Quality Management Standards

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Quality Management

Standards

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

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

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

Value adding activities


Information flow

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

Source: AIAG ISO/TS 16949:2002 Implementation Gu

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 system documentation


Quality Manual
Control of documents
Control of records

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

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

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
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

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 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

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