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Risks and context

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Guest user Created:   May 02, 2018 Last commented:   May 02, 2018

Risks and context

"How are the internal and external issues identified in Clause 4 of ISO 9001:2015 related to the risks and opportunities also mentioned in clause 4? How are the issues defined as compared to the risks and opportunities?”
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ISO 9001 PROCEDURE FOR DETERMINING CONTEXT OF THE ORGANIZATION AND INTERESTED PARTIES

The list of interested parties and their expectations.

ISO 9001 PROCEDURE FOR DETERMINING CONTEXT OF THE ORGANIZATION AND INTERESTED PARTIES

The list of interested parties and their expectations.

Expert
Carlos Pereira da Cruz May 02, 2018

Answer:

Considering your strategic orientation your organization will determine relevant internal and external issues.

As an example of internal issues, you can have:

Quality problems;
Low productivity;
Delay problems;
New subcontractor.
As an example of external issues, you can have:

Raw materials price evolution;
New legislation that will affect what your customers, or your customers’ customers will buy;
New technology that will affect how you manufacture, or how you sell;
New consumer trends that will affect demand quality and volume.

With this kind of issues in stake, we can look at them also as uncertainty generators. And risk is the effect of uncertainty on expected results.

Quality problems, low productivity and delays can be viewed as the manifestation of risks. If your organization want to reduce the probability or frequency of those risks one good way to accomplish that is to change, to improve the processes where those risks are generated

New consumer trends are an external issue that can be viewed as a risk, or an opportunity, perhaps your organization can focus production on a particular category where demand is increasing, and you have a competitive advantage. Do you need to make changes in the production? Or in the commercial approach to the market? Do you need changes in how to buy, or whom to subcontract?

The following material will provide you information about the context and risks:

- ISO 9001 – 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/
- Risk-based thinking replacing preventive action in ISO 9001:2015 – The benefits – https://advisera.com/9001academy/knowledgebase/risk-based-thinking-replacing-preventive-action-in-iso-90012015-the-benefits/
- ISO 9001:2015 Risk Management Toolkit – https://advisera.com/9001academy/iso-90012015-risk-management-toolkit/
- free online training ISO 9001:2015 Foundations Course – https://advisera.com/training/iso-9001-foundations-course/
- book – Discover ISO 9001:2015 Through Practical Examples – https://advisera.com/books/discover-iso-9001-2015-through-practical-examples/

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May 02, 2018

May 02, 2018

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