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- Keshav Ram Singhal
Blog on 'Quality Concepts and ISO 9001: 2008 Awareness' at http://iso9001-2008awareness.blogspot.in

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Friday, April 20, 2018

Seven Signs of a Strong Culture of Quality

Seven Signs of a Strong Culture of Quality

I read an article 'Seven Signs of a Strong Culture of Quality' written by Rachel Beavins Tracy that looked to seven signs of a strong quality culture: (i) Quality starts at design, (ii) Monitoring and measurement are priorities, (iii) Risk is part of decision-making criteria, (iv) The goal is not compliance, (v) Accountability is built-in, (vi) Leadership is clearly supportive, and (vii) People take ownership of problems.

The article is published at EtQ blog. Please CLICK HERE to read the article.


Keshav Ram Singhal

Tuesday, April 17, 2018

Quality Concepts and ISO 9001:2008 QMS Awareness: Understanding the meaning – Continual improvement ...

Quality Concepts and ISO 9001:2008 QMS Awareness: Understanding the meaning – Continual improvement ...: I was addressing a group of participants in a training programme on ‘ISO 9001 QMS Awareness’, while discussing and telling requirements r...

Saturday, April 14, 2018

Difference between 7.1.6 and 7.2

Difference between 7.1.6 and 7.2

One of the readers asked difference between 7.1.6 and 7.2.

Clause 7.1.6 of ISO 9001:2015 QMS standard deals with the requirements related to the knowledge specific to the organization, which is a support resource for an organization. Clause 7.2 of ISO 9001:2015 QMS standard deals with the requirements related to the comptence of persons. Competence is the ability to apply knowledge and skills to achieve desired results. Competent person is also a resource for an organization.

Clause 7.1.6 requires determining organizational knowledge (necessary for the operation of its processes), maintaining it and making it available. When addressing changes, it requires considering current knowledge and determining the ways to acquire/access necessary knowledge/updates.

Clause 7.2 requires determining necessary competence of persons, ensuring competent persons doing the job, taking necessary actions to acquire necessary competence, evaluating the effectiveness of the actions taken and retaining documented information.

Clause 7.2 appears compliment to clause 7.1.6.

With best wishes,


Wednesday, March 14, 2018

New Blog on ISO 45001:2018 OH&SMS Awareness

Dear friends,

A new blog has been created to increase awareness on ISO 45001:2018, Occupational health and safety management system standard.

I seek your blessings.

Please CLICK HERE to visit the blog.


Keshav Ram Singhal

Friday, January 26, 2018

Resource Validation

Resource Validation

Resource = A stock or supply of money, materials, staff, and other assets that can be drawn on by a person or organization in order to function effectively.

Resources in ISO 9001:2015 QMS standard refers to people (human resources), infrastructure, environment, monitoring and measuring resources (such as monitoring and measuring equipment) and organizational knowledge, necessary for the effective implementation of organization's QMS, operation and control of organization's processes, so that product/service conformity is achieved.

Someone asked me about resource validation in ISO 9001:2015 QMS. I just thought what is the purpose of resources in the QMS. Resources are necessary for the effective implementation of organization's QMS, operation and control of organization's processes, so that product/service conformity is achieved. The second thought that drive my attention is the term validation. Validation is a term that is used for confirmation, through the provision of objective evidence that the requirements for a specific intended use or application have been fulfilled (3.8.13 - ISO 9000:2015).

Validation = the action of checking or proving the validity, fitness or accuracy of something
Validation = the action of making or declaring something legally or officially acceptable
Validation = Recognition or affirmation that a person or their opinions are worthwhile

Although the term 'resource validation' does not appear in clause 7 of the ISO 9001:2015 QMS standard, however we need to carry out resource validation by ensuring specifically that (i) human resources are competent for which we need to fulfill the requirements mentioned in clause 7.2 of ISO 9001:2015 QMS standard, and (ii) monitoring and measuring resources are suitable for their purpose for which we need to carry out calibration/verification as per clause 7.1 of ISO 9001:2015 QMS standard.

