CertiKit Webinar

Welcome to our webinar on clause 8 of ISO management systems written in the Annex
SL format..

As we go through the webinar, if you have any questions, please drop them in the
conversation window and I’ll pick up as many as possible at the end.

This webinar is being recorded and will be available tomorrow.

So before we dive into this webinar, a little information about CertiKit and myself.

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 Helped more
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• CertiKit are a leading creator of compliance toolkits and provider of ISO services
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 Ted Spiller
CertiKit’s Compliance Consultant:
• Consultant for ISO management systems,
including 9001, 14001, 45001, and 22301
assisting new and current CertiKit customers
• Technical author assisting the development of
the toolkits
• A certified ISO9001, 14001, 45001 and 22301
Lead Auditor with experience covering the past
20 years
• A certified lead IMS Implementer (ISOs 9001,
14001 & 45001)
• Blackbelt Lean Six Sigma practitioner

Responsible for providing Compliance Audit consultancy for ISO9001, 14001, 45001 and
22301 Management Systems to new and current CertiKit customers, and providing
guidance and advice, when needed, to customers who are implementing ISO9001,
14001, 45001 and 22301 using our management system toolkits.

I am qualified Lead Auditor in 9001, 14001, 45001 and Auditor for 22301 and have
gained a lot of experience over the last 22 years, holding senior management positions
within Defence, Aerospace, Airport Management and Training sectors.

I’m also a Lead Implementer for ISO’s 9001, 14001 and 45001

I am also a Lean Six Sigma Blackbelt practitioner.

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 What will we cover today?
What is clause 8?

Clause 8 in ISO9001

Clause 8 in ISO14001

Clause 8 in ISO45001

Clause 8 in ISO27001

Links to other areas of the standards to be aware of

Summary

During this short webinar we will be looking at:

• What is the management review and why we need it?
• What is clause 8
• Clause 8 in ISO9001
• Clause 8 in ISO14001
• Clause 8 in ISO45001
• Clause 8 in ISO27001
• Links to other areas of the standards to be aware of
• Summary

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 What is Clause 8 about?
In the context of ISO management systems, Clause 8 refers to the "Operation" clause. This clause is a
fundamental part of ISO management system standards, such as ISO 9001, ISO 14001, ISO 45001, and
others.

The purpose of Clause 8 - Operation is to provide guidelines and requirements for effectively
implementing the processes and activities necessary to achieve the organization's objectives and deliver
the products or services in line with its policies and plans.

1. Operational Planning
2. Resource Management
3. Product or Service Provision
4. Control of Processes, Products, and Services
5. Emergency Preparedness and Response
6. Performance Evaluation
7. Improvement

In the context of ISO management systems, Clause 8 refers to the "Operation"

clause. This clause is a fundamental part of ISO management system standards,
such as ISO 9001 (Quality Management System), ISO 14001 (Environmental
Management System), ISO 45001 (Occupational Health and Safety Management
System), and others.

The purpose of Clause 8 - Operation is to provide guidelines and requirements

for effectively implementing the processes and activities necessary to achieve the
organization's objectives and deliver the products or services in line with its
policies and plans.

Clause 8 typically covers a range of topics related to the day-to-day operations of

an organization and its management system. The specific content may vary
depending on the type of management system, but some common themes
include:

1. Operational Planning: This involves defining processes and resources needed

to achieve the organization's goals. It includes considerations for identifying risks,
opportunities, and potential impacts on quality, environment, health and safety,

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or other relevant aspects.

2. Resource Management: Ensuring that the necessary resources (human,

infrastructure, technology, etc.) are available and allocated appropriately to
support the operation of the management system and the organization's overall
objectives.

3. Product or Service Provision: This covers the processes involved in creating,

producing, or delivering the organization's products or services while adhering to
specified requirements, including quality, environmental, and safety criteria.

4. Control of Processes, Products, and Services: Implementing controls to ensure

that processes and products/services meet defined standards and requirements.
This may involve inspections, testing, monitoring, and corrective actions.

