ISO 9001 Clause 10.1 General
- wilkshireconsulting
- May 2
- 2 min read
In ISO 9001 10.1 General focuses on setting the foundation for how an organization should approach improvement. It requires that an organization identify and act on opportunities to improve its products, services, processes and the overall effectiveness of the Quality Management system (QMS). The idea of 10.1 is to consistently enhance customer satisfaction and adapt to changing needs, risks, or opportunities.
In this blog post we will be discussing the following:
Key Requirements of 10.1
How can your organization comply
What this clause does NOT require
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.
Key Requirements of 10.1
The organization must determine and select opportunities for improvement and implement any necessary actions to meet customer requirements and enhance customer satisfaction. Specifically, this includes:
1. Improving products and services:
· Ensuring output consistently meets requirements.
· Enhancing performance, durability, usability, or other customer-valued features.
2. Correcting, preventing, or reducing undesired effects:
· Addressing inefficiencies, defects, waste, or anything that hinders performance.
· Minimizing negative impacts on customers, stakeholders, or operations.
3. Improving the performance and effectiveness of the QMS:
· Making systems, processes, and controls more effective and efficient.
· Ensuring better alignment with the organization’s strategic goals.
How can your organization comply with 10.1
· Monitor performance using data and KPIs.
· Analyze customer feedback and complaints.
· Conduct regular reviews and audits.
· Implement process improvements, new technologies, or training.
· Foster a culture of innovation and employee involvement.
What clause 10.1 does NOT require
1. It does NOT mandate a specific method of improvement (e.g., Kaizen, Six Sigma), but you can use those if suitable.
2. It does NOT require improvement only after problems occur – proactive and innovative improvements are encouraged.
In conclusion, clause 10.1 General emphasizes encouraging organizations to take structured and ongoing approach to improvement. It aims to ensure that improvements are purposeful, data-driven, and aligned with both customer expectations and business strategies. Clause 10.1 lays the groundwork for more specific actions described in the next 2 blog posts on Clauses 10.2 Corrective action and 10.3 Continual improvement.
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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Phone: (248) 890-9283
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