Risk in a ISO 9001- 2015 Environment

Posted September 14, 2017

Paradigm 3 ISO 9001 2015 Requires Risk Management

Managing risk has now become a major focus of ISO 9001. Specific language has been added to the standard to require organizations to assess and mitigate risk.

6.1.2 The organization shall plan:

    A. Actions to address these risks and opportunities;
    B. How to:
    1. Integrate and implement the actions into its quality management system processes
    2. Evaluate the effectiveness of these actions. Actions taken to address risks and opportunities shall be proportionate to the potential impact on the conformity of products and services.

This will now make it mandatory to identify what the risks and opportunities are in your organization. The organization will need to analyze and prioritize the risks and opportunities by defining what is acceptable, and what is unacceptable. Once the risks are identified the organization needs to plan actions to address the risks. That plan may be a method to avoid or eliminate the risk. If that option is not available the plan should endeavor to mitigate the risk. Once the plan is developed a strategy needs to be established to implement the plan, assess and improve its effectiveness. This will enable the organization to continually improve by learning from experience.

Managing this type of system via a paper based system requires endless consistent effort by numerous persons in logging tracking and following up and collecting evidence on actions taken in various formats then collating then in an auditable form. This will result in endless hours spent managing the system. Paradigm 3 provides a flexible template which will seamlessly move you through from identifying a risk, to the investigation of best practices to mitigate this risk and implementing the solution. Our software provides management of the complete process, assigning actions to specific persons, tracking and recording the actions they take to complete the task.

Utilizing our software will provide you with a fully auditable trail of your efforts to identify and address the risk associated with your organization. Keeping you in full compliance with the new requirements of the ISO standard.

Find out more about our Paradigm 3 Document and Compliance management software by contacting Interax at 1-800-884-3160 x 707. You can also look through our website at interaxgrp.com to see the many other benefits that this particular customizable software offers to both larger corporations and smaller businesses. Paradigm 3 offers sustainable solutions so that you can have complete confidence in your ISO 9001 -2015 management system.