GUIDE TO ISO 9001/ 14001/ 45001, Created on: 20.11.

2020

Clause ISO 9001-2015 ISO 14001-2015 ISO 45001-2018

No.

4.0 Context of organization- संदर्भ:

This clause requires detail of following elements
a. Type of company and sector in which it operates, issues faced by it and how these are handled
b. Listing out interested parties and their needs and expectations and how these are handled
c. Defining of scope (दायरा) both Process and Geographical scope and its physical boundaries
d. Structure of SHEQ (Safety, Health, Environment and Quality) management system
4.1 Understanding the Organization and its context

Context is defined by
1. List of issues on a broader level (company level) which can affect the working of company.
The issues can be external and internal. Issues can be further divided into categories such as Technological
issues, Social issues, Physical boundaries issues, Supply chain partners issues, Regulatory Issues, Emissions
issues, Political issues, Environmental issues, Health and Safety Issues, Issues with contractors, Working
conditions issues, Human Resources issues, other relevant interested party issues and so on...See sec. 4 of
SHEQ Manual.
2. Defining method adopted to address the issues and its monitoring mechanism.
4.2 Needs and expectations of Interested Parties Needs and expectations of
(इच्छु क दलों की आवश्यकताएं और अपेक्षाएं) Workers and Interested Parties
This sub clause requires two things:
1. Identify interested parties
2. List down relevant requirements of identified interested parties** and workers (for ISO
45001:2018) and outline mechanism to manage and comply with their requirements

** Interested party is a person or organization that can affect, be affected by, or perceive it to be affected by a
decision or activity”. Examples of Interested parties are

Legal and regulatory authorities, Owners, shareholders, parent company, Suppliers, contractors and
subcontractors, Workers’ representatives such as safety committee, Trade unions, Clients, Visitors, Local
community and neighbors of the organization, The general public, Medical and emergency services, The media,
Non-governmental organizations (NGOs), Occupational health and safety organizations and Occupational
safety and health-care professionals etc. (See sec. 4) of SHEQ Manual.

4.3 Determining the scope

(दायरे का निर्धारण)
This sub clause requires defining boundaries (geographical scope) and process scope in such a manner that
it includes the organization’s functions, physical boundaries, and its activities, products and services.
4.4 SHEQ Management System
 This clause requires that following elements are well defined in the SHEQ system.
1. Inputs for the processes and expected outputs
2. Sequence and interaction of these processes
3. Criteria ( performance indicators) and methods of monitoring and measurements
4. Resources needed for these processes
5. Assigning of Responsibilities, Authorities and Accountabilities
6. Risks and Opportunities associated with these processes
7. Evaluation of processes

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8. Improvement of processes
9. Integration of requirements of Environment, Occupational Health and Safety with other processes such as
Design, Procurement, Human Resources etc. (अन्य प्रक्रियाओं जैसे डिजाइन, प्रोक्योरमेंट, मानव संसाधन आदि के साथ पर्यावरण,
व्यावसायिक स्वास्थ्य और सुरक्षा की आवश्यकताओं का एकीकरण)
5.0 Leadership& commitment-नेतृत्व और प्रतिबद्धता:
This clause requires following;
a. Demonstrate that top management is committed to meet all SHEQ requirements
(ISO 9001/14001/45001)
b. Ensuring that all resources required to meet above point are provided to
1. Achieve intended results
2. Promoting improvement
3. Fulfillment of all legal and regulatory requirements
c. Declaration of SHEQ policy
d. Defining organizational roles, responsibilities and authorities
e. Providing a framework for consultation and participation of workers for Health & Safety issues
This sub clause requires the following elements are well defined in SHEQ system.
Management shall demonstrate (प्रदर्शन करना)
1. leadership and commitment with respect to fulfill all the requirements of the;
a) Quality management System
b) Environment Management System &
c) OH&S management system

By taking accountability and responsibility (जवाबदेही और जिम्मेदारी)for the effectiveness (प्रभावशीलता)and ensuring that the
policy and objectives are established and aligned with the context and strategic direction of the organization
(यह सुनिश्चित करना कि नीति और उद्देश्यों की स्थापना संगठन के संदर्भ और रणनीतिक दिशा के साथ की जाती है)
2. Ensuring that all resources are available for implementation and maintenance of management
system.
3. achieving its intended results (इच्छित परिणाम)
4. promoting improvement;
5. fulfilling all obligations, regulatory requirements and other requirements
(सभी दायित्वों,नियामक आवश्यकताओं और अन्य आवश्यकताओं)
6. Enhancement of customer satisfaction is focused
(ग्राहकों की संतुष्टि का Promotion कें द्रित है)
5.2 Policy–नीति - Quality policy/ Environmental policy & OH&S policy-
This sub clause requires that, management shall establish, implement and maintain a policy that;
i) Is appropriate to the purpose and context of the organization including framework for setting
objectives, fulfills all compliance obligations, legal and other requirements, eliminate hazards
and reduce OH&S risks with the consultation and participation of workers and other relevant
interested parties and includes a commitment of top management for continual improvement.

