The Role of Risk Assessment in the QMS

  • ISO 9001 Certification in Bangalore says that whether anyone has wondered regarding what risk assessment has to do with the Quality Management System? You are not alone.  There has been much talk regarding the risk assessment is required, when it should be done, and how to do it. In this article i will talk a bit about what is required and when.  There are many different ways to perform the risk assessment, and apart from specific customer requirements have the choice is up to the company how this would be done. Even the current draft of ISO 9001 states that, “Although risks have to be identified and acted upon there is no requirement for formal risk management.”

    What risk assessment is required in the QMS?

    ISO 9001 cost in Saudi Arabia as alluded to above, there is not currently a requirement for risk assessment in the ISO 9001 standard; however, for those who already deal with AS9100 for aerospace companies and the risk assessment is already included in the QMS requirements.  From a review of the draft of ISO 9001 it can be expected that even if changes are made, the inclusion of the risk assessment is certain, which will bring this standard in the line with other risk based management system requirements such as ISO 14001 for the Environmental Management Systems.  In preparation for these changes, and also most importantly, to help your business have an better planning, adding the risk assessment as a part of your QMS can be very advantageous.

    Where can risk assessment fit in?

    ISO 9001 Consultants in Bangalore has the following processes are identified as a good places to look at risk and decide what to do about it.  Assessing and dealing with the risks identified in these processes can improve the ability to deal with problems in a effective time and less costly manner.  The idea is to think about what is the potential problems could occur and then decide what to do about them, with acceptable decisions including the risk avoidance, risk mitigation and risk acceptance.

    Quality Management System Planning.  Where are the risks in your processes? What risks there may arise and when making the changes to the processes? What resources are required to address the risks?

    Planning or Product or Service Realization. When planning for delivering the product or service, have been identified that where in the process there is the risk of problems occurring? Do we know what needs to be done when the problem occurs, or can there be a preventive maintenance plan in the place where to avoid the problem?

    Review of Requirements for Product or Service. Are the risks that we will not be able to meet the requirements for the product or service? Is there a new design that stretches the limits of our abilities or knowledge? Is there any new technology that we will be using for the first time to meet requirements?

    Design. What are the risk areas in the design where requirements may not be met? What are the risks  present when a design change is made? How do we make sure that we can deal with a product or service non-conformance when it occurs?

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