Overview of ISO 9001 /14001/

45001
INTEGRATED
MANAGEMENT SYSTEM
The International Organization for Standardization (ISO) is an international standard-setting body composed of
representatives from various national standards organizations.
Correspondent
members observe the
development of ISO
standards and strategy by
attending ISO technical and
policy meetings as
observers. Correspondent
members can sell and adopt
ISO International Standards
nationally.
Subscriber members keep
up to date on ISO’s work Full members (or member
bodies) influence ISO
but cannot participate in
standards development and
it. They do not sell or strategy by participating and
adopt ISO International voting in ISO technical and
Standards nationally. policy meetings. Full
members sell and adopt ISO
International Standards
nationally.

Founded on 23 February 1947, the organization

promotes worldwide proprietary, industrial and
commercial standards. It is headquartered in Geneva,
Switzerland, and works in 162 countries
 GENERIC STANDARDS
ISO 9001, ISO 14001 and ISO 45001 are 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 a
 no matter what the organization's scope of
activity
 if it wants to establish a quality management
system, ISO 9001 gives the essential features
 or if it wants to establish an environmental
management system, ISO 14001 gives the
essential features.
 or if it wants to establish an occupational health
and safety management system, ISO 45001 gives
the essential features.
ISO 9001, ISO 14001 and ISO 45001 in brief
ISO 9001, ISO 14001 and ISO 45001 are among ISO's
most well known standards ever.

 ISO 9001 helps organizations to implement Quality

Management.

 ISO 14001 helps organizations to implement

Environmental Management.

 ISO 45001 helps organizations to implement

Occupational Health and Safety Management
 Processes, not products

ISO 9001, ISO 14001 and ISO 45001 concern

the way an organization goes about its work.

 They are not product standards.

 They are not service standards.

 They are process standards.

 They can be used by product manufacturers

and service providers.
 ENVIRONMENTAL MANAGEMENT
ISO 14001 is for Environmental Management. This
means what the organization does to:
 Minimize harmful effects on the environment
caused by its activities,
 to conform to applicable Regulatory
Requirements, and to
 achieve continual improvement of its
Environmental Performance
 Occupational health and safety management

What is an OH&S Management System ?

An Occupational Health and Safety Management System

(OH &M MS) is coordinated and Systematic approach to
managing health and safety risks.
 OH&S (Cont…)
What is ISO 45001 ?
 ISO 45001 is global standard for
occupational health and safety
management system (OH&S MS)

 Specifies requirement for an

OH&SMS

 Applies to all types and sizes of

organizations.
 DEVELOPMENT OF ISO 45001

2 2
0 0
1 9 9 9 0 1
7 8

OHSAS OHSAS ISO

18001:1999 18001:2007 45001:2018
(1st Issue) (2nd Issue) (1st Issue)

2018 - 2021
Transition time, Recertification
audits to the new standard
 What is Quality……..
Not
Satisfied ? Satisfied ?

How was it ?
4
1
Requirements

2
Product / Service

“Degree to which a set of inherent characteristics fulfills requirements”

 QUALITY MANAGEMENT
ISO 9001 is for Quality Management.
 Quality refers to all those features of a product (or
service) which are required by the customer.
 Comply with any regulations applicable to those
products or services.
 Ensure that its products or services satisfy the
customer's quality requirements and
 Quality management also means what the
organization does to
 enhance customer satisfaction, and
 achieve continual improvement of its
performance.
 ISO 9001:2015 / ISO 14001:2015 /
ISO 45001:2018
Clause No-1 Scope
Clause No-2 Normative Reference
Clause No-3 Terms & definition
Clause No-4 Context of the organization
Clause No-5 Leadership
Clause No-6 Planning
Clause No-7 Support
Clause No-8 Operation
Clause No-9 Performance evaluation
Clause No-10 Improvement
Normative references = “indispensable”

ISO 9001:2015 identifies only one document as

“normatively referenced” and “indispensable for its
application”:
ISO 9000:2015
Quality management systems —
Fundamentals and vocabulary
-- extremely important and
necessary
-- too important to be
without
SYNONYM essential
 Cars have become an
indispensable part of our
lives.
 Mr. XXX made himself
indispensable to the
department
 A good dictionary is
indispensable for learning a
foreign language
Quality Assurance Vs Quality Control