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This sub clause requires that top management shall establish, implement and maintain an applicable
policy that;
1. Is appropriate to the purpose and context of the organization and supports its strategic direction;
2. Provide a framework for setting objectives& compliance obligations
(उद्देश्यों और अनुपालन दायित्वों)
3. Includes a commitment for setting objectives& compliance obligations;
4. Includes a commitment to satisfy applicable requirements & continual improvement and enhancement of
environmental performance.
5. Be maintained and available as documented information
6. Be communicated, understood and applied within organization and relevant interested parties, as
appropriate (उचित रूप में संगठन और प्रासंगिक इच्छु क पार्टियों के भीतर संवाद,समझा और लागू किया जाए)

5.3 Organizational roles, responsibilities & authorities

(संगठनात्मक भूमिकाएँ,जिम्मेदारियाँ और अधिकार)
This sub clause requires that the top management shall assign responsibilities and authorities for relevant
rules and communicate these as to understand within the organization.
1. Ensuring that management system confirms to the requirements if these International Standards.
2. Ensuring that the processes are delivering the intended outputs (इच्छित परिणाम)
3. Opportunities for improvement (सुधार के अवसर) are reported to top management.
4. Ensuring promotion of customer focus throughout the organization.
5. Ensuring that the integrity of management system (प्रबंधन प्रणाली की अखंडता)
is maintained when changes to system planned or implemented.
5.4 ---- Consultation and participation of
workers
(परामर्श और श्रमिकों की भागीदारी)
Applicable to ISO 45001:2018
This ISO 45001:2018 sub clause requires that the organization shall;
1. Provide a mechanism, time, training and resources necessary for consultation and participation of
workers;
2. Provide timely access to clear, understandable and relevant information about the OH&S management
system;
3. Determine and remove obstacles or barriers to participation and minimize those that cannot be
removed.(बाधाओं को निर्धारित करना/ दूरकरना /कमकरना)
6.0 Planning–योजना
This clause requires
1. Action plan to address the risks and opportunities
2. Identification of Environmental Aspects and their impact
3. Identification of Health & Safety Hazards and their risk
4. Listing of Environmental compliance obligations and legal & other requirements related to OH&S
5. Listing of SHEQ objectives and targets
6. Planning to achieve the objectives
7. Planning action to manage the change
)

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6.1.1 Actions to address risks and opportunities.
This sub clause requires that when planning the organization shall consider the issues (4.1) referred to the
requirements (4.2) and determine the risks and opportunities that need to be addressed to assure that system can
achieve its intended result(s).
1.to give assurance;
a) It enhance desirable effects (वांछनीय प्रभाव)
b) prevent or reduce undesired affects;
c) Achieve improvements.
6.1.2 Quality objectives & Environmental aspects and
planning to achieve impacts
them (पर्यावरणीय पहलू और प्रभाव)
(गुणवत्ता उद्देश्य और उन्हें प्राप्त करने
की योजना बनाना)
1. How to integrate and 1. The organization shall determine
implement actions into - the environmental aspects of its
QMS processes activities, products & services that
2. Evaluate the can control and those that can
effectiveness of these influence their environmental
actions. impacts, considering a life cycle
perspective (जीवन चक्र के परिप्रेक्ष्य पर
विचार करते हुए, उनके पर्यावरणीय प्रभावों को
प्रभावित करते हैं)
When determining
environmental aspects, the
organization shall consider;
*emission to AIR
*Release of water
*Release to land
* Use of raw materials and
natural resources,
*Use of energy
* Energy emitted – heat,
radiation, vibration, noise & light
*generation of waste and by-
products &
* Use of space.
* design and development facilities,
*Manufacturing process including
storage
*Maintenance of facilities
*Assets and infrastructure
*Transportation & service delivery
including packing
*Storage, use of END-OF-LIFE
treatment of products
*Waste management, including re-
use, re-furbishing, re-cycling &
disposal.
2. Consider for changes, including
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Hazards identification &
assessment of risks and
opportunities
(जोखिम और अवसरों की पहचान और मूल्यांकन)
(Sub- clause 6.1.2.1)
Hazard identification
The organization shall;
1. Establish, implement and maintain
a process(s) to identify hazards that
are ongoing and proactive
considering;
(a) work organization
(b)Social factors such as – workload,
working hours, victimization /
harassment and bulling (उत्पीड़न और
बुलिंग) including leadership and the
culture of the organization.
2. Routine and non routine activities
and situations and hazards arising
from:-
*Infrastructure
*Equipments
*Materials
*Substances
*Physical condition of workplace
*Product service design,
*research& developments
*Testing
*Production
*Assembly
*Construction
*Service delivery
*Maintenance & disposal
3.Human factors
4.How the work is performed
5.past relevant incidents due to
internal or external causes
6.Potential emergency situations
7.people – workers, contractors,
 GUIDE TO ISO 9001/ 14001/ 45001,
planned or new developments, a
new or modified activities, product
& services
3.Abnormal conditions and
reasonably foreseeable emergency
situations (असामान्य स्थिति और यथोचित
आपातकालीन स्थिति)
4. Established criteria to determine
significant environmental aspects
having significant environmental
impacts (महत्वपूर्ण पर्यावरणीय प्रभावों वाले
महत्वपूर्ण पर्यावरणीय पहलुओं को निर्धारित करने के
लिए स्थापित मानदंड)
5. Communication among various
level(विभिन्न स्तरों के बीच संचार)
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visitors and other in the vicinity of
work place who can be affected by
the activities of the organization
8. workers location not in the direct
control of the organization
9.Other issues like- design or work
area, process(s) installations,
Machines & equipments, OCP and
work organization including
adaptation to the needs
(जरूरतों के लिए अनुकू लन)
and capabilities of workers involved;
10.situations occurring in the
vicinity of workplace
(कार्यस्थल के आसपास के क्षेत्र)
caused by the work related activities
under the control / not under the
control of the organization
11. Actual process changes in work
organization (कार्य संगठन) operations,
processes, activities and the OH&S
management System.
12. Change in knowledge or
information about hazards.
13 Emergency preparedness and
evaluation of effectiveness of the
action taken as per HIERARCHY of
controls.
(आपातकालीन नियंत्रण की प्रभावशीलता के अनुसार
कार्रवाई की प्रभावशीलता की तैयारी और मूल्यांकन)
14. When planning the organization
shall ;
(i) Consider best practice(s)
(ii) Technological options
(iii) Financial,
(iv) Operational& business
requirements.
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6.1.2.2 ---- ---- Assessment of OH&S Risks and other

