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Cayman Business Systems
ISO - QS 9000 Cooperative & Information Exchange
The following document is provided as a service to those seeking to achieve and/or maintain ISO and/or QS 9000 compliance.It is now December 1999. This document was originally posted in 1996. I do not intend to update it, but it may be useful to you to give you a basic understanding of how the specs fit together. With ISO/TS16949 and the year 2000 revision of the ISO900x series released, a whole new future is nearly upon us anyway!
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The Expanded Version!
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NOTE: This Alignment in this Document Is Now Technically OBSOLETE!
For Illustration / Information Only!
Requirement QS 9000 2nd Edition ISO 9001:1994 VDA 6 Management Responsibility4.1 4.1 M01. Quality Policy (Statement)4.1.1 4.1.1 M01. Quality Objectives4.1.1 4.1.1 M01.02 Organization (Quality)4.1.2 4.1.2 - Responsibility & Authority4.1.2.1 4.1.2.1 M02.02 Resources and Trained Personnel4.1.2.2 4.1.2.2 - Quality Training/Education- - M02.06, 05.02, 05.03 Mgmt. Representative (Quality System Responsibility)4.1.2.3 4.1.2.3 M02.03 Organizational Interfaces (per APQP & CP)4.1.2.3 - - Management Review4.1.3 4.1.3 M01.04 Business Plan4.1.4 - - Analysis and Use of Company-Level Data4.1.5 - - Customer Satisfaction & Customer Complaints4.1.6 - P15.05 Quality System4.2 4.2 - General4.2.1 4.2.1 - Quality System Procedures4.2.2 4.2.2 - Quality Planning (per APQP & CP)4.2.3 4.2.3 - Use Of Cross Functional Teams (per APQP & CP)4.2.3 - - Feasibility Reviews (per APQP & CP)4.2.3 2.5.1 - Control Plans (Prototype, Pre-Launch & Production)4.2.3 2.5.1 - PFMEA (per PFMEA Ref. Manual)4.2.3 2.5.1 - Key/Critical/Special Characteristics4.2.3 2.5.1 - Quality Assurance Manual- - M02, 02.01, 02.04 Contract Review4.3 4.3 P06, 06.01 General4.3.1 4.3.1 - Review4.3.2 4.3.2 - Amendment To Contract4.3.3 4.3.3 - Records4.3.4 4.3.4 - Design Control4.4 4.4 P07 General4.4.1 4.4.1 - Research & Development- - P07.01 Design & Development Planning/Tests4.4.2 4.4.2 P07.02, 07.03 Design & Development Activity Required Skills4.4.2 - - Organizational & Technical Interfaces4.4.3 4.4.3 - Design Input4.4.4 4.4.4 - Design Input (Add'l Requirements)4.4.4 - - Design Output4.4.5 4.4.5 P07.04 Design Output (Add'l Requirements)4.4.5 - - Design Review4.4.6 4.4.6 - Design Verification4.4.7 4.4.7 - Design Validation4.4.8 4.4.8 - Design Changes4.4.9 4.4.9 - Design Changes (Add'l Requirements per PPAP)4.4.9 - - Document, Data & Specification Control4.5 4.5 P16., P16.01 General4.5.1 4.5.1 - Reference Documents4.5.1 - - Document Identification for Special Characteristics4.5.1 - - Document and Data Approval & Issue4.5.2 4.5.2 - Engineering Specifications4.5.2 - - Receipt, Review, & Distribution Procedure- - P16.02 Document & Data Changes & Modifications4.5.3 4.5.3 P16.02 Purchasing (Control Of Purchases)4.6 4.6 P08, 08.02, 08.05, 08.07 General/Responsibility4.6.1 4.6.1 - Approved Material for Ongoing Production4.6.1 - - Supplier Assessment (Evaluation of Sub-Contractors)4.6.2 4.6.2 - Supplier Development4.6.2 - - Scheduling Subcontractors4.6.2 - - Purchasing Data4.6.3 4.6.3 P08.01 Restricted Substances4.6.3 - - Verification of Purchased Product4.6.4 4.6.4 P08.04 Supplier Verification at Sub-Contractor's Premises4.6.4.1 4.6.4.1 - Customer Verification of Sub-Contracted Product4.6.4.2 4.6.4.2 - Purchased Product Initial Samples (PSW)- - P08.03 Purchaser (Customer) Supplied Product4.7 4.7 P18, 18.01-03 Product Identification and Traceability4.8 4.8 M04.04, P08.08, 10.02, 10.04 Process Control4.9 4.9 P09, 10 Government Safety and Environmental Regulations4.9 - - Designation of Special Characteristics4.9 - - Tooling & Equipment (Preventative) Maintenance4.9 - P10.05, 10.06 General4.9.1 - - Written Work/Process Instructions4.9.1 - P09.01 Process Parameter Monitoring4.9.1 - - Preliminary Process Capability Requirements4.9.2 - - On-Going Process Performance Requirements4.9.3 - - Modified Beginning/On-Going Capability Requirements4.9.4 - - Verification of Job Set-Ups4.9.5 - - Process Changes/Change Control4.9.6 - P10.07 Appearance Items4.9.7 - - Inspection and Tests4.10 4.10 P110.03, 11 