ISO 9001:2015 → ISO 9001:2026 Gap Analysis

ISO 9001:2015 → ISO 9001:2026 Gap Analysis
Professional Digital Edition
A complete, structured and practical gap analysis from Clause 4 to Clause 10 for organizations transitioning from ISO 9001:2015 to ISO 9001:2026.
The ISO 9001:2015 → ISO 9001:2026 Gap Analysis is a Professional Digital Edition in Microsoft Excel (.xlsx) format, designed to support organizations in the organized and systematic review of the transition to the new standard.
The tool provides structured examination of the relevant requirements, analysis and classification of the type of change, practical observations and fields for documentation, actions and follow-up.
It supports self-assessment by the organization/user, internal review of the current situation and organized planning of the required transition actions.
The tool is a clause-by-clause gap analysis and does not constitute a conformity assessment, certification or official certification-readiness assessment.
CONTENTS
• ISO 9001:2015 → ISO 9001:2026 Gap Analysis in Microsoft Excel (.xlsx) format.
• Structured clause-by-clause gap analysis.
• Systematic examination of the relevant transition requirements from ISO 9001:2015 to ISO 9001:2026.
• Classification of the type of change for categorization of the changes.
• Change analysis for the organized examination of the relevant differences.
• Practical observations supporting the understanding and application of the changes.
• Fields for documentation / evidence, where required.
• Fields for actions, responsible persons, dates and status.
• Ability to use the tool for internal self-assessment of the transition and action planning.
• Greek and English content in the same file.
FREQUENTLY ASKED QUESTIONS (QUESTIONS & ANSWERS)
1) What exactly is the ISO 9001:2015 → ISO 9001:2026 Gap Analysis?
It is an independent digital clause-by-clause gap analysis tool in Microsoft Excel format, designed to support the organized and systematic review of the transition from ISO 9001:2015 to ISO 9001:2026.
2) Does it cover all Clauses of ISO 9001:2026?
The tool covers Clauses 4 to 10.
3) Can I perform a self-assessment?
Yes. It can be used for personal or internal business self-assessment of the transition and for preparation of the Quality Management System.
The end user can review the relevant points, enter their own information and observations, identify areas requiring further review and organize the required actions.
4) How does the gap analysis work?
For each designated assessment point, the user can review the relevant transition and use the corresponding fields of the file for:
• classification of the type of change,
• change analysis,
• practical observations,
• documentation / evidence,
• required actions,
• responsible persons,
• dates and status.
In this way, the analysis can be used as an organized basis for internal review and transition planning.
5) What does the classification of the type of change mean?
The “Change Type” field is used to systematically categorize the type of change being examined.
The classification forms part of the structure of the file and supports the user in understanding and further processing the relevant transition points.
6) What does the change analysis include?
The change analysis provides an organized examination of the differences between the editions of the standard, so that the user can consider what the change means for their own Quality Management System and identify points requiring further action or review.
7) What can I enter under Documentation / Evidence?
The user can enter information relating to the implemented Quality Management System, such as procedures, instructions, records, documents or other relevant evidence connected to the point being examined. The information entered is used to support the user’s own internal assessment and documentation.
8) Can I use the results of the gap analysis for my own needs?
Yes. The user may use the results, entries, analyses, observations and reports generated through use of the tool for their own needs, in accordance with the License Agreement.
9) Is the tool a conformity or certification assessment?
No. The ISO 9001:2015 → ISO 9001:2026 Gap Analysis is an independent analytical self-assessment tool for the transition.
It does not constitute:
• a conformity assessment,
• a certification audit,
• certification,
• an official certification-readiness assessment,
• legal or other professional advice,
• an official ISO tool.
The final assessment, judgment and decision regarding the status and required actions remain with the end user and, where required, the appropriate professional.
10) Do I need a specific Excel version?
The file is provided in Microsoft Excel (.xlsx) format and has been tested in Microsoft Excel 2021. It does not require VBA/macros, add-ins or connection to external systems.
Microsoft Excel is recommended for proper operation of the file elements. Full compatibility with all other spreadsheet applications or different versions of Excel is not guaranteed. Modifications to worksheets, fields, formulas, links or other structural elements may affect the functionality of the file.
11) Can I modify the file?
The file includes elements of functional and technical structure, as well as protected worksheets and fields.
Permitted end-user entries are limited to the designated fields of the tool.
Modification, reproduction or systematic recreation of the structure, worksheets, forms, tables, terminology, mappings or functional logic of the tool is subject to the restrictions of the License Agreement.
LANGUAGE
English and Greek.
IMMEDIATE DIGITAL DELIVERY
Upon purchase, the user receives two (2) digital files:
• Microsoft Excel (.xlsx) – ISO 9001:2015 → ISO 9001:2026 Gap Analysis
• PDF – License Agreement containing the terms of use and the file opening code.
SUPPORT
The purchase includes the possibility of one (1) electronic communication within 2 calendar days from the date of purchase, by email, regarding questions relating to the file and its basic use, in accordance with the applicable support terms.
Support does not include customized organization assessment, conformity assessment, certification-readiness assessment, development or modification of procedures and documents, application of the tool to a specific organization, consulting services, ongoing consulting support or training.
PRODUCT INFORMATION, INTELLECTUAL PROPERTY & LEGAL COMPLIANCE
The ISO 9001:2015 → ISO 9001:2026 Gap Analysis is an independent digital analytical tool for assessing the transition from ISO 9001:2015 to ISO 9001:2026 and is provided as a Microsoft Excel digital file. The structure, organization, terminology, frameworks, forms, analytical tables, mappings, observations, instructions and functional/technical structure of the tool constitute elements of the creative work of Topatsis Consulting, to the extent protected by applicable copyright law.
The purchase grants a right of use in accordance with the terms of the accompanying Professional Digital License Agreement. The license applies to one (1) end user and does not grant the right to reproduce, distribute, transfer, resell or create a derivative product from the tool.
The results, entries, analyses, observations and data generated or entered by the user may be used for their own needs, in accordance with the terms of the License Agreement.
ISO 9001 is a third-party standard. The names, trademarks, logos and other intellectual property rights relating to ISO, the ISO 9001 standard and/or any other third-party entities, organizations, products or services that may be referred to or depicted in this tool belong to their respective rights holders.
This tool is not an official ISO tool and does not imply any official relationship, approval, validation or sponsorship by ISO or any other third-party rights holder, unless expressly stated otherwise.
References to ISO 9001:2015 or ISO 9001:2026, as well as to any other third-party products, services, organizations or entities, within the tool are made solely for reference, informational and descriptive purposes concerning the subject matter of the tool.
The tool is an independent analytical self-assessment tool for the transition and does not replace the role, judgment or contribution of the Quality Manager and/or external Consultant, where applicable.
It does not constitute a conformity assessment, certification-readiness assessment, certification, legal or other professional advice or an official ISO tool.
The final assessment, judgment, decision and responsibility regarding the status of the Quality Management System and the required transition actions remain with the end user and, where required, the appropriate professional.
For complete and official information regarding the standard, its application and its requirements, it is recommended to obtain the standard from official ISO sources.
© 2026 Topatsis Consulting. All Rights Reserved.
Document ID: DGA-2026, Version: V1.0