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HISTORY

World War - I
In UK Bombs Manufactured were of poor quality, as
they get fused by the time they reach to the front.
UK Defense Minister prepared procedures for
manufacturing of Bombs and circulated in all
Factories.
He commanded, to manufacturers that the bomb
must be produced as per the written procedure.
Team of Government Inspector was formed to cross
check on the manufacturing process of Bombs in
factories.

By end of World War - I
Bombs manufactured were of superior quality.
But by that time World War-I came to end.
Give rise to the idea of Writing Procedures
Condition of Japan Products was, as China Products as of now.
Attractive
Multiple Functions
Not expensive, so affordable for common class of people
Easily available
POOR IN QUALITY
But, still people buy all over the world .. ?
On the other hand
Product of USA and Germany were of Superior Quality
Domination as Made in Germany and Made in USA
World War II
The atomic bombings of Hiroshima and
Nagasaki near the end of World war II
against the Empire of Japan by the
United States (U.S.)
World War - II
Market in Japan
was totally
destroyed
People who use to Speak and Write on Quality Improvement.
But, there thoughts having no value in US.
Japan invited there people for United States (US)
Fitness for useJuran

Conformance to requirement.Crosby

Aim at the need of the customer - present and future..Edward Deming
Quality means
QUALITY ALSO MEANS :
Value for money
Customer Satisfaction
Customer Delight
Subjective
Relative
Habit
QUALITY IS :
Edward Deming the Quality Guru, has said Everyone
in the organization is responsible for Quality, and
Ultimate responsibility is of the top management
Quality Objectives should be SMART

S Specific
M Measurable
A Achievable
R Realistic
T Time Bound

QUALITY OBJECTIVES
Why adopt ISO 9000?
To comply with customers who require ISO 9000
To improve the quality system
To minimize repetitive auditing by similar and different
customers
To improve subcontractors performance
Discover ISO
ISO's name
Because "International Organization for Standardization" would have different
acronyms in different languages ("IOS" in English, "OIN" in French for
Organization international de normalization), its founders decided to give it also
a short, all-purpose name. They chose "ISO", derived from the Greek isos,
meaning "equal". Whatever the country, whatever the language, the short form
of the organization's name is always ISO.
BASIC INTRODUCTION TO ISO 9001
ISO is the world largest standards
developing organization. Between 1947
and the present day, ISO has published
more than 16 500 International Standards
Founding

ISO was born from the union of two
organizations - the ISA (International
Federation of the National Standardizing
Associations),. established in New York in
1926, and the UNSCC (United Nations
Standards Coordinating Committee),
established in 1944.

In October 1946, delegates from 25
countries, meeting at the Institute of Civil
Engineers in London, decided to create a
new international organization, of which
the object would be "to facilitate the
international coordination and unification
of industrial standards". The new
organization, ISO, officially began
operations on 23 February 1947.

Geneva H. Q.
(representation
147 countries)
HOW DID ISO GET STARTED ?
1906 International Electro Technical Commission
1926 International Federation of the National Standardizing Associations
(ISA)
1946 London delegates from 25 countries decided to create a new
international organization the object of which would be to facilitate the
international co ordination and unification of industrial standards.
1947 ISO began to officially operation function.
1951 The First ISO Standard was Published
1987 Standards are Created
1.To eliminate country to country differences
2.To eliminate terminology confusion
3.To increase quality awareness

ISO 9001:2008
Quality Management
Systems (QMS)
A system to manage the quality
of your organizations products /
services.
The term Product also means Service
in ISO 9001 Standard.
ISO 9000:2000 Consists of 3 Areas
ISO 9000:2008 Quality Management Systems: fundamentals and
vocabulary

ISO 9001:2008 Quality Management Systems Requirements For the
Standards (required for certification)
1.Documentation
2.Management responsibility
3.Resource management
4.Product/service realization
5.Measurement, analysis, improvement

ISO 9004-2008 Quality Management Systems Guidelines for performance
improvement
Customer focus
Leadership
Involvement of people
Process approach
System approach to management
Continual improvement
Factual approach to decision making
Mutually beneficial supplier relationships

