Guest user Created: Mar 12, 2018 Last commented: Mar 12, 2018

Addressing risks

"I am in the phase of transition and have my certification audit on March 26. we are a medical laboratory, medium sized about 30 employees. we already have ISO 9001:2008 implemented. my question is about addressing risks: should it be the risks for final results? or risks that we have found in the SWOT analysis”

0 0

Assign topic to the user

Select user

Expert

Carlos Pereira da Cruz Mar 12, 2018

Answer:

ISO 9001:2015 recommends us to deal with risks and opportunities at three levels.

4.4.1 f) – risks about processes – Every process has intended outcomes and possible undesirable effects. What can affect negatively or positively the ability to meet those intended outcomes or to avoid those undesirable effects
5.1.2 b) – risks about products and services
6.1.1 a) – risks about intended outcomes of the QMS as a whole (quality objectives)

The following material will provide you information about the risk-based approach:

- 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 repl acing 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/

Quote

0 0

Comment as guest or Sign in

HTML tags are not allowed

Name *

Email *

I accept the Privacy and Terms

Notify me when someone replies

Mar 12, 2018

Expert Advice Community