Quality Concepts and ISO 9001 QMS Awareness
An Effort to create awareness. ..... Editor - Keshav Ram Singhal, Ajmer, India
Welcome
Tuesday, May 19, 2026
Status of the ISO/FDIS 9001:2026 QMS
Thursday, April 9, 2026
Four Common Terms Used in Management System Standards
Four Common Terms Used in Management System Standards
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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
Tuesday, March 10, 2026
Measurement Management System – An Introduction
Measurement Management System – An Introduction
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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
Sunday, March 8, 2026
Quality Culture
Quality Culture
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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
Saturday, February 28, 2026
ISO 9001 - Certification Not the Goal, but a Culture
Tuesday, February 24, 2026
Standard Development Timeline for ISO 9001:2026
Standard Development Timeline for ISO 9001:2026
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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
KRS
Sunday, February 22, 2026
The Role of Top Management in Quality
The Role of Top Management in Quality
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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
Thursday, February 19, 2026
Top Management Mindset and Approach Towards Quality
Top Management Mindset and Approach Towards Quality
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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
Friday, January 16, 2026
Appreciative Inquiry as a Supportive Tool in Quality Management — A Balanced Approach Integrating Risk-based Thinking
Appreciative Inquiry as a Supportive Tool in Quality Management
— A
Balanced Approach Integrating Risk-based Thinking
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Symbolic Image Courtesy NightCafe
In
recent days, while reading the Kindle book “Business for Good in Action –
Celebrating AIM2Flourish Stories Through Appreciative Inquiry” by Dr.
Divya Singhal and Crystal Ferro, a thought emerged in my mind: How can
Appreciative Inquiry be effectively applied in Quality Management?
Through
this exploration, I understood that Appreciative Inquiry (AI) is a positive
and participative approach widely used by organizations for organizational
development, change management, team building, and individual growth of people.
Instead of focusing on problems and deficiencies, it emphasizes successes,
strengths, and future possibilities.
The
concept of Appreciative Inquiry was developed in the 1980s by Dr. David L.
Cooperrider, associated with Case Western Reserve University (USA),
and originated from his PhD dissertation.
Core
Philosophy of Appreciative Inquiry
The
fundamental idea of Appreciative Inquiry is:“Rather than fixing what is
wrong, build on what works well.” In brief, Appreciative Inquiry is based
on five core principles:
1.
Positivity
Principle –
Positive questions generate positive energy and constructive solutions.
2.
Constructivist
Principle – Our
conversations and language shape our organizational reality.
3.
Simultaneity
Principle – The
moment we ask a question, change begins.
4.
Poetic
Principle –
Organizations are like open books; whichever chapters we focus on, grow
stronger.
5.
Anticipatory
Principle – A
positive image of the future guides present actions.
Benefits
of Appreciative Inquiry in Organizations
When
Appreciative Inquiry is practiced in organizations, it delivers several
benefits:
·
Increased
employee involvement and motivation
·
Encouragement
of innovation and creativity
·
Development
of a positive organizational culture
·
Reduced
resistance to change
·
Stronger
leadership and teamwork
Traditionally,
organizations ask questions such as:“What is wrong with our process?” In
contrast, Appreciative Inquiry asks:“When did our process work at its best,
and why?”
Thus,
Appreciative Inquiry represents a mindset that is strength-based rather than
deficiency-based, making it highly effective for quality, lean,
innovation, leadership, and continual improvement initiatives.
Appreciative
Inquiry and Quality Management: A Critical Reflection
Although
Appreciative Inquiry is a powerful approach for continual improvement, a
legitimate concern arises: Can it lead to ignoring deficiencies and
weaknesses, making it unsuitable for Quality Management? The reality is
that Appreciative Inquiry becomes effective in Quality Management only when
used correctly. Misuse of this approach—not the approach itself—creates
risk.
How
Appreciative Inquiry Supports Quality Management
1.
Building a Positive Quality Culture
Quality
does not emerge from processes alone; it emerges from people’s mindset.
Appreciative Inquiry shifts organizations from a blame-oriented culture to a learning
and improvement-oriented culture. This fosters fear-free reporting,
stronger suggestion systems, and greater employee participation.
2.
Identifying and Expanding Best Practices
Traditional
internal audits focus primarily on identifying nonconformities.
Appreciative Inquiry complements this by asking: Where did the process
deliver excellent results, and why? This
helps organizations identify repeatable best practices, strengthening standardization
and benchmarking in Quality Management.
3.
Energizing Continual Improvement
Continual
improvement is a core requirement of ISO 9001. Appreciative Inquiry
reframes improvement from a corrective burden into a growth
opportunity, encouraging employees to participate voluntarily and
enthusiastically in improvement initiatives.
4.
Enhancing Leadership and Team Engagement
Appreciative
Inquiry views employees not as problem sources but as solution
partners. This strengthens ownership, collaboration, and enables cross-functional
quality improvement across the organization.
5.
Supporting Change Management
In new
quality initiatives, Appreciative Inquiry helps reduce resistance by presenting
change as a continuation of past successes, rather than a response to
failure.
Addressing
the Risks of Appreciative Inquiry
A
common concern is that Appreciative Inquiry may overlook weaknesses. This risk
arises only when the approach is misunderstood. Potential risks of
improper use include:
·
Critical
nonconformities being overlooked
·
Weak
root cause analysis
·
Gaps
in regulatory and customer requirement compliance
Therefore,
using Appreciative Inquiry in isolation can be risky.
The
Solution: Appreciative Inquiry + Risk-based Thinking
The
answer lies in developing a Balanced Quality Improvement Model by
integrating Appreciative Inquiry with Risk-based Thinking, which is a
core requirement of ISO 9001:2015 QMS standard.
This
integration allows organizations to use positive framing along with gap
analysis.
For example, instead of asking only “What went wrong?”, we also ask: “When
did this process operate without defects, and why?” From these insights,
gaps and risks can be identified more constructively.
Integrating
Appreciative Inquiry with the PDCA Cycle
Appreciative
Inquiry can be effectively embedded into the PDCA (Plan–Do–Check–Act) cycle:
·
Plan – Identify strengths, successful
experiences, and opportunities
·
Do – Execute processes with
motivation and engagement
·
Check – Review data, conduct audits, and
identify nonconformities
·
Act – Apply AI-based improvement and
standardization
Importantly,
Appreciative Inquiry does not imply avoiding nonconformities. Instead, audit
findings are treated as learning opportunities, and blame-free root
cause analysis is encouraged.
The
Right Place of Appreciative Inquiry in Quality Management
Appreciative
Inquiry is highly effective in:
·
Culture
building
·
Employee
engagement
·
Best
practice sharing
·
Innovation
and continual improvement
However,
its role is limited in areas such as:
·
Regulatory
compliance
·
Safety-critical
processes
·
Legal
and statutory gap management
·
Handling
serious nonconformities
Conclusion
Appreciative
Inquiry is a powerful enabler in Quality Management, but it is not a
substitute for defect identification. The right approach is to identify
problems to correct them, and to identify strengths to make improvements
sustainable. When integrated with risk-based thinking and the PDCA cycle,
Appreciative Inquiry helps organizations evolve into true learning
organizations, capable of sustained excellence.
Best
wishes,
Keshav
Ram Singhal