This document discusses risk-based thinking and risk management as addressed in ISO 9001:2015. It covers key elements of ISO 9001:2015 that incorporate risk management principles. The reasons for adopting risk-based thinking are to improve customer satisfaction, ensure quality consistency, and establish a preventative culture. Risk is defined as the effect of uncertainty on expected results. The document recommends adapting a risk management framework, evaluation matrix, and register to the organization's needs. It also outlines internal and external risk reporting and monitoring risks over time.
What is requirement of Risk based Thinking in ISO 9001:2015 & ISO 14001:2015 ?
What is Risk? How to identify? How to assess and control?
How to incorporate Risk based thinking in to QMS & EMS?
Hello guys i prepared QMS kick off meet PPT. Here I have shown how to start a project in any organization. What contents we need to discuss with top management at the time of start of QMS implementation. Kindly comment and share your views.
Kindly write your comment it will greatly help me to create new PPT and it will definitely motivate me.
An overview of ISO 55000 designed to help you manage risk and realize the value of your organization's assets. Presented by Randy Heisler at the 2014 AREGC Conference in Louisville, KY.
What is requirement of Risk based Thinking in ISO 9001:2015 & ISO 14001:2015 ?
What is Risk? How to identify? How to assess and control?
How to incorporate Risk based thinking in to QMS & EMS?
Hello guys i prepared QMS kick off meet PPT. Here I have shown how to start a project in any organization. What contents we need to discuss with top management at the time of start of QMS implementation. Kindly comment and share your views.
Kindly write your comment it will greatly help me to create new PPT and it will definitely motivate me.
An overview of ISO 55000 designed to help you manage risk and realize the value of your organization's assets. Presented by Randy Heisler at the 2014 AREGC Conference in Louisville, KY.
A brief Introduction to ISO 9001 2015-Quality Management SystemSARWAR SALAM
Introduction to Quality Management System ISO 9001-2015 as outlined in EDC Romfor's IMS. Preparation, role and resposibility allocation for Audit purposes.
Management review is the routine evaluation of whether management systems are performing as intended and producing the desired results as efficiently as possible. It is the ongoing “due diligence” review by management that fills the gap between day-to-day work activities and periodic formal audits.
Global Manager Group provides presentation on IMS auditor training that helps organization to learn how effective auditing of integrated management system as per ISO 9001, ISO 14001 and ISO 45001 requirements which gives you maximum benefits and increase health safety efficiency in the organization with IMS Certification.
For more information visit https://www.globalmanagergroup.com/
ISO 45001 will be the new standard concerning Occupational Health and Safety. As its publication date is approaching, the main aim of this webinar will be to provide insights on some of the key implementation steps. Additionally, the webinar explores some possible ways of transitioning from OHSAS 18001 to ISO 45001.
Main points covered:
• Understanding the organizations objectives
• Identification of requirements for ISO 45001 implementation
• The role of top management in ISO 45001implementation
• The establishment of a positive and an effective safety culture within your organization
• Actions to be undertaken in case of hazard identification
Presenter:
Eldeen Pozniak is the Director of Pozniak Safety Associates Inc. and an International Management Consultant specializing in Occupational Health and Safety. She has provided a variety of ground to executive – level multi-project management and oversight and direction of the safety management systems, program elements and organizational culture from strategic and action plans to on-site implementation. Moreover, she has a unique blend of high level strategic, business, and safety management system understanding, and specific technical safety knowledge.
Link of the recorded session published on YouTube: https://youtu.be/xF5ejJFdUdw
139 pages MS word document gives detailed description of the IMS processes and their interaction and might be selected by the Organization as the Only IMS document.
Compliant with the new versions of ISO 9001:2015 and ISO 14001:2015
SO 9001:2015 requires to address the risks and opportunities in each process of the QMS.
The principal questions of risk management are:
- Key Risks Wording and
- Risk Treatment Areas
Examples for 'Management Review', 'Technical
Maintenance', and 'Control of Personnel' processes.
Use in ISO 9001:2015 Internal auditors and personnel training.
This presentation gives a bried overview of the various parts & purpose of the ISO 9001:2015 QMS.
It revolves around the PDCA Cycle and useful in Manufacture & construction Industry.
- FSMS Management system audit and certification
- Understanding of how the FSMS management system operates
- FSMS Personnel training
- and more in our new FSMS Manual Template fully aligned with the new ISO/DIS 22000:2018.
