically), and implemented Informal System: May have procedure but not documented or may be documented but no formal procedure exists Not Established: Process is not defined, documented (in writing or electronically), and implemented 1 Does your company’s Quality Management System (QMS) currently meet national or international standards (i.e. ISO 9001)? 5: QMS is certified to ISO standard 3: QMS exist but not certified to ISO standard 1: No documented QMS 2 Does your company have a Quality Manual that describes the systems and controls to assure the quality of its products and/or services? 5: Quality Manual established 3: Quality Manual documented but not rev controlled 1: No Quality Manual established 3 Does your company have a Contract Review Policy/Procedure? 5: Policy/ Procedure established 3: Informal system exists 1: No Policy/ Procedure established 4 Does your company utilize a documented engineering change control system (EC/ECO) Policy/Procedure? 5: Policy/ Procedure established 3: Informal system exists 1: No Policy/ Procedure established 5 Does your company have a Document and Quality Records Control and Retention Policy/Procedure? 5: Policy/ Procedure established 3: Informal system exists 1: No Policy/ Procedure established 6 Does your company have a Purchasing Policy/Procedure that includes requirements for maintaining an Approved Supplier List (ASL) for product and service providers with product and/or quality system impact? 5: Policy/ Procedure established 3: Informal system exists 1: No Policy/ Procedure established 7 Does your company use Good Documentation Practices (GDP’s)? 5: Policy/ Procedure established 3: Informal system exists 1: No Policy/ Procedure established 8 Does your company utilize controlled travelers, work orders, bill of materials, or job routers? 5: Documentation established 3: Informal system exists 1: No documentation established 9 Does your company have an Identification and Traceability Policy/Procedure that can be utilized to determine date of manufacture/service and product/equipment status? 5: Policy/ Procedure established 3: Informal system exists 1: No Policy/ Procedure established