ISO 9000:2015
Quality management systems —
Fundamentals and vocabulary

3.2 related terms to organization

QC : Part of quality Management focused on fulfilling

quality requirement

QA : Part of quality Management focused on providing

confidence that quality requirements will be fulfilled.
 Q QA is a set of activities for ensuring quality in the PROCESS by
1 A which product is being developed

Definition Q QC is a set of activities for ensuring quality in the PRODUCT by

C which product is being developed

Q QA aims in PREVENT DEFECTS with a FOCUS ON PROCESS used

2 A to make the product. It is a PROACTIVE QUALITY PROCESS

Focus on Q QA aims TO IDENTIFY (AND CORRECT ) DEFECTS in the FINISHED

C THE PRODUCT. Quality control thus is an REACTIVE PROCESS

The goal of QA is to IMPROVE DEVELOPMENT AND TEST

Q
PROCESS so that defect do not arises when the product is
A
3 being developed

Goal
Q The goal of QC is to IDENTIFY DEFECTS after a product is
C developed and before its released.
 Q Establish a good QUALITY MANAGEMENT SYSTEM and its
4 A assessment of its adequacy. Periodic conference audit of the
operation of the system
HOW FINDING AND ELIMINATING SOURCE OF QUALITY PROBLEM
Q through tools and equipment . So that the customer
C requirement continually met.

Q PREVENTION OF THE QUALITY PROBLEMS through planned and

5 A systematic activity including documentation.

WHAT
Q The ACTIVITIES OR TECHNIQUE USED TO ACHIEVE and maintain
C the product quality, process and service

Q EVERYONE ON THE TEAM INVOLVED in developing the product

6 A is responsible for the quality assurance

Responsibility
Q Quality control is usually the responsibility of a SPECIFIC TEAM
C that test the PRODUCT FOR DEFECT
ISO 9000 series
Three standards in the series:
ISO 9004
ISO 9000 ISO 9001 Managing for the
sustained success of an
Quality management Quality management organization—
systems—Fundamentals systems—Requirements A quality management
and vocabulary approach

Requirements aimed Guidance for organizations

Essential background for primarily at giving
the proper understanding confidence in the products
and implementation of and services
ISO 9001 an organization provides,
thereby improving
customer satisfaction
that choose to progress
beyond ISO 9001
requirements to address
a broader range of topics
that can lead to continual
improvement of the
organization's overall
performance

New Revisions released together in 2015 Currently under revision

Organization & its Quality Management System (4)
context (4)

Support &
Operation
(7,8)

Plan Do
Customer
Satisfaction
Customer Performanc Results
Requirem Planning Leadership e Evaluation
of QMS
ents (6) (5) (9)

Products &
Services

Needs &
Act Check
expectations
of relevant Improvement
interested (10)
parties (4)
 Quality Management Principal
Quality management principles provide a framework for organizations to enhance
performance and customer satisfaction. They include customer focus, leadership,
engagement of people, process approach, improvement, evidence-based decision
making, and relationship management.

Relationship
Leadership
Engagement
Customer
Improvement
Process Management
Evidence-based
of Decision
People Making
Focus
Approach
Importance
Making
Empowering
Continuous decisions basedtoon
employees
improvement, atake data and information
ownership
core quality
Establish
Key a vision
Principle:
•Understanding and managing
directionand
Understanding for the organization.
interrelated
Relationship
of their work
principle, urgesmanagement
and contribute
constant istoathe
pursuit crucial
of better.
processes
improvement
Create as a system
of processes and products.
principle in quality management, asemployees
Meeting
It an
demands environment
Customer
analyzing that encourages
Requirements
processes, it
identifying to
•Improving
Promoting
achieve the
quality effectiveness
teamwork
objectives.and and efficiency
collaboration of
inefficiencies,
focuses and implementing
on managing relationships change.
with
1.processes
Customer
among employeesfocus is a
to foster fundamental
a culture of
This proactive
stakeholders approach
to achieve minimizes
mutual errors,
benefits.
•Identifying inputs,
sharedefficiency,
responsibility outputs, and interactions
principle
boosts and and
in quality management. collective
keeps us ahead success.
by
Stakeholders
between processes
Creating aexpectations,
culture of continuous
exceeding not just meeting
2.•Applying
It involves
•Customers:
improvement, understanding
Building
a systematic
where strong
approach
employeesand meeting
relationships
to achieve
are
them.
Using
desired
with
customer aoutcomes
systematic
customers
encouraged helps
to seek
requirements approach
understand
opportunities
and to for
gather
expectations.their and
analyze
needs and
learning evidence
expectations.
and growth.
3. By putting the customer at the center
•Suppliers: Collaborating closely with
05 06 07
of all processes,
suppliers
and
ensures
components.
customer
organizations
the qualitycan ensure
of materials
satisfaction and loyalty. 03 04
•Partners: Working closely with partners 02
fosters innovation and continuous 01
improvement.
A Process Approach
An important aspect of a QMS is its process-oriented approach. Instead of looking at
departments and individual processes, it requires an organization to look at how
processes interact and integrate with each other.
 Process Approach

