ISO 9001:2008

Awareness Program

Purpose of Program
Awareness of ISO 9001:2008.
Self Improvement
Improvements in routine working
To improve the health of organizations
Quality Management System

FAQ?
What

is ISO?
From where it comes?
How it is helpful for us?
How it works?
What we have to do?

Contents Of Program
Background of ISO
ISO Family
Quality Management Principle
Process Approach
ISO 9001:2008 Overview
Detail Of Different Clauses Of ISO
9001:2008

What is ISO 9001:2008?

ISO = International Organization for

Standardization
ISO has representation from 162 countries
and has issued many standards
ISO 9001:2008 is a model for a quality
management system.

Who created the standard?

International Organization for

Standardization - Geneva
Standards created in 1987
To eliminate country to country differences
To eliminate terminology confusion
To increase quality awareness

ISO 9000:2005 Consists of 3 Areas

ISO 9000:2005 Quality Management Systems:

fundamentals and vocabulary
ISO 9001:2008 Quality Management Systems
Requirements (required for certification)
Management responsibility
Resource management
Product/service realization
Measurement, analysis, improvement
ISO 9004-2009 Quality Management Systems
Guidelines for performance improvement

Generic standards
ISO 9001 is a generic standards.
Generic means that the same standards can
be applied:
to any organization, large or small,
whatever its product or service,
in any sector of activity, and
whether it is a business enterprise, a public
administration, or a government department.

Generic standards (cont.)

Generic also signifies that
no matter what the organization's scope of
activity
if it wants to establish a quality
management system, ISO 9001 gives the
essential features

Certification and registration

Certification is known in some countries as

registration.
It means that an independent, external
body has audited an organization's
management system and verified that it
conforms to the requirements specified in the
standard (ISO 9001).
ISO does not carry out certification and
does not issue or approve certificates,

Accreditation

Accreditation is like certification of the certification

body.
It means the formal approval by a specialized body an accreditation body - that a certification body is
competent to carry out ISO 9001:2008 certification in
specified business sectors.
Certificates issued by accredited certification bodies
- and known as accredited certificates - may be
perceived on the market as having increased
credibility.
ISO does not carry out or approve accreditation.

Certification not a requirement

Certification is not a requirement of ISO

9001.
The organization can implement and take
benefit from an ISO 9001 system without
having it certified.
The organization can implement them for the
internal benefits without spending money
on a certification programme.

Certification is a business
decision

Certification is a decision to be taken for

business reasons:
if it is a contractual, regulatory, or market
requirement,
If it meets customer preferences
if it will motivate staff by setting a clear goal.

Ten Steps to ISO Registration

10. Registration!
9. Final assessment by registrar
8. Take corrective actions
7. Pre-assessment by registrar
6. Submit quality manual for approval
5. Perform self-analysis audit
4. Select a third-party registrar and apply
3. Develop and implement the quality system
2. Select the appropriate standard
1. Set the registration objective

What is a Quality Management

System?

Quality Management System is a

web of interconnected processes
that are used to manage a
business.

Operating Cycle of ISO.

The Plan Do Check Act (PDCA) cycle is the

operating principle of ISO's management system
standards

Plan establish objectives and make plans (analyze your

organization's situation, establish your overall objectives
and set your interim targets, and develop plans to
achieve them).
Do implement your plans (do what you planned to).
Check measure your results (measure/monitor how far
your actual achievements meet your planned objectives).
Act correct and improve your plans and how you put
them into practice (correct and learn from your mistakes
to improve your plans in order to achieve better results
next time).

ISO 9001:2008
CONTINUAL
CONTINUALIMPROVEMENT
IMPROVEMENTOF
OFTHE
THEQUALITY
QUALITY
MANAGEMENT
MANAGEMENTSYSTEM
SYSTEM

Management
responsibility
Customers

Customers

Clause 5

Clause 6

Measurement,
analysis and
improvement

Resource
Resource
management
management

Satisfaction

Clause
8
Input
Requirements

Product
realization
Clause 7
Value adding activities
Information flow

Output

Product
Product

PROCESS REQUIREMENTS
With What?
(Materials / Equipment)

Inputs

How?
(Methods / Procedure)

Objectives
and
Targets

Process

Process
Linkages

WHO?
Special Skills? / Competence?

Outputs

Measure

Management Principles

A Quality Management Principle is a

comprehensive and fundamental rule or
belief, for leading and operating an
organization, aimed at continually improving
performance over the long term by focusing
on customers while addressing the needs of
all stakeholders.

8 Management Principles

Principle 1 : Customer Focus

Principle 2 : Leadership
Principle 3 : Involvement Of People
Principle 4 : Process Approach
Principle 5 : System approach to management
Principle 6 : Continual Improvement
Principle 7 : Factual approach to decision making
Principle 8 : Mutually beneficial supplier
relationships

Principle 1 : Customer Focus

Organizations depend on their customers &

therefore should understand current & future
customer needs, should meet customer
requirements & strive to exceed customer
expectations

Principle 2 : Leadership

Leaders establish unity & direction of the

organization. They should create & maintain
the internal environment in which people can
become fully involved in achieving the
organization's objectives.

Principle 3 : Involvement Of
People

People at all levels are the essence of an

organization and their full involvement
enables their abilities to be utilized for the
organization's mutual benefit.

Principle 4 : Process Approach

The application of a system of processes within

an organization, together with the identification
and interaction of these processes, and their
management to produce the desired outcome,
can be called Process Approach

Principle 5 : System approach to

management

Identifying, understanding & managing

interrelated processes as a system
contributes to the organization's
effectiveness & efficiency in achieving its
objectives.

Principle 6 : Continual
Improvement

Continual Improvement of the organization's overall

performance should be the primary driver of the
organizations Quality Management System.

Continuous
Improvement

Continual Improvement

Principle 7 : Factual approach to

decision making

Effective decisions are based on the analysis

of data & information

Principle 8 : Mutually beneficial

supplier relationships

An organization & its suppliers are

interdependent, and a mutually beneficial
relationship enhances the ability of both to
create value

Clauses of ISO 9001-2008

1.Scope
2.Normative References
3.Term & Definitions
4.Quality Management System
5.Management Responsibility.
6.Resources Management
7.Product Realization
8.Measurment,Analysis and Improvement

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

QUALITY SYSTEM
DOCUMENTATION STRUCTURE
1st Level

Quality Manual
2nd Level

Policy and Objectives

What the company wishes to

achieve

Procedures
3rd Level

Work Instructions
Machine instructions
Computer inputs
Detailed work instructions

4th Level

Technical Data
International standards
Computer operating manuals
Detailed product specifications

How the company

implements its policy
Structured to reflect
process flow of events

Detailed instructions
How to complete
a job or task

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

MANAGEMENT RESPONSIBILITY
5.6 Management Review
General
Review input
Review output

RESOURCE MANAGEMENT
6.1 Provision of resources
6.2 Human resources
General
Competence, awareness and training
6.3 Infrastructure
6.4 Work environment

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

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

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

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

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

MEASUREMENT, ANALYSIS, AND

IMPROVEMENT
8.3 Control of nonconforming product
8.4 Analysis of data
8.5 Improvement
Continual improvement
Corrective action
Preventive action

Any Questions or
Query?

Thanks
Varinder Sandhu
Abhived Bhardwaj
Balram Sharma