ISO 9001:2015/Amd 1:2024

As part of ISO’s commitment to action on climate change, approved unanimously by all ISO Member Bodies in the so-called London Declaration, (https://www.iso.org/ClimateAction.html), amendments to over 30 of ISO’s Management System Standards, including ISO 9001, have now
been issued to include climate change considerations, as follows:

4.1 Understanding the organization and its context.
The organization shall determine external and internal issues that are relevant to its purpose and that affect its ability to achieve the intended result(s) of its quality management system.

Added: The organization shall determine whether climate change is a relevant issue.

4.2 Understanding the needs and expectations of interested parties.
The organization shall determine:

• the interested parties that are relevant to the quality management system.
• the relevant requirements of these interested parties.
• which of these requirements will be addressed through the quality management system.

Added: NOTE: Relevant interested parties can have requirements related to climate change

The overall intent of the clauses 4.1 and 4.2 remains unchanged, as these clauses already included the need for the organization to consider internal and external issues that can impact the effectiveness of their management system (from ISO/IAF Joint Communiqué). These new inclusions are to ensure that climate change is firmly on the organization’s radar screen and is given special attention as one of the external issues to be considered in the design and implementation of their quality management system. This amendment does not require an organization to have climate change initiatives unless it has been identified as a relevant issue to achieve the intended results of the QMS.

This addendum takes into account the notion of climate change and concerns clauses 4.1 and 4.2, i.e. the understanding of the organization and its context, as well as the needs and expectations of stakeholders. Non-prescriptive, these changes only require taking into account global warming as a potential problem or as a subject of possible requirements of said stakeholders. ISO has published an amendment to clause 4.1 of ISO 9001 (ISO 9001:2015/ Amd1:2024), along with all other management system standards, adding the requirement for the organization to determine if climate change is a relevant issue (when determining the issues relevant to its purpose and that affects its ability to achieve the intended results of its management system). The amendment also adds a note to clause 4.2 of the standard, indicating that relevant interested parties may have climate change-related requirements. This change takes effect immediately, and it would appear from the International Accreditation Forum(IAF)’s decision log that there will be no lead-in period for the change for certified organizations, certification bodies(CBs) and accreditation bodies (ABs) and that certification bodies can raise findings about the new requirement with immediate effect. These amendments should not be confused with the current ongoing revision of ISO 9001 which is expected to be published in around 2 years and would then be subject to the usual 3-year transition period. So, what is the real-world impact of this amendment for certified organizations? In a nutshell, you need to be able to demonstrate to your third party that you have specifically determined whether or not climate change is an issue relevant to your management system or or not. There is no actual requirement to document the issues you have determined to be relevant, although many organizations choose to do so. You could include it in your next management review, or schedule an additional review to make this assessment. IAF have indicated that ABs expect to ensure that CBs have assessed how the decision has been made. If it is a relevant issue, or you identify that interested parties do have requirements you would then need to demonstrate how the quality management system is addressing them, if you haven’t done so already.

CLIMATE CHANGE IN THE CONTEXT OF ISO 9001

Relevant Issues related to climate change, to be determined by the organization, if any, are those
relevant to its purpose and strategic direction and that affect the organization’s ability to achieve
the intended results of the quality management system:

• the ability to consistently provide products and services that meet customer and applicable
  statutory and regulatory requirements, and
• enhance customer satisfaction through the effective application of the system, including
  processes for improvement of the system and the assurance of conformity to customer and
  applicable statutory and regulatory requirements (ISO 9001, clause 1).

