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20150403 - TUV ME - ISO 9001 2015 and Risk Management - Linkdin

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  • ISO 9001:2015 – ELEMENTS ADDRESSING RISK MANAGEMEN
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20150403 - TUV ME - ISO 9001 2015 and Risk Management - Linkdin

  1. 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. 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. 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. 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. 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. 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. 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. 8. TYPES OF RISK TUV ME │ ISO 9001:2015 & Risk Management8 !!! focus should be on product for ISO 9001:2015 !!!
  9. 9. RISK MANAGEMENT FRAMEWORK TUV ME │ ISO 9001:2015 & Risk Management9 !!! organization can adapt the framework !!!
  10. 10. RISK EVALUATION MATRIX TUV ME │ ISO 9001:2015 & Risk Management10 !!! organization can adapt the risk evaluation matrix !!!
  11. 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. 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. 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
  14. 14. Thanks www.tuvme.com www.tuv-nord.com

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