5. Emergency Preparedness and Response: Establishing plans and procedures to

handle potential emergencies or unexpected situations that could impact the
organization's operations, safety, or environment.

6. Performance Evaluation: Monitoring, measuring, and analysing relevant data to

assess the performance of processes, products, and services against established
objectives and criteria.

7. Improvement: Identifying opportunities for improvement and taking corrective

and preventive actions as necessary to enhance the organization's operations and
management system.

In essence, Clause 8 - Operation guides organizations on how to execute their

plans, deliver their products/services, and maintain the effectiveness of their
management system in line with the defined requirements and policies. It
emphasizes the practical implementation of the management system standards,
helping organizations to achieve consistent and desirable outcomes while
managing risks and opportunities.

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 ISO 9001
Clause 8 in ISO 9001 requires you to plan, control,
and implement quality processes.

Clause 8 in ISO9001 requires you to plan, control and implement process necessary for
your products and service to conform with the your requirements and the requirements
of the standard.

It also has the only mandatory procedure, which is clause 8.4 - Control of externally
provided processes, products and services.

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 Clause 8 – ISO9001 changes
The following sub-sections make up clause 8 in the ISO9001 Quality Management system.

8.1 Operational planning and control

8.2 Requirements of products and services

8.3 Design and development of products and services

8.4 Control of externally provided processes, products

and services

8.5 Production and service provision

8.6 Release of products and services

8.7 Control of nonconforming outputs

ISO 9001 is an international standard that outlines the requirements for a quality
management system (QMS) within an organization. Clauses 8.1 to 8.7 of ISO 9001
pertain to the planning and realization of products and services, which are crucial
aspects of maintaining consistent quality throughout an organization's processes. Here's
a brief explanation of each of these clauses:

8.1 Operational Planning and Control:

This clause emphasizes the importance of systematically planning and controlling the
processes needed to produce products and services that meet customer requirements.
It involves defining criteria for processes, ensuring availability of resources, and
identifying potential risks and opportunities that could affect the quality of outputs.

8.2 Requirements for Products and Services:

In this clause, organizations are required to establish and document the criteria for
reviewing, verifying, and validating product or service requirements. This ensures that
customer needs and expectations are clearly understood and translated into specific
characteristics that products or services must possess.

8.3 Design and Development of Products and Services:

Organizations must follow a structured approach to design and development, including
identifying design inputs, conducting reviews, verifying designs, and validating them to

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ensure they meet the specified requirements before moving into production.

8.4 Control of Externally Provided Products and Services:

This clause pertains to controlling the quality of products and services that are provided
by external suppliers. Organizations are required to assess and select suppliers based on
their ability to meet quality standards, establish clear requirements, and monitor supplier
performance.

8.5 Production and Service Provision:

This clause addresses the actual processes of producing and providing services. It covers
factors such as controlling production and service provision, ensuring product and service
conformity, preventing mix-ups, and preserving the integrity of products during handling
and storage.

8.6 Release of Products and Services:

Before products or services are delivered to customers, organizations must have a
process in place to verify that all requirements have been met. This includes inspections,
tests, and approvals to ensure the final output is of the desired quality.

8.7 Control of Nonconforming Outputs:

This clause deals with products and services that do not meet established requirements,
referred to as "nonconforming outputs." Organizations need to have procedures for
identifying, segregating, evaluating, and taking appropriate action on such
nonconformities to prevent their unintended use or delivery.

These clauses collectively emphasize the significance of meticulous planning, effective

control, and continuous monitoring to ensure that products and services consistently
meet or exceed customer expectations. Adhering to these clauses helps organizations
enhance their quality management systems and ultimately deliver better value to their
customers.

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 Links to other areas of the 9001 standard
Clause 8: Operation. This clause focuses on the operational processes within an
organization and ensures that products and services meet customer
requirements and are delivered effectively. Alignment with other clauses:

Clause 4: Context of the Organization: The context analysis identifies the external and
internal factors that can affect the organization's operations, helping to determine risks and
opportunities.
Clause 5: Leadership: Leadership's commitment to quality and their involvement in the
operational processes are critical for successful implementation.
Clause 6: Planning: Quality objectives are established, and operational planning takes place
to achieve these objectives.

