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Organizational knowledge in ISO 9001:2015

One of the areas included in the Final Draft of the ISO 9001 revision (ISO/FDIS 9001:2015) is 7.1.6 Organizational knowledge. The stated requirement is: “The organization shall determine the knowledge necessary for the operation of its processes and to achieve conformity of products and services.” In fact, a recent article by Arun Hariharan makes the […]


White Paper – How to apply Risk-based Thinking to ISO 9001:2015

For the past several months we’ve published a series of blog posts on the application of Risk-based Thinking for ISO 9001:2015. It’s been a very popular series and there was demand for the series to be collated into a single document for easy reference. We’ve done just that and the white paper that resulted is […]


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

This is the final part in our series on how you might apply Risk Assessment techniques to meet the possible Risk Based Thinking (RBT) requirements of the forthcoming ISO9001:2015 standard. Events are moving along for the new version: the last formal draft of ISO/FDIS 9001 has just been issued, and final publication is scheduled on […]


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

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 Parts X through XV, we considered examples of the type of documents needed to support our Six Step process for applying RBT; including suggested document templates […]


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

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 IX), we summarised the Six Step Risk Management Method. In this and the following two posts we shall show examples of the […]


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

How to apply Risk-based Thinking to Quality Processes – a Summary Over the past weeks we’ve been looking at the topic of risk-based thinking (RBT) in the context of ISO 9001:2015. This is something of a sore point among Quality professionals. Some believe that RBT is an ill-considered introduction in the latest revision of the […]


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 […]