Risks for OH&S Management System
(Sub- clause 6.1.2.2)
---- ---- This ISO 45001:2018 clause
requires that the organization
shall;
1.Establish, implement & maintain a
process(s) to assess;
a) OH&S risks from the identified
hazards, while taking into account
the effectiveness of the existing
controls;
b) Determine and assess other risks
related to the establishment,
implementation, operation and
maintenance of the OH&S
management system.
c) Methodology and criteria for
assessment shall be defined with
reference to scope, nature and
timing to ensure that they are
proactive rather than reactive and
are used in a Systematic way
(प्रतिक्रियाशील के बजाय सक्रिय और एक व्यवस्थित में
उपयोग किया जाता है)
6.1.2.3 --- --- Assessment of OH&S
opportunities and other
opportunities for OH&S
Management System
(Sub- clause 6.1.2.3)
--- --- This ISO 45001:2018 clause requires
that organization shall;
1. Determine and shall have access to
up-to-date legal requirements and
other requirements that are
applicable to hazards,निर्धारित करें और अप-
टू -डेट कानूनी आवश्यकताओं और अन्य आवश्यकताओं
के लिए उपयोग किया जाना चाहिए जो खतरों पर लागू होते
हैं
Changes in its planning, policy,
process or activity (s) OH&S risks and
OH&S management system.
2.determine how these legal and
other requirements apply to the
organization and what needs to be
communicated,
3. Take these legal and other
requirements into account when
establishing, implementing and
maintaining and continually

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6.1.3 --- Compliance obligations
(Sub- clause 6.1.3)
This ISO 14001:2015 sub clause
requires that organization shall;
1. determine and shall have
access to compliance obligations
to its environmental
aspect(निर्धारित करें और इसके पर्यावरणीय
पहलुओं के अनुपालन दायित्वों तक पहुंच हो)
2. Determine how these
compliance obligations apply to
the organization;
3. Take these compliance
obligations into a/c when
establishing, implementing,
maintaining and continually
improving its environment
management system.
6.1.4 --- Planning action
(योजना बनाने की क्रिया)
This sub clause of
ISO 14001:2015 requires that the
organization shall;
a) take action to address its;
*significant environmental aspects,
compliance obligations & risk and
opportunities as identified in 6.1.1
b)how to :–
integrate and implement the
actions into its environmental
management system process (s)
6.2 & Quality objectives and Environmental objectives and
6.2.1 planning to achieve planning to achieve them
them (पर्यावरणीय उद्देश्य और उन्हें
(गुणवत्ता के उद्देश्य और उन्हें प्राप्त करने प्राप्त करने की योजना)
की योजना)
This sub clause requires that organization shall;
Establish objectives at relevant functions, levels & processes needed for above
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improving (लगातार सुधार)
OH&S Management System.
Determination of legal and other
requirements
(Sub- clause 6.1.3)
This ISO 45001:2018
sub clause requires that
organization shall;
Establish , implement and
maintain a process(s) to;
1. Determine and have access to
up-date legal requirements that
are applicable to hazards, OH&S
risks & OH&S management
system.
2. Determine how these legal
requirements and other
requirements apply to
organization and what need to be
communicated,
3. Take these legal requirements
and other requirements into
consideration when establishing
Implementing, maintaining and
continually improving the OH&S
management system.
Planning action
(योजना बनाने की क्रिया)
This sub clause of
ISO 45001:2018requires that the
organization shall;
a) take action to;
Address the significant risks and
opportunities
b) Address legal requirements and
other requirements,
(the process of actions needed to
determine and address its risks and
opportunities to the extent necessary to
have confidence that they are carried
out as planned)
OH&S objectives and planning to
achieve them
(उद्देश्यों और उन्हें प्राप्त करनेकी योजना बना)
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(प्रासंगिक कार्यों,स्तरों और प्रक्रियाओं के उद्देश्य)

1.The objectives shall;
a) be consistent with policy(s) (नीति के अनुरूप होना)
b) be measurable (मापने योग्य हो)
c) shall take into a/c all applicable requirements;
d) be relevant to products, services & to enhancement of customer satisfaction;
e) be monitored;
f) be communicated;
g) be updated, as appropriate.
6.2.2 This sub clause requires planning how to achieve objectives for which organization shall determine;
1. What will be done?
2. What resources will be required?
3. Who will be responsible?
4. When it will be completed?
5. How the results will be evaluated, including indicators for monitoring
(निगरानी के लिए संके तक सहित परिणामों का मूल्यांकन कै से किया जाएगा)
6. How the processes actions taken to achieve will be integrated into organization business
7. (प्राप्त करने के लिए की जाने वाली प्रक्रियाओं को संगठन व्यवसाय में एकीकृ त किया जाएगा)
6.3 This clause of --- ---
ISO 9001:2015 requires
that the need for
changes to the QMS
shall be carried out in a
planned manner and be
considered for;
1. The purpose of
changes and their
potential consequences
(संभावित परिणाम)
2. The integrity of QMS;
3.The availability of
resources;
4.The allocation or
reallocation of
responsibilities and
authorities.(जिम्मेदारियों और
अधिकारियों का आवंटन)

7.0 Support/Resources-साधन:
This clause requires defining all types of support or resource needed for maintaining SHEQ system.
These resources includes; people, awareness, communication, documented information and its control,
infrastructure, environment for processes, monitoring and measuring resources, measurement
traceability and organizational knowledge.
7.1 This clause requires that organization shall determine and provide the resources -
a) The capabilities of and constraints on, existing internal resources; ( such as people,
infrastructure, environment for processes, monitoring and measuring resources, measurement
traceability, organizational knowledge) for the establishment, implementation, maintaining and
continually improving of the management system by considering ;
(मौजूदा आंतरिक संसाधनों की क्षमता और बाधाओं पर)
b) What need to be obtained from external providers?

