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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