Does ISO 9001 require a procedure for addressing risks and opportunities?

Does ISO 9001 require a procedure for addressing risks and opportunities?

With the release of ISO 9001 Certification in Oman, there is a new necessity for the recognizable and evaluation of risks and opportunities for the Quality Management System (QMS). These new requirements have carried with them some confusion not only about what needs to be done, but also what should  be documented with regards to risks and opportunities for your QMS. In this article I might want to clear up some confusion about what is required, what is necessary, and what is helpful to you.

What is actually required by ISO 9001:2015?

Identify the risks and opportunities : What should be addressed to ensure your QMS does what is required,, builds on attractive results, prevents or reduces problem outcomes, and achieves improvement?

Plan your reaction: What activities do you have to take to address the risks and opportunities identified?

Integrate into your QMS : How would you be able to take these plans and fit them into your regular activities so that they happen easily?

Evaluate effectiveness : How will you know whether your actions have worked, or if they should be updated? This involves analyzing the data  and management review to assess the effectiveness

Do you need a documented procedure?

It is imperative to note in the necessities above that there is no command for documented information for any of these steps. The standard itself does not express that  you need to document anything  as for  risks and opportunities, simply that you should  perform the processes in the segment above, as well as update the risks and opportunities as a result of process non-conformities.

For instance, you could choose to assess your risks and opportunities at a management meeting, recognize a risk decide what you will do (locate a second supplier to reduce the risk ), and guarantee that the employees who are performing the QMS procedure included know about what they have to do(acquiring manager initiates the procedure to locate  a second supplier), and you could then guarantee that you are consistent with the ISO 9001 Certification in South Africa necessities, even though none of this is composed down.

So, do you require a documented procedure? The appropriate response,according to ISO 9001 Certification in Nigeria, is that a documented  method isn't required, but your organization  may have an alternate requirement for  documented information and records with respect  QMS risks and opportunities.

Why should I have a documented procedure?

Even though the ISO 9001 Certification in Egypt standard does not require a documented strategy, there are a few  instances where having a documented methodology is an essential way to ensure consistency. For instance: 

Is this a new process? If you have been performing a business SWOT investigation for a considerable length of time,  and utilize this to address the requirements of ISO 9001:2015, then you don’t necessarily need to record your procedure.However, if this is a new process for your organization, then it can be helpful to document what you do in order to not only be consistent, but also to help identify approaches to enhance the procedure. 

Are new individuals associated with the procedure? Regardless of whether you have been doing a process for a long time, if you are going to include new individuals in the process, it can help these new participants to understand the procedure if it is composed down.

Will it make integration easier? While determining what your plans to address the risks and opportunities are, and how to coordinate these into your QMS activities, it may be helpful to have a documented procedure on how these risks were resolved with the end goal  to explain your thinking to the individuals  who were not involved in the initial identification; however, you still need to implement the changes throughout the association.

Will it help when reviewing for effectiveness? This goes not only for the documented method, but also for documenting the risks and opportunities you identify and the plans to address them. It is imperative to think about how you will assess the effectiveness of your planning and actions taken if you have not written down the procedure you followed to land at your plans, or the plans themselves, to guarantee effective conclusion.

Think before you create the decision not to document:
There are many valid reasons to have a documented risk and opportunity technique, and it is up to your organization to determine what is required for you to have an effective ISO 9001 Certification in Iran process implemented. While I am typically an advocate of not composing unnecessary procedures, it is a smart thought  to think through what the procedure will be utilized for, and how it will be used, before you make the decision that a documented system will not be helpful to your organization.  A short and simple documented method can be a great help for your employees, if done  effectively. 
Remember, the documented data of your Quality Management System is proposed to work for you, so take the opportunity to make sure that you make useful and helpful documented information when it will benefit your organization.

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