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7.1.2 This sub clause requires (People) that organization shall determine and provide the persons
necessary for the effective implementation of management system
7.1.3 This sub clause requires (Infrastructure) necessary that organization shall provide for the
effective operation of its process(s) and to achieve conformity of product and services like;
a) Building and associated utilities
b) Equipments, including hardware and software;
c) Transportation resources;
d) Information and communication technology
7.1.4 This sub clause of ISO 9001:2015requires;
(Environment for operation of process) suitable for the operation of its process(s) and to achieve
conformity of product and services includes;
1. Social (non-discriminatory, calm, non-confrontational)
सामाजिक (गैर-भेदभावपूर्ण, शांत, गैर-टकराव)
2. Psychological (stress free, burn-out prevention, emotionally protective)
मनोवैज्ञानिक – (तनाव,जलन से मुक्त ,भावनात्मक रूप से सुरक्षात्मक)
1 Physical (temperature, heat , humidity, light, air-flow, hygiene & noise)
7.1.5 This sub clause of ISO 9001:2015 requires;
(Monitoring and measurement resources)to ensure valid and reliable (वैध और विश्वसनीय)results to verify
the conformity of product and services includes;
a) The available resources are suitable for specific requirements
b) Resources are maintained to continuing their fitness for their purpose.
7.1.5.2 This sub clause of ISO 9001:2015 requires;
(Measurement traceability) to provide confidence in the validity of measurement results for which the
measuring instruments(माप परिणामों की वैधता जिसके लिए मापक यंत्र हैं)shall be;
1. Calibrated or verified or both at specified intervals or prior to use against measurement when
standard traceable to International or National measurement exists. The basis used for
calibration or verification shall be retained as documented information by identifying the status
and safeguard from adjustment, damage or deterioration that would invalidate the calibration
status and subsequently the measurement results.

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7.1.6 This sub clause of ISO 9001:2015 requires regarding the Organizational knowledge which shall
be determined as necessary for the conformity of product and services based on;
a) Internal sources( e.g. intellectual property) बौद्धिक सम्पदा, experience, lessons from failures,
improvements in process(s) product and services) )
b) External sources (e.g. standards, academics, conferences, knowledge from customer or external
private providers) ग्राहक या बाहरी निजी प्रदाताओं से ज्ञान
7.2 This sub clause is about (Competence) which shall be determined as necessary for
performance and effectiveness of the management system. The organization shall ensure
that;
a) The persons are competent on the basis of appropriate education, experience and training and
b) Where applicable to take actions to acquire the same and evaluate the effectiveness of action
taken.
7.3 This sub clause requires (awareness)of organization to ensure that the person (s) working under the
control are aware of the;
1 Policy (Quality /Environment & OH&S Policies)
2 Relevant objectives (Quality objectives, Significant Aspects &their environmental impacts,
Hazards, Risks, mitigation actions, opportunities, implications and potential consequences of
non conforming outputs (गैर अनुरूप आउटपुट के संभावित परिणाम)
)

3 Their contribution to the effectiveness of the management system including benefits of

improved performance and
4 The implications of not conforming activities, processes, products & services or not fulfilling
compliance obligations.
7.4 This sub clause requires (communication) internal and external including;
1. On what it will communicate?
2. When to communicate?
3. With whom to communicate?
4. How to communicate and
5. Who communicates?
6. The organization shall take into a/c diversity aspects ( e.g. gender, language, culture, literacy,
disability ) when considering the communication needs.
7. Take into a/c the legal and other requirements
(Retain documented information as evidence)
7.5 Documented information ( प्रलेखित जानकारी)– is necessary for the effectiveness of the management
system –(प्रबंधन प्रणाली की प्रभावशीलता के लिए आवश्यक है)
7.5.2 This sub clause requires (creating and updating) a document to ensure that;
1. Ensure its identification and description (e.g. title, date, author or reference number)
2. Format (e.g. language, software version, graphics & media)
Review and approval for suitability and adequacy (उपयुक्तता और पर्याप्तता के लिए अनुमोदन)of the created
document.