Relevance of these issues will vary significantly depending on the size and sector of the organization, the products and services provided, its position in the supply chain, its geography, the scope of the organization’s quality management system, and potentially other factors. These
may span the spectrum from no relevance to extremely relevant. The inclusion of the new text in 4.1 requires organizations to consider climate change to determine if there are or not relevant issues that will need to be addressed. Although the text is new, auditors may find that some organizations are already considering and addressing issues related to climate change within the scope of the quality management system (e.g.: energy supplier invoices, stating the percentage of supplied energy coming from renewable sources; claims on carbon credit, on product claims on energy consumption reduction, replacement of raw materials or consideration of eco-design of products to reduce climate change impact, etc.). Auditors will also find organizations that have already considered climate change and determined that it was not a relevant issue for their QMS. For other organizations, this may be a new consideration. The note at 4.2 is a reminder that there may exist, currently or potentially in the future, requirements related to climate change dictated by customers and relevant interested parties. A climate change issue can be relevant for different management system disciplines, such as environmental, health and safety, energy, finance, or other aspects of an organization’s activities. While these may have ancillary significance, they are not generally addressed within the scope of the quality management system audit. If an organization has an integrated management system with other management system disciplines, it is likely that the same issue is analyzed in different perspectives by the organization in a holistic manner. Auditors need to be aware of this and focus on the intended outcomes of the QMS and its processes, bearing in mind that there might exist overlaps in certain areas (e.g. design of product considering environmental aspects).

How could climate change relate to a Quality management system?

Climate change can relate to a Quality Management System (QMS) in several ways, impacting both internal processes and external factors that influence product and service quality. Here are some key ways in which climate change can intersect with a QMS:

1. Resource Management: Climate change can affect the availability and quality of resources used in production processes, such as water, energy, and raw materials. A QMS can incorporate measures to monitor and optimize resource usage to mitigate the impact of climate-related resource constraints or fluctuations.
2. Supply Chain Management: Climate change can disrupt supply chains through extreme weather events, changes in agricultural productivity, transportation disruptions, and shifts in demand patterns. A robust QMS can include risk management processes to identify, assess, and address climate-related risks in the supply chain, ensuring continuity of supply and minimizing disruptions to product quality and delivery schedules.
3. Product Lifecycle Assessment: Climate change considerations can be integrated into product lifecycle assessments within the QMS, evaluating the environmental impacts of products from raw material extraction to end-of-life disposal or recycling. This can involve assessing carbon footprints, energy consumption, emissions, and waste generation associated with products and identifying opportunities for reducing environmental impacts throughout their lifecycle.
4. Regulatory Compliance: Climate change-related regulations, standards, and reporting requirements can impact product design, manufacturing processes, and business operations. A QMS can ensure compliance with relevant environmental regulations and standards, such as emissions limits, energy efficiency requirements, waste management regulations, and carbon reporting obligations.
5. Customer Expectations: Increasingly, customers are demanding environmentally sustainable products and services, driving businesses to adopt greener practices. A QMS can help organizations understand and meet customer expectations related to climate change by incorporating environmental criteria into product specifications, quality criteria, and customer satisfaction metrics.
6. Risk Management: Climate change poses various risks to organizations, including physical risks (e.g., extreme weather events, supply chain disruptions), regulatory risks (e.g., compliance obligations, carbon pricing), reputational risks (e.g., negative public perception, brand damage), and financial risks (e.g., increased costs, market volatility). A QMS can include risk assessment and mitigation processes to proactively identify, evaluate, and manage climate-related risks to ensure business continuity and protect product quality and brand reputation.
7. Continuous Improvement: Climate change adaptation and mitigation efforts require ongoing monitoring, evaluation, and improvement. A QMS facilitates continuous improvement by establishing processes for setting environmental objectives, monitoring performance indicators, conducting audits and reviews, and implementing corrective and preventive actions to enhance environmental sustainability and resilience in response to climate change.

In summary, climate change can significantly impact the effectiveness of a Quality Management System by influencing resource availability, supply chain resilience, regulatory compliance, customer expectations, risk management, and continuous improvement efforts. Integrating climate change considerations into a QMS helps organizations adapt to environmental challenges, enhance product quality, and ensure long-term business sustainability.

1. AUDITING CLIMATE CHANGE ISSUES WITH IMPACT IN THE QMS AND ITS RESULTS

1. Has the organization determined whether climate change is a relevant issue?
2. Does the organization’s determination align with applicable statutory and regulatory
   requirements applicable to their products and services?
3. Does the organization’s determination align with their contractual requirements?

