Visibility Blog

Analyze and prioritize your risks and opportunities (ISO 9001:2015 Changes)

Posted by Kellie Righini on Nov 5, 2015 11:00:00 AM

One of the key changes in the 2015 revision of ISO 9001 is to establish a systematic approach to risk, rather than treating it as a single component of a quality management system.  By taking a risk-based approach, an organization becomes proactive rather than purely reactive, preventing or reducing undesired effects and promoting continual improvement. Preventive action is automatic when a management system is risk-based. 


ISO 9001:2015 defines risk as “the effect of uncertainty on an expected result.”  The term “uncertainty” is clarified as a lack of information or knowledge about an event that can be expressed in terms of consequences the likelihood of occurrence.


  1. An effect is a deviation from the expected – positive or negative
  2. What could happen and what the effect of this happening might be
  3. Also considers how likely it is

The objectives of inserting more risk management into ISO 9001 are aimed at addressing a variety of management needs such as:

  • Moving to more of a data-driven decision process that increases objectivity (not just going on a hunch)
  • Being able to more accurately prioritize risks and allocate resources to mitigating them more successfully (optimize business effectiveness)
  • Capturing, retaining and transferring organizational knowledge regarding risk mitigation as employees and managers change (removing tribal knowledge)
  • Broadening the knowledge base regarding risk and creating communication and trust among those who are involved (more companywide commitment and ownership)

Designed to support optimization of operational management strategies and remove Risk factors, the ERP software solution consists of integrated modules that enable effective management of customer relationships, quotes, projects, costs, material and resource planning, product engineering and manufacturing, business performance, finance and global issues, where supply chain collaboration is key to your success. 

Check out this powerpoint presentation from ISO on Risk-Based Thinking by clicking here

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Topics: Quality Management

ISO Certified: Would You Want Your Doctor Cramming For Surgery?

Posted by Kellie Righini on Sep 21, 2015 9:30:00 AM

Have you ever procrastinated and found yourself staying up late, as if you were cramming for a test? Instead of learning the material, you are merely memorizing the answers just to pass. Come on, be honest, we’ve all done it. If you do this, chances are you do not retain the material. How would you feel if your doctor, the one about to operate on you, prepared this way?

This type of preparation is quite common when it comes to ISO Certified companies getting ready for a Register’s audit. The week before the audit, employees are running around trying to organize documents, update training records, and obtain required signatures in order to pretend that they have been compliant, and following procedures.

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Topics: Quality Management

Quality Management in ERP - Why It's So Vital

Posted by Scott Cranford on Sep 1, 2015 9:00:00 AM

Does your ERP system measure up when it comes to quality management? Are you still maintaining certain quality data outside of your ERP?

What follows is a guide for what quality actually means, as part of an integrated manufacturing ERP solution.


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Topics: Quality Management