Bob Deysher – Senior Consultant, Quality Systems/Risk Management/Auditing
Member Bodies in the London Declaration have amended over 30 of ISO’s Management System Standards, including ISO 9001. As amendments they are not considered revisions; there is no transition period.
“[U]pon publication, certification bodies should include the new text in their auditing or the organization and its context. As with normal practice, where a certified organization cannot demonstrate that external and internal issues that have been determined as relevant, including Climate Change, have been considered, a suitable finding should be raised.”
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.
Items in this declaration that should be considered by an auditor (first, second, or third-party audits):
- An auditor’s beliefs in climate change are irrelevant to the audit, per ISO 19011:2018. Guidelines for auditing management systems, auditors are to be objective. They need to assess if the organization has addressed climate change effectively and whether it is relevant or not.
- The climate change addition is consistent with Clause 4.1 and 4.2 which define the need for both external and internal issues that impact an organization’s management systems.
- This amendment does not require climate change initiatives unless it has been identified as relevant by the organization (auditee).
Other items driven by climate change that an auditor needs to consider:
- Relevancy will vary depending on the size and sector of the organization and the products and services provided.
- Auditors may find that some organizations are already considering and addressing issues related to climate (use of renewable resources, energy reduction product designs, etc.)
- Auditors may also find organizations that have already considered climate change and determined that it is not a relevant issue.
- If an organization has an integrated management system with other management system disciplines, the same issue may be analyzed differently. A holistic approach is appropriate if it benefits the entire quality management system.
Auditing ISO 9001:2015 with a Focus on Climate Change – An Auditor’s Approach
It is important to remember what ISO 9001:2015 (Clause 1) asks an organization to consider. If climate change is relevant, then climate change will impact an organization’s purpose and strategic direction 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.
While the climate change amendment can significantly impact an organization, it is important to appreciate the 309 other requirements in ISO 9001:2015. From this auditor’s perspective, climate change needs to be integrated in the audit process and assess how it interacts with all clauses. My audit approach to ISO 9001:2015 has not changed but key questions have been added.
Audit Process
The sequence of ISO 9001:2015 audits that I follow is to review Clause 9.3 Management Review first. By looking at the Management Review I get a summary of the health of the quality management system, and I can focus future questions on what is revealed in terms of suitability, effectiveness, and alignment with the strategic direction of the organization. I would expect to see issues with climate change addressed with 9.3.2 b, changes in external and internal issues that are relevant to the quality management system, and I would be looking for how the organization determined whether climate change is relevant or not. I would subsequently look for any action taken by the organization based on Clause 4.1.
Determining whether climate change has an impact on the strategic direction of the organization can take different directions based on the type of business. It’s helpful if the auditor reviews the following document to update their appreciation for potential events:
ISO 9001 Auditing Practices Group
Guidance on: Auditing Climate Change issues in ISO 9001, Edition 1, Date: 2024-03-19
Referring to Management Review, climate change impacts to interested parties should be noted in 9.3.2.c.1, customer satisfaction and feedback from relevant interested parties based on Clause 4.2. A detailed listing of potential impact can also be seen in the previously listed reference. What an auditor needs to remember is the addition to Clause 4.2 is a NOTE and not a requirement. The organization can highlight issues to relevant parties if they deem them important.
Finally, Management Review can highlight opportunities as well as changes to its quality management system as an output if climate change is relevant. It’s also possible to assess Clause 5.1 Leadership with an expectation that the organization’s leadership has demonstrated a commitment to accountability, ensuring that the quality policy and quality objectives are established for the quality management system and are compatible with the context and strategic direction of the organization.
If climate change is relevant, it is up to the organization to determine if and how climate change issues impact their quality management system. Other areas of ISO 9001:2015 that can be impacted are:
- Clause 4.3 Scope – Do climate change issues impact the scope or change the applicability of certain requirements and any changes in products and services?
- Clause 6.1 Risks and Opportunities – Do climate change issues impact anywhere along an organization’s value stream (customer requirements to customer satisfaction)?
- Clause 6.3 Changes – Do Scope changes or Risk and Opportunities require changes to the quality management system and its processes?
- Clause 7.1 Resources – If climate change issues are relevant, how does this impact resources to deliver products and services?
- Clause 8.2 Requirement for Products and Services – Where in the definition of either products or services does climate changes impact requirements and documentation? Can new definitions be validated?
- Clause 8.3 Design and Development of Products and Services – Does verification and validation cover design changes that are driven by climate change?
- Clause 8.4 Control of Externally Provided Processes, Products, and Services – Do requirements related to climate change potentially impact externally provided processes, products, and services? Do controls and information need updating?
- Clause 8.5 Production and Service Provision – Do issues related to climate change indicate the need for specific controls of production and service?
- Clause 9 Performance Evaluation – Do monitoring and measurement controls need updating and has customer satisfaction been impacted?
Final Comments
The addition of the climate change amendment adds to the issues a consultant needs to evaluate during an ISO 9001:2015 audit, with a focus on whether it is relevant to the organization’s quality management system. It can have an impact on an organization’s internal and external context, its customers, and other interested parties. The auditor needs to perform the audit to all the requirements but carefully evaluate how climate change issues were reviewed by the organization.
If deemed relevant by the organization, climate change issues may be embedded in risk and opportunities, changes made to the quality management system, or even in the scope of the organization. New statutory and regulatory requirements with climate change relevance that are applicable to products and services need to be assessed and action taken if necessary. New product and service features driven by climate change need to be verified and evaluated.
Many ISO 9001:2015 clauses will be impacted if climate change relevancy is established by an organization. An auditor needs to be aware how these changes will drive change in an organization’s entire quality management system.
References
- ISO 9001 Auditing Practices Group
Guidance on: Auditing Climate Change issues in ISO 9001, Edition 1, Date: 2024-03-19 - Deciphering the latest changes to the Harmonized Structure, ISO/TMEG,/JTEG, 27 September 2023
- Deploying ISO’s London Declaration to Climate Action via Management System Standards, ISO/TMEG,/JTEG, 27 September 2023, By Nigel Croft, JTCG Chair, Dick Hortensius, JTCG Secretary, Sam Somerville, TC176/SC2 Chair and Mark Schuessler on 27 September 2023
- ISO introduces climate change requirements to type A management systems standards, CQI/IRCA
- ISO’s shared approach to fighting climate change, 22 April 2022
- ISO 9001:2015 – Quality management systems — Requirement