4.1 New Requirement: The organization shall determine whether climate change is a
relevant issue.

Determining whether climate change is a relevant issue while identifying external and internal issues relevant to the Quality Management System (QMS) involves systematically evaluating factors that may impact the organization’s ability to achieve its quality objectives. Here’s how an organization can determine the relevance of climate change as an issue during this process:

1. External issues:
   • Market Trends and Regulatory Landscape: Assess how climate change may influence market trends, customer preferences, and regulatory requirements relevant to the organization’s products and services. Consider whether there are emerging regulations related to environmental sustainability, greenhouse gas emissions, energy efficiency, or other climate-related issues.
   • Supply Chain Vulnerability: Evaluate the vulnerability of the organization’s supply chain to climate-related risks, such as disruptions in raw material availability, transportation delays, or changes in supplier reliability. Consider whether climate change impacts on suppliers or transportation routes could affect the organization’s ability to deliver quality products and services.
   • Stakeholder Expectations: Consider the expectations of stakeholders, including customers, suppliers, investors, regulators, and communities, regarding the organization’s response to climate change. Assess whether there is increasing pressure from stakeholders for businesses to address environmental sustainability and climate-related risks.
2. Internal Issues:
   • Operational Impacts: Evaluate how climate change may directly or indirectly affect the organization’s operations, facilities, and resources. Consider whether changes in weather patterns, extreme weather events, or resource constraints (e.g., water scarcity) could impact production processes, quality control measures, or infrastructure resilience.
   • Resource Management: Assess the organization’s resource management practices, including energy usage, waste generation, and water consumption, in the context of climate change. Identify opportunities to improve resource efficiency, reduce greenhouse gas emissions, and enhance environmental sustainability as part of the QMS.
   • Risk Management: Evaluate the organization’s risk management processes to identify and mitigate climate-related risks that could impact product quality, customer satisfaction, or business continuity. Consider whether existing risk assessment methodologies adequately address climate-related hazards and vulnerabilities.
3. Integration with QMS:
   • Alignment with Quality Objectives: Determine whether addressing climate change aligns with the organization’s quality objectives, strategic goals, and commitment to customer satisfaction. Consider whether improvements in environmental sustainability and resilience to climate-related risks can contribute to enhancing overall product and service quality.
   • Documentation and Monitoring: Document the organization’s assessment of climate change as a relevant issue within the context of the QMS. Establish mechanisms for monitoring and measuring performance related to climate-related objectives, targets, and key performance indicators (KPIs) to ensure continuous improvement and compliance with relevant standards.

Auditing considerations for climate change impacts from external and internal issues can include:

• Changes in statutory or regulatory requirements such as restriction on the use of certain
  materials, product circularity, product life cycle, product origin, claims, etc.
• Use of bio-based, renewable materials.
• Potential impacts on the products and services or on the QMS processes, by changes
  determined in other management system disciplines, e.g. need to reduce energy consumption, reduce waste, reuse or recycle materials.
• Extended lifetime of products, post-delivery services and assistance
• Requirements to move to carbon neutral products and services.
• Issues impacting the processes and infrastructure, due to energy and other considerations.
• Vulnerability of the organization to deliver its products and services due to more frequency of storms, waterflows, fires, drought, that may imply shortages in the supply or difficulties in
  distribution.
• Concerns related to overall knowledge and control of the supply chain in issues related to
  climate change.
• Market trends on sustainability of products and services and related information and claims
• Competing products and services with potential better performance in climate change related issues.