1. ISO 9001:2015 (Quality Management System):

Clause 8: Operation This clause focuses on the operational processes within an

organization and ensures that products and services meet customer
requirements and are delivered effectively.

Alignment with other clauses:

 Clause 4: Context of the Organization: The context analysis identifies the

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 external and internal factors that can affect the organization's operations,
helping to determine risks and opportunities.
 Clause 5: Leadership: Leadership's commitment to quality and their
involvement in the operational processes are critical for successful
implementation.
 Clause 6: Planning: Quality objectives are established, and operational
planning takes place to achieve these objectives.

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 Links to other areas of the 9001 standard
Clause 7: Support: Resources, including competent personnel and infrastructure, are
provided to support the operational processes.
Clause 9: Performance Evaluation: Monitoring, measuring, analysing, and evaluating
operational performance help to identify areas for improvement.
Clause 10: Improvement: Actions to improve operational processes are taken based on the
results of performance evaluations.

1. ISO 9001:2015 (Quality Management System):

Clause 8: Operation This clause focuses on the operational processes within an

organization and ensures that products and services meet customer
requirements and are delivered effectively.

Alignment with other clauses:

 Clause 7: Support: Resources, including competent personnel and

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 infrastructure, are provided to support the operational processes.
 Clause 9: Performance Evaluation: Monitoring, measuring, analysing, and
evaluating operational performance help to identify areas for improvement.
 Clause 10: Improvement: Actions to improve operational processes are taken
based on the results of performance evaluations.

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ISO 14001
With Clause 8 in ISO 14001, you are required to
develop operational planning, emergency
response, and environmental monitoring.

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 Clause 8 – ISO14001 changes
The following subsections make up clause 8 in the ISO14001
Environmental Management system.

8.1 Operational planning and control

8.2 Emergency preparedness and response

ISO 14001 is an international standard that focuses on environmental management

systems (EMS), helping organizations establish a framework to manage their
environmental responsibilities effectively. Clauses 8.1 and 8.2 of ISO 14001 are part of
the "Operation" phase, which deals with the execution of the environmental
management system. Here's a brief explanation of each of these clauses:

8.1 Operational Planning and Control:

This clause highlights the importance of planning and controlling an organization's
operations in a manner that takes into account the potential environmental impacts. It
requires organizations to establish and maintain procedures that ensure their operations
are carried out in accordance with the environmental objectives and targets set in the
earlier phases of the EMS. The aim is to prevent or minimize adverse environmental
effects and promote sustainable practices.

Key points addressed in this clause include:

• Identifying Significant Environmental Aspects: Organizations need to identify

activities, products, and services that can have a significant impact on the
environment.

• Legal and Other Requirements: Ensuring compliance with relevant environmental

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 laws, regulations, and other requirements is a crucial part of operational planning.

• Operational Control: Organizations must implement controls to manage and mitigate

the identified environmental aspects. This might involve specifying procedures, work
instructions, and performance criteria for activities that have potential environmental
impacts.

8.2 Emergency Preparedness and Response:

This clause focuses on preparing for and responding to environmental emergencies.
Organizations need to identify potential environmental emergencies, establish
procedures to address them, and periodically test and review these procedures to ensure
their effectiveness. The aim is to minimize the impact of emergencies on the
environment, human health, and safety.

Key points addressed in this clause include:

• Emergency Preparedness: Organizations must develop plans to effectively respond to

various types of environmental emergencies, such as spills, leaks, or other incidents
that could harm the environment.

• Response Procedures: Clear procedures and responsibilities must be defined for

managing emergencies, including communication, containment, and corrective
actions.

• Training and Drills: Personnel should be trained in emergency response procedures,

and regular drills or simulations should be conducted to ensure readiness.

Continuous Improvement: Lessons learned from emergency situations should be used to

improve emergency response plans and procedures over time.

These clauses collectively guide organizations in aligning their operations with

environmental objectives, minimizing negative environmental impacts, and being
prepared to handle emergencies that might arise. This approach helps organizations
demonstrate their commitment to sustainable practices and responsible environmental
management.

