Identifying the potential organizational risks has always been a primary objective for businesses to ensure their smooth functioning. Mostly considered by value-driven, growth-oriented organizations, risk assessment has emerged as a vital aspect of the decision-making process. Adherence to the ISO 9001 standard, which it is typically regraded as an evidence-based, objective process for making the most appropriate business decisions that help in fostering organizational growth and improvement, is one way to do this. Hence, if you are seeking for an ISO 9001 certification, risk assessment is an area which, surely needs your focus.



As per the ISO 9001 standard, there are four important steps organizations need to follow for addressing the risks and opportunities, which are:


  • Recognize the areas of potential risks and opportunities
  • Prepare your response
  • Incorporate your response into the Quality Management System
  • Gauge its effectiveness


Each of the steps require organization to proceed as per the core principles stated in ISO 9001 relating to the conception of risks and opportunities. Following is an in-depth overview of all the four steps which an organization must focus on for dealing with the risks and opportunities while remaining ISO 9001 compliant.


Step 1: Recognize the risks and opportunities


In this step, a company will generally encounter two kinds of risks, mainly: internal and external. The external risks involve different types of regulatory, financial, legal, and cultural risks that may affect the organization.


On the other hand, internal risks are confined to factors or individuals within the organization including any kind of issue related to resource allocation or deficiency, organization’s structure, or hierarchy.


While determining the risks and opportunities, the top-level managers or risk analysts need to focus on the business point of view. Moreover, they must understand that a potential risk can also serve as the harbinger of an opportunity. Hence, they need to evaluate the end point and beginning point of a risk and opportunity, respectively. This will further help them in reducing the impact of one by making use of the other.


Step 2: Prepare your response


As per the ISO 9001 standard, organizations must develop a plan to address the various risks and opportunities they have found after in-depth analysis. By conducting an extensive assessment of all the potential risks, the organization will be able to:


  • Gauge how disruptive the potential risks are
  • See what kind of resources they require for mitigating the risks
  • Decide if the risks are worth encountering in order to capitalize on the opportunities
  • While adhering to the regulations of the ISO 9001 standard, they need to develop an action plan which, would not only help them prevent the occurrence of such risks but also capitalize on the opportunities at their best.


Step 3: Incorporate your response into the Quality Management System


In this step, the organization needs to integrate the well-framed plan meant to address the possible risks and opportunities into the broader framework of ISO 9001 Quality Management System (QMS). As per the ISO 9001 requirements, which emphasizes universal application, it is important that the plan being developed for dealing with the risks and opportunities must be compatible enough with all the other company procedures.


Step 4: Gauge its effectiveness


Just like any other process in the organization which is operating in adherence to the ISO 9001 standard, an organization needs to incorporate a few efficient processes for maintaining proper record keeping and precise documentation. This will help them in getting organized insights on the effectiveness and measure it accordingly. In this step itself, it is also important to prepare a detailed assessment of the willingness of the organization in encountering the risks and pursue the opportunities accordingly.


Without having an in-depth understanding of the organizational goals in terms of navigating the risks and opportunity, it won’t be possible for the higher management to assess the efficacy or productiveness of the processes being implemented so far for mitigating the risks and capitalizing on the opportunities.


Similar to any other procedure of an organization that works as per the ISO 9001 standards, this step will enable managers to facilitate continuous scanning of the possible inefficiencies that need to be improved.


The bottom line


ISO 9001, being an all-encompassing standard, includes a list of guiding principles for organizations to address the possible risks and opportunities in the most systematic and well-structured manner. Following these principles would ultimately help them in implementing a foolproof plan of capitalizing on the opportunities and preventing or combating the risks when addressed. As a recommended choice, it is always better to seek professional guidance of ISO consultants for forming an objective-oriented strategy in conducting a comprehensive risk assessment and planning the necessary steps for achieving maximum operational productivity. They would not only help in attaining an ISO 9001 certification but also guide you through all the processes, procedures, and protocols meant for working as per the guidelines of this ISO standard.

Author's Bio: 

Damon Anderson is a highly distinguished and qualified ISO consultant and owns a reputed consultation agency for helping organizations to operate as per the various ISO standards. During his free time, he also likes to write informative blogs on various relevant topics including tips to follow for achieving an ISO 9001 certification, importance of implementing an ISO 9001 quality management system and more.

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