The document discusses ISO 9000 and ISO 14000 standards. ISO 9000 defines quality management system requirements, while ISO 14000 addresses environmental management system requirements. Both standards use the PDCA (Plan-Do-Check-Act) model and aim to help organizations improve processes, increase customer satisfaction, and meet regulatory requirements through certified management systems.

1. ISO 9000 AND
ISO 14000
Miss. Gayatri K. Bahatkar
Assistant Professor

2. What is ISO:
 ISO is a name used for the International
Organization for Standardization ISO.
 It is derived from the GREEK Word 'isos"
that means "equal".
 ISO is the World's largest developer of
standards.
 It was formed in 1947 in Geneva
Switzerland.
 It is a federation of national standard
bodies of 164 countries.

3. ISO 9000
 Series of standards, developed and
published by the International
Organization for Standardization (ISO)
 Define, as establish and maintain an
effective quality assurance system for
manufacturing and service industries.
 ISO are set of standards addressing
quality management system
requirements (QMS) & ISO 14000
Addresses Environmental management
system requirements (EMS)

4. ISO 9000 series
 ISO 9000: Explains fundamental quality concepts and
provides guidelines for the selection and application
of each standard.
 ISO 9001: Model for quality assurance in design,
development, production, installation and servicing.
 ISO 9002: Model for quality assurance in the
production and installation of manufacturing
systems.
 ISO 9003: Quality assurance in final inspection and
testing.
 ISO 9004: Guidelines for the applications of
standards in quality management and quality
systems.

5. OBJECTIVES:
 To Facilitate International Trade Of Goods and
Services
 To obtain competitiveness by obtaining
required quality in a cost effective way.
 Promoting a Total Quality Control System
(TQC)
 Provide confidence to costumers

6. Benefits of ISO 9000
 Increases marketability
 Reduced operational expenses
 Better management control
 Increased customer satisfaction
 Improved internal communication
 Reduction of product-liability risks.
 Improved health, safety and reduction
of waste

7. Limitation of the ISO 9000
 Cost
 ISO Certification Process
 Employee Buy-in
 Competitive Disadvantage

8. ISO 9000 series Quality Management
Principles
It based on seven quality management
principles
 QMP-1-Customer focus
 QMP 2 – Leadership
 QMP 3 – Engagement of people
 QMP 4 – Process approach
 QMP 5 – Improvement
 QMP 6 – Evidence-based decision making
 QMP 7-Relationship management

9. Principle 1 – customer focus
 Organization depends upon their costumer and
therefore should understand current and future
customer needs, should meet customer
requirements and strive to exceed customer
expectation
Principle 2- Leadership
 Leaders established unity of purposed and
direction of the organization. They should create
and maintain the internal environment better

10. Principle 3 – Engagement of people
 People at all levels are the essence of an
organization and their full involvement enables
their abilities to be used for the organization’s
benefit.
Principle 4 – Process approach
 A desired result is achieved more efficiently when
activities and related resources are managed as a
process.
Principle 5 – Improvement
 Improvement of the organization’s overall
performance should be a permanent objective of
the organization

11. Principle 6 – Evidence-based decision making
 Effective decisions are based on the analysis
of data and information.
Principle 7- Relationship management
 An organization and its external providers
(suppliers, contractors, service providers)
are interdependent and a mutually
beneficial relationship enhances the ability
of both to create value.

12. Steps in ISO 9000 Registration
process
New standard is proposed is
relevant technical committee
Working group of experts start
discussion to prepare a
working draft
1st working draft shared with
technical committee & with
ISO
If proposal is accepted
If consensus is reached within the TC

13. Draft shared with all ISO
national members, who are
asked to comment
Final draft sent to all ISO
members
ISO international standards
If standards is approved by
member vote
If consequences is rechecked

14. ISO 9001 Process based approach
ISO 9001 standard promotes the adoption of a process approach when
developing, implementing and improving the effectiveness of a quality
management system, to enhance customer satisfaction by meeting customer
requirements. Management of the processes and the system as a whole can be
achieved using the PDCA cycle with an overall focus on risk-based thinking aimed
at taking advantage of opportunities and preventing undesirable results.
The PDCA cycle can be briefly described as follows:
Plan: Establish the objectives of the system and its processes, and the resources
needed to deliver results in accordance with customers' requirements and the
organization's policies, and identify and address risks and opportunities.
Do: Implement what was planned.
Check: Monitor and (where applicable) measure processes and the resulting
products and services against policies, objectives, requirements and planned
activities, and report the results.
Act: Take actions to improve performance, as necessary.

