Quality Management Standards
Quality Management Standards
Quality Management Standards
Standards
Customer focus
Leadership
Involvement of people
Process approach
System approach to management
Continual improvement
Factual approach to decision making
Mutually beneficial supplier relationships
ISO 9001:2008
CONTINUAL
CONTINUALIMPROVEMENT
IMPROVEMENTOF
OFTHE
THEQUALITY
QUALITY
MANAGEMENT
MANAGEMENTSYSTEM
SYSTEM
Management
responsibility
Customer
s
Customer
s
Clause 5
Measurement,
Resource Clause 6 Clause analysis and
management
improvement
8
Satisfaction
Clause 7
Input
Requirement
s
Product
realization
Output
Product
PROCESS REQUIREMENTS
With What?
(Materials / Equipment)
Inputs
How Many?
(Measurement /
Controls)
Objective
s
and
Targets
WHO?
Special Skills? /
Competence?
Business
Process
Outputs
Process
Linkages
How?
(Methods/Procedures
)
5
SCOPE OF STANDARD
1. Scope
General
Application
2. Normative reference
3. Terms and definition
e.g., Supplier
Organization
Customer
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
QUALITY MANAGEMENT
SYSTEM REQUIREMENTS
4.2 Documentation
requirements
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
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 postdelivery activities
Validation of processes when no other method
Identification and traceability of product and
its status
Care of customer property
Preservation of product
15
PRODUCT REALIZATION
7.6 Control of monitoring and
measuring devices
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
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
4th Level
Technical Data
International standards
Computer operating
Diaco Inc.
manuals
asahi515874@comcast.net
Detailed product
505 780-3185
Detailed
instructions
How to complete
a job or task
21
TQM
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?
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
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 YOURE NOT PART OF THE
SOLUTION, YOURE PART OF THE
PROBLEM.
CONTINUOUS IMPROVEMENT
Customers are not interested in excuses,
theyre interested in results.
Be proactive - because if you dont
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