ISO 9001:2015 - Risk-based thinking

OBJETIVES 

At the end of this training, participants will be able to:

• Identify the concepts of risk and opportunity;
• Identify the concepts associated with risk-based thinking and its advantages;
• Relate risk-based thinking to strategy, organisational objectives and operations/processes;
• Identify, interpret and relate the references to risk-based thinking in the NP EN ISO 9001:2015 standard;
• Identify risk analysis tools;
• Integrate risk-based thinking in practice in the QMS;
• Promote risk-based thinking at all levels in the organisation, involving employees in a preventive and proactive approach.

PROGRAMME CONTENTS

Module 1 | Concepts

• Uncertainty/potential events and their effects.
• Probability X consequences/severity.
• Risk.
• Opportunity.

Module 2 | Risk-based thinking and its benefits

• Why is thinking risk-based?
• The QMS designed, implemented and maintained on the basis of a proactive attitude of prevention and improvement;
• The fundamental pillars and enablers of the QMS: risk-based thinking; organisational knowledge management and change management.
• Addressing risks/opportunities and meeting objectives is inherent to the QMS and is an integral part of planning;
• Utilise risk-based thinking to define the extent of process planning and controls to be applied;
• Risk-based thinking and PDCA.

Module 3 | Risk-based thinking and NP EN ISO 9001:2015

Module 4 | References to risk-based thinking in NP EN ISO 9001:2015

• Identification of clauses, interpretation and relationship between them

Module 5 | Risk-based thinking applied in practice

• Constraints: context, stakeholder needs and expectations, objectives;
• Strategic, business and operational risks;
• Inherent risk and residual risk;
• Definition of the approach to be used, more or less formal;
• Examples of risk analysis tools: FMEA, "What if?" checklists, SWOT analysis, among others;
• Example of a framework for risk management: identifying, analysing, assessing and treating risks; how can ISO 31000 help?
• Monitoring and evaluation of effectiveness.

Module 6 | Engaging employees

• Promote and foster risk-based thinking among Senior Management and employees;
• Promote and foster a proactive and preventive attitude in the Organisation;
• Encourage the recording of near misses and success stories;
• Recall the benefits of eliminating the causes of non-conformities and implementing effective corrective actions;
• Provide appropriate training on the topic at all levels in the organisation.

DURATION
16 Hours