Get compliant with ISO 9001:2015 and simplify compliance for your organisation.
Focuses on analysing and monitoring how well a business is operating against the requirements of its QMS. This clause requires businesses to establish processes for measuring and evaluating their QMS's effectiveness.
Outlines the general requirements for monitoring, measuring, analysing, and evaluating the organisation’s quality management system.
This clause emphasises the importance of collecting data and information that is relevant to the performance of the organisation’s processes and the achievement of its quality objectives.
The organisation must establish and maintain a process for monitoring, measuring, analysing, and evaluating the quality management system.
The process must include the collection of data and information that is relevant to the organisation’s quality objectives and the performance of its processes.
The organisation must ensure that the methods used are appropriate for the nature and scope of its activities.
The organisation must ensure that the results are documented and retained as documented information.
The organisation must use the results of monitoring, measurement, analysis, and evaluation to evaluate the effectiveness of the quality management system and identify opportunities for improvement.
The clause requires organisations to monitor customer perceptions regarding their products and services, as well as to evaluate the level of customer satisfaction. This information can be used to identify areas for improvement in the quality management system and to take appropriate corrective actions.
To comply with this clause, organisations need to establish a process for collecting and analysing customer feedback. The process should include:
Analysing and evaluating data related to the performance of your quality management system (QMS). This means collecting information about how well your QMS is working, looking for trends or issues, and figuring out how you can make improvements.
To do this, you need to first decide what data to collect and how to collect it. You might want to collect information on things like customer satisfaction, product quality, delivery times, and efficiency. Once you have the data, you need to analyse it to look for patterns and variations, and figure out what it tells you about how well your QMS is performing.
After you’ve analysed the data, you need to evaluate it to see if your QMS is working as planned. This means comparing your actual performance to your goals, and figuring out where you’re falling short. Once you’ve identified areas for improvement, you can take action by implementing corrective actions or making changes to your QMS.
By analysing and evaluating your QMS performance data, you can continuously improve your system and keep your customers happy. It’s an important part of ISO 9001:2015, and it helps ensure that your business is always striving to be the best it can be.
Organisations need to conduct an internal audit to make sure that the quality management system (QMS) is working properly.
To conduct an internal audit, you need to first plan it out. This means deciding what you’re going to audit, who is going to do it, and how you’re going to do it. You’ll also need to make sure that everyone involved knows what’s going on and why.
Once you’ve planned your audit, it’s time to conduct it. This means looking at your QMS to see if it’s meeting the requirements of ISO 9001:2015, as well as your own internal requirements. You’ll be looking for evidence that your system is working effectively and efficiently, and that you’re meeting your objectives.
After you’ve conducted your audit, you’ll need to document the results. This means writing down what you found, what you did about it, and what you plan to do in the future. You’ll also need to keep records of your audit, including any evidence you gathered and any corrective actions you took.
Overall, internal audits are an important part of ISO 9001:2015 because they help you make sure that your QMS is working as it should be. By conducting regular audits and addressing any issues you find, you can continuously improve your QMS and ensure that you’re providing high-quality products or services to your customers.
Organisations need to have a process for reviewing the performance of their QMS at the management level.
To meet this requirement, organisations need to plan and conduct management reviews of their QMS at defined intervals. The purpose of these reviews is to evaluate the performance and determine whether it’s meeting the organisation’s objectives and the requirements of ISO 9001:2015.
During the review, organisations should look at a range of topics, including:
The output of the management review should include decisions and actions related to:
It’s important to document the results of the management review, including any decisions and actions taken. Organisations also need to communicate the results to relevant employees within the organisation.
Clause 9.3.2 outlines the requirements for inputs into the management review process. This means that before you conduct a management review, you need to gather and review relevant information that will inform the review.
The inputs to the management review process include:
It’s important to gather and review these inputs before conducting a management review. By doing so, you can ensure that the review is informed by relevant information and that any necessary actions are taken to improve the QMS.
Requires that the results of the management review be documented and communicated to relevant personnel within the organisation.
The outputs of the management review can include various items, such as:
Once the management review outputs have been identified, they should be documented and communicated to relevant personnel within the organisation. This ensures that everyone is aware of any changes or improvements that need to be made to the QMS and their responsibilities for implementing them.
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