Process Approach

Process Approach 

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Para 0.3.1 of ISO 9001:2026 QMS standard states that an organization should run its quality management system as a set of linked processes, not as isolated departments. The purpose is to meet customer requirements and to improve customer satisfaction. The necessary requirements for doing this are mentioned in clause 4.4 of the standard.

In plain language, we can say a process is not a department, it is a set of activities that turns inputs into outputs. The output of one process is often the input to the next. If an organization only manages “Purchasing” and “Production” as separate functions, problems hide at the handoff. The process approach manages those connections.

The standard adds four ideas -

1. Identify processes and manage their interactions so planned results match the quality policy and strategy.  

2. Run the whole system together using the PDCA cycle (Plan–Do–Check–Act).  

3. Use risk-based thinking to prevent unwanted results.  

4. Use opportunity-based thinking (stated more clearly in the 2026 edition) to pursue useful results.

Applied well, this gives consistent fulfilment of requirements, a view of each process in terms of value, risk and opportunity, effective process performance, and improvement based on data.

Figure 1 provided in ISO 9001:2026 standard is the picture mentioning sources of inputs, inputs, activities, outputs, receivers of outputs, and monitoring check points chosen for that process and its risks. (Readers are requested to refer to this figure in ISO 9001:2026 standard.) 

We provide you two linked examples.

Example 1 — Production / manufacturing

Production is not just a machine line. Its sources are purchasing, design and the customer order. Inputs are materials, drawings and energy. Activities are setup, manufacture and packing. Outputs are finished product and records, received by the warehouse or the customer.

The check points match this process’s risks:

1. Incoming / receiving inspection — Stop wrong material entering the line.  

2. In-process checks — Catch setup or parameter drift early.  

3. Final inspection / test — Stop nonconforming product reaching the customer.

That is process approach in practice: process + controls + risk. Purchasing’s output becomes production’s input — the two processes are one system.

Example 2 — Purchasing 

Purchasing is not just raising a purchase order. Its sources are a production requisition, design specifications and the approved-supplier list. Activities are selecting the provider, issuing the order and receiving the item. Outputs are purchased product and certificates, received by the warehouse and production.

The check points are different because the risks are different:

1. Evaluation / re-evaluation of the provider — Avoid an unsuitable supplier.  

2. Review of purchasing information / contract — Avoid a wrong specification on the order.  

3. Verification of what was received — Stop nonconforming product entering production.

A low-risk catalogue item from a proven supplier may need only a document and quantity check. A safety-critical custom part may need source inspection plus incoming dimensional and material checks. That is the rule: check points vary with the process steps and the related risks.

Ten questions to ask when designing and reviewing a process 

A process should not only be defined; it should also be periodically reviewed to determine whether it remains suitable, adequate and effective. The following questions can help an organization when designing a new process or reviewing an existing process: 

(1) What is the purpose of the process?

(2) What are the inputs and intended outputs of the process? 

(3) Who provides the inputs and who receives the outputs?

(4) What activities and sequence are required to achieve the intended outputs?

(5) What resources, knowledge and infrastructure are required?

(6) What are the risks and opportunities associated with the process?

(7) What controls are needed to address the identified risks and opportunities?

(8) How will the performance and effectiveness of the process be monitored and measured?

(9) How does the process interact with other processes within the QMS?

(10) What changes or improvements are needed to achieve better results?

These questions help ensure that a process is designed, controlled, monitored and continually improved to achieve its intended results and contribute to the effectiveness of the QMS. 

In short, process approach requires to manage work as a chain of processes; the above two diagrams show that chain — purchasing feeds production — and put controls where each process’s risk actually sits.

Regards,

Keshav Ram Singhal 

ISO 9001:2026 Launch — Key Highlights

ISO 9001:2026 Launch — Key Highlights

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Today, 16 September 2026, ISO 9001:2026 is officially published. It is the sixth edition of ISO 9001, and the ISO official website now lists it as Published, Edition 6, 2026. An online ISO Event was held today, featuring four speakers who shared their perspectives on ISO 9001:2026. A brief summary of the event is given below.