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 Links to other areas of the 14001 standard
Clause 8: Operation. This clause focuses on the implementation of
environmental controls and measures to address the identified significant
environmental aspects and ensure compliance with legal and regulatory
requirements. Alignment with other clauses:

Clause 4: Context of the Organization: Understanding the environmental context helps

identify the environmental aspects and impacts to be addressed in the operational
processes.
Clause 5: Leadership: Leadership commitment is crucial for the effective implementation of
environmental controls and resource allocation.
Clause 6: Planning: Environmental objectives and targets are set, and operational planning
takes place to achieve these objectives.

2. ISO 14001:2015 (Environmental Management System):

Clause 8: Operation This clause focuses on the implementation of environmental

controls and measures to address the identified significant environmental
aspects and ensure compliance with legal and regulatory requirements.

Alignment with other clauses:

 Clause 4: Context of the Organization: Understanding the environmental

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 context helps identify the environmental aspects and impacts to be
addressed in the operational processes.
 Clause 5: Leadership: Leadership commitment is crucial for the effective
implementation of environmental controls and resource allocation.
 Clause 6: Planning: Environmental objectives and targets are set, and
operational planning takes place to achieve these objectives.

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 Links to other areas of the 14001 standard
Clause 7: Support: Resources, awareness, and competence are provided to support the
operational processes.
Clause 9: Performance Evaluation: Monitoring, measuring, analysing, and evaluating
environmental performance helps identify areas for improvement.
Clause 10: Improvement: Actions to improve environmental performance are taken based on
the results of performance evaluations.

2. ISO 14001:2015 (Environmental Management System):

Clause 8: Operation This clause focuses on the implementation of environmental

controls and measures to address the identified significant environmental
aspects and ensure compliance with legal and regulatory requirements.

Alignment with other clauses:

 Clause 7: Support: Resources, awareness, and competence are provided to

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 support the operational processes.
 Clause 9: Performance Evaluation: Monitoring, measuring, analyzing, and
evaluating environmental performance helps identify areas for
improvement.
 Clause 10: Improvement: Actions to improve environmental performance are
taken based on the results of performance evaluations.

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ISO 45001
With Clause 8, ISO 45001 requires you to plan,
control hazards and mitigation, manage change and
procurement, and prepare emergency responses.

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 Clause 8 – ISO45001 changes
The following subsections make up clause 8 in the ISO45001
Occupational Health and Safety Management system.

8.1 Operational planning and control

8.2 Emergency preparedness and response

ISO 45001 is an international standard that sets the requirements for occupational
health and safety management systems (OHSMS). It provides a framework for
organizations to manage and improve their occupational health and safety performance.
Clauses 8.1 and 8.2 of ISO 45001 are part of the "Operation" section of the standard,
focusing on the implementation and control of the OHSMS. Here's a brief explanation of
each of these clauses:

8.1 Operational Planning and Control:

This clause emphasizes the need for organizations to establish and maintain procedures
to effectively plan, implement, and control their operational processes in a manner that
addresses health and safety risks and opportunities. The primary goal is to prevent work-
related injuries, illnesses, and incidents.

Key aspects covered in this clause include:

• Identification of Hazards and Risks: Organizations need to identify potential hazards

in their operational processes and assess the associated risks to worker health and
safety.

• Determination of Necessary Controls: Based on the hazard and risk assessments,

organizations must determine appropriate controls to mitigate or eliminate these

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 hazards and reduce the associated risks.

• Operational Controls: Procedures and measures must be established to ensure that

workers are protected from identified hazards during their tasks. This might involve
specifying safe work practices, using protective equipment, and implementing
engineering controls.

8.2 Management of Change:

This clause addresses the need for organizations to effectively manage changes that could
impact occupational health and safety. Changes can include modifications to processes,
equipment, personnel, or the working environment.

Key points addressed in this clause include:

• Identification of Changes: Organizations must have a process to identify and assess

changes that could affect health and safety. This ensures that potential risks associated
with changes are recognized and addressed.

