Professional Training and Development Center

presents

AN OVERVIEW OF ISO 9000

 Overview of ISO 9000

ISO 9000 is a series of quality management

systems standards created by the
International Organization for
Standardization (ISO), a federation of 157
national standards bodies out of total 195
countries in the world.
 Overview of ISO 9000

The ISO 9000 quality management

systems (QMS) Standards are not
specific to products or services,
but apply to the processes that
create them.
 Overview of ISO 9000
• The Standards are generic in nature so
that they can be used by manufacturing,
service & software companies.

• First released in 1987 and revised in a

limited manner in 1994, they underwent a
major revision in 2000 & amendment in
November 2008.
 Overview of ISO 9000
• The approval Standard, ISO 9001:2008,
uses a simple process-based structure,
which fits easily the process management
structure of most businesses.
 Overview of ISO 9000
• ISO 9000 has evolved into
a Standard designed to
assist organizations in
achieving 'quality' while
helping to assure
customers that quality will
be achieved.
 Overview of ISO 9000
• Whatever definition
you choose to use for
quality, and there are
many, it is essential
that your customers
are happy with the
product/service being
supplied.
 Overview of ISO 9000
• ISO 9000 is intended
to assist that aim by
helping to ensure
that the
product/service is
right - for both the
organization itself and
its customers.
 Overview of ISO 9000
• The ISO 9000: 2008 edition
clearly requires organizations to
satisfy their customers and
undertake continual
improvement of their quality
management systems.

• Hence compliance with ISO

9001:2008 should result in
significant benefits for
organizations and their
customers.
 Overview of ISO 9000
ISO 9000 series consists of :

• ISO 9000:2005 - Fundamentals and vocabulary

• ISO 9001:2008 - Requirements

• ISO 9004:2009 - Guidelines for performance

improvement
 Overview of ISO 9000

• ISO 9000 is an introduction to the

philosophy of quality management and also
contains the definitions used in ISO 9001
and ISO 9004.
• It also contains the 8 management
principles which provide the foundation for
the ISO 9000 series of Standards.
 Overview of ISO 9000
The Eight Management Principles are :
• Customer focus
• Leadership
• Involvement of people
• Process approach
• System approach to management
• Continual improvement
• Factual approach to decision making
• Mutually beneficial supplier relationships
 Overview of ISO 9000
• These principles are NOT
elements against which
the organization can be
directly assessed but their
influence can be seen
throughout the Standard.
 Overview of ISO 9000
• These eight management principles
should be considered by any
organization wishing to comply with the
spirit, as well as the text of ISO 9001.
 Overview of ISO 9000

ISO 9001 is the only part of the ISO 9000

family against which an organization can
become certified.
Overview of ISO 9000

ISO 9002 and ISO 9003 became

obsolete in December 2000.
Overview of ISO 9000
• ISO 9001:2008
contains all of the
requirements which
an organization must
address within their
Quality Management
System (QMS) if they
wish to be certified
against the Standard.
 Overview of ISO 9000

• The majority of these requirements would be

identified by many organizations as
'common sense' topics which they would
want to address in order to run their
business well e.g. sales, design,
purchasing, training, calibration of test
equipment, control of records etc.
 Overview of ISO 9000
There are 8 sections in ISO 9001:

1. Scope
2. References
3 .Terms and definitions
4. Quality management system
5. Management responsibility
6. Resource management
7. Product realization
8. Measurement, analysis and improvement
 Overview of ISO 9000

It is sections 4, 5, 6, 7 & 8 which contain the

Requirements themselves and organizations
wishing to be certified against ISO 9001:2008
will need to demonstrate that they have
addressed all of these requirements.
 Overview of ISO 9000

There are over 250 individual requirements

in ISO 9001 that can be condensed into
five key statements.
 Overview of ISO 9000
The organization shall:
• Determine the needs and expectations of customers
• Establish policies, objectives and a work environment
necessary to motivate people to satisfy these needs
• Design, implement and manage a system of inter-related
processes to implement the policy and attain the
objectives
• Measure and analyze the effectiveness of each process
in fulfilling its objectives and
• Pursue the continual improvement of the system from an
objective evaluation of its performance.
 Overview of ISO 9000

Certification to ISO 9001:2008

ISO 9001:2008 registration (certification) gives the

organization the benefit of an objectively
evaluated and enforced quality management
system.
Overview of ISO 9000

Certification to ISO 9001:2008 is

a tangible expression of a firm’s
commitment to quality that is
internationally understood &
accepted.
 Overview of ISO 9000
• ISO 9001:2008 certification
(registration) is carried out by
certification bodies
(registrars)- accredited
organizations that review the
your quality manual and
working practices to ensure
that they meet the
requirements.
Overview of ISO 9000

It is important to clarify which aspects

of the organization are covered by the
certificate .
 Overview of ISO 9000

This is addressed through the Scope

of Certification, and this must clearly
identify what is included so as not to
mislead.
Overview of ISO 9000

It is a requirement that all

elements of ISO 9001 must be
addressed by the organization.
 Overview of ISO 9000
However, there are
specific circumstances
under which certain
requirements of the
Standard can be
excluded, yet compliance
with ISO 9001:2008 still be
claimed:
 Overview of ISO 9000
• any excluded requirements do not affect
the ability of the organization to meet
customer and regulatory requirements
• any excluded requirements do not affect
the ability of the organization to provide
conforming products or services
• any excluded requirements must only
come from section 7 (Product realization)
of ISO 9001.
 Overview of ISO 9000
An example may be
customer property.

