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Clause 9 - Performance evaluation

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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.

Table of Contents

9.1 Monitoring, measurement, analysis and evaluation

9.1.1 General

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.

9.1.2 Customer satisfaction

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:


  • Identifying the methods for obtaining customer feedback: Such as customer surveys, complaints, or compliments.
  • Defining the criteria for evaluating customer satisfaction: Such as response time, quality of product or service, and overall experience.
  • Conducting regular customer satisfaction surveys: Collect feedback on a regular basis to identify trends in customer satisfaction and to measure improvements over time.
  • Analysing the results of customer satisfaction surveys: To Identify areas for improvement in the quality management system.
  • Taking corrective actions: Based on the results of the analysis, organisations need to take corrective actions to improve customer satisfaction and prevent recurrence of any issues.

9.1.3 Analysis and evaluation

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.

9.2 Internal audit

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.

9.3 Management review

9.3.1 General

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 effectiveness of your QMS in achieving your objectives and meeting customer requirements
  • The effectiveness of your processes and any opportunities for improvement
  • The status of any corrective actions or preventive actions taken since the last management review
  • Changes in the external and internal context of your organisation that could affect your QMS
  • The results of any internal audits or external assessments


The output of the management review should include decisions and actions related to:


  • Opportunities for improvement and any necessary changes to the QMS
  • Resource needs for the QMS
  • Any needs for changes in organisational processes and structure
  • Any needs for changes to the QMS documentation


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.

9.3.2 Management review inputs

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:


  • Results of internal and external audits: This includes any findings from internal audits, as well as any findings from external audits or assessments that have been conducted on your organisation.


  • Customer feedback: This includes feedback from customers about your products or services, as well as any complaints or issues they may have raised.


  • Process performance and product conformity: This includes data on how well your processes are performing, as well as data on the conformity of your products or services to customer requirements.


  • Status of corrective and preventive actions: This includes information on any corrective or preventive actions that have been taken since the last management review, as well as their effectiveness.


  • Changes to internal and external issues: This includes information on any changes to the external or internal context of your organisation that could affect your QMS.


  • Recommendations for improvement: This includes any recommendations for improvement that have been made since the last management review.


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.

9.3.3 Management review outputs

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:


  • Decisions and actions related to opportunities for improvement: The management team should identify areas where the QMS could be improved and determine what actions need to be taken to address these opportunities. These actions should be assigned to responsible parties and should have deadlines for completion.


  • Changes to the QMS documentation: The review may uncover areas where the QMS documentation needs to be updated or revised. This could include updating policies, procedures, or work instructions to reflect changes in the organisation or to improve efficiency.


  • Resource needs: The management team should identify any resource needs required to implement changes to the QMS. This could include additional staffing, training, or equipment.


  • Changes to organisational processes and structure: The review may identify areas where changes to the organisation’s processes or structure are needed to improve the QMS. These changes could include re-organizing departments or modifying workflows.


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.