• Assessment of Impacts: Before implementing changes, organizations need to evaluate

the potential impact on worker health and safety and take appropriate measures to
control these impacts.

• Communication and Training: Workers and relevant stakeholders should be informed

about changes and provided with necessary training to safely navigate the new
conditions.

• Monitoring and Review: The effects of changes on health and safety should be
monitored and reviewed to ensure that the intended outcomes are achieved and that
new risks are promptly addressed.

These clauses guide organizations in effectively managing their operational processes to

ensure the health and safety of their workers. By identifying risks, implementing controls,
and managing changes carefully, organizations can maintain a safe and healthy work
environment and continuously improve their OHSMS performance.

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 Links to other areas of the 45001 standard
Clause 8: Operation. This clause focuses on the operational controls necessary
to manage occupational health and safety risks and ensure a safe working
environment for employees and other stakeholders. Alignment with other
clauses:

Clause 4: Context of the Organization: Understanding the context helps identify the
occupational health and safety risks and opportunities in the operational processes.
Clause 5: Leadership: Leadership commitment is crucial for implementing and maintaining
effective operational controls.
Clause 6: Planning: Objectives and action plans are established to control occupational health
and safety risks in the operational processes.

3. ISO 45001:2018 (Occupational Health and Safety Management System):

Clause 8: Operation This clause focuses on the operational controls necessary to

manage occupational health and safety risks and ensure a safe working
environment for employees and other stakeholders.

Alignment with other clauses:

 Clause 4: Context of the Organization: Understanding the context helps

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 identify the occupational health and safety risks and opportunities in the
operational processes.
 Clause 5: Leadership: Leadership commitment is crucial for implementing
and maintaining effective operational controls.
 Clause 6: Planning: Objectives and action plans are established to control
occupational health and safety risks in the operational processes.

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 Links to other areas of the 45001 standard
Clause 7: Support: Resources, training, and awareness are provided to support the
operational controls.
Clause 9: Performance Evaluation: Monitoring, measuring, analysing, and evaluating
occupational health and safety performance helps identify areas for improvement.
Clause 10: Improvement: Actions to improve occupational health and safety performance are
taken based on the results of performance evaluations.

3. ISO 45001:2018 (Occupational Health and Safety Management System):

Clause 8: Operation This clause focuses on the operational controls necessary to

manage occupational health and safety risks and ensure a safe working
environment for employees and other stakeholders.

Alignment with other clauses:

 Clause 7: Support: Resources, training, and awareness are provided to

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 support the operational controls.
 Clause 9: Performance Evaluation: Monitoring, measuring, analysing, and
evaluating occupational health and safety performance helps identify areas
for improvement.
 Clause 10: Improvement: Actions to improve occupational health and safety
performance are taken based on the results of performance evaluations.

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ISO 27001
With Clause 8 in ISO 27001, you are required to
develop operational planning and control,
information security risk assessments and
treatments.

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 Clause 8 – ISO27001 changes
The following subsections make up clause 8 in the ISO27001 Quality
Management system.

8.1 Operational planning and control

8.2 Information security risk assessment

8.3 Information security risk treatment

ISO 27001, which is the international standard for information security management
systems (ISMS). This clause provides the framework to establish operational planning
and control, risk assessment and treatment, business continuity planning and disaster
recovery and monitoring, measurement, analysis and evaluation. Here's a brief
explanation of these clauses:

1. Clause 8.1 - Operational Planning and Control:

This clause focuses on the operational aspects of managing information security within
an organization. It emphasizes the need to establish processes and controls that ensure
information security requirements are met while carrying out daily operations.

Key points covered in this clause include:

• Risk Assessment and Treatment: Organizations must continue to assess risks to their
information assets and implement appropriate measures to manage and mitigate
these risks.

• Selection of Controls: Based on the risk assessment, organizations need to select and
implement appropriate security controls from the ISO 27001 Annex A, which provides
a comprehensive set of controls addressing various aspects of information security.

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• Documentation of Controls: The controls selected for implementation must be
documented, along with the procedures and guidelines for their effective use.