Refer 0.2 Quality Management Principles (page no. V) of
ISO 9001:2000 manual

Quality Management Principles
Organization depend on Customer.
Must understand current and feature customer needs.
Must exceed customer expectations
CUSTOMER FOCUS
LEADERSHIP
Leader establish unity of purpose and direction of the organization.
Maintain healthy environment in an Organization, in which people can
become fully involved in achieving the organizations objectives.
People at all levels are the
essence of organization.
Peoples full enrolment enables to
achieve the objectives of
organization.
INVOLMENT OF PEOPLE
A desired result is
achieved more efficiently
when related resources
(Men / Machines /
Materials / Money /
Methods) and activities
are managed as a
process.
PROCESS APPROCH TO MANAGEMENT
R
E
C
R
U
I
T
M
E
N
T

P
R
O
C
E
S
S

Identifying, Understanding and
Managing the inter-related
processes as a system,
improves the organizations
effectiveness and efficiency.
SYSTEM APPROCH TO MANAGEMENT
Continual improvement should be a permanent objective of the organization.
CONTINUAL IMPROVEMENT
Effective decisions must be based on the analysis of the data and information
FACTUAL APPROCH TO DECISION MAKING
An organization and its suppliers
are interdependent.
Mutually beneficial relationship
with the suppliers enhances the
ability of both to create value.
MUTUALLY BENEFICIAL SUPPLIER
RELATIONSHIPS

PLAN DO CHECK - ACT CYCLE (PDCA)

Based upon work by W. A. Stewart and made popular by
W.E.Deming

Goal: Optimize and improve a single process model/production line
Approach: Uses such techniques as
1.feedback loops
2.Statistical quality control
3.Design of experiments
4.Data models based upon multiple replications
Result: Predictive models of the relationship between process and
product.


PLAN DO CHECK ACT
Continuous improvement ?
ISO Organization
General
Assembly

Council
Technical
Management Board
Technical Advisory
Groups
Technical Committees
Policy
Development
Committees
Technical Committees
Technical Committees
Technical Committees
Continual Improvement of the quality management system
Customers
(and other
interested
parties)
Requirements
Customers
(and other
interested
parties)
Satisfaction
Product
realization
Resource
management
Measurement,
analysis and
improvement
Management
responsibility
Product
Input
Output
Key
Value adding activities
Information flow
Clause 1.0
General

Standard is generic means applicable to all types of Organization, regarding
of type, size and product provided.
Enhance in meets customer needs and regulatory requirements.
Aims to enhance customer satisfaction through effective application of
system and processes for continual improvement.
Application : Exclusions are made limited to requirements within clause 7,
and such exclusions do not affect the organizations ability, or responsibility.
e.g. Clause 7.3 Design and Development is applicable for production industry and not
applicable for Service Industry. Clause 7.6 Control of monitoring and measuring
equipments
Clause 2.0
Normative references

The following referenced documents are indispensible (essential) for the
application of this document. For dated references, only the edition cited
applies. For undated references, the latest edition of the references
document (including any amendments) applies.

ISO 9001:2005, Quality management systems Fundamentals and vocabulary

Clause 3.0
Terms and Definitions:
Speaks about different terms and definitions used in ISO 9001 QMS Standard:
Conformity
Non-Conformity
Defect
Preventive action
Corrective action
Document
Record
Quality Manual
Quality plan
Objective evidence
Inspection
Verification
Review
Audit
Audit findings
Audit conclusions
Auditee
Auditor
Audit Team
Continuous
Continual
Measurement
Analyses

Clause 4.0
Quality management system:

General Requirement:
The organization shall-
Determine the processes needed for the quality management system and their application
throughout the organization.
Determine the sequence and interaction of these processes.
Determine criteria and method needed to ensure that both the operation and control of these
processes are effective.
Ensure the availability of resources and information necessary to support the operation and
monitoring of these processes.
Monitor, measure where applicable, and analysis these processes, and
Implement actions necessary to achieve planned results and continual improvement of these
processes.


