ISO 9001 Clause 10 Improvement Overview
- wilkshireconsulting
- 3 minutes ago
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In ISO 9001 10 Improvement ensures that an organization continuously enhances the effectiveness of its Quality Management System (QMS) and improves its ability to meet customer needs and regulatory requirements. The idea of clause 10 improvement is not to just react to problems but to proactively seek ways to make processes, products, services and customer satisfaction better.
10 Improvement consists of 3 different sections:
10.1 General
10.2 Nonconformity and corrective action
10.3 Continual improvement
International Organization for Standardization. ISO 9001:2015 Quality Management Systems – Requirements
10 Improvement
10.1 General
The organization shall determine and select opportunities for improvement and implement any necessary actions to meet customer requirements and enhance customer satisfaction.
These shall include:
a) improving products and services to meet requirements as well as to address future needs and expectations;
b) correcting, preventing or reducing undesired effects;
c) improving the performance and effectiveness of the quality management system.
NOTE Examples of improvement can include correction, corrective action, continual improvement, breakthrough change, innovation and re-organization.
10.2 Nonconformity and corrective action
10.2.1 When a nonconformity occurs, including any arising from complaints, the organization shall:
a) react to the nonconformity and, as applicable:
1) take action to control and correct it;
2) deal with the consequences;
b) evaluate the need for action to eliminate the cause(s) of the nonconformity, in order that it does not recur or occur elsewhere, by:
1) reviewing and analysing the nonconformity;
2) determining the causes of the nonconformity;
3) determining if similar nonconformities exist, or could potentially occur;
c) implement any action needed;
d) review the effectiveness of any corrective action taken;
e) update risks and opportunities determined during planning, if necessary;
f) make changes to the quality management system, if necessary.
Corrective actions shall be appropriate to the effects of the nonconformities encountered.
10.2.2 The organization shall retain documented information as evidence of:
a) the nature of the nonconformities and any subsequent actions taken;
b) the results of any corrective action.
10.3 Continual improvement
The organization shall continually improve the suitability, adequacy and effectiveness of the quality management system.
10.1 General
The organization must identify and select opportunities for improvement and implement any necessary actions to meet customer requirements and enhance customer satisfaction.
Key focus areas include:
· Improving products and services to meet requirements and address future needs.
· Correcting, preventing, or reducing undesired effects.
· Improving overall QMS performance and effectiveness.
Purpose: Continual improvement is required not just when things go wrong but as a regular part of running the organization.
10.2 Nonconformity and corrective action
When a nonconformity occurs – such as something doesn’t meet the requirements, the organization must:
1. React to the nonconformity, and if applicable:
o Take action to control and correct it.
o Deal with the consequences.
2. Evaluate the need for action to eliminate the cause of the nonconformity.
o Review and analyze the nonconformity.
o Determine the root cause(s)
o Implement corrective action to prevent recurrence
3. Verify the effectiveness of any corrective action taken.
4. Update risks and opportunities if necessary.
5. Make changes to the QMS if needed.
6. Retain documented information about:
o The nature of the nonconformities
o Actions taken
o Results of corrective actions
Corrective actions aim not only to fix immediate problems but also address root causes so the same issues do not happen again.
10.3 Continual improvement
The organization must continually improve the suitability, adequacy and effectiveness of the QMS.
Approaches may include:
· Innovation (new technologies, methods)
· Improvements in efficiency, effectiveness, or performance
· Enhancing customer satisfaction
· Improving the way risks and opportunities are managed
This ensures that the organization doesn’t become complacent and is always striving to perform better, even when things are working “fine.”
In conclusion, Clause 10 Improvement overview emphasizes the importance of continual improvement to enhance the effectiveness of the QMS and increase customer satisfaction. Requiring organizations to address nonconformities by identifying root causes and implementing corrective actions to prevent recurrence. Overall, this clause fosters a proactive culture focused on long-term growth, efficiency, and quality enhancement. In the next blog post we will be diving deeper into 10.1 General.
Related blog posts –
ISO 9001 Clause 9.3 Management Review
ISO 9001 Clause 9.2 Internal Audit
ISO 9001 9.1 Monitoring, Measurement, Analysis and Evaluation
ISO 9001 Clause 9 Performance Evaluation Overview
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