Quality Management
Standards
1
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
2
ISO 9000 : 2008
Eight quality management principles
1.
2.
3.
4.
5.
6.
7.
8.
Customer focus
Leadership
Involvement of people
Process approach
System approach to management
Continual improvement
Factual approach to decision making
Mutually beneficial supplier relationships
3
ISO 9001:2008
CONTINUAL IMPROVEMENT OF THE QUALITY
MANAGEMENT SYSTEM
Management
responsibility
Customers
Clause 5
Customers
Measurement,
Resource Clause 6 Clause 8 analysis and
management
improvement
Satisfaction
Clause 7
Requirements
Input
Product
realization
Value adding activities
Information flow
Product
Output
PROCESS REQUIREMENTS
With What?
(Materials / Equipment)
Inputs
How Many?
(Measurement / Controls)
Objectives
and
Targets
Business Process
Process
Linkages
WHO?
Special Skills? / Competence?
Outputs
How?
(Methods/Procedures)
5
Source: AIAG ISO/TS 16949:2002 Implementation Guide
SCOPE OF STANDARD
1.
Scope
General
Application
2.
Normative reference
3.
Terms and definition
e.g., Supplier
Organization
Customer
6
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
7
QUALITY MANAGEMENT SYSTEM
REQUIREMENTS
4.2 Documentation requirements
Management system documentation
Quality Manual
Control of documents
Control of records
8
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
9
MANAGEMENT RESPONSIBILITY
5.5 Responsibility, authority and
communication
Responsibility and authority
Management representative
Internal communication
10
MANAGEMENT RESPONSIBILITY
5.6 Management Review
General
Review input
Review output
11
RESOURCE MANAGEMENT
6.1 Provision of resources
6.2 Human resources
General
Competence, awareness and training
6.3 Infrastructure
6.4 Work environment
12
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
13
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
14
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
15
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
16
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
17
MEASUREMENT, ANALYSIS, AND
IMPROVEMENT
8.3 Control of nonconforming product
8.4 Analysis of data
8.5 Improvement
Continual improvement
Corrective action
Preventive action
18
ISO 9001:2008
A Structured
Approach
to Quality
Management
19
Documented Systems
20
QUALITY SYSTEM
DOCUMENTATION STRUCTURE
1st Level
Quality Manual
2nd Level
Procedures
3rd Level
Work Instructions
Machine instructions
 Computer inputs
 Detailed work instructions
Policy and Objectives
What the company wishes to
achieve
How the company
implements its policy
Structured to reflect
process flow of events

4th Level
Detailed instructions
How to complete
a job or task
Technical Data
International standards
 Computer operating manuals
 DetailedDiaco
product
specifications
Inc. asahi515874@comcast.net

505 780-3185
21
TQM
• TOTAL QUALITY MANAGEMENT
TQM
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
• 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.
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
WHY TQM?
B/C IT IS FOR BENEFIT OF ALL
STAKEHOLDERS
• INTERNAL SATKEHOLDER
• EXTERNAL STAKEHOLDER
COMPONENTS OF TQM
1.
2.
3.
4.
PRICE REDUCTION
CUSTOMER SATISFACTION
INVOLVEMENT OF EVERYONE
CONTINUOUS QUALITY
IMPROVEMENT
5. LEADERSHIP
PRICE REDUCTION
• COST AN ESSENTIAL ELEMENT OF
TQM
• CROSBY PHILOSPHY
QUALITY IS FREE
QLTY IS THE RIGHT OF CUSTOMER
Who determines quality?
THE CUSTOMER
If the customer does not
perceive you as offering
quality service you are
not.
INVOLVEMENT OF EVERYONE
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.
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
LEADERSHIP
• NO EFFORT FOR QUALITY
IMPROVEMENT CAN SUCCEED
WITHOUT COMMITMENT OF TOP
MANAGEMENT
LEADERSHIP
A NATION WITHOUT
LEADERSHIP IS THE HERD
OF SWINE
EINSTEIN