General4.10.1 4.10.1 - Acceptance Criteria4.10.1 - - Accredited Laboratories4.10.1 - - Receiving Inspection & Testing4.10.2 4.10.2 P08.06, 11.01 Incoming Product Quality4.10.2 - - Written Inspection & Test Instructions- - P09.06 First Piece Inspection- - P09.04 In-process Inspection & Testing4.10.3 4.10.3 P09.05 Final Inspection & Testing4.10.4 4.10.4 P11.03 Layout Inspection & Functional Testing4.10.4 - - Inspection & Test Records4.10.5 4.10.5 - Inspection, Measuring and Test Equipment4.11 4.11 P12, 12.02 General4.11.1 4.11.1 - Control Procedure4.11.2 4.11.2 - Records4.11.3 - - Calibration Recall & Control System- - P12.01, 12.04 Calibration Procedures- - P12.01 Gage R&R Studies (Measurement Systems Analysis)4.11.4 - P12.03 Inspection and Test Status (Indication Of)4.12 4.12 - Product Location4.12 - - Supplemental Verification4.12 - - Control of Nonconforming Product4.13 4.13 P13, 13.01 General4.13.1 4.13.1 - Suspect Product4.13.1 - - Nonconformity Review & Disposition4.13.2 4.13.2 - Control of Reworked Product4.13.3 - - Deviations (Eng. Approved Product Authorization)4.13.4 - P13.02 Corrective Action4.14 4.14 P14, 14.01-02, 13.03, 13.04 General4.14.1 4.14.1 - Problem Solving Methods4.14.1 - - Corrective Action4.14.2 4.14.2 - Returned Product Test/Analysis4.14.2 - - Recurring Defect Prevention (Prevention Action)4.14.3 4.14.3 P14.04 Customer Returns Analysis & Monitoring- - P06.04, 06.05, 17.05 Failure Analysis - Root Cause- - P06.05, 14.03 Handling Storage, Packaging and Delivery4.15 4.15 P15 General4.15.1 4.15.1 - Handling4.15.2 4.15.2 P15.01 Storage4.15.3 4.15.3 - Inventory4.15.3 - - Packaging4.15.4 4.15.4 P15.03 Customer Packaging Standards4.15.4 - - Labeling4.15.4 - - Preservation4.15.5 4.15.5 - Transportation- - P15.02-03 Delivery4.15.6 4.15.6 - Supplier Delivery Performance Monitoring4.15.6 - - Production Scheduling4.15.6 - - Shipment Notification System4.15.6 - - Quality Records4.16 4.16 P16, 16.01, 11.01, 11.02 Records Retention4.16 - P16.04 Superseded Parts4.16 - - Costs Related to Quality- - M03, 03.01 Management Reports & Monitoring- - M01.03 Prevention Costs- - M03.02 Appraisal Costs- - M03.03 Internal Failure Costs- - M03.04 External Failure Costs- - M03.05 Internal Quality Audits4.17 4.17 M02.05, 02.06 Inclusion of Working Environment4.17 Training4.18 4.18 M05, 05.01, 05.04 Training as a Strategic Issue4.18 - - Process & Operations- - M05, 05.01 Formal Qualification (Certification, Etc.)- - M05.05 Induction Training Program- - M05.04 Servicing4.19 4.19 - Feedback of Information from Service4.19 - - SPC & Statistical Techniques4.20 4.20 P17, 17.03 Identification of Need4.20.1 4.20.1 - Procedures4.20.2 4.20.2 - Selection of Statistical Tools4.20.2 - - Knowledge of Basic Statistical Concepts4.20.2 - - Machine Capability Studies- - P09.02 Process Capability Studies- - P09.02 Process Performance Studies- - Ongoing Process Control- - P17.02, 17.04 Process Corrective Action- QS 9000 - Section IISector Specific Requirements from QS 9000 Production Part Approval Process- General1.1 Engineering Change Validation1.2 Continuous Improvement General2.1 Quality & Productivity Improvements2.2 Techniques for Continuous Improvement2.3 Manufacturing Capabilities Facilities, Equipment, and Process Planning & Effectiveness3.1 Mistake Proofing3.2 Tool Design & Fabrication3.3 QS 9000 - Section IIICustomer Specific Requirements from QS 9000 ChryslerSignificant Characteristics Annual Layout Internal Quality Audits Design Validation/Production Verification (Yearly) Corrective Action Plan (Chrysler 7D elements) Packaging, Shipping and Labeling Process Sign-Off FordControl Plans & FMEAs Shipping Container Label Equipment Standard Parts Critical Characteristics Set-Up Verification Control Item Fasteners Heat Treating Process & Design Changes for Supplier Responsible Designs Supplier Modification of Control Item Requirements Engineering Specification (ES) Test Performance Requirements System Design Specification Ongoing Process Monitoring Prototype Part Quality Initiatives QOS Qualification & Acceptance Criteria for Materials General MotorsGeneral Procedures & Other Requirements Miscellaneous Requirements Product Liability User/Installation Instructions Product Safety & Reliability Cleanliness & Working Conditions