How to successfully implement ISO 9001:2015 with a minimal documents approachPECB
The webinar covers:
• Replacing the Quality Manual
• Replacing All Other Procedures
• Checking Yourself to Ensure You've Met All Requirements
Presenter:
This webinar was presented by Debra Hay Hampton, PECB Certified Trainer and Lead Auditor of Quality and Environmental Management Systems.
Link of the recorded session published on YouTube: https://youtu.be/PnCjPlGGb68
In Best Practices in Strategic Planning for A/E Firms, we begin by providing you with the results of a survey that PSMJ did with 75 firms on how they conduct strategic planning.
Next, we provide you with some information on what we have gleaned from the survey. We have mined the data to figure out what works and what doesn’t work in strategic planning.
Then, to help you conduct better strategic planning at your firm, we talk specifically about some things that we have learned over the many years we have been engaged in strategic planning with architecture and engineering firms.
We wrap up with some recommendations on best practices in strategic planning. Our goal is to provide new insight into how your firm can maximize your strategic planning efforts for success in 2016.
A brief Introduction to ISO 9001 2015-Quality Management SystemSARWAR SALAM
Introduction to Quality Management System ISO 9001-2015 as outlined in EDC Romfor's IMS. Preparation, role and resposibility allocation for Audit purposes.
Management review is the routine evaluation of whether management systems are performing as intended and producing the desired results as efficiently as possible. It is the ongoing “due diligence” review by management that fills the gap between day-to-day work activities and periodic formal audits.
Global Manager Group provides presentation on IMS auditor training that helps organization to learn how effective auditing of integrated management system as per ISO 9001, ISO 14001 and ISO 45001 requirements which gives you maximum benefits and increase health safety efficiency in the organization with IMS Certification.
For more information visit https://www.globalmanagergroup.com/
ISO 45001 will be the new standard concerning Occupational Health and Safety. As its publication date is approaching, the main aim of this webinar will be to provide insights on some of the key implementation steps. Additionally, the webinar explores some possible ways of transitioning from OHSAS 18001 to ISO 45001.
Main points covered:
• Understanding the organizations objectives
• Identification of requirements for ISO 45001 implementation
• The role of top management in ISO 45001implementation
• The establishment of a positive and an effective safety culture within your organization
• Actions to be undertaken in case of hazard identification
Presenter:
Eldeen Pozniak is the Director of Pozniak Safety Associates Inc. and an International Management Consultant specializing in Occupational Health and Safety. She has provided a variety of ground to executive – level multi-project management and oversight and direction of the safety management systems, program elements and organizational culture from strategic and action plans to on-site implementation. Moreover, she has a unique blend of high level strategic, business, and safety management system understanding, and specific technical safety knowledge.
Link of the recorded session published on YouTube: https://youtu.be/xF5ejJFdUdw
139 pages MS word document gives detailed description of the IMS processes and their interaction and might be selected by the Organization as the Only IMS document.
Compliant with the new versions of ISO 9001:2015 and ISO 14001:2015
SO 9001:2015 requires to address the risks and opportunities in each process of the QMS.
The principal questions of risk management are:
- Key Risks Wording and
- Risk Treatment Areas
Examples for 'Management Review', 'Technical
Maintenance', and 'Control of Personnel' processes.
Use in ISO 9001:2015 Internal auditors and personnel training.
This presentation gives a bried overview of the various parts & purpose of the ISO 9001:2015 QMS.
It revolves around the PDCA Cycle and useful in Manufacture & construction Industry.
- FSMS Management system audit and certification
- Understanding of how the FSMS management system operates
- FSMS Personnel training
- and more in our new FSMS Manual Template fully aligned with the new ISO/DIS 22000:2018.
How to successfully implement ISO 9001:2015 with a minimal documents approachPECB
The webinar covers:
• Replacing the Quality Manual
• Replacing All Other Procedures
• Checking Yourself to Ensure You've Met All Requirements
Presenter:
This webinar was presented by Debra Hay Hampton, PECB Certified Trainer and Lead Auditor of Quality and Environmental Management Systems.
Link of the recorded session published on YouTube: https://youtu.be/PnCjPlGGb68
In Best Practices in Strategic Planning for A/E Firms, we begin by providing you with the results of a survey that PSMJ did with 75 firms on how they conduct strategic planning.
Next, we provide you with some information on what we have gleaned from the survey. We have mined the data to figure out what works and what doesn’t work in strategic planning.
Then, to help you conduct better strategic planning at your firm, we talk specifically about some things that we have learned over the many years we have been engaged in strategic planning with architecture and engineering firms.
We wrap up with some recommendations on best practices in strategic planning. Our goal is to provide new insight into how your firm can maximize your strategic planning efforts for success in 2016.