- Keshav Ram Singhal

Tuesday, January 2, 2018

Workshop on ISO 9001:2015 QMS Transition Auditor's Training

*Workshop on ISO 9001:2015 QMS Transition Auditor's Training*

Two days workshop on 'ISO 9001:2015 Transition Auditors’ Certificate Course' is being organized on January 22 - 23, 2018 by National Centre for Quality Management (NCQM), Mumbai NCQM Learning Centre, G-501, Kailas Industrial Complex, Vikhroli-Hiranandani Link Road, Vikhroli (W), Mumbai 400 079. the course contents are as under:

1. Evolution of ISO and subtle differences in terminology used in ISO
2. Overview on ISO 9000: 2000 series of Standards
3. Overview on ISO 9000: 2008 series of Standards
4. Major changes in ISO 9001:2015 over ISO 9001:2008
5. Understanding requirements of ISO 9001:2015 Standard
6. Exercises
6.1. Exercise 1: QMS terms and definitions
6.2. Exercise 2 : ISO 9001 Quiz
6.3. Exercise 3 : fact or Inference
6.4. Exercise 4: Identifying Clause/sub clause of certain non conformities.
6.5. Exercise 5: Identifying NCs, writing nonconformity report (NCR) an audior closing an NCR as an Auditee
7. Written test
8. Workshop evaluation
9. Feedback and follow-up plan

Successful candidates will be awarded a certificate from NCQM. Others will get certificate of attendance.

*More information* about the registration, fees and other details may be obtined from: National Centre for Quality Management
G - 503, Kailas Industrial Complex,
Vikhroli - Hiranandani Link Road ,
Vikhroli (W), Mumbai 400 079.
Tel: (022) 4011 1962 / 2517 0483 / 69
Email: drr@ncqm.com; ncqmmumbai@yahoo.co.in
Website: www.ncqm.com

Courtesy Source: NCQM Email dated 01 January 2018

*Please share information among interested people.*


Keshav Ram Singhal
Email - keshavsinghalajmer@gmail.com

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Monday, December 11, 2017

Revised Edition of Training Handbook on 'ISO 9001:2015 QMS Awareness'

Revised Edition of Training Handbook on 'ISO 9001:2015 QMS Awareness' released.


# 01 - Learning objectives
# 02 - Historical background
# 03 - Standard development timeline for ISO 9001:2015
# 04 - Why new version?
# 05 - Key feature changes
# 06 - Structure and terminology
# 07 - Meaning of certain terms
# 08 - Foreword of the standard
# 09 - Introduction
# 10 - ISO 9001:2015 clauses in brief
# 11 - Context of the organization
# 12 - Leadership
# 13 - Management representative in ISO 9001:2015 QMS?
# 14 - Planning
# 15 - Support
# 16 - Operation
# 17 - Performance evaluation
# 18 - Improvement
# 19 - Tips for organizations using ISO 9001:2008
# 20 - Transition Planning
# 21 - Developing and implementing ISO 9001:2015 QMS
# 22 - Risk-based Thinking - An integral part of ISO 9001:2015 QMS
# 23 - Understanding the process approach and PDCA
# 24 - Quality management principles
# 25 - Change management in ISO 9001:2015
# 26 - Adding value to the audit
# 27 - Evaluation questionnaire
# 28 - Feedback
# 29 - Acknowledgement

If you are interested to see the preview, please send an email to keshavsinghalajmer@gmail.com.


Keshav Ram Singhal

Monday, December 4, 2017




# 01 - Introduction

# 02 - The 2008 global financial crisis and risk management

# 03 - Definition of risk

# 04 - Nature and impact of risk

# 05 - Why we need risk-based thinking?

# 06 - Risk-based thinking in ISO 9001:2015 QMS

# 07 - Benefits of applying risk-based thinking

# 08 - Summarized hint for applying risk-based thinking

# 09 - Risk awareness culture in your organization

# 10 - Risk management or formal risk-based approach

# 11 - Process diagram for Risk-based thinking (RBT)

# 12 - Understanding the organization and its context, Step-by-step process

# 13 - External and internal issues of an organization, Some external issues, Some internal issues

# 14 - Format - Context of the organization - Determining external and internal issues

# 15 - Understanding the needs and expectations of interested parties

# 16 - Format - Determining interested parties and their needs and expectations

# 17 - Interested parties and their needs and expectations - A few examples

# 18 - Planning and addressing risks and opportunities

# 19 - Overview of risk assessment tools and techniques

# 20 - Brainstorming

# 21 - Check-lists

# 22 - Failure Modes and Effect Analysis (FMEA)

# 23 - Delphi technique for risk determination

# 24 - A simple method to determine risks and opportunities

# 25 - Format for determining risks and opportunities

# 26 - Examples of some risks

# 27 - Opportunities and a few examples

# 28 - Risk register

# 29 - Risk matrix and risk matrix chart diagram

# 30 - Conclusion

# 31 - Bibliography (a list of a few books and web pages)

# 32 - Evaluation Questionnaire

# 33 - Your feedback

# 34 - Acknowledgement

By attending the training and/or reading this literature, a participant will be able to understand:
- Concept of risk-based thinking,
- ISO 9001:2015 QMS requirements related to risk-based thinking,
- Benefits of using risk-based thinking,
- An overview of various risk assessment tools - Techniques and methodologies that you may apply in your QMS,
- Using risk-based thinking to achieve better internal controls.
- Demonstrating risk-based thinking during audits (internal and external).