1. Katie Clift — Context and Communication

Katie Clift, Head of Public Relations at ISO, placed ISO 9001 in a broader context. Her role was not limited to explaining the Technical changes; she also highlighted why ISO 9001 remains relevant in today's changing Business environment.

The key themes in her discussion included -

* Changing Customer expectations

* Digital transformation and AI

* Supply-chain complexity

* Resilience

* Innovation

* Organizational performance

* And, most importantly — Trust 

2. Sam Somerville — The Thinking Behind the Revision

Sam Somerville, Chair of ISO/TC 176/SC 2 and a key person associated with the ISO 9001 Revision project as its Convenor, highlighted the Technical and Practical aspects of the Revision. The essence of her message was that the purpose of ISO 9001:2026 is not to completely change ISO 9001, but to make it clearer and more useful for current and future Organizational realities. Therefore, the fundamental QMS framework of ISO 9001:2015 does not disappear. Fundamentals such as Customer focus, Process approach, Leadership, Performance evaluation and Continual improvement remain important. At the same time, the 2026 edition places particular emphasis on:

* Improving the language and clarity of Requirements

* Greater emphasis on Leadership and Quality culture

* Addressing Risks and Opportunities more clearly

* Change management

* Organizational knowledge

* Greater clarity regarding Climate-change considerations

* Better alignment with other ISO Management-system standards

Thus, the Revision may be better understood not simply as a change in Clauses, but as an effort to make the QMS more relevant and effective.

3. Isabela Santos — Practical/Business Perspective

Isabela Santos discussed ISO 9001:2026 from a Practical and Business perspective, focusing on how the Revised standard can support People, Projects and Organizational performance. This aspect is particularly important because ISO 9001 should not be viewed merely as a “Compliance document”, but as a Management framework that connects: People → Processes → Performance → Improvement → Business outcomes. From this perspective, a QMS is not merely a means of obtaining or maintaining certification; it can become a Management framework that contributes to better organizational operations and results.

4. Sergio Mujica — The Broader ISO Message

Sergio Mujica, ISO Secretary-General, spoke about the global role of ISO 9001 and its importance for the future. According to him, more than one million organizations are connected with ISO 9001 today, and the standard is used in 189 countries. Therefore, the ISO 9001:2026 Revision should not be viewed merely as a Technical revision. Its broader purpose is to connect Quality with Organizational performance, Trust and Sustainable growth.

What Were the Reactions of People?

Before the launch, reactions from Quality professionals to ISO's LinkedIn announcement were diverse. Some welcomed it as a long-awaited Update and drew attention to issues such as Climate change, Supply-chain resilience and Digital transformation. Some reactions suggested that for Organizations having a mature ISO 9001:2015 QMS, the change may not be a major “Revolution.” Some people have described the Revision as “Evolution, not revolution.” On the other hand, some Professionals also raised the question of whether the Revised standard would actually be sufficiently simple and user-friendly for End users. These reactions indicate that there is considerable interest in ISO 9001:2026, along with natural questions about its Practical implementation.

My Reaction

In my view, the best way to understand ISO 9001:2026 is to understand “New emphasis” rather than simply “New standard.” The significance of ISO 9001:2026 is not merely in knowing which Clause has changed. More importantly, it is about understanding how a QMS can actually help an Organization make better decisions, understand Risks and Opportunities, manage Changes, develop a Quality culture and achieve better Performance. This is where the approach that I have followed for many years through "ISO 9001 Awareness" appears particularly Relevant.

I see three important Themes -

1. From Compliance to Effectiveness - Merely maintaining a Certificate is not enough; the QMS should create Value in the Organization's actual work.

2. From Documentation to Organizational Thinking - ISO 9001:2026 should not be reduced to an Exercise of merely changing Documents. What is more important is that QMS thinking should become visible in the Organization's actual work and decision-making.

