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

Revised Edition of Training Handbook on 'ISO 9001:2015 QMS Awareness' released at reduced Support Contribution.

CONTENTS

# 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.

Thanks,

Keshav Ram Singhal

TRAINING HANDBOOK ON 'ISO 9001:2015 QMS - APPLYING RISK-BASED THINKING (RBT)'

TRAINING HANDBOOK
ON
ISO 9001:2015 QMS - APPLYING RISK-BASED THINKING (RBT)


CONTENTS

# 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.

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.