If you are interested to see the Preview of the Training Handbook, please send an email to:
keshavsinghalajmer@gmail.com or krsinghal@rediffmail.com.

Friday, December 1, 2017

Delphi technique for risk determination

Delphi technique for risk determination

The Delphi technique can be used to determine risks. Delphi technique is an information-gathering technique used as a way to reach a consensus of experts on a subject. Experts on the subject participate in this technique anonymously. The Delphi Technique is a method used to estimate the likelihood and outcome of future events. A group of experts exchange views, and each independently gives estimates and assumptions to a coordinator, who reviews the data and thereafter prepares a summary report. The group members discuss and review the summary report, and give updated forecasts to the coordinator, who again reviews the updated data and prepares a second report. This process continues until all participants reach a consensus. This technique can be applied at any stage of the risk determination process or at any phase of a system life cycle, wherever a consensus of views of experts is needed.

The experts at each round have a full record of what forecasts other experts have made, but they do not know who made which forecast. Anonymity allows the experts to express their opinions freely, encourages openness and avoids admitting errors by revising earlier forecasts.

The technique is an iterative process. It first aims to get a broad range of opinions from the group of experts. A group of experts are questioned using a semi-structured questionnaire. The experts do not meet so their opinions are independent. The results of the first round of questions, when summarised, provide the basis for the second round of questions. Results from the second round of questions feed into the third and so on to final round. The aim is to clarify and expand on issues, identify areas of agreement or disagreement and begin to find consensus. Following steps should be undertaken:

- Select a Coordinator.
- Select experts for the group as the technique relies on a panel of experts.
- Define the issue of risk determination to the group members.
- Round one questions - Ask general questions to gain a broad understanding of the experts view. The questions may go out in the form of a questionnaire or survey. Collate and summarise the responses, removing any irrelevant material and looking for common viewpoints.
- Round two questions - Based on the answers to the first questions, the next questions should delve deeper into the risk determination to clarify specific issues. These questions may also go out in the form of a questionnaire or survey. Again, collate and summarise the results, removing any irrelevant material and look for the common ground. We should remember that the exercise is done to build consensus.
- Round three questions - The final questionnaire aims to focus on supporting decision making. Again, collate and summarise the results, removing any irrelevant material and look for the commonly agreed points. You may have more than three rounds of questioning to reach a closer consensus.
- Act on coordinator's findings - After the round of questions, hope that the team experts will have reached a consensus and the coordinator will have a view of future risks and opportunities. Analyse the findings and put plans in place to deal with future risks and opportunities.

Predicting the future is not an exact science, but the Delphi Technique can help in understanding the likelihood of future events and what impact they may have on the process, product and service. Delphi technique is labour intensive and time consuming, so a slow process. Since the opinion in Delphi technique needs to be expressed in writing, the participants need to be able to express themselves clearly in writing.

Thursday, July 6, 2017

Understanding Statistical Tools and Techniques - 11 - PROCESS MAPPING


Process mapping is a workflow diagram that brings forth a clear understanding of a process or a number of processes. A process map is a planning and management tool that visually describes the flow of work. Process map shows a series of events that produce an end result. A process map is also known as a flowchart, process flowchart, process chart, functional flowchart, functional process chart, process model, workflow diagram, business flow diagram or process flow diagram.

The purpose of process mapping is to gain better understanding of a process and to improve efficiency. It provides insight into a process. It helps the involved people to know the process steps and brainstorm ideas for process improvement. It is a documented information that increase communication.

Process mapping involves following steps:

Step 1 - Select the process for which process mapping is to construct and determine boundaries of the process - where to start (beginning of the process) and where to end (process end).

Step 2 - List all steps involved in the process with sufficient information.

Step 3 - Sequence all steps from start to end.

Step 4 - Draw process map by using appropriate symbols.

Step 5 - Check the flowchart for completeness and include pertinent information.

Step 6 - Finalize the flowchart.

Common process mapping symbols are described in the below figure:

How you liked the write-up. Please post your comments. Thanks.

- Keshav Ram Singhal