ISO/FDIS 9001:2026 Released

ISO/FDIS 9001:2026 Released

********** 

The International Organization for Standardization (ISO) has officially released ISO/FDIS 9001:2026 for final ballot and review this month. Following this milestone, the final publication of the core standard, ISO 9001:2026, is highly anticipated in September 2026.

While the official ISO/FDIS 9001:2026 draft is not publicly available for free and must be purchased directly from the ISO Store, several leading certification bodies (such as BSI, DQS, BV, etc.) have proactively published complimentary whitepapers and comparative guidelines. These resources provide an insightful, clause-by-clause analysis of the key changes in the FDIS. The core takeaways are summarized below:

1. Clause 4 (Context of the Organization): This update mandates that organizations explicitly evaluate the impacts of environmental factors and climate change within their specific context. Moving forward, businesses will need to seamlessly integrate Environmental, Social, and Governance (ESG) aspects into their overall risk profile.

2. Clause 5 (Leadership): Fostering a robust quality culture and ethical behavior across the organization will now fall squarely on the shoulders of top leadership. Auditors will look beyond a mere documented quality policy; they will actively assess whether employee behavior genuinely aligns with quality and ethical standards in practice.

3. Clause 6 (Planning): The new amendment cleanly separates "Risks" and "Opportunities" into dedicated subsections, requiring organizations to proactively address both. Consequently, establishing a robust framework that balances "Risk-based Thinking" with "Opportunity-based Thinking" becomes essential.

4. Clause 7 (Support): Employee training and competency awareness programs must now expand beyond the traditional quality policy to encompass organizational culture and ethics. As a direct result, organizations will need to strategically revise their existing training content and matrices.

5. New Annex: A comprehensive, 15-page guiding annex has been introduced to clarify the specific requirements spanning Clauses 4 through 10. This addition will be immensely beneficial to users for benchmarking, and it is expected to significantly minimize interpretation gaps between external auditors and organizations.

Provided the remaining voting and administrative processes proceed smoothly, this much-anticipated, modernized quality management system standard—ISO 9001:2026—will be in our hands by September 2026.

Regards,

Keshav Ram Singhal 

 

Status of the ISO/FDIS 9001:2026 QMS

Status of the ISO/FDIS 9001:2026 QMS 

********** 

Courtesy Indicative Image GoogleGemini

The present status of the upcoming ISO 9001:2026 Quality Management System (QMS) revision is outlined below -

Current Status

* Consensus - At the international experts' meeting held in Mexico City in February 2026, a consensus was reached on the core requirements of the main sections (Clauses 1 to 10) of the forthcoming standard. 

* Compilation of Comments - Following the overwhelming approval of the Draft International Standard (DIS) by Member States in December 2025 (achieving a 97% consensus), global feedback and comments have been compiled. The Working Group is currently finalizing the informative text and the newly proposed Annex A.

* Publication of the FDIS - The Final Draft International Standard (ISO/FDIS 9001:2026 QMS) is officially expected to be published for final voting by June 2026.

Tentative Timeline

The International Organization for Standardization (ISO) has targeted the following timeline for the upcoming phases:

* June 2026 - Official publication of the ISO/FDIS 9001:2026 and the commencement of the final voting period.

* September 2026 - Official global release and publication of the revised international standard, ISO 9001:2026 QMS.

Other Timeline Expected

* September 2026 – August 2027 - Transition readiness period for Certification Bodies (CBs) to align their processes, train auditors according to the new standard, and complete their formal accreditation updates.

* August 2027 - Expected rollout of the very first corporate certifications issued under the new ISO 9001:2026 edition.

* September 2029 - Culmination of the official 3-year transition period, at which point the current ISO 9001:2015 QMS standard will be fully retired and cease to be valid.

Key Changes Expected in the New Standard

While the final text will only be set in stone upon publication in September 2026, consensus among technical committee experts indicates that this revision will be evolutionary rather than revolutionary. The core High-Level Structure (HLS) remains intact, but several progressive updates are being integrated -

* Clause 4 (Context of the Organization) - Will explicitly embed considerations for Climate Change and Sustainability, integrating the baseline expectations introduced in the 2024 ISO climate amendments.

* Clause 5 (Leadership) - Places greater accountability on top management, making it mandatory for leadership to actively promote, cultivate, and demonstrate a Quality Culture and Ethical Behaviour across the organization. 

* Clause 6 (Planning - Risk and Opportunity) - Refines the frameworks governing risks and opportunities to bring greater operational clarity, systematically balancing risk-based thinking with proactive opportunity-based thinking.

