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Clause 10 - Improvement

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Requires businesses to use the results of their performance evaluations to improve their processes continually. This includes identifying areas for improvement and taking action to make changes that will lead to better results.

10.1 General

Improving the effectiveness and efficiency of the organisation quality management system (QMS) is an ongoing process that should be ingrained in the organisation’s culture.

 

Organisation should identify opportunities for improvement and implement actions to address them, and evaluate the effectiveness of these actions and take corrective actions if necessary.

 

To meet the requirements of clause 10.1, the organisations should:

 

  • Continuously monitor and measure the performance of their QMS: This involves establishing metrics and targets for measuring the effectiveness and efficiency of the QMS. Regularly review and analyse of the data to identify opportunities for improvement may be needed.

 

  • Identify opportunities for improvement: This involves a in deep assessment of your QMS and identifying areas where it could be improved. 

 

  • Implement actions to address opportunities for improvement: This involves taking action to address the identified opportunities for improvement. This could include implementing new processes, modifying existing ones, or providing additional training to employees.

 

  • Evaluate the effectiveness of the actions taken: This involves assessing whether the actions taken to address opportunities for improvement have been effective. This could involve measuring performance against established metrics or conducting internal audits.

 

  • Take corrective actions if necessary: If the actions taken to address opportunities for improvement are not effective, organisations need to take corrective actions. This could involve modifying the actions taken or identifying new opportunities for improvement.

10.2 Nonconformity and corrective action

Organisations should have a process in place to identify, document, review, and take corrective action for nonconforming products or services.

 

Nonconformity refers to a situation where a product or service does not meet the specified requirements, whether it be due to a malfunction, deviation, or omission. Organisation should have a process in place to identify and document such instances, as well as to determine their causes and take appropriate corrective action to prevent their recurrence.

 

To meet the requirements of clause 10.2, organisations should:

 

  • Identify nonconforming products or services: This involves establishing procedures to identify nonconformities and make sure that all employees are aware of these procedures.

 

  • Document nonconformities: Nonconformities should be documented using a system that allows for tracking and trending. This could include using a database, spreadsheet, or other electronic system.

 

  • Review nonconformities: Causes and potential impact on the customer or the organisation should be determined. This could involve conducting a root cause analysis, reviewing customer feedback, or conducting an internal audit.

 

  • Take corrective action: Based on the review, corrective action should be taken to prevent the nonconformity from recurring.

 

  • Verify effectiveness: The effectiveness of the corrective action should be verified to ensure that it has addressed the cause, and prevented its recurrence.

 

  • Update documentation: Any relevant documentation should be updated to ensure that it is accurate and reflects the current state of the QMS.

10.3 Continual improvement

Continual improvement is necessary for the effectiveness of the quality management system (QMS).

 

In order to provide a continuous improvement the organisations should:

 

  • Establish a culture of continual improvement: This involves creating a mindset and culture within the organisation that values and encourages continuous improvement.

 

  • Establish quality objectives: Organisations should establish measurable quality objectives that align with the quality policy and meet the needs of their customers.

 

  • Monitor and measure performance: Organisations should establish a system for monitoring and measuring the performance of their QMS in all areas.

 

  • Analyse data: Organisations should analyse the data collected from monitoring and measuring to identify trends, patterns, and opportunities for improvement.

 

  • Implement corrective and preventive actions: Organisations should implement corrective and preventive actions based on the results of their analysis to address nonconformities, prevent their recurrence, and improve the effectiveness of their QMS.

 

  • Conduct management review: Organisations should conduct regular management reviews of their QMS to evaluate its effectiveness, identify opportunities for improvement, and ensure alignment with organisational objectives.

ISO 9001:2015 Clauses

ISO 9001 Overview
Clause 4 - Context of the organisation
Clause 5 - Leadership
Clause 6 - Planning
Clause 7 - Support
Clause 8 - Operation
Clause 9 - Performance evaluation
Clause 10 - Improvement

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