ISO 9001 9.1 Monitoring, Measurement, Analysis and Evaluation
- wilkshireconsulting
- 3 days ago
- 3 min read
In ISO 9001 9.1 Monitoring, Measurement, Analysis and Evaluation focuses on ensuring that an organization effectively assesses its quality management system (QMS) performance using objective data and meaningful analysis. The core objective of this clause is to ensure decisions are made based on data and evidence, not just intuition or on assumptions. It is divided into three subclasses below.
In this blog post we will be discussing the following:
9.1.1 General Requirements
9.1.2 Customer Satisfaction
9.1.3 Analysis and Evaluation
International Organization for Standardization. ISO 9001:2015 Quality Management Systems – Requirements
9.1 Monitoring, measurement, analysis and evaluation
9.1.1 General
The organization shall determine:
a) what needs to be monitored and measured;
b) the methods for monitoring, measurement, analysis and evaluation needed to ensure valid results;
c) when the monitoring and measuring shall be performed;
d) when the results from monitoring and measurement shall be analysed and evaluated.
The organization shall evaluate the performance and the effectiveness of the quality management system.
The organization shall retain appropriate documented information as evidence of the results.
9.1.2 Customer satisfaction
The organization shall monitor customers’ perceptions of the degree to which their needs and expectations have been fulfilled. The organization shall determine the methods for obtaining, monitoring and reviewing this information.
NOTE Examples of monitoring customer perceptions can include customer surveys, customer feedback on delivered products and services, meetings with customers, market-share analysis, compliments, warranty claims and dealer reports.
9.1.3 Analysis and evaluation
The organization shall analyse and evaluate appropriate data and information arising from monitoring and measurement.
The results of analysis shall be used to evaluate:
a) conformity of products and services;
b) the degree of customer satisfaction;
c) the performance and effectiveness of the quality management system;
d) if planning has been implemented effectively;
e) the effectiveness of actions taken to address risks and opportunities;
f) the performance of external providers;
g) the need for improvements to the quality management system.
NOTE Methods to analyse data can include statistical techniques.
9.1.1 General Requirements
This subclause requires the organization to determine:
1. What needs to be monitored and measured: such as customer satisfaction, product conformity, process efficiency and supplier performance.
2. The methods to ensure valid results: this means using proper tools, equipment, and methods that are suitable for accurate monitoring and measurement.
3. When monitoring and measurement should be performed: establish schedules or frequencies such as monthly performance reviews and quarterly audits.
4. When the results should be analyzed and evaluated: evaluation must be timely to support business decisions and identify improvement areas.
5. Documentation: maintain records to provide evidence of results and evaluations (often referred to as documented information).
The purpose of this section is to ensure that all necessary performance data is collected using reliable methods and evaluated at the right time.
9.1.2 Customer Satisfaction
Customer satisfaction is a key indicator of how well the QMS is performing. ISO 9001 requires that you:
1. Monitor customer perceptions of the quality of products/services.
2. Use methods such as:
· Customer surveys
· Feedback forms
· Online reviews
· Complaints and return rates
· Repeat business metrics
The purpose if this section is to understand how satisfied customers are and where improvements are needed.
9.1.3 Analysis and Evaluation
Once data is collected, it must be analyzed and evaluated to:
1. Demonstrate conformity of products/services
2. Ensure QMS effectiveness
3. Identify opportunities for improvement
This involves examining:
· Trends in nonconformities
· Process performance
· Customer satisfaction data
· Supplier quality
· Internal audit results
· Risk management effectiveness
Tools used might include:
· Statistical analysis
· Pareto charts
· Control charts
· SWOT analysis
· Root cause analysis
The purpose of this section is to use this data to make informed decisions about continuous improvement, strategic planning, and risk mitigation.
In conclusion, implementing Clause 9.1 Monitoring, Measurement, Analysis and Evaluation ensures that organizations make data-driven decisions by systematically monitoring, measuring, analyzing, and evaluating their quality management system performance. In the next blog post we will be diving deeper into 9.2 – Internal Audit.
Related blog posts –
ISO 9001 Clause 9 Performance Evaluation Overview
ISO 9001 - 8 Operation Clause 8: 8.1 – 8.7
ISO 9001 – 7 Support Overview Clause 7: 7.1 – 7.5
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