As 9100 Module 1

One Day
AS 9100B:2004
Course
Module 1
© LCL Management Services Tel/fax 905-593-8867 email: artjlewis@rogers.com Issue 2 - 01/01/06 Slide 1
Art Lewis – Consultant/Trainer/Auditor
Art applies over 25 years of business and operational management experience to
provide results-oriented ISO 9001/QS 9000/AS 9100 and TS 16949 training
and consultancy in the US, Canada and Mexico.
As an Auditor, he has conducted registration, pre-assessment and gap audits to
ISO/QS 9000, for more than 300 organizations in the manufacturing and
service sectors.
As a Consultant, he has helped over 60 clients achieve ISO/QS 9000 and
automotive TS 16949 certification on time and within budget.
As a Trainer, he has delivered public and on-site quality management training to
over 3000 students. Courses include ISO/QS/TS - Lead Auditor, Internal
Auditing, Quality System Documentation, Introduction to ISO/QS/TS as well
as customized automotive courses in PPAP’s, FMEA’s, APQP and Control
Plans.
In addition to quality management services, he also provides business planning,
restructuring, process streamlining and other value-added services.
Art has held certification for IATCA Lead Auditor as well as AIAG QS 9000
Lead Assessor. He holds a Bachelor of Commerce degree and is a Certified
Management Accountant (CMA).
Course Objectives
Upon completion, students will understand:
 Purpose of a quality management system
 Eight quality management principles
 Purpose and requirements of ISO 9001:2000
 Purpose and requirements of AS
9100B:2004
 Acceptable objective evidence to meet
requirements of the AS 9100 standard
AS 9100B:2004
Quality Management
Concepts & Principles
Quality Management System
Quality: degree to which a set of inherent characteristics
fulfils requirements
System: set of interrelated or interacting elements.
Quality Management System: coordinated activities to
direct and control an organization with regard to
quality.
ISO 9000:2000
The ISO 9000 family of standards were introduced to help

organizations of all types and sizes implement and operate
effective quality management systems.
Quality management system
AS 9100B:2004
• Meet requirements Quality Standard
• Consistency Management
• Assurance System
QMS
Principles
Processes
Quality Quality Quality Quality

Planning Assurance Control Improvement
• Policies • Proactive • Reactive controls • Effectiveness
• Objectives controls • Detect n/c’s • Efficiency
• Processes • Prevent n/c’s • Fulfill Reqmt’s • Capability
• Resources • Confidence • Inspection, tests • Use QI Tools
• Controls • Track progress
• Documentation
Quality Management System
To develop and implement an effective quality
management system:
 Determine needs and expectations of customers
 Establish quality policy and quality objectives
 Determine necessary processes and responsibilities
 Provide resources to attain quality objectives
 Establish methods for process measurement
 Determine process efficiency and effectiveness
 Determine means to prevent nonconformities
 Apply process for continual improvement of system
Quality Management Principles
1. Customer Focus
2. Leadership on Purpose and Direction
3. Involvement of People at All Levels
4. Process Approach to Resources and Activities
5. Systems Approach to Management
6. Continual Improvement as a Permanent Objective
7. Factual Approach to Decision Making
8. Mutually Beneficial Supplier Relationships
Process Approach
 ISO 9001 promotes adoption of process approach.
A process is a system of activities which uses
resources to transform inputs into outputs.
A process approach systematically identifies and
manages processes and interaction of processes.
 Can apply PDCA methodology to all processes
(PDCA = Plan-Do-Check-Act)
Process Management
Your
Supplier Customer
Company
Internal Processes
Sales/ QMS PROCESSES
Marketing
Design &
Development Purchasing
Production
Scheduling Maintenance
Tooling
General Production
Management Industrial
Engineering
Quality
Warehouse
Management
HR
Packaging
Accounting
Shipping
Process Approach
Process activities
• Value-added tasks
• Controls
• Objectives
Supplier Customer
Input Output
• Data/materials Production • Product/services
• Controls • Controls
• Measurables • Measurables
Resources
• Controls
• Measurables
Process control – Deming Model
(Plan – Do – Check – Act)
ACT PLAN
ANALYZE ‘SAY WHAT YOU DO’
REVIEW ACTIVITIES
DECIDE/ACT OBJECTIVES
CHANGE/IMPROVE CONTROLS
EFFECTIVENESS DOCUMENTATION
RESOURCES
Any Process
CHECK
MONITOR & MEASURE
DO
KEEP PERFORMANCE ‘DO WHAT YOU SAY’
RECORDS IMPLEMENTATION
SUMMARIZE DATA COMPLY WITH PLAN
For Continual Improvement