• Clearly if a company never

deals with such property
then the requirement would
not be apply.
 Overview of ISO 9000

The company's quality manual must also

clearly identify what specific requirements
of ISO 9001 have been excluded and the
justification for the exclusion.
 Overview of ISO 9000

• What ISO 9001:2008 is not :

ISO 9001 is NOT a product Standard

- it contains no product requirements
Overview of ISO 9000

ISO 9000 is a series of

generic requirements for
quality management systems.
 Overview of ISO 9000
Approval to ISO 9001
means that you meet
the minimum
requirements of
quality management.
 Overview of ISO 9000

ISO 9004:2009
Guidelines for
performance
improvement
 Overview of ISO 9000

ISO 9004 is not a guide

on how to implement ISO
9001, rather a guide on
how to improve on the
basic requirements that
ISO 9001 specifies.
 Overview of ISO 9000
• The requirements
statements in ISO
9001 may be seen
sometimes as a little
brief and it rarely,
tells the user 'how' to
achieve compliance
with it.
 Overview of ISO 9000
• ISO 9004 takes the
basic requirement
and expands on it. It
gives options for the
organization to
consider if they wish
to progress beyond
basic compliance
and into excellence.
 Overview of ISO 9000
• Given that 'Continual
Improvement' is a
requirement of ISO
9001:2008,
• it is strongly recommended
that one consider using ISO
9004 as a way forward in
the journey of continual
improvement.
 Overview of ISO 9000
Benefits of ISO 9001
• Improved consistency of service and product
performance
• Higher customer satisfaction levels
• Improved customer perception
• Improved productivity and efficiency
• Cost reductions
• Improved communications, morale and job
satisfaction
• Competitive advantage and increased
marketing and sales opportunities
 Overview of ISO 9000
Dun and Bradstreet findings :
85% of registered firms report
external benefits like :
• Higher perceived quality
• Greater customer demand
95% report internal benefits
like:
• Greater employee awareness
• Increased operational
efficiency
 Overview of ISO 9000
Case Studies show that ISO
Registration resulted in:
• Reduction in customer claims
• Improvement in delivery time
• Reduced defect levels
• Reduction in production cycle time
• Increase in on-time delivery
• International acceptance and
recognition
• Facilitated trade in international
markets
• Promoted safety, reliability and
quality in food products.
 Our Role
BUSINESS RELY ON SYSTEMS, SYSTEMS ARE
OUR BUSINESS.

• Study of existing system in the organization

• Finding gaps between the existing system & the
standard
• Design & prepare systems documentation after
bridging the gaps
• Awareness training to employees on the Standard
• Guidance in implementation of documented System
• Assistance in conducting Initial Internal Audit
• Assistance in conducting Initial Management
Review Meeting
• Coordination with the Certification Body
• Assistance in closing Non - conformities observed
during Certification audit
• Facilitate delivery of the Certificate
• Maintaining the system after Certification
 Our Clients
Some of our esteemed clients are:
• Cipher Dynamics IT Services (P) Ltd.
• Indiamart Intermesh Ltd.
• Velocis Systems (P) Ltd.
• Kayako Infotech Ltd.
• K & A Securities (P) Ltd.
• Showa India (P) Ltd.
• FIL Industries Ltd.
• Asian Academy of Film & Television
• Veer Hues Ltd.
• Sarita Forgings (P) Ltd.
• G.K. Enterprises (P) Ltd.
• Tina Organics (P) Ltd.
 about us
• Founded by Mr. Anil Kumar Pant in 2006.
• B.E.(IIT-R), PGPIM(IMI), Lead auditor :ISO 9001, ISO 27001, ISO 22000,
Six Sigma GB,
• 19 Years of work experience at senior positions
• Organizations worked : NDDB/Tetrapak, Hyderabad Industries, Lazard
Credit Capital, Cosmos Fibreglass Ltd., Oswal Electricals, NPI Packagings,
BSI Benchmark Certification
• Have audited approx. 500 organizations e.g. Orient Ceramics, Food
Corporation of India, MM Aqua Technologies, BMIET, SSIET, AIT, RIT,
PDMREA, TMIMT, IIFT, Atlas Cycles, Anant Raj Industries Ltd., Singh
Plasticizers, Sofcon Systems, Dynamic Engineers, Kunal Auto, Manak
Engineering Services etc.
• Have provided Consulting services to approx 100 clients
• Provide consulting services for: ISO 9001, ISO 14001, OHSAS 18001,
ISO/TS 16949, ISO 20000, ISO 22000, ISO 27001, HACCP, Six Sigma,
TPM, Integrated Management Systems
 Our Methodology
• Train & make people understand ISO 9001 & its implications
• Interview MD/Directors/CEO/HOD/TL/Members
• Draft Scope, Quality Policy, Objectives, QAP for the
organization/core teams
• Document the processes
• Identify gaps/Non conformities (NCs)
• Assist organization to take appropriate Corrective & preventive
actions and close gaps/NCs
• Assist the organization in reviewing the performance of the QMS
• Get the organization certified
• Assist the organization on the path of continual improvement
 THANK YOU

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