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Risks and opportunities in ISO 9001

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Guest user Created:   May 29, 2017 Last commented:   May 29, 2017

Risks and opportunities in ISO 9001

9001:2015, section 6.1, Actions to address risks and opportunities; the risks and opportunities of internal and external issues that affect you to achieve the intended result(s) of the quality management system. Is it about programmatic risk? Not System Safety Risk via Safety Management System (SMS). What is the context of opportunity?
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ISO 9001 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 9001 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

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Strahinja Stojanovic May 29, 2017

Could you please clarify my understanding by providing an example?
Thank you very much, Mr. Stojanovic.

Answer:

The standard requires organization to identify and address risks and opportunities related to the QMS effectiveness, which includes quality and conformity of products and services, customer satisfaction, QMS performance etc. Risks related to occupational health and safety for example, shouldn't be considered when identifying risks and opportunities for the QMS,

Same as the risks, the opportunities are focused on the QMS, its effectiveness and ability to achieve the objectives and this is the place to look for them.

The risk can arise either from external or internal context. For example, he organization can have outdated equipment and there is a risk of nonconforming products in the production process, as an action to address the risk, the organization can increase frequency of preventive maintenance of the equipment to avoid failures.

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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May 29, 2017

May 29, 2017

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