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7.5.3 This sub clause requires ensuring control of documented information-

(प्रलेखित सूचना का नियंत्रण)
1. Ensure that it is available and suitable for use, when and where it is needed,
2. It is adequately protected (e.g. from loss or confidentiality, improper use or loss of integrity)
3. Its distribution, access ( authority to view or change the document) retrieval and use
4. Storage and prevention and preservation of integrity
5. Retention and disposition.
8.0 Operations-संचालन-
This clause requires the information regarding the operational part ;
Namely, establishing criteria for process, operation planning and controls, design and development,
release of product and services, control of changes, emergency preparedness including procurement to
fulfilling the requirements of applicable International Standards.
8.1 This sub-clause requires - Operational planning and control needed to meet the requirements
for, and
(actions as determined under clause 6.0)The organization shall plan, implement and control the processes
needed to meet the requirements for the provision of;
ISO 9001:2015 ISO 14001:2015 ISO 45001 : 2018
Planning & provision of products Planning & provision of establishing, Planning & provision of process to
and services by establishing criteria implementation maintain and control eliminate hazards and to reduce
for the processes, acceptance of over criteria and processes to provide OH&S risks including management
product and services to information about potential significant changes, procurement and the
demonstrate conformity and to environmental aspects and their impacts emergency preparedness.
review the consequences of un including emergency preparedness.
intended changes and action taken
to mitigate adverse effects.
a) Shall control planned changes and review the consequences of changes, taking actions to mitigate the
adverse effects, as necessary.
b) Control of out-sourced processes consistent with a life cycle perspective
c) To communicate the environmental requirements to external providers, including contractors;
d) To ensure and provide information about potential significant environmental impacts associated with the
“Transportation or delivery, use, end-of-life treatment and final disposal” of its products and services.
(Retain documented information as evidence)
This sub-clause of (ISO 45001:2018) requires - Operational planning and control on elimination of
8.1.2 hazards and reduction of OH&S risks using the hierarchy of controls or a combination of them as under;
a) Eliminate the hazard
b) Substitute with less hazardous processes, operations, materials or equipment;
c) Use engineering control s and reorganization of work;
d) Use administrative controls, including training;
e) Use adequate personal protective equipment (PPEs)

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8.1.3 --- Management of change

This sub-clause of (ISO 45001:2018) requires – a process (for temporary or permanent changes) that impact the
OH&S performance including;
1.New products, services and processes or change of existing products, services and processes including ;----workplace
locations and surroundings,
----work re-organization,
----working conditions,
----equipment,
----work force
---- Change in legal and other requirements
----change in knowledge or information about hazards and OH&S risks,
----development in knowledge and technology,
The organization shall review the consequences of intended change (इच्छित परिवर्तनों के परिणाम)
Taking actions to mitigate any adverse effects, as necessary (आवश्यकतानुसार किसी भी प्रतिकू ल प्रभाव को कम करें)
NOTE- Change can result in risks and opportunities.
ISO 9001 : 2015 ISO 14001 :2015 & ISO 45001 : 2018
This sub clause is regarding the This sub clause requires the need of emergency preparedness and
8.2
requirements for products and response;
services
8.2.1 Customer communication shall The organization shall establish, implement and maintain the process(s)
include; needed to prepare for and respond potential emergency situations
1.providing information relating identified in 6.1.1
to product and services, Prepare to respond by planning actions to prevent or mitigate adverse
2. handling enquiries, contracts environmental impacts from emergency situations / First Aid
or orders including changes, a) Respond to actual emergency situations,
3.obtaining customer feedback b) Take action to prevent or mitigate the consequences of
including complaints, emergency situations, appropriate to the magnitude of the
4.handling and controlling of emergency (आपातकाल की भयावहता)
customer property a) and the potential environmental impacts,
5. Establishing specific b) Periodical test of planned response actions, where practicable,
requirements for contingency c) Periodic review and revise the process(s) and planned response
actions, when relevant actions, in particular after occurrence of emergency situation of
(प्रासंगिक होने पर आकस्मिक कार्यों के लिए tests.
विशिष्ट आवश्यकताओं की स्थापना) d) Provision of training related to emergency preparedness to
workers and other interested parties as appropriate,

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8.2.2 This sub clause needs the --- ---

determination of
requirement for product and
services. (ISO 9001:2015)
When determining the ---
requirements for the products
and services to be offered to
customer the organization
include ;
i) Any applicable statutory or
regulatory requirements
ii)Those necessary for the
organization &
iii) The organization can meet
the claims for the product and
services it offer.
8.2.3 This sub clause needs the ---
review of requirements for
product and services. (ISO
9001:2015)
8.2.3.1 These sub clauses of (ISO 9001:2015) requires to consider and review
8.2.3.2 the specific customer requirements (deliver and post delivery)
& Specific organization requirements and contracts requirements differing from previously expressed &
8.2.4 changes to requirements for product and services
8.3 These particular sub clauses (ISO 9001:2015)
are specifically defined for design and development of products and services and requires that;
8.3.1 This sub clause requires;
Establishing, implementing and maintaining a design and development process that is appropriate and
ensures the subsequent provision of product and services.
8.3.2 Design and development planning (डिजाइन और विकास योजना)
This sub clause (ISO 9001:2015) requires that;
The organization shall consider;
a) The nature and duration and complexity of the design and development activities,
b) The required process stages, including design and development reviews;
c) The required design and development verification and validation activities,
d) The responsibilities and authorities related to design and development process,
e) The internal and external resources required for design and development,
f) The needs of control interfaces between persons involved in design and development,
g) The need of involvement of customer and users in design and development,
h) The requirement of subsequent provisions of products and services,
i) The level of control expected for design and development process by customers and other relevant
interested parties,
j) The documented information needed to demonstrate that design and development requirements
have been met.
8.3.3 Design and developments inputs.
This sub clause (ISO 9001:2015) requires that;
The organization shall consider;

