Venture Care - Does ISO 9001 certification require a procedure


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Venture Care helps in ISO Registration ( ISO 9001 Certification, ISO 14001 Environment Management, ISO 13845 Medical Devices,ISO 50001 Energy Management System etc. ).


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Does ISO 9001 certification require a procedure for addressing risks and opportunities

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With the release of ISO 9001certification there is a new requirement for the identification and assessment of risks and opportunities for the Quality Management System QMS. These new requirements have brought with them some confusion not only about what needs to be done but also what needs to be documented with regards to risks and opportunities for your QMS. What is actually required by ISO 9001:2015 In section 6.1 of the standard there are a few activities that need to take place with regards to the risks and opportunities of the QMS:  Identify the risks and opportunities – What needs to be addressed to ensure your QMS does what is needed builds on desirable outcomes prevents or reduces problem outcomes and achieves improvement  Plan your response – What actions do you need to take to address the risks and opportunities identified  Integrate into your QMS – How can you take these plans and fit them into your regular activities so that they happen easily  Evaluate effectiveness – How will you know whether your actions have worked or if they need to be updated This involves analyzing the information section 9.1.3 and management review to assess the effectiveness section 9.3.2. For more details on what is required by the ISO 9001:2015 standard see this article on How to address risks and opportunities in ISO 9001 certification. Do you need a documented procedure It is important to note in the requirements above that there is no mandate for documented information for any of these steps. The standard itself does not state that you need to document anything with respect to risks and opportunities just that you must perform the processes in the section above as well as update the risks and opportunities as an outcome of process non-conformities. For instance you could choose to assess your risks and opportunities at a management meeting identify a risk possibility of a single-source supplier of a critical part not delivering decide what you are going to do find a second supplier to reduce the risk and ensure that the employees who are performing the QMS process involved are aware of what they need to do purchasing manager initiates the process to find a second supplier and you could then claim that you are compliant with the ISO 9001:2015 requirements even though none of this is written down.

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So do you need a documented procedure The answer according to ISO 9001:2015 is that a documented procedure is not required but your company may have a different need for documented information and records regarding QMS risks and opportunities. Think before you make the decision not to document. There are many good reasons to have a documented risk and opportunity procedure and it is up to your organization to determine what is needed for you to have a successful process implemented. A short and simple documented procedure can be a great help for your employees if done correctly. Remember the documented information of your Quality Management System is intended to work for you so take the time to make sure that you create useful and helpful documented information when it will benefit your company. Get to know more about ISO certification process and ISO Registration

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