IMPLEMENTATION MANAGEMENT

Process

IDENTIFICATION IMPROVEMENT
 How process is measured

EFFICIENT EFFECTIVENESS
(No waste) (Desired result achieved)

INPUT Process OUTPUT

Right Resource:
Qualified People Desired Result:
Right Facilities/equipment Quality Product
Correct material Quality Service
Proven method Customer Satisfaction
 Development of ISO 9001
2000 : Quality 2015 :
1987: Quality 1994 2008
Mgmt. System New Structure
Assurance - Small Minor
Process including Risk
20 Elements revision revision
Approach Based Thinking

Development of ISO 14001

1993: 1996: ISO 2004: ISO 20015: ISO
1992: BS Committee to publish 1st updates EMS updates EMS
7750 Launch develop Version ISO to ISO to ISO
14000 std. 14001:1996 14001:2004 14001:2015

The
Thelatest
firstversion of ISO
revision 14001:2015
ofAtThe
the standard brought
came many
eight deeper
years changes
later, in to
theRio
same time, Environmental
Declaration Management
on environment and
the Environmental Management Systems. The most significant one is
2004, and introduceddevelopment some
System minor
standards
was changes
were published
approved by to ISO 14001:1996,
inUnited
the other
adopting
countries,the high-level
like Spain structure.
and Ireland, and the European
mostly focused
Also, new requirements on
Nations making
during
for risks
Commission
the its requirements
Conference
and opportunities
developed
on Environment
the Eco-managementwereandmore
introduced,
understandable, and
but
Audit Development
also
Scheme to held in
facilitate
(EMAS), Rio de
similar totheJaneiro on June
integration
BS 7750 with extra with
along with the removal of mandatory 1992.
requirements like
procedures and other
public reporting.
other standards such as. ISO 9001.
modifications
 Development of ISO 45001:2018

• Guidance to
2007 • ISO 45001
2018
Occupational • OHSAS 18001 Proposed ISO • March 2018 ISO
health and released by BSI 45001 Published the
Safety final Standard

1996 2013
 Approach of ISO 9001
Key is to engage all three gears

Third Gear added

New

PROCESS
APPROACH

P-D-C-A Already there

Approach
Risk Based Thinking We have to identify Risk
out of process & action
plan is to be based on
Process risk

RISK :
Effect of uncertainty
on an expected result
-ISO 9001:2015
Risk Based Thinking
4.0 Context of the Organization
4.1 4.2
Understand Understanding the
organization and its needs &
context expectation of
interested parties

4.0
Context of
the
organization

4.3
Determining the 4.4
scope of the QMS,EMS,OHS
QMS,EMS & OHS and its processes
4.1 Understand organization and its context

Determine External and Internal Monitor and review the

Issues information

Relevant to purpose and strategic

direction About External and Internal Issues

# Issues that are relevant to Organization purpose and its strategic direction

# Issues that will affect the ability to achieve the intended result of QMS

Ask the question to yourself What are Internal issues/challenges to run your business
What are External issues/challenges
RELATED TO QUALITY, ENVIRONMENTAL AND OCCUPATIONAL HEALTH & SAFETY
INTERNAL ISSUES EXTERNAL ISSUES