The new ISO 9001:2015 committee draft is published and distributed. There are changes which affect organizations who applied this standard. As it is among most famous ISO standards, follow up the changes would be critical and it is time to consider changes which might affect organizations' management systems.
Developing Metrics and KPI (Key Performance IndicatorsVictor Holman
Get a FREE performance management kit and access to all of Victor's full videos at:
www.lifecycle-performance-pros.com
This presentation covers the basics of developing successful performance metrics, from developing winning KPIs, learning how to develop the right metrics, the rules of developing KPIs and metrics and common performance metrics for managing a successful organization.
Key Performance Indicators (KPIs) should be used to understand performance and drive better decision-making. However, most companies struggle to find the vital few KPIs. Here is a list of the 25 top KPIs is use today.
A key change in the 2015 revision is to establish a systematic approach to risk, rather than treating it as a single component of a quality management system.
PECB Webinar: Corrective Action or Preventative Action - The new risk based m...PECB
The webinar covers:
• How the concepts of corrective and preventive action change in the new version of the standard
• Understanding risk-based thinking approach
• Understanding the new risk based methodology for ISO 9001:2015
Presenter:
This webinar was presented by Jason Teliszczak, PECB Certified Trainer and CEO/Founder of JT Environmental Consulting, Inc.
Link of the recorded session published on YouTube: https://www.youtube.com/watch?v=NSNIgSYNgSI
Risk Management for Medical Devices - ISO 14971 Overview Greenlight Guru
Risk Management for Medical Devices. An overview of ISO 14971 & how to apply a "Risk-based Approach" to your QMS processes to address the upcoming changes to ISO 13485.
Building Practical Risk Application into your QMSPECB
During the last few years, risk management continues to be a topic of interest for so many companies. There are plenty of benchmarking trends that point to risk. Risk it should be seen in enterprise strategic initiatives. So far, for many of us, the concept of risk remains an enigmatic and elusive concept.
Main points covered:
· Where and how to build Risk
· What are the best methodologies to solve the Risk
· What is the importance of Risk Management into your QMS
Presenter:
This webinar was presented by Walt Murray President and CEO of ARC Experts is representing Quality and Compliance Consulting (QCC) services team for Master Control, Inc. Walt is a globally recognized compliance and risk consultant, is a quality management and regulatory affairs professional with more than 32 years of experience working with internationally recognized, highly regulated companies, including Aventis, Merck etc. Walt has performed more than 400 1st, 2nd and 3rd-party audits.
Slides of the webinar: https://youtu.be/eR49OL7Ofxg
The webinar covers:
• Important changes in QMS
• Context of the organization
• Planning - Risk Assessment & Identification of Objectives
Presenter:
This live session was presented by Tariq Khan, PECB Partner and Trainer, who is also the country manager for IMS Reliance.
Link of the recorded session published on YouTube: https://youtu.be/MhDWbDPHMeA
PECB Webinar: ISO 31000 – Risk Management and how it can help an organizationPECB
We will cover:
• Brief overview of the Standard content
• What is Risk Management?
• Guidance on how to position Risk Management in an organization
• Three examples of where Risk Management must be considered
Presenter:
This webinar will be presented by Steve Tremblay, Owner and Executive ITSM/ISO Consultant at Excelsa Tech.
Investors in Risk Management provides expert-driven risk maturity assessment services to assess and improve the risk management maturity using our Risk Management Maturity Model (RMMM) to mitigate the impact of uncertainty on business objectives.