* Clause 7 (Support) - Expands the horizon of employee awareness. Under the new guidelines, personnel awareness must extend beyond basic quality objectives to include a fundamental understanding of organizational quality culture and business ethics.

* Introducing a New 'Annex A' - For the first time in the history of the ISO 9001 standard, a comprehensive 15-page Informative Annex is being added. This section will serve as a definitive guidebook to help users, organizations, and auditors interpret complex requirements and standardized terminology uniformly.

Conclusion

In conclusion, the development of ISO/FDIS 9001:2026 QMS is on track and moving forward efficiently. With the final draft slated for voting in June 2026, organizations worldwide should expect the revised standard in September 2026.

Regards,

Keshav Ram Singhal 

#ISO9001 #QualityManagement #QMS #ISO90012026 #QualityCulture #AuditingStandards #BusinessEthics #ContinuousImprovement #KeshavRamSinghal`

 

Four Common Terms Used in Management System Standards

Four Common Terms Used in Management System Standards

********** 

Photo Courtesy NightCafe 

The terms Determine, Establish, Implement, and Maintain used in Management System standards (such as ISO 9001, ISO 14001) are not just common words—they represent a sequence. These terms are crucial to the development and operation of any management system. Below, an attempt has been made to explain their meaning and differences in a simple manner.

1. Determine

Meaning - To identify, analyze, and decide what is needed.

Example -

* Risks and opportunities are determined.

* The organization determines its risks and opportunities.

Determine is the first step in the development and operation of a management system—it answers the question, "What is to be done?" 

2. Establish 

Meaning - To set up or create something formally with a defined structure and documentation. To formalize and structure a system, procedure, or policy.

Example -

* A quality policy is established.

Establish is the second step in the development and operation of a management system—“How to create the structure?”

3. Implement 

Meaning - To put the established system or process into action. To actually implement and use the established system or process.

Example -

* The procedure is implemented in daily operations.

Implement is the third step in the development and operation of a management system—“To actually start work.”

4. Maintain

Meaning - To keep the management system running effectively and up to date. To continually maintain the management system's effectiveness, monitor it, and make improvements as needed.

Example -

* The management system is maintained.

Maintain is the fourth step in developing and operating a management system—“ensuring continuity and improvement.”

Example

Suppose an organization is implementing a Quality Management System (QMS).

* Determine - First step - Decide what processes the organization needs.

* Establish - Second step - Document and design those processes.

* Implement - Third step - Implement those processes.

* Maintain - Fourth step - Continually monitor and improve the system.

Conclusion

These four terms form a complete cycle in the development and operation of a management system, which is the foundation for the success of any management system. Correct understanding and use of these terms can be a good step towards effective compliance with international standards and continual improvement.

Regards,

Keshav Ram Singhal 

Measurement Management System – An Introduction

Measurement Management System – An Introduction

********

The International Organization for Standardization (ISO), the world's international standardization body, published the standard ISO 10012 on Measurement Management Systems in 2003. A revised second edition of this standard has been published in 2026,  incorporating several significant updates. This standard was developed by ISO's technical committee, ISO/TC 176 (Quality Management and Quality Assurance), in collaboration with the European Committee for Standardization (CEN). This standard describes the requirements for a measurement management system, which organizations can meet in order to implement an effective measurement management system.

The key changes in the new standard are:

— The document has been reorganized to follow a uniform structure for management system standards.

— Several important revisions have been made to address the expectations of interested parties.

The new version of the standard introduces a significant revision of ISO 10012:2003, aiming to provide a foundation for organizations to implement and continually improve a measurement management system for the effective application of the measurement process throughout the entire measurement process. The primary objective of a measurement management system is to establish confidence in the validity and reliability of measurement results and to ensure that measurements related to the products and/or services provided by an organization support the required quality levels. This also includes managing risks associated with measurement processes, which can produce inaccurate measurement results and impact the quality of the organization's products or services.

This measurement management system can be applied to processes involved in the design, development, verification, monitoring, and delivery of accurate measurement results. This standard provides organizations with a clear framework for meeting the requirements of a measurement management system. This standard can be applied to any industrial sector where measurement management is required. It can also be implemented in conjunction with other management system standards, such as ISO 9001 (Quality Management System) and ISO 14001 (Environmental Management System).

This standard is generally used by organizations where measurement plays a critical role and inaccurate measurements can lead to risks (e.g., product quality impacts, safety hazards, compliance failures). It is applicable to any type or size of organization, but it is primarily adopted in the following sectors:

- Manufacturing industries — where precise measurements are essential in production (e.g., automotive, machinery, electronics, metalworking, etc.).

