ISO 9000 Quality Systems

Instructor Dr. Akshay Dvivedi

2014-2015
This material is for classroom discussion and teaching only

Objectives of standardization
(as per ISO)

To facilitate international exchange of goods &

services and to develop mutual co-operation in
the sphere of intellectual, scientific, technological
and economic activity

Benefits to ISO 9001 is used when you are

seeking to establish a quality
Manufacturer management system that provides
Trader confidence in your organizations
User ability to provide products that fulfil
Society customer needs and expectations.

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 What is ISO-9000

It is a set of written standards laying down a quality

system.
It defines the basic elements of the system through
documentation .
It creates a quality system rooted in your customers
requirements.
It ensures uniform systems that are universally
recognized.
It creates the discipline required for a total quality
process.

ISO 9000 certification

Standardization of activities.
Audits to ensure compliance.
Statistical tools as techniques.
Bureaucratic because of written down procedures and
quality manual.
Responsibility of quality [assurance] manager.
Conformity to specifications.
ISO certification gives a concrete goal.
Internal orientation on processes.
Focusing on quality goals based on internal
capabilities.

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 Practices described in
ISO 9004 can be
implemented to make quality
management system
effective and efficient
(achieve business goals and
objectives).
ISO 9001 is used when you
Definition of concept are seeking to establish a
quality management system
ISO 8402 that provides confidence in
your organizations ability to
IS 13999 provide products that fulfil
customer needs and
expectations.

Selection and use of standards

ISO 9000
IS 14000

Three ISO 9001

Quality Management
Quality IS 14001
Quality system elements
Assurance ISO 9002
ISO 9004 Models IS 14002
IS 14004 ISO 9003
IS 14003

ISO 9000 Basic Elements

Fundamentals and Vocabulary used in entire ISO

9000 family of standards
Quality management/ Assurance standards.
Specific Quality assurance standards & practices.
Guidelines for auditing Quality systems.
Quality assurance requirements for measuring
equipment's

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 Motivation for ISO 9000

REACTIVE PROACTIVE

Customer Demand Market Leadership

Competitive Pressures Quality Benefits
Corporate Mandate Part of a larger strategy
Requirements from Reduction in Production Cost
Regulations

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 ISO - TQM

TQM

Customer ISO 9000

Satisfaction

Improvement Employees

ISO -TQM

Competitive Industry/
Elements Technology
Elements

Enhancements and Expansion

ISO 9000 ELEMENTS

Foundation

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 Can ISO-9000 Lead to TQM ?

ISO-9000 standards complement TQMs emphasis

on the human elements.
ISO-9000 helps you assess your companys
quality requirements.
ISO-9000 translates quality concepts into
achievable targets.
ISO-9000 provides an opportunity to create and
improve quality systems.
ISO-9000 helps spread the message of quality
across the organization.

Why isnt ISO-9000 TQM ?

ISO-9000 is based on standards and ignores the

human elements.
ISO-9000 lays down only systems, it says nothing
about implementation.
ISO-9000 certification is unsustainable and prone to
the day-after effect
ISO-9000 makes no demands on or assurances about
final product quality.
ISO-9000 transfers the onus of ensuring quality to
the certifier.

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Difference Between ISO and TQM
ISO-9000 Certification
Standardization of activities.
Audits to ensure compliance
Statistical tools as techniques
Bureaucratic because of
written down procedures and
quality manual
Responsibility of quality
[assurance] manager.
Conformity to specifications.
Difference Between ISO and TQM
ISO-9000 Certification
ISO certification gives a
concrete goal.
Internal orientation on
processes.
Focusing on quality goals
based on internal capabilities.
TQM Approach
Continuous Improvement.
Self assessment to find
opportunities for improvement.
Statistical tools to understand
variation in processes.
Culture improvement and high
involvement of people
Responsibility and role of top
management
Customer satisfaction and
customer orientation. Contd
TQM Approach
A never ending TQM journey.
Orientation on organization
and relations within and
outside the organization
Focusing on goals based on
external benchmarks
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 Hierarchy of Documentation

