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Quality Concepts and ISO 9001 QMS Awareness An Effort to create awareness. ..... Editor - Keshav Ram Singhal, Ajmer, India

  • Four Common Terms Used in Management System Standards
    by noreply@blogger.com (Keshav Ram Singhal) on April 9, 2026 at 5:57 am

    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. DetermineMeaning - 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. MaintainMeaning - 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.”ExampleSuppose 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.ConclusionThese 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
    by noreply@blogger.com (Keshav Ram Singhal) on March 10, 2026 at 9:15 am

    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
    by noreply@blogger.com (Keshav Ram Singhal) on March 8, 2026 at 12:22 pm

    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
    by noreply@blogger.com (Keshav Ram Singhal) on February 28, 2026 at 7:31 am

    ISO 9001 - Certification Not the Goal, but a Culture**************Symbolic image courtesy NightCafeAshok 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
    by noreply@blogger.com (Keshav Ram Singhal) on February 24, 2026 at 9:51 am

    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 TransitionFollowing 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 NoteISO 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