- Aerospace and Aviation — where safety and measurement accuracy are paramount.

- Defence.

- Healthcare and Medical devices — in instrument calibration and measurement.

- Engineering and Production Operations — in general production and operational environments.

- Testing and calibration laboratories — Although ISO/IEC 17025 is more specific for these organizations, ISO 10012 can be used as a support or supplement.

- Energy, pharmaceuticals, and other regulated sectors — Where measurement data is critical to decision-making, compliance, or product quality.

With the new version, this standard has emerged as a more robust auditable and certifiable management system standard. The 2003 version did not provide the same level of clarity and structured framework as the new edition. Many organizations seek third-party certification to demonstrate credibility to customers, regulators, or the supply chain.

In short, any organization that relies on measurement and wants to control measurement risks, especially where product/service quality, safety, or compliance are at stake, can use this standard.

This standard contains ten clauses and two annexes, with Clauses 4 to 10 describing the requirements for a measurement management system. 

Regards,

Keshav Ram Singhal

Quality Culture

Quality Culture 

**********

Symbolic image courtesy NightCafe 

How can a quality culture be developed in practice?
This question still troubles many minds.
Quality culture does not emerge simply from leadership orders,
but through planned and leadership-driven efforts.

Establish a clear quality vision and policy,
and translate it into practice throughout the organization.
Ensure active leadership participation,
and implement standard expectations in daily work.

Expectations should not remain limited to documentation.
Make continual improvement a part of life by adopting the PDCA cycle.
Make employees aware and empowered,
and encourage innovation through an employee suggestion scheme.

Conduct training and awareness programs periodically.
Focus on root cause analysis instead of blame.
Make quality goals measurable and ensure transparent reviews.
Let the flame of quality culture be lit through these continuous efforts.

Regards,
Keshav Ram Singhal

ISO 9001 - Certification Not the Goal, but a Culture

ISO 9001 - Certification Not the Goal, but a Culture

**************

Symbolic image courtesy NightCafe

Ashok Pradhan (fictitious name), Managing Director of ABC Company (fictitious name), had been feeling quite uneasy for the past few days. Finally, he called a meeting of the company's top officials, plant managers, and unit in-charges, where he began his speech bluntly, stating, "We failed in implementing ISO 9001 — not because the standard was flawed, nor because we failed to read it, but because we implemented it mechanically, as a formality.” The Managing Director's statement was shocking to all participants. A hush fell over the meeting, and everyone began to reflect. Ashok Pradhan had laid bare the harsh reality of the organization before his team without any hesitation. He continued, "We hired a reputable consultant. The procedures were carefully written. The documents were attractive, the language was impressive, and the structure was organized. Our management system looked excellent on paper, and based on that, we achieved ISO 9001 certification. We were delighted that we were an ISO 9001 certified organization. But we forgot a fundamental question: were our organization's established procedures actually being followed? We didn't even try to find out what the real shortcomings were in our system. We prioritized preparing for the audit over self-assessment. Gradually, our energy shifted from "system improvement" to "passing the audit." 

When top leadership openly acknowledges failure, it is not weakness — it is the beginning of transformation. Ashok Pradhan was holding a mirror up to his organization, and everyone listened quietly. He continued, "As a result, our ISO 9001 management system became a "symbolic display" instead of a vibrant management tool—a decorative compliance for auditors, a showpiece for customers, a window dressing for the certification body. And somehow, through this window dressing, we got certification. But did the certification stabilize and streamline our organization's operations? Did operational problems stop? Were customers satisfied? The truth is that our organization's operations remain in a precarious state. Problems are recurring. Leadership in most units is still embroiled in daily crises. Customers experience inconsistency."

What Ashok Pradhan said to his colleagues revealed the pain of "showpiece compliance" versus "actual implementation" of ISO 9001, a reality facing many organizations today. Ashok Pradhan has correctly captured the core problem—the system at ABC Company was created, but not lived up to.

If we analyze the reality, we face some fundamental questions. First, is the organization's ISO 9001 management system protecting the organization's business? If the system isn't getting to the root of problems, identifying risks, if corrective actions aren't effective, and if leadership isn't making data-driven decisions, then it isn't protecting the business—it's merely fulfilling a formality. Second, has ISO 9001 become merely a certification tool? When audit preparation becomes the organization's priority, documentation becomes divorced from actual practice, and employees perceive processes as an "extra burden," then the system becomes a "certificate-obtaining tool," not a "management tool." We need to consider what the real expectations are. What, after all, is the purpose of ISO 9001? ISO 9001 is not a documentation system, but a management methodology. This is more a standard of 'how to live' than 'what to write'. 