Stability of Work Force Political Environment

Staff Retention Social environment

Contractual agreement with
Customer Legal, Statutory requirements

Payment Terms from customers Customer Expectation

Manual system of working / no
automation Price Volatility of Raw Material
Legacy software / not adequate for
change business process Economic Situation

High Receivables Nature and impact of economic

market
Culture within the organization General Level of customer
confidence
Ageing Machinery /equipment's Trade association and lobbying
/assets power
Reducing Market Share
SOME ORGANIZATION USES TOOLS LIKE

HELPFUL HARMFUL
To achieve the objective To achieve the objective
(Attribute for the (Attribute for the
INTERNAL ORIGIN

Organization)
EXTERNAL ORIGIN

Environment)
INTERESTED PARTIES
Individual, group, or an organization that gets
affected, has potential to get affected or
consider themselves to get affected by the
organization’s operation
Interested parties impact organization’s ability
to consistently provide product and service
meeting customer requirement's and
applicable statutory requirement
Interested Parties

 Identify all relevant interested parities

 Identify needs and expectation of interested parties

 Regular monitor and review information about

interested Parties and their relevant requirement.

 Impact in case they are not fulfilled / associated Risk

4.3 Determining scope of the QMS

Determine the Scope

Boundaries and applicability of QMS

 The external and Internal Clauses (4.1)

On the basis of
 The requirement (4.2)
(ISO 9001:2015)
 Product and service provided
 5. Leadership
5. 3
5.1 5. 2 Organizational
Leadership & Roles,
Commitment Policy Responsibility and
Authority

5.0
Leadership
 5.1 Leadership and commitment
Create
Customer
Focus &
Importance of Intended
QMS results are
Availability of
resource for achieved
QMS

Top Mgmt.
to Ensure
Engage Direct
& Support
Support for Persons
other relevant
mgmt. roles
Promote
improvement
 5.2 Policy
5.2.1 / 5.2.2 Quality Policy

- Quality Policy to support strategic direction

- Policies to be made available to all relevant

interested parties
5.3 Organizational Roles, Responsibility and Authority

 Top Mgmt. shall ensure that the

responsibility and authorities for relevant
roles are assigned, communicated and
understood within the organization.
6 Planning

6.2
6.1
6. 3
Action to address
Quality Objectives Planning of
risk and
and planning to changes
opportunities
achieve them

6.0
PLANNING
6.1 Action to address risk and opportunities
• 6.1.1 & 6.1.2 when planning for QMS –
– To consider
• The issues(referred to in 4.1) and the requirement
(referred to in 4.2) and
• TO Determine the Risk and Opportunities that need to be
addressed
• TO Plan actions
– To address risk and opportunities
– How to integrate and implement the action onto QMS process
– Evaluate effectiveness of these action
 In ISO 9001:2015 risk can be +ve or –ve
 In ISO 31000 & 14001 risk is –ve and Opportunities are +ve
 An interested parties can have both Risk & Opportunities
 Risk and opportunities (continues… )
Interested Concern Risk Opportunities Monitoring
Parties
Suppliers Their Reputation Non Superior Annual
and Quality / conformance Performance Performance
Delivery / Price Review / Random
inspection
Employees Stability Control Source of Annual
Motivation Product Innovation Performance
Quality Review
Shareholders Source of Looking for Support Review BOD
investment , short term More Investment report
Company ROI
direction
Community Impact on your Demands Promote Community
reputation and which reduces Development newsletter,
ability to produce profit membership in
community orgn.
Risk and opportunities (continues… )
Interested Concern Risk Opportunities Monitoring
Parties
Intermediaries Increased Sale, Damage to More contact and Report of NCs and
impact your Product sales Sales
reputation
Alliances Increased Your Increased sales Monitor press,
Opportunities, reputation is newsletter
concern for tied to their
reputation
Influencers Is their advice of Different Wide range of Monthly meeting
value ? frame of experience
values
Regulators Compliance Not managing Good rating Regulators
changes updates rating