3. From Quality Department to Quality Culture - Quality is not the responsibility of the Quality Manager or Quality Department alone. Leadership, People, Processes and Decision-making should all reflect Quality thinking.

Climate Change — A Special Aspect

One particular aspect is that ISO 9001:2026 connects Climate change with the QMS in the context of Organizational context and Interested parties, rather than creating a separate “Environmental Management System” subject within ISO 9001. This continues the direction established by the ISO 9001:2015/Amd 1:2024 Amendment. Therefore, the important question for Organizations is not simply: “Have we mentioned Climate change in our QMS Document?” Rather, the question should be: “Does Climate change affect our Organization's Context, Interested parties, Risks, Opportunities or the Intended results of our QMS?” If it does, it should be appropriately addressed within the QMS.

An Important Milestone

The most significant achievement today is that ISO 9001:2026 is no longer an FDIS or Proposed revision — it is now an official International Standard. The ISO Official record gives its Publication date as 16 September 2026.

The next important stage for Organizations, Consultants, Auditors, Certification Bodies and Quality professionals is to understand ISO 9001:2026, analyse its changes, and determine how these changes can be effectively integrated into QMS implementation. The real value of ISO 9001:2026 lies not merely in understanding the Revised requirements, but in using them to achieve better Quality, better Performance and better Organizational outcomes. 

Regards,

Keshav Ram Singhal

Why Should You Read "Quality Concepts and Management Systems Awareness" Blog?

Why Should You Read "Quality Concepts and Management Systems Awareness" Blog?

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Today, Quality is much more than a characteristic of a product or service. It is closely connected with the way an organization works—its processes, people, leadership, decision-making, risks, customers, interested parties and its commitment to continual improvement. “Quality Concepts and Management Systems Awareness” blog is an attempt to help readers understand these subjects in a simple, practical and meaningful way.

Who is this blog for?

This blog is not meant only for Quality Professionals or people directly involved with ISO Standards. It can be useful for anyone who wants to understand Quality, Management Systems and related concepts. It may be particularly useful for:

* Quality Professionals

* Management System Professionals

* Internal Auditors

* Consultants

* Managers

* HR Professionals

* Trainers

* Students

* ISO Coordinators

* Management Representatives

* Anyone interested in developing awareness of ISO Standards and Management Systems.

Why should one read this blog?

1. To understand difficult concepts in simple language - Management System Standards often use technical language that may not be easy for everyone to understand. The blog attempts to explain important concepts in simple language, with examples and a practical perspective, so that readers can understand not only the terminology but also its meaning.

2. To understand not only “what”, but also “why” and “how” - Knowing a requirement is not enough. It is equally important to understand: What is the requirement? Why is it important? What is its purpose? How can it be applied in an organization? How can it be evaluated during an audit? The articles in the blog attempt to explore these questions.

3. To look at ISO Standards from a practical perspective - ISO Standards should not be viewed merely as a means of obtaining certification. A Management System can help an organization establish systematic processes, achieve intended results, address risks and opportunities, improve performance and promote continual improvement. The blog attempts to present this practical perspective.

4. To develop a better understanding of Internal Auditing - Internal auditing is not simply about finding nonconformities. An effective auditor needs to understand requirements, objective evidence, processes, performance and opportunities for improvement. The blog discusses auditing-related concepts with the intention of developing a more thoughtful and practical approach to auditing.

5. To stay aware of new Management System Standards and developments - The field of Management Systems continues to evolve. Along with ISO 9001, new and revised standards and developments are emerging in areas such as Human Resource Management, Environmental Management, Measurement Management and other disciplines. The blog aims to create awareness about such developments and their significance.

6. To understand Quality beyond Certification - Certification of conformity to applicable ISO Standards can be valuable, but the purpose of Quality Management is not merely to obtain a certificate. An effective Management System can contribute to better processes, better decision-making, improved risk management, customer satisfaction and continual improvement. This broader perspective is an important theme of the blog.