How can we improve this situation? Some solutions are available. First, leadership must actively participate. ISO 9001 isn't just the responsibility of the quality department or a single individual. Everyone, including top leadership, must "live" the system. Second, the organization's processes must be followed and their performance must be measured. Written procedures are only meaningful if they are followed, performance is measured, and corrective action is taken upon deviations. Third, the organization must adopt a risk-based approach. Instead of waiting for problems to occur—work to identify and prevent risks early. Fourth, the organization must change the purpose of internal audits. It must understand that the objective of audits should not be "catch" problems but "find opportunities for improvement." Fifth, the PDCA cycle must be brought to life within the organization. Plan–Do–Check–Act should not be merely written on the wall, but should become part of daily operations. In conclusion, we can say that ISO 9001 is never a destination. It is not a destination to achieve certification, but a continuous journey towards operational excellence.

Certification is an outcome. An organization's strong management system is the cause. If the organization focuses on the cause, the result will follow. However, if the organization focuses only on the result (certificates), the system will become a mere window dressing. As a final thought, we can say that a quality system is vibrant when leadership is committed, employees are engaged, processes are implemented, and improvement is continuous. Otherwise, ISO 9001 becomes just a certificate hanging on the wall. Obtaining ISO 9001 certification should not be the organization's goal, but rather, improving organizational culture. Designing an ISO 9001 system is easy; embedding it into organizational culture is the real challenge. Quality comes from behavior, not from certification. 

ISO 9001 is not merely a standard of compliance — it is a standard of effectiveness. It is not enough to demonstrate that a process exists in documentation; it must function in practice and deliver measurable, meaningful results. Certification is evidence — but performance is proof. 

Regards,

Keshav Ram Singhal 

Standard Development Timeline for ISO 9001:2026

Standard Development Timeline for ISO 9001:2026

*********

The revision of ISO 9001 is progressing under the responsibility of ISO/TC 176/SC 2. The tentative development timeline is as follows:

Timeline

* Summer 2023 – Decision to revise the standard taken; ISO/TC 176/SC 2 confirmed the need for revision.

* Late 2023 – Early 2024 – Expert meetings held to gather global inputs and stakeholder feedback.

* Around April 2024 – Committee Draft 1 (CD1) issued for member body review.

* November–December 2024 – Committee Draft 2 (CD2) developed based on received comments.

* August/September 2025 – Draft International Standard (DIS) published for public comment and ballot.

* Around November 2025 – Comments received; voting period closed.

* Mid 2026 – Final Draft International Standard (FDIS) expected.

* September 2026 – Target publication of the revised QMS standard.

Post-Publication Transition

Following publication, certified organizations are expected to have a standard three-year transition period (approximately until September 2029).

* During this transition window, certifications to ISO 9001:2015 will remain valid.

* After the transition deadline, all audits and certifications must align with the 2026 version of the standard.

Important Note

ISO development timelines may shift slightly depending on ballot results, resolution of comments, or the need for additional revisions.

For the most authoritative and up-to-date information, it is advisable to consult the official committee site of ISO/TC 176/SC 2.

Regards,

KRS

History of ISO 9001 Standard

 

History of ISO 9001 Standard

The history of the ISO 9001 standard traces its origins back to the 1950s, when government departments in the United States and the United Kingdom began establishing quality standards for military procurement. These early quality assurance systems laid the foundation for modern quality management standards.

In 1979, the British Standards Institution (BSI) published BS 5750, the first formal quality system standard applicable to industry. BS 5750 became highly successful and served as the basis for the development of international quality management standards.

Building on this success, the International Organization for Standardization (ISO) published the first ISO 9001, along with ISO 9002 and ISO 9003, in 1987. These standards were revised in 1994 to enhance clarity and consistency.

A major revision occurred in 2000 with the publication of ISO 9001:2000 on 15 December 2000. This edition introduced the process approach and emphasized continual improvement and customer satisfaction, marking a significant shift from the earlier element-based structure.

The fourth edition, ISO 9001:2008, was published on 15 November 2008. This version provided clarifications and improved compatibility with ISO 14001 but did not introduce major new requirements.

The fifth edition, ISO 9001:2015, was published on 15 September 2015. It introduced the High-Level Structure (Annex SL), risk-based thinking, greater leadership involvement, and alignment with modern business practices.