Certifying Do they Dependent on Global view of Annual

bodies understand the auditors QMS Surveillance
organization training audits
and the
standards
6.2 Quality Objectives and planning to
achieve them
 The organization shall establish Quality Objectives at relevant Function, levels and
processes needed for Quality management system
 The quality objective shall
 Be consistent with quality policy
 Be measurable
 Take into account of applicable requirements
 Be relevant to conformity of product & service enhancement of customer
satisfaction
 Be monitored
 Be communicated
 Be updated as appropriate
The organization shall maintain documented information on the quality objective.
 SMART Objective
imed
& pecific
rackable &
 Timescales add CLARITY tretching
 What is to be done
 Organize & priorities
 Need to stretch us
 Long  Milestone &
 Best performance from
reviews
challenges

elevant Setting
&
einforced
Objective easurable
&
 Level of Experience
otivating
 Support &
Development greed
 Feedback &
chivable
 Build Commitment
 Create Ownership
 Critical for CLARITY
6.2 Quality objective and Planning to achieve them

6.2.2 when planning how to achieve the its quality

objective the organization shall determine-
 What will be done
 What resources will be required
 Who will be responsible

 When it will be completed

 How the result will be evaluated

6.3 Planning for changes

In a Planned manner

To consider
 The purpose of change and potential
consequences
 Availability of resource and
 Allocation / reallocation of responsibility
and Authority
7 Support

7.3 7.4
Awareness Communicati
7.2 on
Competence

7.0 7.5
7.1 SUPPORT Documented
Resources Information
7.1 Resources

7.1 7.1.2 7.1.3

General People Infrastructure

7.1.3.1 7.1.4 7.1.5

Plant Facility and Environment for Monitoring and
equipment the operation of measuring
planning Process resources

7.1.6
Organizational
Knowledge
7.1 General
– To access capability and constraints on existing
internal resources
– What needs to be obtained from external provider
7.1.2 People
– Determine and provide the person necessary for the
effective implementation of its QMS and for the
operation and control of its processes
7.1.3 Infrastructure
7.1.4 Environment for the operation of Process
– Human and physical factors also to be included now
– Social
– Psychological
– Physical
7.1.5 Monitoring and measuring resources

7.1.5.2
7.1.5.1 Measurement
General traceability

Monitoring
&
Measuring
Resources
 7.1.6 Organization Knowledge

Acquire or access
Make any necessary
Determine the Maintain
knowledge additional
knowledge knowledge
available knowledge and
required updates
7.2 Competence
• We have to determine the necessary
competence of person(s) doing work under its
control that affects the performance and
effectiveness of the quality management
system;
• Ensure that these persons are competent on
the basis of appropriate education, training, or
experience;
• Where applicable, take actions to acquire the
necessary competence, and evaluate the
effectiveness of the actions taken;
• Retain appropriate documented information as
evidence of competence.
7.3 Awareness

The organization shall ensure that persons doing

work under the organization’s control are aware
of:
a) The quality policy;
b) Relevant quality objectives;
c) Their contribution to the effectiveness of the
quality management system, including the
benefits of improved performance;
d) The implications of not conforming with the
quality management system requirements.
7.4 Communication

The organization shall determine the internal

and external communications relevant to the
quality management system, including:
a) on what it will communicate;
b) when to communicate;
c) with whom to communicate;
d) how to communicate;
e) who communicates.
7.5 Documented Information
7.5.2
Creating &
Updating

7.5.3
7.5 Control Of
7.5.1 Documented
Documented
Information
General Information
7.5 Documented information
The organization’s quality management system
shall include:
a) documented information required by this
International Standard;
b) documented information determined by the
organization as being necessary for the
effectiveness of the quality management system

7.5.2 Creating and updating

 7.5 Documented information

Quality Manual addresses each area of the standard with a statement explaining how the
organization maintains compliance to requirements.
Procedures are “high-level” documents that detail how the organization’s processes are
designed and controlled.
Work Instructions are very specific and detail all necessary instructions required for
performing a specific task.
Records must be maintained to show compliance to quality system requirements
7.5.3 Control of documented information
7.5.3.1 Documented information required by the quality
management system and by this International Standard
shall be controlled to ensure:
a) it is available and suitable for use, where and when it is
needed;
b) it is adequately protected (e.g. from loss of
confidentiality, improper use, or loss of integrity).
7.5.3.2 For the control of documented information, the
organization shall address the following activities, as
applicable:
a) distribution, access, retrieval and use;
b) storage and preservation, including preservation of
legibility;
c) control of changes (e.g. version control);
d) retention and disposition.
8. Operation
8.3 8.4
8.5
Design & Control of
Externally Provided Production &
Development processes, Service
of Products & products and
Services Provision
Services