7. To access knowledge developed over the years - The blog contains a growing collection of articles on Quality Management and Management Systems. Earlier articles provide useful background and foundational concepts, while newer articles discuss current and emerging standards and developments. Together, these articles can serve as a long-term knowledge resource for readers interested in Quality and Management Systems.

What can you expect from this blog?

The purpose of this blog is not simply to help readers memorize clauses of a standard. The broader objective can be expressed as Understand → Apply → Audit → Improve (Understand the concept. Apply it in the context of the organization. Evaluate its effectiveness. And continuously look for opportunities to improve).

A humble invitation

If you are interested in Quality, ISO Standards, Management Systems, Auditing, Risk-based Thinking, Process Approach, PDCA and Continual Improvement, you may find this blog useful. You can start with any article that interests you and then explore related articles. Your feedback, suggestions and questions are valuable in making this knowledge resource more useful to readers. Read. Understand. Reflect. Share your experience. Thank you for visiting.

Regards,

Keshav Ram Singhal

Guidelines for the application of ISO 9001

Guidelines for the application of ISO 9001

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The document that provides guidelines for applying ISO 9001 is ISO/TS 9002:2016 (Quality management systems — Guidelines for the application of ISO 9001). It is under revision as ISO/DIS 9002 and will be published as a full International Standard, ISO 9002, replacing the 2016 Technical Specification. It does not add to, subtract from, or change the requirements of ISO 9001; it only offers guidance and examples.

ISO 9001:2026 is scheduled for publication on 16 September 2026. The revised ISO 9002 is expected in the first quarter of 2027 so that it can align with the new ISO 9001 text. The DIS enquiry for ISO 9002 closed on 8 September 2026; the project is now in comment resolution.

Best wishes,

Keshav Ram Singhal

Accreditation

Accreditation

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Disclaimer - Logos in the Image are used for identification and educational awareness purposes only. No affiliation, sponsorship or endorsement is implied.

Accreditation is the formal recognition by an independent, third party that confirms that a Conformity Assessment Body (CAB) is competent, impartial, and reliable to perform its assigned conformity assessment activities in accordance with relevant standards and requirements. Accreditation is a foundation of trust. It gives confidence that the organization or people performing conformity assessment are competent, impartial, and reliable. A CAB is not necessarily a certification body. CAB is a broader term that includes Testing and Calibration Laboratories, Medical Laboratories, Certification Bodies, Inspection Bodies, Validation and Verification Bodies, and other conformity assessment bodies.

Simply put, certification is an assessment of an organization's management system, product, process, service, or other specified requirements, whereas accreditation is an assessment of the competence and impartiality of the conformity assessment body performing that assessment. Therefore, accreditation may be simply understood as the “assessment of those who perform conformity assessment” or, in simple terms, the “check on the checkers.”

To whom is accreditation granted?

Accreditation is generally granted to Conformity Assessment Bodies (CABs). These may include Testing and Calibration Laboratories, Medical Laboratories, Certification Bodies, Inspection Bodies, Validation and Verification Bodies, and other specified conformity assessment bodies.

In India, NABL (National Accreditation Board for Testing and Calibration Laboratories) provides accreditation to Testing Laboratories, Calibration Laboratories, Medical Laboratories, Proficiency Testing Providers, Reference Material Producers, and Biobanks. NABL's accreditation system is established in accordance with the requirements of ISO/IEC 17011.

Similarly, NABCB (National Accreditation Board for Certification Bodies) provides accreditation to Certification Bodies, Inspection Bodies, Validation and Verification Bodies, and other specified conformity assessment activities. For example, NABCB accredits Inspection Bodies according to ISO/IEC 17020 and Management System Certification Bodies according to ISO/IEC 17021-1.

An important point to understand here is that ISO/IEC 17011 specifies requirements for an Accreditation Body, whereas the CAB being accredited applies the relevant standard according to the nature of its conformity assessment activity.