4.2 NOTE: Relevant interested parties can have requirements related to climate change

Relevant interested parties in the context of a Quality Management System (QMS) can indeed have requirements related to climate change. Here are some examples of interested parties whose needs and expectations might involve climate change considerations:

1. Customers: Customers may increasingly prioritize environmentally sustainable products and services. They may expect the organization to demonstrate environmental responsibility by minimizing greenhouse gas emissions, reducing energy consumption, using renewable resources, and implementing eco-friendly practices throughout the product lifecycle. Climate change concerns could influence their purchasing decisions, making it essential for organizations to address these expectations to maintain customer satisfaction.
2. Regulators and Government Agencies: Regulatory bodies may impose requirements related to climate change mitigation, adaptation, and reporting. These requirements could include regulations to reduce greenhouse gas emissions, improve energy efficiency, promote renewable energy sources, manage waste and emissions, or disclose environmental performance metrics. Organizations must ensure compliance with relevant regulations and anticipate future regulatory developments related to climate change.
3. Investors and Shareholders: Investors and shareholders may consider climate change risks and opportunities when evaluating the organization’s financial performance and sustainability practices. They may expect transparency and disclosure regarding the organization’s exposure to climate-related risks, its resilience strategies, and its commitment to environmental stewardship. Addressing climate change concerns can enhance investor confidence and support long-term financial sustainability.
4. Suppliers and Business Partners: Suppliers and business partners may be subject to climate-related risks and regulatory requirements that could impact their ability to fulfill contractual obligations. Organizations may need to assess the climate resilience of their supply chain, collaborate with suppliers to mitigate shared risks, and incorporate climate considerations into procurement practices and supplier selection criteria.
5. Employees and Labor Organizations: Employees and labor organizations may have concerns about the organization’s environmental impact, workplace safety, and job security in the context of climate change. They may expect the organization to provide a safe and healthy work environment, support sustainable practices, offer training on climate-related issues, and engage in meaningful dialogue and collaboration on environmental initiatives.
6. Local Communities and Non-Governmental Organizations (NGOs): Local communities and NGOs may advocate for climate action and environmental protection initiatives that affect the organization’s operations and reputation. They may expect the organization to be a responsible corporate citizen, engage in community outreach and partnerships, address environmental concerns, and contribute positively to local sustainability efforts.

The examples of relevant interested party requirements for climate change can include:

• Statutory and regulatory, environmental or climate change requirements for the product or
  service provided, and those that affect the organization’s ability to provide that product or
  service.
• Customer requirements regarding climate change, zero discharge, or carbon neutrality of the products.
• Parent company policies and strategies.
• Requirements related to product information on aspects related to climate change (sustainability of the origin, reuse, recyclability, end of life, embedded carbon, “greenwashing labelling” etc.), including product claims and associated existing legal, statutory, and other requirements.
• Industry codes and standards changes related to climate change.
• Environmental agreements with community groups or non-governmental organizations.
• Permits, licenses, or other forms of environmental authorization.
• Climate change related requirements on processes such as packaging, manufacturing,
  servicing, logistics, among others.

4.3 Determining the scope of the QMS

The organization must check if these relevant climate change issues impact the QMS scope or change the applicability of certain requirements; Is there a need to change the scope of the QMS.
Relevant examples:

• The organization considered to move location due to the higher risk of flooding in its current location.
• The organization is provided different products and services.
• The organization did not apply development of product but changes in raw materials or processes, determined the need for its applicability.

6.1 Actions to address risks and opportunities.

The organization must considered these issues to determine risks and opportunities.

Relevant examples:

• These issues may lead to changes in support, such as infrastructure, monitoring and
  measuring equipment, knowledge, communication or other.
• There may be relevant changes in operational processes.
• Changes that may need to be monitored and measured.
• The risks that need to be addressed.
• Has the organization determined new opportunities?

The organization may need to determine new opportunity related to the new product and services or changes in the existing offerings:

• Financing opportunities for changes in its infrastructure and processes
• Communication related to products and services addressing climate change related
• issues.
• New markets for its products and services

The organization may need to determine how the determined risks and opportunities impact the
intended results of the QMS. The organization may need to have planned actions for these risks and opportunities.

6.3 Changes

The organization may need to determine if potential risks and opportunities determined or changes in scope, imply changes in the QMS and its processes. Also if the planned actions considered all the items referred in 6.3 a) to d).