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a) Functional and performance requirements,

b) Information derived from previous similar design and development activities,
c) Statutory and regulatory requirements,
d) Standards or “code of practice” that the organization has committed to implement,
e) Potential consequences of failure due to the nature of the product and services,
f) Inputs should be complete, unambiguous (स्पष्ट)
g) Conflicts should be resolved from design and development.
8.3.4 Design and developments controls.
This sub clause (ISO 9001:2015) requires that;
The organization shall ensure;
a) The results to be achieved to be defined,
b) Reviews are conducted to evaluate that the ability of the results of design and development to meet the
requirements,
c) Verification activities are conducted to ensure that the design and development outputs meet the input
requirements.
d) Validation activities are conducted to ensure that the resulting product and services meets the
requirements for the specific application or intended use,
e) Any necessary action(s) are taken on problems determined during the reviews, or verification and
validation,
8.3.5 Design and development outputs.
This sub clause (ISO 9001:2015) requires that;
The organization shall ensure;
a) meets the input requirements;
b) are adequate for the subsequent processes for the provision of products and services,
c) include or reference monitoring and measuring requirements, as appropriate, and acceptance
criteria,
d) Specify the characteristics of the products and services that are essential for their intended purpose
and their safe and proper provision.
8.3.6 Design and development changes.
This clause (ISO 9001:2015) requires that;
The organization shall identify, review and control changes made during, or subsequent to the design and
development of product and services to extent necessary to ensure that there is no adverse impact on
conformity to requirements and shall have documented information of;
a) Design and development changes;
b) The results of reviews;
c) The authorization of the changes;
d) The action taken to prevent adverse impacts.

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8.4 Control of externally provided processes, products and services.

8.4.1 This sub clause (ISO 9001:2015) requires that;
The organization shall ensure that externally provided processes, products and services conform to
requirements;
The organization shall determine the controls when;
a) products and services from externally providers are intended for incorporation into
the organization’s own products and services,
b) the products and services are provided directly to the customer(s) by external
providers on behalf of the organization,
c) a process or part of process is provided by an external providers as a result of a decision by the
organization.
The organization shall determine and apply criteria for the evaluation, selection, monitoring of performance
and revaluation of external providers
(संगठन मूल्यांकन,चयन,प्रदर्शन की निगरानी और बाहरी प्रदाताओं के पुनर्मूल्यांकन के लिए मापदंड निर्धारित करेगा और लागू करेगा)

8.4.2 Type and extent of control.

This sub clause (ISO 9001:2015) requires that;
The organization shall:
a) The externally provided processes remain within the control of its Quality Management System.
b) Define both the controls that intends to apply to an external provider and those it intends to apply
to the resulting outputs;
c) Take into consideration;
1. The potential impact of the externally provided products, services on the organization,
whether it consistently meet the applicable statutory and regulatory requirements
2. The effectiveness of the controls applied by the external provider.
d) To determine the verification and other activities, necessary to ensure that the externally provided
processes, products and services meet requirements,
8.4.3 Information for external providers.
This clause (ISO 9001:2015) requires that;
The organization shall communicate to external providers its requirement for;
a) The processes, products and services to be provided,
b) The approval of;
1. Products and services,
2. Methods, processes & equipment;
3. The release of product and services,
c) Competence, including any required qualification of persons,
d) The external provider’s interactions with the organization,
e) Control and monitoring of the external provider’s performance to be applied by the organization,
f) Verification or validation activities that the organization or its customer, intends to perform at the
external provider’s premises.

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8.5 Production and service provisions.

This sub clause (ISO 9001:2015) requires that the organization shall ;
8.5.1 Control of production and service provisions which includes;
a) the availability of documented information that defines;
----the characteristics of the product to be produced or the service to be
Provided, or the activities to be performed.
----the results to be achieved.
b) The availability and use of suitable monitoring and measuring resources,
c) The criteria for control of processes or outputs, and acceptance criteria have been met.
e) The use of suitable infrastructure and environment for the operation of processes.
f) Appointment of competent person(s) to prevent human error.
g) The implementation of release, delivery and post delivery activities.
8.5.2 Identification and traceability.
This sub clause (ISO 9001:2015) requires that;
The organization shall use suitable means to identify outputs when it is necessary to ensure the
conformity of the product and services. The organization shall control the unique identification of the
outputs when traceability is a requirement, and shall retain the documented information necessary to
enable traceability.
8.5.3 Property belonging to customer or external providers.
This sub clause (ISO 9001:2015) requires that;
The organization shall exercise care with customer property while is under the organization’s control or in
use.
The organization shall identify, verify, protect and safeguard its lost, damage or otherwise found to be
unsuitable for use.
The organization shall report to customer and shall have documented information on what has occurred.
(Customer property can include—materials, components, tools and equipment, premises, intellectual property and
personal data)
8.5.4 Preservation - संरक्षण
This sub clause (ISO 9001:2015) requires that;
1. The organization shall preserve the outputs during production and service provisions, to the extent
necessary to ensure conformity to requirements.
(Preservation can include—identification, handling, contamination control, packaging, storage, transmission or
transportation and protection)
8.5.5 Post delivery activities.
This clause (ISO 9001:2015) requires that the organization shall meet the requirements for post
delivery activities associated with the products and services and shall determine and consider ;
a) Statutory and regulatory requirements,
b) The potential undesired consequences associated with the product and services,
c) The nature, use and intended lifetime (जीवन भर का इरादा) of its products and services
a) Customer’s requirements
b) Customer feedback.
(post delivery activities includes – under warranty provisions, contractual obligations such as maintenance services
and supplementary services such as recycling or final disposal)
8.5.6 Control of changes;
This sub clause (ISO 9001:2015) requires – that the organization shall review and control changes for
production or services provisions, to the extent necessary to ensure continuing conformity with
requirements and shall retain documented information describing the results of review of changes, the
person(s) authorizing the change and any necessary actions arising from review.