15. Act on anything that
went wrong to avoid
errors of the same
nature in future
Plan what you are
doing

16. STEPS FOR ISO REGISTRATION PROCESS
1. Finding and selecting an ISO registrar: An
accredited registrar is an organization accredited
by a recognized accrediting body for its
competence to audit and issue certification
confirming that an organization meets the
requirements of a standard (ISO 9001 or ISO
14001). Registrars must be accredited in a
particular industrial sector for them to be able to
certify a company in that sector.
2. Creating an application/contract: The
applicant and the registrar should agree on a
contract. This contract usually defines rights and
obligations of both parties and Includes liability
issues, confidentiality, and access rights.

17.  3. Quality Documents Review: The ISO auditor reviews all the
quality manuals and documents related to various policies and
procedures being followed in the organization. A review of
existing work will help the ISO auditor to identify the possible
gaps against the requirements stipulated in the ISO standards.
 4. Making an Action Plan: After the ISO auditor communicates
the existing gaps in the organization, an action plan is
prepared by the organization to eliminate these gaps. The list
of the required tasks to be performed is prepared to bring the
desired changes in the organization. The training of the
employees is required to work efficiently while adapting to
new procedures. It is also necessary to make all the employees
aware of the ISO standards in terms of work efficiency and
quality standards.

18. 5. Performing internal audits: The organization needs to
audit each process internally before they come in to do the
certification audit. This will give a chance to make sure
that the processes are doing as per plan, and if not,
corrective action can be taken to fix problems.
6. Initial Certification Audit: The initial certification audit
is divided into two categories- Stage 1 and Stage 2.
 Stage 1: The ISO auditor will audit the changes made in
the organization as per the suggestions. They will then
try to identify the possible non-conformities in the
systems and procedures to the desired quality
management system.
 They will divide these non-conformities into minor and
major non-conformities. The applicant must carefully
assess all these non-conformities and get it aligned as
per the desired quality standards through modification in
the techniques and processes used by the organization.

19.  Stage 2: After all the required changes are done in the
organization, the ISO auditor does the final auditing.
The auditor will check whether all the non-conformities
have been eliminated or not as per ISO quality
standards. If the ISO auditor is satisfied, he will prepare
the final ISO audit report and forward it to the
registrar.
7. Completing the ISO Certification: After all non-
conformities are addressed and all the findings are put in
the ISO audit report, the registrar will grant the ISO
certification the organization.
8. Surveillance Audits: Surveillance audit is basically
conducted to ensure that ISO quality standards are being
maintained by the organization. It is conducted from time
to time (usually once in three years).

20. Risk based thinking
Risk is inherent in all aspects of a quality
management system. There are risks in all systems,
processes, and functions. Risk-based thinking ensures
these risks are identified, considered, and controlled
throughout the design and use of quality management
system.
Risk-based thinking approach includes the following
steps:
(a) Identifying and understanding the risks
(b) Planning the actions to address the risks
(c) Implementing the plan
(d) Checking the effectiveness of the action
(e) Continuous improvement that is learning from
experience

21. ISO 14000
 Environmental management
 Help organizations to work within
healthy environment
 Help to meet the challenge of climate
change
 Develop 570 international standards
 An integral part of EMAS

22. Standards under ISO 14000 series
 ISO 14001-Set criteria for EMS
 ISO 14010-Standards about auditing
 ISO14020-Standards about environmental
labeling
 ISO 14030- Standards on environmental
performance evaluation
 ISO 14040-Standards on environmental
life cycle assessment

23. Objectives of an Environmental Management System
 The purpose of this International Standard is to provide
organizations with a framework
 To protect the environment and respond to changing
environmental conditions in balance with socio-economic
needs. It specifies requirements that enable an organization
to achieve the intended outcomes it sets for its
environmental management system.
A systematic approach to environmental management can
contribute to sustainability Development by.
 Protecting the environment by preventing or mitigating
adverse environmental impacts Mitigating the potential
adverse effect of environmental conditions on the
organization
 Assisting the organization in the fulfillment of compliance
obligations
 Enhancing environmental performance

24.  Controlling or influencing the way the organization’s
products and services are designed Manufactured,
distributed, consumed and disposed of by using a life
cycle perspective That can prevent environmental
impacts from being unintentionally shifted elsewhere
Within the life cycle;
 Achieving financial and operational benefits that can
result from implementing environmentally sound
alternatives that strengthen the organization’s
market position:
 Communicating environmental information to
relevant interested parties.