For example:

* Testing and Calibration Laboratories → ISO/IEC 17025

* Medical Laboratories → ISO 15189

* Management System Certification Bodies → ISO/IEC 17021-1

* Inspection Bodies → ISO/IEC 17020

* Product, Process and Service Certification Bodies → ISO/IEC 17065

* Validation and Verification Bodies → ISO/IEC 17029

Difference between Certification and Accreditation

Suppose an organization implements a Quality Management System (QMS) according to ISO 9001. The organization undergoes an audit by a Certification Body and, after successfully meeting the applicable certification requirements, receives an ISO 9001 certificate. This is Certification. Now suppose the Certification Body itself is accredited by an Accreditation Body, such as NABCB, for the relevant certification activity. The Accreditation Body assesses whether the Certification Body has the required competence, impartiality, and processes to perform certification activities within its defined scope. This is Accreditation. Therefore, certification and accreditation are two different but interconnected levels of conformity assessment.

A simple way to remember the difference is: 

Certification → assesses conformity of the organization / product / process / service.

Accreditation → assesses the competence and impartiality of the conformity assessment body.

International Recognition of Certification

Accreditation plays an important role in the international acceptance of conformity assessment results and certificates. The general framework can be understood by an example: An organization takes certification from an accredited certification body, who has taken accreditation from National Accreditation Body (say NABCB in India), which is a signatory to Global ACI MRA. This provides the International recognition of accredited conformity assessment results.  

Effective 1 January 2026, Global Accreditation Cooperation Incorporated (Global ACI) commenced full operations and launched its Multilateral Recognition Arrangement (MRA), bringing together the work previously carried out through the International Accreditation Forum (IAF) and the International Laboratory Accreditation Cooperation (ILAC). The objective is to provide a unified international accreditation framework that supports confidence and acceptance of accredited conformity assessment results and certificates across borders. It should, however, be remembered that international recognition depends on the applicable MRA, accreditation scope, scheme, and relevant regulatory or purchaser requirements. Accreditation by itself does not mean that every certificate is automatically accepted for every purpose in every country.

Why is Accreditation Important? Accreditation provides several important benefits:

* Regulators, customers, and buyers gain confidence in the CAB's technical competence and impartiality.

* The credibility of test reports, inspection reports, and certificates is enhanced.

* The risk of inaccurate, weak, or inadequate conformity assessment is reduced.

* It helps reduce technical barriers to international trade.

* It promotes the acceptance of accredited testing, inspection, and certification results across countries.

* It provides governments and regulatory bodies with a reliable conformity assessment infrastructure.

Thus, accreditation supports confidence, consistency, competence, impartiality, and international acceptance. Accreditation is not a permanent or unconditional recognition. The Accreditation Body conducts periodic surveillance, reassessment, and other scheduled evaluations to ensure that an accredited CAB continues to meet the applicable requirements.

Accreditation is also always granted for a defined Scope of Accreditation. An organization receives accreditation only for those standards, activities, sectors, tests, inspections, certification schemes, or other conformity assessment activities that have been assessed and included within its stated scope. Therefore, it is important not only to ask: “Is the organization accredited?” but also: “Is it accredited for the relevant activity and within the required scope?”

In short, Certification indicates that conformity to specified requirements has been assessed. Accreditation provides confidence that the body performing that conformity assessment is competent, impartial, and reliable according to applicable requirements. Therefore, accreditation is a crucial layer of the quality infrastructure. It strengthens confidence in test reports, inspection reports, validation and verification results, and certificates and supports their acceptance across national borders.

In the context of the international acceptance of a management system certificate, it is important to consider:

* Whether the Certification Body issuing the certificate is accredited;

* Whether its accreditation scope covers the relevant certification activity;

* Whether the applicable certification scheme and requirements are covered; and

* Whether the relevant Accreditation Body participates in the applicable Global ACI MRA arrangement.