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8.6 Release of products and services;

This sub clause (ISO 9001:2015) requires that the organization shall;
1) Implement planned arrangements, at appropriate stages, to verify that the product and service
requirements have been met.
2) The release of product and services to the customer shall not proceed until the planned
arrangements have been satisfactorily completed, unless otherwise approved by the relevant
authority and, as applicable, by the customer.
(Documented information on the release of product and services be retained which includes)
a) Evidence of conformity with the acceptance criteria,
b) Traceability to the person(s) authorizing the release.
8.7 Control of non-conforming outputs;
8.7.1 This sub clause (ISO 9001:2015) requires that the organization shall;
Ensure that the outputs that do not conform to their requirements are identified and controlled to prevent
their unintended use or delivery.
The organization shall deal with non conforming outputs in one or more ways:-
a) Correction,
b) Segregation, containment, return or suspension of provision of product and services,
c) Informing the customer,
d) Obtaining authorization for acceptance under concession (Deviations)
8.7.2 This sub clause (ISO 9001:2015) requires that the organization shall;
Conformity to the requirements shall be verified after corrections are made;
( Documented information of these activities is retained which)
a) Describes the non conformities,
b) Describes the action taken,
c) Describes any concessions (deviations)obtained,
d) Identifies the authority deciding the action in r/o the non conformity.
9.0 Performance evaluation निष्पादन मूल्यांकन -This clause requires details about
1. Monitoring, Measurement, Analysis and evaluation of processes, achievement of targets, Customer
satisfaction indices and evaluation of Environmental & OH&S compliance.
2. Internal Audits
3. Management Review
9.1 This sub clause requires Monitoring, measurement, analysis & evaluation

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ISO 9001:2015
9.1.1- The organization shall
determine:
*what need to be monitored and
measured
*the method for monitoring,
measurement, analysis and
evaluation needed to ensure valid
results,
*when the monitoring and
measurement shall be performed
*when the results from monitoring &
measurement shall be analyzed and
evaluated.
9.1.2 This sub clause requires evaluation of compliance (customer satisfaction)
ISO 9001:2015
The organization shall;
*monitor customer perceptions(ग्राहक
धारणाएं)of the degree to which their
needs and expectations have been
fulfilled,
* The organization shall determine
the methods for obtaining,
monitoring and reviewing this
information.
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ISO 14001:2015
9.1.1 -The organization shall monitor,
measure, analyze and evaluate its
environmental performance and shall
determine;
*what need to be monitored and
measured
*the method for monitoring,
measurement, analysis and evaluation
needed to ensure valid results,
*the criteria against which the
environmental performance shall be
evaluated including indicators;
*when the monitoring, measurement
shall be performed.
*when the results from monitoring &
measurement shall be analyzed and
evaluated.
ISO 14001:2015
Evaluation of compliance - The
organization shall;
*determine the frequency that
compliance will be evaluated
*Evaluate compliance and take action
if needed,
*Maintain knowledge and
understanding of its compliance
status,
*Retain documented information as
evidence of the compliance
evaluation results.
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ISO 45001:2018
9.1.1 -In order to achieve the
intended outcome of the OH&S
Management System the procedure
should be monitored, measured and
analyzed for;
*Occupational health complaints
*Health of workers
*Work environment
*Work related incidents, injuries and
ill health and complaints including
trends,
*effectiveness of controls
*Emergency exercises & new controls
*Competence
*Identified legal requirements &
updated
*SOP, Policies, Rules & regulations
*Insurance requirements
*Benchmarks
*OH&S statistics
*Criteria, Indicators etc.
ISO 45001:2018
The organization shall;
*The frequency and timing of
compliance,
*Keeping in view the variations in
operations conditions, changes in
legal requirements and other
requirements and the past
performance of the organization.
* The organization can use variety of
methods to maintain its knowledge
and understanding of its compliance
status.
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9.1.3 This sub clause requires analysis & evaluation

The organization shall analyze and evaluate appropriate data and information arising from monitoring and
measurement to evaluate the results for;-
a) Conformity to product and services. --- ---
b) The degree of customer
satisfaction,
c) The performance and effectiveness
of quality management system
d) Effectiveness of planning
e)Effectiveness of actions taken to
address risks and opportunities
e) Performance of external providers
f) The need for improvement of the
Quality management system.
9.2 Internal audit (आंतरिक लेखा परीक्षा)
9.2.1 This sub clause requires that;
The organization shall plan, establish and maintain an audit program(s), including frequency, methods,
responsibilities, planning requirements and reporting, changes affecting the organization and results of
previous audits;
9.2.2 – Internal audit program;
*organization shall define the audit criteria and scope for each audit *shall ensure objectivity and
*auditors should conduct audits to ensure objectivity and the impartiality of impartiality of internal audit.
the audit process.
*ensure that the audit results are reported to relevant management.

