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


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With the release of ISO 9001 Certification in Bangalore, there is a new requirement for the identification and assessment of risks and opportunities for the Quality Management System (QMS). ISO 9001 consultant in Bahrain These new requirements have brought with them some confusion not only about what needs to be done but also what needs to be documented with regards to risks and opportunities for your QMS. In this article, I would like to clear up some confusion about what is required, what is necessary, and what is beneficial to you.

What is required by ISO 9001 in Bangalore?

In section 6.1 of the standard, there are a few activities that need to take place with regards to the risks and opportunities of the QMS:

Identify the risks and opportunities – What needs to be addressed to ensure your QMS does what is needed, builds on desirable outcomes, prevents or reduces problem outcomes, and achieves improvement?

Plan your response – What actions do you need to take to address the risks and opportunities identified?

Integrate into your QMS – How can you 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 need to be updated? This involves analyzing the information (section 9.1.3) and management review to assess the effectiveness (section 9.3.2).

Do you need a documented procedure?

ISO 9001 Services in Bangalore It is important to note in the requirements above that there is no mandate for documented information for any of these steps. The standard itself does not state that you need to document anything concerning risks and opportunities, just that you must perform the processes in the section above, as well as update the risks and opportunities as an outcome of process non-conformities (section 10.2).

For instance, you could choose to assess your risks and opportunities at a management meeting, identify a risk (possibility of a single-source supplier of a critical part not delivering), decide what you are going to do (find a second supplier to reduce the risk ), and ensure that the employees who are performing the QMS process involved are aware of what they need to do (purchasing manager initiates the process to find a second supplier), and you could then claim that you are compliant with the ISO 9001 consultant in Bangalore requirements, even though none of this is written down. So, do you need a documented procedure? The answer, according to ISO 9001 Implementation in Bangalore, is that a documented procedure is not required, but your company may have a different need for documented information and records regarding QMS risks and opportunities.

Why should I have a documented procedure?

Even though the ISO 9001 Certification in Bahrain standard does not require a documented procedure, there are some instances where having a documented procedure is an important way to ensure consistency. For example:

Is this a new process? If you have been performing a business SWOT analysis for years, and use this to address the requirements of ISO 9001 Services in Bahrain, then you don’t necessarily need to write down your process. However, if this is a new process for your company, then it can be helpful to document what you do to not only be consistent but also to help identify ways to improve the process. Are new people involved in the process? Even if you have been doing a process for a long time, if you are going to include new people in the process, it can help these new participants to understand the process if it is written down.

Think before you make the decision not to document.

There are many good reasons to have a documented risk and opportunity procedure, and it is up to your organization to determine what is needed for you to have a successful process implemented. While I am normally a proponent of not writing unnecessary procedures, it is a good idea to think through what the procedure will be used for, and how it will be used before you decide that a documented procedure will not be beneficial to your company. A short and simple documented procedure can be a great help for your employees if done correctly. Remember, ISO 9001 Implementation in Bahrain the documented information of your Quality Management System is intended to work for you, so take the time to make sure that you create useful and helpful documented information when it will benefit your company.

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