In simple words: Certification checks conformity. Accreditation checks the competence and impartiality of those who perform conformity assessment. That is why accreditation can aptly be described as the “check on the checkers.”

Regards,

Keshav Ram Singhal 

Short Note - Nonconformity in Internal Audits

 Short Note - Nonconformity in Internal Audits

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Typically, in an internal audit, the auditor looks for nonconformities to report on, to prove that s/he has done the job well. But in doing so, s/he forgets about evidence. Nonconformity should be based on objective evidence. Every nonconformity identified by an internal auditor should be based on objective evidence. This is a particularly important auditing principle.

Empirically, an auditor should be able to determine "Requirement → Evidence → Finding → Nonconformity" rather than "Opinion → Suspicion → Nonconformity."

The auditor should objectively evaluate the audit evidence against the applicable audit criteria. Auditing itself is a systematic, independent, and documented process for obtaining and objectively evaluating audit evidence. A good audit is based on objective evidence, not opinion.

Regards,

Keshav Ram Singhal

Publication date announced for the revised ISO 9001:2026 QMS standard

 Publication date announced for the revised ISO 9001:2026 QMS standard is 16 September 2026.

Best wishes,

Keshav Ram Singhal 

Short Note - Nonconformities in Internal Audits

Short Note

Nonconformities in Internal Audits

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The primary purpose of an internal audit is to determine whether the management system (MS) conforms to the planned arrangements; whether the MS conforms to the requirements of applicable standards (such as ISO 9001, ISO 14001, etc.); whether it conforms to the organization's own established management system requirements; and whether it is effectively implemented and maintained.

Therefore, identifying nonconformities is a crucial part of assessing the actual health and effectiveness of the management system implemented in the organization.

Audit results should help management take appropriate and effective actions for improvement. Therefore, a nonconformity should not simply remain an entry in the audit report. It should become the basis for correction, corrective action and, ultimately, improvement of the management system.

Regards,

Keshav Ram Singhal 

Short Note - Nonconformity

Short Note

Nonconformity

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Let us understand what Nonconformity means.

Many ISO management system standards define nonconformity as the non-fulfilment of a requirement.

A requirement may originate from different sources. It may be:

- a requirement of the applicable management-system standard;

- a statutory or regulatory requirement;

- a customer requirement;

- a contractual requirement;

- an organizational policy;

- a documented procedure or process requirement;

- an internally established objective or commitment;

- a requirement established by the organization; or

- another requirement applicable to the management system.

Therefore, a nonconformity exists when there is a gap between what is required and what is actually happening, and the gap is supported by objective evidence.

In simple terms, we can state:

Requirement + Objective Evidence of Non-fulfilment = Nonconformity

For example, if an organization's procedure requires measuring equipment to be calibrated at defined intervals, and objective evidence shows that the required calibration was not carried out, there is a nonconformity. Here, the issue is not whether the auditor personally considers calibration desirable. The issue is that an applicable requirement exists and objective evidence demonstrates that the requirement has not been fulfilled.

Regards,

Keshav Ram Singhal 

Short Note - Auditing

Short Note

Auditing

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Auditing is an important mechanism for evaluating the conformity, implementation and effectiveness of a management system. The system may relate to any discipline, such as quality, environment, occupational health and safety, information security, human resources, energy, or another organizational discipline. The auditor compares objective evidence with defined audit criteria. The result of this evaluation may indicate conformity, nonconformity, risks, opportunities for improvement, or other findings.

Among these, nonconformity has a special significance.

A nonconformity is not simply something that an auditor does not like or something that could have been done better. It is a finding supported by objective evidence showing that a specified requirement has not been fulfilled.

The value of identifying a nonconformity, however, goes much beyond recording a failure. A well-understood and properly analysed nonconformity can become an important input for correction, corrective action, risk reduction, prevention of recurrence and continual improvement.

Regards,

Keshav Ram Singhal