9.3 Management review (प्रबंधन की समीक्षा)

9.3.2 Management review inputs
ISO 9001:2015
The management review of quality
management system shall be planned
and carried out by taking into
consideration;
ISO 14001:2015
The management shall review the
organization’s environment
management system at planned
intervals to ensure its continuing
suitability, adequacy and
effectiveness by taking into
consideration;
ISO 45001:2018
The management shall review the
organization’s OH&S management
system at planned intervals to ensure
its continuing suitability, adequacy
and effectiveness by taking into
consideration;

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a)the status of action from previous a)the status of action from previous a)the status of action from previous
management review; management review; management review;
b) changes in external and internal b) changes in b) changes in
issues that are relevant to Quality i) external and internal issues that i) external and internal issues that are
Management System are relevant to Environment relevant to OH&S Management
c) information on the performance and Management System System
effectiveness of QMS including trends ii)the needs and expectations of ii)the needs and expectations of
in; interested parties, including interested parties, including legal
i) customer satisfaction and feedback compliance obligations requirements and other
from relevant parties; iii)its significant environmental requirements
ii)the extent to which quality aspects iii) significant risks and
objectives have been met; iv) risks and opportunities, opportunities,
iii) process performance and c) the extent to which c) the extent to which OH&S
conformity of products and services; environmental objectives have objectives have been achieved;
iv)non-conformities and corrective been achieved; d)information on OH&S performance
actions; d)information on environmental including trends in;
v) Monitoring and measurement performance including trends of i) incidents, nonconformities and
results; i) nonconformities and corrective corrective actions and continual
vi) Audit results actions; improvements. ii)monitoring and
vii) the performance of external ii)monitoring and measurement measurement results;
providers, results; iii)fulfillment of legal requirements
d)the adequacy of resources, iii)fulfillment of compliance iv)audit results;
e)the effectiveness of actions taken to obligations e)consultation and participations of
address risks and opportunities; iv)audit results; workers
f) opportunities for improvement, e)adequacy of resources, f) adequacy of resources,
f)relevant communication(s) from g) relevant communication(s) from
interested parties, complaints, interested parties, complaints,
g) opportunities for continual g) opportunities for continual
improvements improvements and communication
the relevant outputs to workers.
9.3.3 Management review outputs
This sub clause requires that the management review shall include decisions and actions related to;
a) Opportunities for improvement;
b) Any need for changes to management system
c) Action (s) needed when objective not achieved;
d) Resources needs
10.0 Improvement - सुधार
10.1 This sub clause requires information regarding the improvement part of process (s) Including non-
conformity, incidents, corrective actions and continual improvement.
This sub clause requires that organization shall determine and select opportunities for improvement and implement
any necessary actions to meet/achieve/consider;

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ISO 9001:2015
Customer requirements and
enhance customer satisfaction
including;
a) Improving products and services to
meet requirements as well as address
future needs and expectations.
b) correcting, preventing or reducing
undesired effects,
c) improving the performance and
effectiveness of the QMS
10.2 Nonconformity and corrective action (गैर-अनुरूपता और सुधारात्मक कार्रवाई)
10.2.1 This sub clause requires that when a nonconformity occurs, arising from complaints, the
organization shall;
ISO 9001:2015
a)react to nonconformity and, as
applicable
i)take action to control and correct it;
ii) deal with the consequences;
b) evaluate the need for action to
eliminate the cause(s) of the non
conformity in order that it does not recur
or occur elsewhere by;-
i) reviewing and analyzing the non
conformity
ii)determining the cause of
nonconformity
iii)determine if similar nonconformity
exist, or could potentially occur,
c) implement any action (s) needed;
d) review the effectiveness of any
corrective action taken;
e)update risks and opportunities
determined during planning, if necessary,
f) make changes to the QMS, if necessary
10.2.2 the organization shall retain documented information as evidence of ---
a) the nature of nonconformity and subsequent actions taken
(गैर-अनुरूपता और उसके बाद की कार्रवाई)
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ISO 14001:2015
The intended outcomes of its
environmental management
system
The organization should consider the
results from analysis and evaluation
of environmental performance,
evaluation of compliance, internal
audits and management reviews and
should take corrective action to
improve as continual improvement,
breakthrough change, innovation and
re-organization.
ISO 14001:2015 ISO 45001:2018
i) deal with the consequences, including
mitigating adverse environmental
impacts;
ii) make changes to the Environment
Management System , if necessary
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ISO 45001:2018
The results from analysis and
evaluation of OH&S performance,
evaluation of compliance,
internal audits and management
review(s)
Improvement includes corrective
action, continual improvement of its
OH&S management system.
Incident, nonconformity and corrective
action—Separate or a combined
process(s) may exist for incident
investigation and non conformity review
for example—
i) Incidents –fall with or without injury,
asbestosis, hearing loss, damage to
building or vehicle where they can lead
to OH&S risks;
ii)Nonconformity—PPE not functioning
properly, failure to fulfill legal
requirement.
iii) Corrective action---as indicated by the
hierarchy of controls –
eliminate hazards – by
*substituting with less hazardous
material,
*redesigning or modifying tools or
equipments,
*developing new procedure,
*improving competence of the affected
workers,
* change of frequency of use, use of
PPEs; Root Cause Analysis –exploring all
possible factors associated with the
incident or the nonconformity by asking
--- What happened, How it happened &
Why it happened?
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b) the results of any corrective action;

10.3 Continual improvement -निरंतर सुधार-
This sub clause requires that organization shall continually improve the suitability, adequacy
and effectiveness of its QMS / EMS & OH&S Management system;
ISO 9001:2015 ISO 14001:2015 ISO 45001:2018
Quality Management System. Environmental Management Occupational Health &Safety
System. Management System.
The organization shall consider the The organization shall continually The organization shall continually
results of analysis and evaluation and improve the suitability, adequacy and improve the suitability, adequacy and
the outputs from management review effectiveness of its environmental effectiveness of its OH&S MS by
to determine if there are needs or management system to enhance adopting of--
opportunities that shall be addressed environmental performance *New technology
(पर्यावरण प्रदर्शन को बढ़ाने के लिए)
as part of continual improvement. *Good practices,
*Suggestions/recommendations
From workers & interested parties,
*New knowledge and understanding
of OH&S related issues;
*New or improved materials;

(NOTE: Maintain and retain documented information as evidence for each activity)

THE END

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