Get 2 Documentation Toolkits for the price of 1
Limited-time offer – ends March 28, 2024

Expert Advice Community

Guest

Context of the organization and risks and opportunities procedure

  Quote
Guest
Guest user Created:   Mar 17, 2016 Last commented:   Mar 17, 2016

Context of the organization and risks and opportunities procedure

1. Since the Context is a one time definition unless it changes sometime well in the future, can it be described in the Quality Manual?
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
Strahinja Stojanovic Mar 17, 2016

2. Can risks and opportunities be described within the Mgmt Review process than with a specific procedure?

Answer:

1. Context of the organization can not be considered as a static thing, it is on a contrary ever changing. The internal issues are subjected to change, not to mention the external context of the organization. Considering context of the organization or at least the changes in the context should be performed during management review, this is even a requirement of the standard (clause 9.3.2 b). For more information, see: How to identify the context of the organization in ISO 9001:2015 https://advisera.com/9001academy/knowledgebase/how-to-identify-the-context-of-the-organization-in-iso-90012015/

2. The standard doesn't prescribe where to describe the risks and opportunities, neither it requires risks and opportunities to be documented. Procedure for addressing risks and opportunities is not mandatory, but it may be created to facilitate identification of the risks and opportunities and planning actions to address them, but it is not common to marge this procedure with the management review process although there are some overlapping. For more information, see: Methodology for ISO 9001 Risk Analysis https://advisera.com/9001academy/blog/2015/09/01/methodology-for-iso-9001-risk-analysis/

Quote
0 0

Comment as guest or Sign in

HTML tags are not allowed

Mar 16, 2016

Mar 16, 2016

Suggested Topics

Guest user Created:   Jun 09, 2021 ISO 9001
Replies: 1
0 0

Risk Management for Pharmaceuticals

Guest user Created:   Oct 06, 2020 ISO 9001
Replies: 1
0 0

Risk identification and mitigation

Guest user Created:   Oct 30, 2019 ISO 9001
Replies: 1
0 0

Preparing a Risk Assessment Procedure