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Quality Management
Standards



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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

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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
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


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
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SCOPE OF STANDARD
1. Scope
General
Application
2. Normative reference
3. Terms and definition
e.g., Supplier Organization Customer
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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
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QUALITY MANAGEMENT SYSTEM
REQUIREMENTS
4.2 Documentation requirements
Management system documentation
Quality Manual
Control of documents
Control of records
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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
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MANAGEMENT RESPONSIBILITY
5.5 Responsibility, authority and
communication
Responsibility and authority
Management representative
Internal communication


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MANAGEMENT RESPONSIBILITY
5.6 Management Review
General
Review input
Review output
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RESOURCE MANAGEMENT
6.1 Provision of resources
6.2 Human resources
General
Competence, awareness and training
6.3 Infrastructure
6.4 Work environment
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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
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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
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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 its
status
Care of customer property
Preservation of product
Includes constituent parts
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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
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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
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MEASUREMENT, ANALYSIS, AND
IMPROVEMENT
8.3 Control of nonconforming product
8.4 Analysis of data
8.5 Improvement
Continual improvement
Corrective action
Preventive action

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ISO 9001:2008
A Structured
Approach
to Quality
Management

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Documented Systems
Diaco Inc. asahi515874@comcast.net
505 780-3185
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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
TQM


TOTAL QUALITY MANAGEMENT
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
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. PRICE REDUCTION
2. CUSTOMER SATISFACTION
3. INVOLVEMENT OF EVERYONE
4. 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 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