2. Clause 8.2 - Information Security Risk Assessment:

This clause centres on the ongoing process of assessing and managing information
security risks. It's a critical component of the ISMS as it helps organizations proactively
identify potential vulnerabilities and threats.

Key aspects covered in this clause include:

• Risk Assessment Process: Organizations need to establish a structured process to

identify, assess, and prioritize information security risks.

• Risk Treatment: Based on the risk assessment results, organizations must decide on
appropriate risk treatment strategies, which may involve avoiding, mitigating,
transferring, or accepting risks.

• Review and Iteration: The risk assessment process should be reviewed and updated
regularly to account for changes in the organization's context and the evolving threat
landscape.

3. Clause 8.3 - Information Security risk treatment

This clause directs the organization to implement the information security risk treatment
plans that were defined in clause 6.1.3.

Key point covered in this clause include:

• During the operation of the ISMS, whenever the risk assessment is updated, the
organization then applies the risk treatment consistent with clause 6.1.3 (information
security risk treatment) and updates the risk treatment plan. Then the risk treatment
plan is again implemented.

• The information security risk treatment process should be performed after each
iteration of the security assessment process in clause 8.2 or when the implementation
f the risk treatment plan or parts of it fails.

These clauses collectively guide organizations in establishing effective information

security management systems, which are crucial in protecting sensitive information from
unauthorized access, breaches, and other security threats.

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 Links to other areas of the 27001 standard
Clause 8: Operation. This clause focuses on the implementation of controls and
measures to protect information assets and ensure the confidentiality, integrity,
and availability of information. Alignment with other clauses:

Clause 4: Context of the Organization: Understanding the information security context helps
identify the risks and opportunities related to information security in operational processes.
Clause 5: Leadership: Leadership commitment is essential for implementing and maintaining
effective information security controls.
Clause 6: Plans are established to protect information assets in operational processes
through information security risk assessments and risk treatments. Planning: Information
security objectives and how to achieve them.

4. ISO 27001:2022 (Information Security Management System):

Clause 8: Operation This clause focuses on the implementation of controls and

measures to protect information assets and ensure the confidentiality, integrity,
and availability of information.

Alignment with other clauses:

 Clause 4: Context of the Organization: Understanding the information

security context helps identify the risks and opportunities related to

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 information security in operational processes.
 Clause 5: Leadership: Leadership commitment is essential for implementing
and maintaining effective information security controls.
 Clause 6: Plans are established to protect information assets in operational
processes through information security risk assessments and risk
treatments. Planning: Information security objectives and how to achieve
them.

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 Links to other areas of the 27001 standard
Clause 7: Support: Resources, training, and awareness are provided to support the
implementation of information security controls.
Clause 9: Performance Evaluation: Monitoring, measuring, analysing, and evaluating
information security performance helps identify areas for improvement.
Clause 10: Improvement: Actions to improve information security performance are taken
based on the results of performance evaluations.

4. ISO 27001:2022 (Information Security Management System):

Clause 8: Operation This clause focuses on the implementation of controls and

measures to protect information assets and ensure the confidentiality, integrity,
and availability of information.

Alignment with other clauses:

 Clause 7: Support: Resources, training, and awareness are provided to

support the implementation of information security controls.

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 Clause 9: Performance Evaluation: Monitoring, measuring, analysing, and
evaluating information security performance helps identify areas for
improvement.
 Clause 10: Improvement: Actions to improve information security
performance are taken based on the results of performance evaluations.

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 In summary
In summary, Clause 8 in each of these ISO management systems deals with
operational aspects related to quality, environmental management, occupational
health and safety, or information security, depending on the standard.

The alignment with other clauses ensures that the operational processes are well-
integrated into the overall management system, thereby contributing to the
achievement of organizational objectives and continuous improvement.

In summary, Clause 8 in each of these ISO management systems deals with

operational aspects related to quality, environmental management, occupational
health and safety, or information security, depending on the standard.

The alignment with other clauses ensures that the operational processes are
well-integrated into the overall management system, thereby contributing to the
achievement of organizational objectives and continuous improvement.

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Do you have any questions?

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