Improving Management Changes in line with ISO 9001 QMS

When you're creating your Quality Management System (QMS) using the necessities of ISO 9001 it's vital to bear in mind that implementing the QMS in line with the requirements is just the start. Your QMS becomes an ongoing project that needs maintenance and improvement, and processes will have to be compelled to be updated and adjusted as time goes on. Because of this, ISO 9001 certification standard additionally includes some necessities on how to manage these changes and once these changes need to be thought of. Read this article further to know what ISO 9001 management of change suggests that for you and your company.

Requirements for ISO 9001 management of change

Because of the immensely varied and different risks and quality related concerns between organizations, this clause is extremely versatile in how change management will be applied from ISO 9001 QMS certification standard necessities. To begin with, ISO 9001 doesn't determine how your process for modification should work, however it needs that you just have a method for implementing planned changes that impact the QMS performance. This specifically needs you to use this method for each temporary and permanent changes.

Additionally, this ISO certification standard specifies some things that will activate the method as a result of these activities change the QMS performance. These activities are:

• Changes in product, services or processes – Before you add new, or make amendments to the existing products, services and processes, you must make sure that you just use your change management process. This method would assess the risks of those changes and facilitate manage those risks. Some samples of these changes, given in the ISO 9001 QMS standard, embody dynamic workplace locations, re-organization of labor, fixing work condition, dynamic instrumentation or people needed for the work.
• Legal changes – If there are changes to the legal or alternative needs that have an effect on your QMS performance, you may want to create the mandatory changes to your processes.
• QMS or Quality related risk data – If you gain new knowledge concerning your quality related concerns or QMS risks, corresponding to new analysis that changes what's acknowledged about a cleaning chemical you are using, this new data must be assessed to visualize if QMS amendment is required.
• Knowledge and technology developments – As you find out about new data or technology that may change how you do business, you furthermore may have to be compelled to assess how this changes the QMS processes, and management the changes.

One further demand in all of QMS certification standard talks regarding unintentional changes. If you notice that one thing has changed while not being planned, corresponding to an error being created in the purchase of a cleansing chemical wherever the wrong chemical was used, you would like to take action to handle any negative effects that this change caused. In this manner, you continue to react to risks posed by mistakes that were created.

When does the ISO 9001 standard mention considering changes in the QMS?

Along with these needs on a way to manage QMS change, the quality has several needs that embrace the thought of changes within the QMS. So, once will ISO 9001 need you to think about these changes?

• Assessing risks and opportunities – It requires that your assessment of risks and opportunities include those that come from changes in the organization, including intended outcomes for the QMS. When the change is planned, this assessment should occur before the change is implemented.
• Identification of quality related concerns – Part of the assessment of quality related concerns in implementation requires that you consider quality related concerns for actual or proposed changes in your company’s organization, operations, processes, activities or the QMS.
• Opportunity assessment – When you are assessing the opportunities, which is a follow-on from above mentioned changes, consideration of your planned changes to the organization should be included; such as adapting work in order to enhance QMS performance.
• Internal communication – One of the types of information that need to be internally communicated within your organization are the changes to the QMS that people need to know.
• Management review – It gives the requirements for management review. One of the outputs from the top management review of the QMS is the need for any changes in the management system. These identified changes should kick off the use of the change management process defined for the organization.
• Corrective action – As part of the corrective action process, the standard requires that you implement any changes necessary to react to process nonconformity using the change management process for the organization. By doing this, corrective changes will be properly managed.