Quality manual

Procedure

Job/ Work
Instructions

Forms Records
Document
Books Files

Contracts Design Purchasing Production Quality Personnel

Marketing Development Materials Installation Assurance Training
Sales Management Servicing Quality
Finance Stores Control

Topic Contractual
ISO 9001 CLAUSE ISO 9002 CLAUSE ISO 9003 CLAUSE

Management responsibility 4.1 4.1* 4.1**

Quality system principle 4.2 4.2 4.2*
Auditing the quality system (internal) 4.17 4.16* ----
Economics quality related costs ---- ---- ----
Quality in marketing(contact review) 4.3 4.3 ----
Quality in spec. and design(design control) 4.4 ---- ----
Quality in procurement(purchasing) 4.6 4.5 ----
Quality in production(process control) 4.9 4.8 ----
Control of production 4.9 4.8 ----
Material control and traceability 4.8 4.7 4.4*
Control of verification status(inspection & test) 4.12 4.11 4.7*
Product verification(inspect & test) 4.10 4.9 4.5*
Control of measuring & test equipment 4.11 4.10 4.6*
Nonconformity (control of nonconformity 4.13 4.12 4.8*
Corrective action 4.14 4.13 ----
Handling & post-production functions 4.15 4.14 4.9*
After-sales servicing 4.19 ---- ----
Quality documentation & records 4.5 4.4 4.3*
Quality records 4.16 4.15 4.10*
Personnel (training) 4.18 4.17* 4.11*
Product safety and liability ---- ---- ----
Use of statistical methods 4.20 4.18 4.12*
Purchaser supplied product 4.7 4.6 ----

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 ISO 9000:2000

ISO 9000 has recently been revised from ISO

9000:1994 to ISO 9000:2000. The key changes of this
revision are the elimination of ISO 9002 & ISO 9003.

ISO 9000:2000 consists of the following:

ISO 9000:2000 -Quality Management Systems Fundamentals
and vocabulary
ISO 9001:2000 Quality Management Systems Requirements
ISO 9004:2000 Quality Management Systems
Guidelines for Performance Improvement.

Standards & Guidelines Purpose

ISO 9000:2000
Quality management systems-
fundamentals & vocabulary
ISO 9001:2000
Quality management systems-
Requirements
ISO 9004:2000,
Quality management systems-
Guidelines for performance
improvement
Establish a starting point for understanding the
standards & defines the fundamental terms &
definitions used in the ISO 9000 family which
you need to avoid misunderstandings in their
use.
This is the requirement standards you use to
assess your ability to meet customer &
applicable regulatory requirements & thereby
address customer satisfaction.
It is now the only standard in the ISO 9000
family against which third-party certification
can be carried.
This guideline standard provides guidance for
continual improvement of your quality
management system to benefit all parties
through sustained customer satisfaction.

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 ISO 9000:2000 Quality Management Principles
1 Focus on Organizations must understand customer needs.
customer organization must meet customer requirements.
Organization must exceed customer expectation.
2 Provide Leaders must establish a unity of purpose & set the
leadership direction the organization should take.
Leaders must create an environment that encourages
people to achieve the organizations objectives

3 Involve Organization must encourage the involvement of

people people at all levels.
Organization must help people to develop and use their
abilities.
4 Use a Organization must use a process approach to manage
process activities and related resources.
approach

Contd.

ISO 9000:2000 Quality Management Principles

5 Take a systems Organizations must identify interrelated processes & treat

approach them as a system.
Organization must use a systems approach to manage
their interrelated processes.
6 Encourage Organizations must make a permanent commitment to
continual continually improve their overall performance.
improvement
7 Get the facts Organizations must base decisions on the analysis of
before you factual information & data.
decide
8 Work with your Organizations must maintain a mutually beneficial
suppliers relationship with their suppliers.

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THANKS!!!

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