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QS-9000 Requirements (per ISO element adopted)
Table
1. ISO9001-1994 Elements Embraced by the QS-9000
ISO 9000 Standard
Element
QS-9000's Further
Requirements Per Item
4.1 Management
Responsibility
- Multi-disciplinary teams
- Business Plan
- Analysis of company level data
- Process for determining customer satisfaction
- Competitive comparisons
4.2 Quality System
-
Utilization of Advanced Quality Planning/Control Plan
-
Identification of Special Characteristics
-
Utilization of cross-functional teams
-
New product manufacturing feasibility
4.3 Contract Review
4.4 Design Control
-
Use of advanced tools
-
Computer-aided design, engineering and analysis
-
Prototype program to verify production
-
Customer approval of design change
4.5 Document and Data
Control
-
Customer-referenced documents
-
Reference Special Characteristics
-
Process to review customer specifications
4.6 Purchasing
-
Customer approved list
-
Compliance to government and safety constraints
-
Subcontractor QS9000 development
-
Providing of planning info to subcontractors
4.7 Control of
Customer Supplied Product
4.8 Product
Identification and Traceability
4.9 Process Control
-
Compliance to gov't safety/environmental
regulations
-
Special Characteristics
-
Total Preventive Maintenance
-
Process monitoring and operator instructions
-
Process capability for Special Characteristics
-
Verification of job set-up
-
Production part approval
-
Appearance item control
4.10 Inspection and
Testing
-
Acceptance criteria of zero
-
Use of accredited laboratories
-
Incoming inspection criteria
-
Layout inspection
4.11 Control of
Inspection, Measurement, and Testing Equipment
-
Maintenance of records of: revision following engineering
changes, gage condition, customer notifications of suspect
material
shipments
-
Statistical Techniques
4.12 Inspection and
Test Status
-
Consistency of location with indication
-
Additional verification/identification requirements
4.13 Control of
Nonconforming Product
-
Control of suspect products
-
Utilization of rework instructions
-
Formal reduction process
- No
visible exterior rework
-
Control customer-approved decisions
4.14 Corrective and
Preventive Action
-
Disciplined problem solving
-
Customer returned product
4.15 Handling,
Storage, Packaging, Preservation, and Delivery
-
Inventory management system
-
Customer packaging standards
-
Customer labeling requirements
- Delivery performance
-
Order-driven scheduling
-
Computerized advanced shipment notice
4.16 Control of
Quality Records
-
Specification of retention periods
4.17 Internal Quality
Audits
-
Suitable work environment
4.18 Training
-
Strategic
-
Periodic evaluation of effectiveness
4.19 Servicing
-
Communication of service concerns
4.20 Statistical
Techniques
-
Consultation of Fundamental Statistical Process Control Reference
Manual (available from
AIAG)
See also:
The QS-9000 Standard
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