Expert Advice Community

Guest

ISO 9001:2015 Risk-based Thinking (A.4)

  Quote
Guest
Guest user Created:   Jun 18, 2020 Last commented:   Jun 18, 2020

ISO 9001:2015 Risk-based Thinking (A.4)

We are currently using a Non-conformance report (risk assessment What if...) and a management of change form to document our risk assessment. Do you feel this will satisfy the standard (ISO 9001:2015). Is a book that explains what risk assessment is in laymans terms? how do chemical companies document risk

0 0

Assign topic to the user

ISO 9001 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 9001 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

Expert
Carlos Pereira da Cruz Jun 18, 2020

First, ISO 9001:2015 has no mandatory requirements concerning risks and opportunities – please check this article - List of mandatory documents required by ISO 9001:2015 - https://advisera.com/9001academy/knowledgebase/list-of-mandatory-documents-required-by-iso-90012015/ . So, whatever the method used by your organization to document your risk assessment is valid if it suits your needs. Having said that, beware that a risk is not necessarily a nonconformity. Following ISO 9001:2015, I recommend organization to determine risks and opportunities around three areas:

  • Around the business, when considering clauses 4.1 and 4.2 according to clause 6.1 – please check slide about “Intended results” in our free webinar on demand - How to implement risk management in ISO 9001:2015 - https://advisera.com/9001academy/webinar/how-to-implement-risk-management-in-iso-90012015-free-webinar-on-demand//
  • Around products and services, when considering clause 5.1.2 b) - please check slide about “Products and services” in the same free webinar on demand
  • Around processes, when considering clause 4.4.1 f) - - please check slide about “Processes” in the same free webinar on demand 

A common way to document the risk assessment is to use a Risk Register – please check the sample from our Documentation Toolkit - ISO 9001 document template - Registry of Key Risks and Opportunities - https://advisera.com/9001academy/documentation/registry-of-key-risks-and-opportunities/

I take the liberty of recommending my book - Discover ISO 9001:2015 Through Practical Examples - https://advisera.com/books/discover-iso-9001-2015-through-practical-examples/ - with a strong focus on the risk-based thinking.

Quote
0 0

Comment as guest or Sign in

HTML tags are not allowed

Jun 18, 2020

Jun 18, 2020