At present, the standard is under revision, and the next edition, ISO 9001:2026, is expected to be published in September 2026.

Regards,
KRS

The Role of Top Management in Quality

 The Role of Top Management in Quality 

*********** 

Quality isn’t just a matter of documentation—it starts with leadership vision and commitment. Eleven Tasks Top Management should pay special attention to -

1. Establish a Clear Quality Policy and Objectives

The organization’s direction must be clear. The quality policy should be practical, measurable, and aligned with business goals.

2. Leadership by Example

A quality culture is developed through behavior, not merely by issuing instructions. As W. Edwards Deming stated, “A bad system will beat a good person every time.”

Top management must demonstrate genuine and practical commitment to quality. By setting the right example, they build a robust system that motivates every employee to implement it effectively.

For instance, in many organizations, top management is not included in internal audits. True leadership means instructing the internal audit team to audit top management as well and identify areas for improvement. When leaders themselves are open to evaluation and correction, it strengthens the entire quality management system.

3. Prioritize the Voice of the Customer

Customer satisfaction, complaint analysis, and feedback should be integrated into strategic decision-making.

4. Adopt Risk-Based Thinking

Identify potential risks and opportunities, and take timely preventive and corrective actions.

5. Develop Competent and Trained Human Resources

Empower employees through regular training, skill development, and awareness programs.

6. Standardization and Continuous Improvement of Processes

Promote a culture of continual improvement by ensuring effective implementation of the PDCA (Plan–Do–Check–Act) cycle.

ISO 9001:2015 standard, published by the International Organization for Standardization, also places strong emphasis on continual improvement.

7. Provide Adequate Resources

Ensure the availability of appropriate and adequate human resources, infrastructure, modern technology, and accurate measuring instruments. Leadership approval and active involvement are especially critical in this area.

8. Data-Driven Decision Making

Decisions should be based on facts, analysis, and reliable data—not merely on intuition or assumptions.

9. Develop an Effective Internal Communication System

Quality objectives, procedural changes, achievements, and challenges should be clearly communicated at all levels of the organization.

10. Conduct Regular Management Reviews

Hold structured management review meetings to comprehensively evaluate quality objectives, key performance indicators (KPIs), audit results, and corrective actions.

11. Promote a Quality Culture

Foster a culture of learning and improvement rather than blame. Encourage employees to contribute ideas, innovate, and take ownership of their responsibilities.

Summary

When top management is aware, committed, and proactive, the entire organization becomes quality-conscious. Quality is not the sole responsibility of any single department—it is the direct outcome of leadership commitment. 

Regards,

Keshav Ram Singhal 

Top Management Mindset and Approach Towards Quality

 Top Management Mindset and Approach Towards Quality

********

One day, I got an opportunity to visit two companies and meet their top management teams.

When I reached the first company, I was informed that the organization was ISO 9001:2015 certified. In the chamber of a senior executive, I also noticed the ISO certification certificate displayed on the wall. I visited their manufacturing units and observed that supervisors were closely monitoring the operators. Inspectors were checking the finished goods. Whenever any defect was found, the nonconforming product was immediately segregated. The operators were warned, and pressure was applied on them to work more carefully. The production targets were clearly displayed on the walls. Production was taking place, but I felt an atmosphere of silence, tension, and pressure on the shop floor.

After that, I visited the second company. The top management informed me that they had not yet obtained any certification for compliance with ISO standards. However, they were planning to implement ISO 9001:2015 and ISO 14001:2015, and for this purpose, they had already sent some employees for training. During my visit to their manufacturing units, I noticed that the processes were clearly defined. Work instructions were displayed on the walls. Problems were openly discussed, and operators were encouraged to provide suggestions on how the processes could be improved further. The focus was on ensuring that processes function properly, and if any issue occurred, it was identified and corrected. When I asked about nonconforming products, I was told that due to continual monitoring and improvement of processes, the number of nonconforming products was very low. And whenever any nonconforming product was produced, the operators and the team discussed the root cause and identified what process improvement was required. The environment in this company appeared calm, positive, and cooperative. I did not feel any stress or fear.

In my opinion, the first company appeared more stressful and defensive, whereas the second company seemed stable, improvement-oriented, and confident. I believe the real difference between the two companies lies in the mindset of their top management and their approach towards quality. While the first company appeared to treat certification as a target, the second company was building Continual Improvement as a strong Quality Culture.

Experience-based learning - Certification may be important, but building a quality culture and focusing on continual improvement is far more important.

Regards,

Keshav Ram Singhal