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    ISO-TC176-SC2 N1196 N1196 - WG23 N065 - ISO 9001 Risk Based

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    Armando Flores Moreno
    This document provides an overview of the key aspects of "risk-based thinking" addressed in ISO 9001:2015: 1) Risk-based thinking involves identifying risks and opportunities that can impact an organization's ability to consistently meet customer and quality objectives, and taking actions to address them. 2) The revised ISO 9001 standard makes risk management more explicit and integrated throughout the management system requirements. Clauses address identifying, analyzing, prioritizing, planning and implementing actions to treat risks. 3) Adopting risk-based thinking can improve customer satisfaction and confidence by taking a proactive, preventative approach to quality management. The presentation provides guidance on conducting risk identification and assessment and monitoring the effectiveness of

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    ISO-TC176-SC2 N1196 N1196 - WG23 N065 - ISO 9001 Risk Based

    Uploaded by

    Armando Flores Moreno
    56 views12 pages
    This document provides an overview of the key aspects of "risk-based thinking" addressed in ISO 9001:2015: 1) Risk-based thinking involves identifying risks and opportunities that can impact an organization's ability to consistently meet customer and quality objectives, and taking actions to address them. 2) The revised ISO 9001 standard makes risk management more explicit and integrated throughout the management system requirements. Clauses address identifying, analyzing, prioritizing, planning and implementing actions to treat risks. 3) Adopting risk-based thinking can improve customer satisfaction and confidence by taking a proactive, preventative approach to quality management. The presentation provides guidance on conducting risk identification and assessment and monitoring the effectiveness of

    Original Description:

    Presentación Análisis de riesgos

    Original Title

    ISO-TC176-SC2_N1196_N1196_-_WG23_N065_-_ISO_9001_Risk_Based_

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    This document provides an overview of the key aspects of "risk-based thinking" addressed in ISO 9001:2015: 1) Risk-based thinking involves identifying risks and opportunities that can impact an organization's ability to consistently meet customer and quality objectives, and taking actions to address them. 2) The revised ISO 9001 standard makes risk management more explicit and integrated throughout the management system requirements. Clauses address identifying, analyzing, prioritizing, planning and implementing actions to treat risks. 3) Adopting risk-based thinking can improve customer satisfaction and confidence by taking a proactive, preventative approach to quality management. The presentation provides guidance on conducting risk identification and assessment and monitoring the effectiveness of

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    Download as PPTX, PDF, TXT or read online from Scribd
    Download as pptx, pdf, or txt
    56 views12 pages

    ISO-TC176-SC2 N1196 N1196 - WG23 N065 - ISO 9001 Risk Based

    Uploaded by

    Armando Flores Moreno
    This document provides an overview of the key aspects of "risk-based thinking" addressed in ISO 9001:2015: 1) Risk-based thinking involves identifying risks and opportunities that can impact an organization's ability to consistently meet customer and quality objectives, and taking actions to address them. 2) The revised ISO 9001 standard makes risk management more explicit and integrated throughout the management system requirements. Clauses address identifying, analyzing, prioritizing, planning and implementing actions to treat risks. 3) Adopting risk-based thinking can improve customer satisfaction and confidence by taking a proactive, preventative approach to quality management. The presentation provides guidance on conducting risk identification and assessment and monitoring the effectiveness of

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    ISO 9001:2015

    Risk Based Thinking

    December 2013
    ISO/TC 176/SC 2/WG23 N065
    1

    Purpose of presentation

    ISO/TC 176/SC 2/WG23 N065

    Provide an overview of how the future ISO


    9001:2015 standard addresses the topic of
    risk.

    Revision presentation

    ISO/TC 176/SC 2/WG23 N065

    developed by the ISO subcommittee responsible


    for communication about the upcoming revisions
    to ISO 9001
    will be updated periodically as the revision
    progresses
    is available to anyone

    ISO/TC 176/SC 2/WG23 N065

    What is risk-based thinking?


    risk-based thinking is something we all do automatically
    and often sub-consciously
    The concept of risk has always been implicit in ISO 9001
    this revision makes it more explicit and builds it into the
    whole management system
    risk-based thinking is already part of the process
    approach
    risk-based thinking makes preventive action part of the
    routine
    risk is often thought of only in the negative sense. Riskbased thinking can also help to identify opportunities.
    This can be considered to be the positive side of risk

    Where is risk addressed in

    ISO/TC 176/SC 2/WG23 N065

    the current draft of


    ISO 9001:2015?

    The main objectives of ISO 9001


    to provide confidence in the organizations ability
    to consistently provide customers with
    conforming goods and services
    ISO/TC 176/SC 2/WG23 N065

    To enhance customer satisfaction


    The concept of risk in the context of ISO 9001
    relates to the uncertainty in achieving these objectives

    Risk in the clauses - Process


    Approach, Leadership, Planning

    ISO/TC 176/SC 2/WG23 N065

    in Clause 4 the organization is required to


    determine the risks which can affect its ability to
    meet these objectives
    in Clause 5 top management are required to
    commit to ensuring Clause 4 is followed
    in Clause 6 the organization is required to take
    action to address risks and opportunities

    Risk in Clauses Operation,


    Evaluation, Improvement

    ISO/TC 176/SC 2/WG23 N065

    Clause 8 - the organization is required to have


    processes which identify and address risk in its
    operations
    Clause 9 the organization is required to monitor,
    measure, analyse and evaluate the risks and
    opportunities
    In Clause 10 the organization is required to
    improve by responding to changes in risk

    Why should I adopt risk-based thinking?


    to improve customer confidence and satisfaction

    ISO/TC 176/SC 2/WG23 N065

    to assure consistency of quality of goods and


    services
    to establish a proactive culture of prevention and
    improvement
    Successful companies intuitively take a riskbased approach

    What should I do?


    Use a risk-driven approach in your
    organizational processes

    ISO/TC 176/SC 2/WG23 N065

    identify what the risks and opportunities are in your


    organization it depends on context
    ISO 9001:2015 will not automatically require you to carry out a full,
    formal risk assessment, or to maintain a risk register
    ISO 31000 (Risk management Principles and guidelines) will
    be a useful reference (but not mandated)

    10

    What should I do? (continued)


    analyse and prioritize the risks and opportunities in
    your organization
    what is acceptable?

    ISO/TC 176/SC 2/WG23 N065

    what is unacceptable?
    plan actions to address the risks
    how can I avoid or eliminate the risk?
    how can I mitigate the risk?
    implement the plan take action
    check the effectiveness of the actions does it work?
    learn from experience continual improvement
    11

    ISO/TC 176/SC 2/WG23 N065

    What is next?

    Additional updates and information will be made available as the revision process proceeds

    12

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