7.1 Resources

If climate change issues have been deemed relevant, then the organization must determine how does this impact resources to achieve conformity of products and services.

Relevant examples:

• The organization must consider if climate change impact on the environment for the operation of processes (7.1.4).
• The organization must determine an appropriate source of knowledge on which to base their decisions (7.1.6).

8.0 Operations

If climate change issues have been determined as relevant and do not imply changes in the QMS, nor on its QMS scope, the organization must be handled within the dispositions of the current QMS.

Relevant examples:

8.2.1 a) The organization must provide information related to products and services.
8.2. b) If there are any claims on products and services related to climate change, the organization must demonstrates it can meet them.
8.2.1 e) The organization must establish specific requirements for contingency actions related to
determined risks in the provision of the products and services.
8.2 a) and 8.2.3 The organization must consider climate change related requirements when determining or reviewing the requirements related to products and services.
8.2.4 The changes in the requirements of products and services to be documented and relevant
persons to be made aware of.
8.3 The organization must address requirements related to climate change in product and service design and development.
8.4 The requirements related to climate change for externally provided products, services, and processes that the organization needs to control, include consideration of the potential impact of the externally provided processes, products and services on the organization’s ability to consistently meet customer and applicable statutory and regulatory requirements, the organization must determine the type and extent of control and information for external providers.
8.5 The organization must determine if the issues related to climate change indicate the need for specific controls of production and service provision.
Relevant examples:

• unique identification and traceability of products to sustainable sources of raw materials,
• appointment of competent persons, including required qualifications,
• post-delivery activities, such as recycling and final disposal,
• evidence of conformity to acceptance criteria,
• Control of non-conforming outputs,

9.0 Performance evaluation and Improvement

If relevant issues related to climate change have been determined by the organization, these may have specific monitoring and measurement needs, eventual implications on monitoring and
measuring customer satisfaction or changes to the audit program.
Relevant examples:

• Reliable sources of information and data, either external or internal
• Monitoring and measurement of organizational impact, results of the introduced changes.

It is also expected that management review inputs consider any changes related to this context issue, and outputs of management review may include related decisions, including opportunities
for improvement.

SPECIFIC CONCERNS
It is up to the organization to determine if and how climate change issues impact the QMS and its intended results. Special attention is necessary for product and service claims related to climate change issues, as with other claims made on products, as the organization shall demonstrate that it ensures it can meet the claims (8.2.1 b). Many of these claims may imply specific methodologies for monitoring and measurement, may require additional third-party verification or be subject to statutory and regulatory requirements.

SUMMARY AND CONCLUSIONS
Climate change issues are one of many issues that organizations are to consider when analysing
their internal and external context and determining requirements from customers and other relevant interested parties. In its communiqué ISO and IAF considered that this is an external factor that is important enough for our community to require organizations to consider it now. The amendment to ISO 9001:2015 has been published on 23 February 2024. Auditors will have to
evaluate how the organization demonstrates it has determined if climate change is a relevant issue, in the context of the quality management system and its intended results. In practice, auditors need to perform the audit to processes related to context, relevant issues and relevant requirements as usual, but evaluating specifically how climate change issues were considered. While some organizations may already address climate change issues, others will be considering it for the first time. Auditors are to be aware that implications of climate change issues and related legal, customer and other interested party requirements, may vary. If relevant climate change issues are determined by the organization, these will need to be addressed within the QMS. This implies determination of risks and opportunities, planning of changes to the QMS, changes in scope or simply addressing related requirements within the other requirements of the QMS. Auditors should look for evidence that the organization has considered the issues and is addressing them within the scope of the organization’s quality management system. Auditors are to evaluate if the organization has identified any contractually agreed customer requirements or statutory and regulatory requirements with climate change relevance that are applicable to its products and services and whether these are being acted upon. Auditors are to be particularly careful evaluating if there are any existing product and service claims related to climate change. If so, organizations need to demonstrate that they ensure these claims can be met, as this may pose a risk to the integrity of the QMS.