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Quality Systems

ISO 9001:2000 and AS9100

PROPRIETARY STATEMENT GOES HERE Lockheed Martin Aeronautics Company


What are the 20 Clauses of ISO 9001:1994

 Quality System Requirements  Continued


 4.1 Management  4.11 Control of inspection,
Responsibility measuring, and test equipment
 42. Quality system  4.12 Inspection and Test status
 4.3 Contract Review  4.13 Control of Nonconforming
 4.4 Design Control product
 4.5 Document and data  4.14 Corrective & Preventive action
control  4.15 Handling, Storage, packaging,
 4.6 Purchasing preservation, and delivery
 4.7 Control of customer-  4.16 Control of quality records
supplied product  4.17 Internal Quality Audits
 4.8 Product Identification &  4.18 Training
traceablity  4.19 Servicing
 4.9 Process control  4.20 Statistical Techniques
 4.10 Inspection and Testing

PROPRIETARY STATEMENT GOES HERE Lockheed Martin Aeronautics Company


Focus on QMS areas of ISO 9001:1994

Customer Vendor
3 Contract Review 7 Control of
(Sub-Contractor)
Customer-Supplied
6 Purchasing
4 Design Control Product
2 Quality System

1 Management
Responsibility 14 Corrective & Product Control
Preventive Action
11 Inspection, Measuring
& Test Equipment
5 Document & Process Control
Data Control 16 Control of 12 Inspection
Quality Records & Test Status
9 Process Control 10 Inspection
& Testing

19 Servicing 8 Product
18 Training 15 Handling, Storage, Identification &
Packaging, Preservation Traceability
& Delivery 13 Control of
17 Internal
20 Statistical Non-Conforming
Quality Audits
Techniques Product
PROPRIETARY STATEMENT GOES HERE Lockheed Martin Aeronautics Company
ISO 1994:2000 - Quality Management Principles

1. Customer-focused Organization
2. Leadership
3. Involvement of People
4. Process Approach
5. System Approach to Management
6. Continual Improvement
7. Factual Approach to Decision Making
8. Mutually Beneficial Supplier Relationships

PROPRIETARY STATEMENT GOES HERE Lockheed Martin Aeronautics Company


ISO 9001: 1994 - what is different?

 SECTIONS  PARAGRAPHS - 1994


 Quality management system  4.2, 4.5, 4.16
 Put structure in what you do
 Management responsibility  4.1, 4.2, 4.3
 Put someone in charge
 Resource management  4.1, 4.9, 4.18
 Provide the resources to
achieve goals
 Product realization  4.2, 4.3, 4.4, 4.6,4.7, 4.8, 4.9, 4.10,
 Design and make it to 4.11, 4.12, 4.15, 4.19,4.20
requirements
 Measurement, analysis and  4.10, 4.17, 4.13, 4.14, 4.20
improvement
 Know where you are and get •NOTE: Major paragraphs of 1994 are
better
covered in 2000; the new standard
has comparison tables in the back

PROPRIETARY STATEMENT GOES HERE Lockheed Martin Aeronautics Company


Why change from 1994 to 2000?

 Requirement for Continuous Improvement every 5 years


 World Wide Customer Needs Analysis
 No requirement for product to meet customer requirements
 Product not Process oriented
 No one operates in 20 elements
 No look at how element affects Process
 Omits Software and Service
 Requirement was for Compliant System not Compliant Product

 PRODUCT and PROCESS must meet Customer Requirements


 Continuous Improvement
 Customer Feedback
 Customer Satisfaction
 Analysis

PROPRIETARY STATEMENT GOES HERE Lockheed Martin Aeronautics Company


ISO 9001:2000 - Model of a process based quality
management system

Continual Improvement of the Quality Management System

 CUSTOMER CUSTOMER
Management
Responsibility

Management Management
Satisfaction
Responsibility Responsibility

input Product outpu


Requirements Product
Realization

Value added activities


Information Flow

PROPRIETARY STATEMENT GOES HERE Lockheed Martin Aeronautics Company


ISO9001 versus AS9100 - What the AS added?

 The earlier AS 9100 version was formatted to match the new ISO
9001:2000 and added “requirements” that provide for -
 Regulatory organizations interfaces
 Configuration Management
 Design and Development V& V., & V&V testing
 Control of changes in Production Process
 Control of production equipment, tools, NC machines
 Control of work in outside facilities
 Control of service operations
 First Article Inspection
 Inspection documentation

 These added requirements enables a standardized approach to supplier


flow down requirements

PROPRIETARY STATEMENT GOES HERE Lockheed Martin Aeronautics Company


ISO and AS and Regulatory Agencies

 FAA issued letter (09/25/00) recognizing AS9100 Quality systems

 FAA participates in US ISO TAG as a US Govt.. Agency - recognizes ISO


as a the system of “choice” by DoD

PROPRIETARY STATEMENT GOES HERE Lockheed Martin Aeronautics Company