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Context and risks and opportunities in ISO 9001

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Guest user Created:   Sep 19, 2016 Last commented:   Sep 19, 2016

Context and risks and opportunities in ISO 9001

Besides defining the scope and parties of interest in implementation of the gaps identified during QMS, what other issues should also be looked at?
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Strahinja Stojanovic Sep 19, 2016

ISO 9001:2015 requires that the company identify a risk management plan, does this plan fall in as a QMS or safety and health?

Answer:

I'm not sure if I understand the question but, beside interested parties and definition of the scope you need to consider internal and external issues relevant to your company QMS. For example, internal issues can be organizational structure, organization culture, resources needs, etc. while external issues might be condition on the market, availability of raw materials, tax policy of the company, etc. For more information, see: How to identify the context of the organization in ISO 9001:2015 https://advisera.com/9001academy/knowledgebase/how-to-identify-the-context-of-the-organization-in-iso-90012015/

ISO 9001 does not require risk management plan or any other document regarding risks. It only requires risks and opportunities to be identified and addres sed and to monitor and evaluate effectiveness of the actions taken to address risks and opportunities. It shouldn't be mixed with occupational health and safety or environmental risks since its focus is on quality and there is no requirement to establish methodology or write a procedure. For more information, see: How to address risks and opportunities in ISO 9001 https://advisera.com/9001academy/blog/2016/06/21/how-to-address-risks-and-opportunities-in-iso-9001/
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Sep 19, 2016

Sep 19, 2016

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