8.2 8.6
Requirements Release of
8
for Products Products &
Operation
& Services services

8.7
8.1
Control of
Operational
Non
Planning &
conforming
Control
outputs
 8.2 Requirements for products and services

8.2
Requirements for products
and services

8.2.1 8.2.2
Customer Determining the 8.2.3
communication requirements for Review of the
products and services requirements for
products and services
8.4 Control of externally provided processes,
products and services
• Products and services are provided directly to
the customer(s) by external provider on behalf
of the organization
• A process or part of process is provided by
an external provider as a result of decision
by the organization

• To include all product and services

Subassembly, sequencing, Sorting, rework,
and calibration services etc.…
8.4.2 Type and extent of Control

The organization shall

Ensures that externally provided
process remains with the control of its
quality management system

Define both the controls

On external provider
On an resulting output
8.5.4 Preservation

The organization shall preserve the outputs

during production and service provision, to
the extent necessary to ensure conformity
to requirements

Note: Preservation can include identification, handling,

contamination control, packing, storage, transmission,
or transportation, and protection
8.5.5 Post Delivery Activities

Determine the extent of post-delivery activities

that are required, consider following:
a) Statutory and regulatory requirements;
b) The potential undesired consequences associated
with its products and services;
c) The nature, use and intended lifetime of its products
and services;
d) Customer requirements;
e) Customer feedback.
9. Performance Evaluation

9.1
9.2 9.3
Monitoring,
measurement, analysis
Internal Audit Management Review
and evaluation

9.0
PERFORMANCE
EVALUATION
 9.1 Monitoring, measurement, analysis
and evaluation
The organization shall Monitoring, measurement, analysis and
evaluation :
a) what needs to be monitored and measured;
b) the methods for monitoring, measurement, analysis and
evaluation needed to ensure valid results;
c) when the monitoring and measuring shall be performed;
d) when the results from monitoring and measurement shall be
analyzed and evaluated.
e) Retain appropriate documented information as evidence of
results
9.1.3 Analysis and evaluation

The results of analysis shall be used to evaluate:

 The degree of customer satisfaction;
 The performance and effectiveness of the quality management
system;
 If planning has been implemented effectively;
 The effectiveness of actions taken to address risks and
opportunities;
 The need for improvements to the quality management system.
9.2 Internal Audit

The organization shall conduct internal audits at planned interval

to provide information on whether the quality management
system :
1. Confirms to:
a. The Organization own requirement for its quality
management system
b. The requirement of this international standard
2. Its effectively implemented and maintained
9.3 Management Review

9.3.1 General
Top management shall review the organization’s quality
management system, at planned intervals, to
ensure its continuing suitability, adequacy, effectiveness
and alignment with the strategic direction of
the organization.
9.3.2 Management Review Inputs
The management review shall be planned and carried out taking into
consideration:
a) the status of actions from previous management reviews;
b) changes in external and internal issues that are relevant to the
quality management system;
c) information on the performance and effectiveness of the
quality management system, including trends in:
– customer satisfaction and feedback from relevant interested parties;
– the extent to which quality objectives have been met;
– process performance and conformity of products and services;
– nonconformities and corrective actions;
– monitoring and measurement results;
– audit results;
– the performance of external providers;
d) the adequacy of resources;
e) the effectiveness of actions taken to address risks and
opportunities (see 6.1);
f) opportunities for improvement.
10. IMPROVEMENT

10.2
10.3
10.1 Nonconformity
Continual
General and corrective
improvement
action

10.0
IMPROVEMENT
10.2 Nonconformity and corrective action

React to the nonconformity and, as applicable:

 take action to control and correct it;
 deal with the consequences;
 update risks and opportunities determined during
planning, if necessary;
 Corrective actions shall be appropriate to the effects
of the nonconformities encountered.
10.3 CONTINUAL IMPROVEMENT

The organization shall continually improve the suitability,

adequacy and effectiveness of the quality
management system

The organization shall consider the results of analysis

and evaluation, and the outputs from
management review, to determine if there are needs or
opportunities that shall be addressed as part of
continual improvement.
Thank You