Clause 4.0
Quality management system:

Documentation Requirement:
General:
The quality management system documentation shall include
Documented statement of a quality policy and quality objectives.
A quality manual
Documented procedures and records required by the international standard, and
Documents, including records, determined by the organization to be necessary to ensure the
effective planning, operation and control of its processes.
Quality Manual
Controls of document
Control of records

DOCUMENT , RECORD AND DOCUMENTATION
Any blank format is a document

When a document is filled-in for a certain period of time
becomes record for that period

Storing or Saving or Filling of Record is Documentation
DOCUMENT CONTROL
Issue No. Date of Issue
Approved By Date of Approval
Authorized By Date of Authorization
Revised By
Date of Review
Document
Can not be changed unless it is approved and authorized by the Top
Management with coordination with the Management Representative
with Proper clarification/ explanation for the reason of change and need
to bring to the notice of External Auditor during audit.
DOCUMENT CONTROL
Reference No.
Approved By Date of Approval
Authorized By Date of Authorization
Record
Date of Record
DOCUMENTED PROCEDURE FOR DOCUMENT
A DOCUMENT
Designed by
Approved by
Authorized by
Life of the Document
Method of Distribution
Who will convert as
record
Method of destruction
Shredding
Burn
Stamping as
Discarded
Revised by
Revised by
Approved by
Authorized by
Method of Storage
Six mandatory procedures
Control of documents
Control of records
Internal Quality Audit
Control of non-conforming products
Corrective action
Preventive action
DOCUMENTED PROCEDURE FOR RECORD
A RECORD
Who will prepare the
records
Method of Storage
Life of the Record
Method of Destruction
Shredding
Burn
Stamping as
Discarded
Analyses of Record
System / Process
Follow of
System/
Process
Evidence of
System/ Process
follow
Analyses System
/ Process follow
Improvements
System /
Process
Continual
Improvement
resulting in
quality
Documentation requirements
System / Process
Follow of
System/
Process
Evidence of System/
Process follow
Analyses System /
Process follow
Improvements
System / Process
Quality
Log Book
Check list
Service Level
Agreement
(SLA)
Standard
Operating
Procedures
(SOP)
Scope of Work
(SOW)
Work
Instructions
(WI)
Work
Schedule (WS)
Service
Provider
Service
Taker
Internal
Audit
Customer
Feedback
Customer
Satisfaction
Survey
Clause 5.0
Management responsibilities:

Communicating to the organization the importance of meeting customer as well as statutory and
regulatory requirements, with the aim of enhancing customer satisfaction.
Establishing the quality policy.
Ensuring that the quality objectives are established.
Conducting management reviews, and
Ensuring the availability of resources.
Top management shall provide evidence of its commitment to the development and
implementation of the quality management system and continually improving its
effectiveness by -

Quality Policy

It is the Vision and
Purpose/Objective of the
Organization
These objectives are laid down
by the Top Management.
Management Review
Review input:
Result of audits.
Customer feedback
Process performance and product
conformity
Status of preventive and corrective
actions.
Follow-up actions from previous
management reviews.
Changes that could affect the quality
management system.
Recommendations for improvement
Review output:
Improvement of the effectiveness of
the quality management system and
its processes.
Improvement of product related to
customer requirements.
Resource needs.
Clause 6.0
Resource management
The organization shall determine and provide the resources needed:
Human Resource - Competency, education, training, awareness, skills and experience
Infrastructure: includes -
Building, workspace and associated utilities.
Process equipments (both hardware and software), and
Support services (such as transport, communication or information system).
Work environment:
Conditions under which work is performed including physical environment and other factors
(such as noise, temperature, humidity, lighting or weather).

Clause 7.0
Product Realization
Planning of Product realization
Customer Related Processes
Design and Development
Purchasing
Production and Service Provisions
Control of monitoring and measurement equipments
Clause 8.0
Measurement, analysis and improvement

Monitoring and Measurement
Customer Satisfaction
Internal Audit
Processes
Product
Control of Non Confirmative
Analyses of Data
Corrective Action
Preventive Action
Improvements
Question &
Answers

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