AS 9100B:2004
 Aerospace requirements based on ISO 9001:2000
 Consolidates the old ISO 9001, 9002, and 9003
 Five sections for requirements:
4. Quality Management System

5. Management Responsibility
6. Resource Management
7. Product Realization
8. Measurement, Analysis, and Improvement
Plan – Do – Check - Act
ACT - Clause 8 PLAN - Clause 4,5,6
• ANALYZE RESULTS • PROCESS ACTIVITES
• IDENTIFY IMPROVEMENT • POLICIES & OBJECTIVES
OPPORTUNITIES • CRITERIA & CONTROLS
• CHANGE/IMPROVE - PROCESS, • INTERACTION WITH OTHER
RESOURCES OR CONTROLS
• REVISE PLAN
Production QMS PROCESSES
• DOCUMENTATION
• RESOURCES
• MONITORING & INSPECTION
CHECK - Clause 8 DO - Clause 7 and 8

• TRACK & MEASURE PROCESS • CARRY OUT PROCESS AS PLANNED
PERFORMANCE • USE PROCESS DOCUMENTATION
• COMPARE TO OBJECTIVES • USE COMPETENT EMPLOYEES
• KEEP RECORDS OF INSPECTION
AS 9100B:2004
STANDARD
AS 9100B:2004
 This standard includes ISO 9001:2000 QMS
requirements (in regular print)
 Specifies additional requirements for the
aerospace industry
 Aerospace requirements are shown in italics
 QMS requirements of this standard are
complementary to contractual, applicable law
and regulatory requirements
ISO 9001:2000
 Five sections for requirements:
4. Quality Management System
5. Management Responsibility
6. Resource Management
7. Product Realization
8. Measurement, Analysis, and
Improvement
Terms and Definitions
 New “supply chain” terms:
supplier → organization → customer
 Use of “product” can also mean “service”
 Key Characteristics: the features of a part,
material or process whose variation has a
significant influence on product fit,
performance, service life or manufacturability
(1. Scope)
1.1 General
Specifies requirements for a QMS to:
 demonstrate it’s ability to consistently provide
product that meets (customer and regulatory)
requirements
 enhance customer satisfaction by:
 effective application of the system
 continual improvement of the system
 assurance of conformity to requirements
Note: Product applies to product intended for, or required, by a
customer
(1. Scope)
1.2 Application
 All requirements of the Standard are generic
 Intended for application to all organizations
 Requirements may be excluded if not applicable
due to nature of organization and its product
 Claims of conformity to the Standard are not
acceptable unless exclusions:
– are limited to Product Realization (clause 7)
– do not affect organization’s ability, or responsibility,
to provide product that meets requirements
Exercise 1
 Identify three benefits of implementing an
AS 9100B:2004 documented quality
management system?
 Provide 3 examples of processes.
 What is meant by the “process approach” to
quality management systems?
 What four tools are used to implement a
QMS and the explain the purpose of each?
Exercise 2
 Can a company exclude some products or services
from the scope of it’s AS 9100 certification?
 What clauses can be excluded from the scope of an
AS 9100 QMS? How must exclusions be
documented?
 Can a QMS be integrated with other management
systems? Name some common requirements?
 Explain the purpose and application of any 3 of the 8
quality management principles?

As 9100 Module 1

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One Day

The ISO 9000 family of standards were introduced to help

Quality Quality Quality Quality

For Continual Improvement

4. Quality Management System

CHECK - Clause 8 DO - Clause 7 and 8

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