Guest user Created: Feb 08, 2018 Last commented: Feb 08, 2018

Risk based approach

"As a Consulting Engineer, I understand that for ISO 9001-2015 and also for ISO 14000-2015; Risk Analysis is a major new development. Also, the idea of Risk Analysis has been carried over into other standards such as ISO/IEC Standard 17025-2017; and other ISO standards which use the same template. With this background, my main concerns are two. 1. How to do a good job of Risk Analysis in a Test Lab setting (ISO/IEC Std. 17025-2017) in an Inspection Body setting (ISO/IEC Std. 17020-2012) and in a Product Certification Body setting (ISO/IEC Std. 17065-2012 and ISO/IEC Std. 17067-2013). 2. How do I use ISO 31000 to do Risk Analysis in the above standards. If you can kindly answer these in the webinar, I will be very grateful. Another good idea is to provide a guidance paper with a template for Risk Analysis.”

0 0

Assign topic to the user

Select user

Expert

Carlos Pereira da Cruz Feb 08, 2018

Answer:

1. For example, in a Test Lab setting or in an Inspection Certification Body I would act in the same way:
a) what are the overall results that you intended to meet with your QMS in those settings?
b) did you map the processes for each of those settings? For each process, what are the overall intended results? For each process, what is its purpose?
c) for each service provided by each setting, what are the performance objectives, the specifications?
Then, for those three kinds of expected results you can ask: what can go wrong? In what ways can those expected results not being met? Each of those ways of failure is a risk. That would be my starting point. I would improve this baseline assessment with iterations done after non-conformities and performance evaluation.
2. ISO 31000 is for doing more than what is requested by ISO 9001:2015. It gives guidance, for example, about possible types of actions concerning risk mitigation, risk avoidance and risk reduction.

Please see bellow some material with 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 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/

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

Feb 08, 2018

Expert Advice Community