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ISO 9001:2015 – How to apply Risk-based Thinking to Quality Processes [Part VII]

RISK MANAGEMENT METHODOLOGY FOR QUALITY MANAGEMENT Steps 1-3 in the method If you have been reading this blog recently, you will know we have been considering the problem of how organizations could apply Risk-based thinking (RBT) to Quality Processes. In the previous post (part VI), we started to introduce our own proposed Risk Management method […]


ISO 9001:2015 – How to apply Risk-based Thinking to Quality Processes [Part VI]

ISO 9001:2015 – How to apply Risk-based Thinking to Quality Processes [Part VI] Risk based thinking is the new ‘preventive actions’ for QMS If you have been reading this blog recently, you will know we have been considering the problem of how organizations could apply Risk-based thinking (RBT) to Quality Processes. To briefly recap the […]


Visualizing Business Processes – what can go wrong?

Most Quality Control and Quality Assurance methods are concerned with business process mapping as a way of understanding a business transaction lifecycle from the customer’s point of view. One widely held view is that business processes are far easier for employees to understand and follow when presented in a graphical representation. If an employee can visualise […]


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ISO 9001:2015 – How to apply Risk-based Thinking to Quality Processes [Part IV]

ISO 31000 Risk management techniques – continued Attributes of a selection of risk assessment tools If you haven’t read my previous posts on the subject of risk assessment tools, you may like to go back before reading about the various Scenario Analysis, Function Analysis, Controls Assessment and Statistical Methods. Part 1 in this series is […]


ISO 9001:2015 – How to apply Risk-based Thinking to Quality Processes [Part III]

ISO 31000 Risk management techniques Attributes of a selection of risk assessment tools If you haven’t yet read my previous posts discussing risk assessment tools, you may like to go back before starting this one about the Scenario Analysis, Function Analysis, Controls Assessment and Statistical Methods. Part 1 in this series is available here. Part […]


ISO 9001:2015 – How to apply Risk-based Thinking to Quality Processes [Part II]

ISO 31000 Risk management techniques: A selection of risk assessment tools you might like to consider Part 1 in this series is available here. Although risks and opportunities have to be determined and addressed, there is no requirement in ISO 9001:2015 for a formal risk management or a documented risk management process. Even so, the […]


ISO 9001:2015 – How to apply Risk-based Thinking to Quality Processes [Part I]

Why taking a risk-based approach is a requirement of ISO 9001 Risk-based thinking is a sore point among many Quality professionals. Even so, identifying risk, analysing the consequences, probability and level of risk (i.e. risk analysis) and risk evaluation using formal techniques are becoming increasingly important tasks in the global business world. ISO 9001:2015 incorporates […]