2. 2
THE ISO 9000 FAMILY
ISO 9000: 2005
• Identifies the fundamentals and vocabulary for Quality Management
Systems (QMS)
ISO 9001:2008
• Specifies requirements for a QMS where capability to provide product that
meets customer and regulatory requirements needs to be demonstrated
ISO 9004:2009
• Provides guidance on QMS that contributes to the satisfaction of
customers and other interested parties
3. 3
ISO 9000 : 2008
Eight quality management principles
1. Customer focus
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
4. ISO 9001:2008
CONTINUAL IMPROVEMENT OF THE QUALITY
MANAGEMENT SYSTEM
Measurement,
analysis and
improvement
Product
Input Output
Management
responsibility
Resource
management
Clause 5
Clause 6 Clause 8
Clause 7
Requirements
Product
realization
Satisfaction
Value adding activities
Information flow
Customers
Customers
5. 5
Inputs
With What?
(Materials / Equipment)
How Many?
(Measurement / Controls)
How?
(Methods/Procedures)
WHO?
Special Skills? / Competence?
Outputs
Process
Linkages
Objectives
and
Targets
Business Process
Source: AIAG ISO/TS 16949:2002 Implementation Guide
PROCESS REQUIREMENTS
6. 6
SCOPE OF STANDARD
1. Scope
General
Application
2. Normative reference
3. Terms and definition
e.g., Supplier Organization Customer
7. 7
QUALITY MANAGEMENT SYSTEM
REQUIREMENTS
4.1 General requirements
Document, implement, maintain and continually improve
Identify and determine sequence and interaction of processes
Determine criteria and methods needed
Ensure availability of resources
Monitor, measure and analyze processes
Implement actions to achieve planned results
9. 9
MANAGEMENT RESPONSIBILITY
5.1 Management commitment
5.2 Customer focus
5.3 Quality policy
Must be documented
Must be used for setting objectives
5.4 Planning
Document objectives- Must be Measurable
Quality management system planning
12. 12
RESOURCE MANAGEMENT
6.1 Provision of resources
6.2 Human resources
General
Competence, awareness and training
6.3 Infrastructure
6.4 Work environment
13. 13
PRODUCT REALIZATION
7.1 Planning of product
realization
7.2 Customer-related processes
Determination of requirements related to the
product
Review of requirements related to the product
Customer communication
14. 14
PRODUCT REALIZATION
7.3 Design and development
Planning, inputs, outputs, systematic
reviews, verification and validation, control
of changes
7.4 Purchasing
Supplier evaluation and selection
Relevant purchasing information
Verification of purchased product
- receiving, source
15. 15
PRODUCT REALIZATION
7.5 Production and service provision
Controlled conditions including product
characteristics, work instructions (as necessary),
suitable equipment, monitoring and measuring
devices, monitoring and measurement, and release,
delivery and post- delivery activities
Validation of processes when no other method
Identification and traceability of product and it’s
status
Care of customer property
Preservation of product
Includes constituent parts
16. 16
PRODUCT REALIZATION
7.6 Control of monitoring and
measuring devices
Calibrated or verified where necessary
Adjusted and re-adjusted as necessary
Identified to enable calibration status
Safeguarded from invalid adjustment
Protected from damage and deterioration
17. 17
MEASUREMENT, ANALYSIS, AND
IMPROVEMENT
8.1 General
8.2 Monitoring and measurement
Customer satisfaction
Internal audit
Monitoring and measurement of processes
Monitoring and measurement of product
21. Diaco Inc. asahi515874@comcast.net
505 780-3185
21
QUALITY SYSTEM
DOCUMENTATION STRUCTURE
1st Level
Quality Manual
2nd Level
Procedures
3rd Level
Work Instructions
Machine instructions
Computer inputs
Detailed work instructions
4th Level
Technical Data
International standards
Computer operating manuals
Detailed product specifications
Policy and Objectives
What the company wishes to
achieve
How the company
implements its policy
Structured to reflect
process flow of events
Detailed instructions
How to complete
a job or task
23. Total quality management is a systemic
approach to productivity improvement
using qualitative and quantitative
methods and involving all stakeholders
to continuously improve the quality of all
products and services.
TQM
24. TQM
• IS THE SET OF MANAGEMENT
PROCESSES AND SYSTEMS THAT
CREATE DELIGHTED CUSTOMERS
THROUGH EMPOWERED EMPLOYEES,
LEADING TO HIGHER REVENUES &
LOWER COST
THE JURAN INSTITUTE, Inc.
25. TQM
• It is the process of individual &
organizational development the
purpose of which is to increase the
level of satisfaction of all the
stakeholders
PIKE, R J BARNES
32. CONTINUOUS IMPROVEMENT
• Improve each and everyday - Do not
focus on problems, focus on
improvements.
• IF YOU’RE NOT PART OF THE
SOLUTION, YOU’RE PART OF THE
PROBLEM.
33. CONTINUOUS IMPROVEMENT
• Customers are not interested in excuses,
they’re interested in results.
• Be proactive - because if you don’t
someone else will.
• Ishikawa Says The organization which
does not make a change in the 06 months
is a dead organizations
34. LEADERSHIP
• NO EFFORT FOR QUALITY
IMPROVEMENT CAN SUCCEED
WITHOUT COMMITMENT OF TOP
MANAGEMENT