25. Benefits of ISO 14001
 Higher conformance with legislative and regulatory
requirements by adopting the ISO standard.
 Reduction in waste, consumption of resources, and operating
costs. Quantify, monitor and control the impact of operations
on the environment, now and in the future.
 As an internationally recognized standard, businesses operating
in multiple locations across the globe can leverage their
conformance to ISO 14001, eliminating the need for multiple
registrations or certifications.
 Positive impact on a company’s asset value. To improved public
perceptions of the business, placing them in a better position
to operate in the international marketplace.
 Increase business’s access to new customers and business
partners.
 Potentially reduce public liability insurance costs for
organization.
 It can serve to reduce trade barriers between registered
businesses.

26. Essential Elements of ISO 14001 The principle elements, stated
in the ISO 14004 standard are highlighted below.
1.Environmental Policy
 An organization should define its environmental policy and
ensure commitment to its EMS across all organizational units.
This is accomplished by developing an environmental policy that
is specific enough to form the basis for concrete actions. This
policy then becomes the framework for environmental planning
and should be both communicated within the organization and
made available to the public. Commitment and support for the
policy must be provided from the highest levels of the
organization to be effective.
2.Employee Involvement
 The first key element for having a successful EMS is to achieve
full participation of all employees, from top management to
shop-floor workers. If people are not involved, every goal and
target will require a lot more time and effort to be reached. The
whole organization is responsible for the implementation,
maintenance and improvement of the EMS. Training of the
employee for the implementation of EMS is also an essential
step.

27. 3. Plan-Do-Check-Act (PDCA) model
 Plan: Establish environmental objectives and processes
necessary to deliver results in accordance with the
organization’s environmental policy. The initial review or the
gap analysis of the processes and products is recommended in
order to identify all elements of the operation that may
interact with the environment called as environmental
aspects. Environmental aspects can include both direct, such
as those used during manufacturing and indirect, such as raw
materials. This initial review assists the organization in
establishing their environmental objectives, goals and targets,
which should ideally be measurable; helps with the
development of control and management procedures and
processes and serves to highlight any relevant legal
requirements, which can then be built into the policy.

28.  Do: Implement the processes as planned. During
this stage, the organization identifies the resources
required and works out those members of the
organization responsible for the EMS
implementation. This includes establishing
procedures and processes, although only one
documented procedure is specified related to
operational control. Other procedures are required
to foster better management control over
elements such as documentation control,
emergency preparedness and response, and the
education of employees, to ensure they can
competently implement the necessary processes
and record results.

29.  Check: During the check stage, performance is monitored and
periodically measured to ensure that the organization’s
environmental targets and objectives are being met. In
addition, internal audits are conducted at planned intervals to
ascertain whether the EMS meets the user’s expectations and
whether the processes and procedures are being adequately
maintained and monitored.
 Act: take action to improve the performance of EMS based on
results After the checking stage, a management review is
conducted to ensure that the objectives of the EMS are being
met, the extent to which they are being met, that
communications are being appropriately managed and to
evaluate changing circumstances, such as legal requirements,
in order to make recommendations for further improvement of
the system. These recommendations are incorporated through
continual improvement, plans are renewed or new plans are
made, and the EMS moves forward.

30. 4. Continual Improvement Process
Continuous improvement process in ISO 14001
has three dimensions:
(a) Expansion: More and more business areas
get covered by the implemented EMS.
(b) Enrichment: More and more activities,
products, processes, emissions, resources etc
get managed by the implemented EMS.
(c) Upgrading: An improvement of the structural
and organizational framework of the EMS, as
well as an accumulation of know-how in dealing
with business-related environmental issues.

31. Difference between ISO 9000 and
14000
 ISO 9000 is an international standard for
the development of quality management
systems that any organization can adopt.
 ISO 14000 is an international standard for
environmental management systems that
any organization can also adopt potentially

32. Advantages
 Creates a more efficient, effective operation
 Increases customer satisfaction and retention
 Reduces audits
 Enhances marketing
 Improves employee motivation, awareness, and
morale.
 Promotes international trade
 Increases profit
 Reduces waste and increases productivity

33.  Common tool for standardization
 Enables to meet the requirements of an
internationally uniform quality system.
 Motivates the employees and develops
pride in them for achieving excellence.