20150403 - TUV ME - ISO 9001 2015 and Risk Management - Linkdin
1. TUV Middle East
Member of TÜV NORD Group
ISO 9001:2015 & Risk Based Thinking
(based on ISO DIS 9001:2015)
By: Shibu Davies – GM
2. Content
ISO 9001:2015 – elements addressing risk management
Risk based thinking
Reason for risk based thinking (as per ISO)
Risk definition
Types of risk
Risk management frame work
Risk evaluation matrix
Risk register
Risk reporting / communication
Risk monitoring / review
TUV ME │ ISO 9001:2015 & Risk Management2
3. ISO 9001:2015 – ELEMENTS ADDRESSING RISK
MANAGEMENT
0.1 General – QMS is influenced by the context of the organization, (b) particularly with
respect to “the risks associated with its context and objectives”
0.3 Process approach – Management of the processes and the system as a whole can
be achieved using a PDCA methodology with an overall focus on “risk based thinking
aimed at preventing undesirable outcomes”
0.5 Risk based thinking – full clause is about risk, key statement – “this international
standard makes risk-based thinking more explicit and incorporates it in requirements for
the establishment, implementation, maintenance and continual improvement of the
QMS”
0.6 Compatibility with other management system standards:
- “Processes for planning and consideration of risks and opportunities (Clause 6)”
- However, this International Standard enables an organization to use the process
approach, coupled with the PDCA methodology and “risk-based thinking” to align or
integrate its QMS with the requirements of other management system standards as it
sees fit
TUV ME │ ISO 9001:2015 & Risk Management3
4. ISO 9001:2015 – ELEMENTS ADDRESSING RISK
MANAGEMENT
3.09 – risk (various terms and definitions related to risk)
4.4 – QMS and its processes – for planning the organization shall determine (f) the
“risks and opportunities” in accordance with the requirements of 6.1, and plan and
implement the appropriate actions to address them
5.1.2 Customer focus – Top management shall demonstrate leadership and
commitment with respect to customer focus by ensuring that (b) “the risks and
opportunities” that can affect conformity of products and services and the ability to
enhance customer satisfaction are determined and addressed
6.1 Action to address risks and opportunities – this full clause is about risk –
including PDCA elements of risk management
8.5.5 Post-delivery activities - In determining the extent of post-delivery activities that
are required, the organization shall consider (a) the “risks associated with the products
and services”
9.3 Management review – The management review shall be planned and carried out
taking into consideration (d) the effectiveness of actions taken to address risks and
opportunities (see clause 6.1)
TUV ME │ ISO 9001:2015 & Risk Management4
5. RISK BASED THINKING
TUV ME │ ISO 9001:2015 & Risk Management5
!!! risk management is an
integral part of any
organization's strategic
management. It is
the process whereby
organizations
methodically address the
risks attaching to
their activities with the goal
of achieving
sustained benefit within
each activity and
across the portfolio of all
activities !!!
identify and treat
risks
integrate risk
management in to
the culture
risk can be
internal or
external
objective of risk
management is
sustainability
risk management
should be an
ongoing process
responsibility shall
be assigned
better to define
and document
this is a
preventive
measure
this is everyone's
responsibility
6. REASON FOR RISK BASED THINKING
(AS PER ISO)
TUV ME │ ISO 9001:2015 & Risk Management6
• Improve customer satisfaction and
confidence
• Assure consistency of quality of the
product
• Establish pro-active culture of prevention
and improvement
• Successful companies intuitively take a
risk-based approach
Reason
7. RISK DEFINITION
TUV ME │ ISO 9001:2015 & Risk Management7
Risk
Effect of uncertainty on an expected result
Note 1: An effect is deviation from expected – positive or
negative
Note 2: Uncertainty is the state, even partial, of deficiency of
information related to, understanding or knowledge of, an
event, its consequence, or likelihood
Note 3: Risk is often expressed in terms of a combination of
the consequences of an event and the associated likelihood
occurrence
Ref.: ISO DIS 9000:2014
8. TYPES OF RISK
TUV ME │ ISO 9001:2015 & Risk Management8
!!!
focus should be on product
for ISO 9001:2015
!!!
10. RISK EVALUATION MATRIX
TUV ME │ ISO 9001:2015 & Risk Management10
!!!
organization
can adapt the
risk
evaluation
matrix
!!!
11. RISK REGISTER
TUV ME │ ISO 9001:2015 & Risk Management11
!!!
organization can
adapt the risk
register
!!!
Ref. # Process Risk Mitigation Contigency
Pro. Sev. Sig.
Rating
Responsibility
Pro. Sev. Sig.
Res. Risk Rating
Rating can be done
based on 3X3 matrix
or 5X5 matrix or any
suitable methods
a. Avoiding risk
b. Taking risk in order to pursue an
opportunity
c. Eliminating the risk source
d. Changing the likelihood or consequences
e. Sharing the risk
f. Retaining risk by informed decision
This will be the risk
rating after the
implementation of
mitigation &
contingency plan
Product related
12. RISK REPORTING / COMMUNICATION
TUV ME │ ISO 9001:2015 & Risk Management12
• Share holders
• Board of directors
• Top management
• Middle management
• Other staff
Internal
reporting /
communication
• Regulators
• Associations
• Other stake holders
External
reporting /
communication
!!!
organization can adapt according to the nature of business
!!!
13. RISK MONITORING / REVIEW
TUV ME │ ISO 9001:2015 & Risk Management13
• Did the intended result achieved
• Did the mitigation and contingency plan
appropriate
Monitoring
/ review