Clause 9 of ISO 9001 is a dedicated clause for performance evaluation that defines the requirements to evaluate the performance of the Quality Management System processes to ensure their smooth functioning. It is very critical for an organization to identify how, when and where, certain processes are to be monitored, measured, analyzed and evaluated in order to check if they meet the pre-defined requirements and meet customer satisfaction. It is also important to check the effectiveness of the Quality Management System to ensure that the objectives are being met. This can be achieved by putting in place an effective measurement, monitoring, analysis and evaluation methods, Internal Audit and Management Review System.

Clause 9 specifies the below mentioned key requirements which are to be met for an effective performance evaluation –

1. How, when and what results will be monitored and measured?
2. Which methods are to be adopted for monitoring and evaluating customer satisfaction?
3. Is an efficient internal audit system in place?
4. Is the QMS being reviewed by Management at planned intervals?

Why is it required?

The primary objective of a Quality Management System is to meet customer requirements and improve customer satisfaction. When we set up quality objectives for our Quality Management System, it is also important to define methods to ensure these are met. Otherwise, the whole exercise of setting up a quality management system will be futile if we do not put mechanisms in place to evaluate the performance of the management system through in-process measures, monitoring systems, internal audits and management reviews. Without effective monitoring, we will end up not meeting the customer requirements and would hear complaints from the customer with respect to the quality of the products or services. And, in the long run, organizations lose their valuable customers and their market shares. Therefore, it is critical for any organization to have systems in place that ensure that performance is evaluating at defined intervals. Let’s see how the areas that this clause talks about help in bringing effectiveness to your quality management system.

• When you put effective monitoring systems in place in your organization, this helps you have controls on the processes defined under “operation”.
• When you define in-process measures and develop metrics, this helps you identify variations in time and you will be able to take actions to control the process. Additionally, this will help process owners and Top Management to understand the process performance through review of these measures and helps them to make
• An Internal Audit System helps you to determine non-conformities in processes early and plan actions to prevent them so that they do not lead to non-conforming products in future.
• Putting in place the monitoring, measurement, analysis, and evaluation criteria and methods helps in determining the continual improvement requirements of the organization.
• Applying key process indicators (KPIs) helps in the achievement of quality objectives
• Having methods to determine customer satisfaction provides helpful insights into consumer intentions on the repurchase and improves customer retention.

ISO 9001 Clause 9 is important for every organization as it helps in continually evaluating its overall performance in comparison to its pre-set objectives. It helps in identifying the problem areas and focusing on the most important areas of the business. It also brings out a consistent set of requirements for checking results against the plan. So, once the processes of QMS are well in place and functioning properly, this will automatically lead to high customer satisfaction, resulting in a high customer base and market share.

Monitoring, Measurement, Analysis and Evaluation

The entire purpose of this section is to help an organization determine which processes are required to be monitored and measured, how are these to be measured and how/when are these to be analyzed and evaluated. By planning all these aspects, the organization can easily keep a check on its critical processes. By performing the above-mentioned steps, a business owner can easily understand which processes are functioning properly and which ones need attention.

ISO 9001 requirements recognize customer satisfaction as a very critical indicator of performance for any organization. Customer satisfaction is used to understand how the product or service offered by the company meets or exceeds the expectations of the customers. By seeking feedback from its customers, a company can make the required improvements in its processes.

Merely gathering the measurements and data does not yield any results until the data is analyzed and evaluated. After the proper analysis and evaluation of the data, the results can be used to evaluate the –

1. Degree of customer satisfaction.
2. The conformity of products and services.
3. The performance of QMS processes.
4. The effectiveness of plans implemented
5. The performance of external providers
6. The effectiveness of actions taken to address risks and opportunities.
7. Needs of improvement within the Quality Management System

This analysis and evaluation will finally lead to the identification of red flags early on and taking actions to ensure that the Quality Management System improves.

Internal Audit

Internal auditing is an independent exercise designed to add value and improve an organization’s operations. An organization can evaluate and improve the effectiveness of its quality management system by conducting internal audits following a systematic and disciplined approach. It is an effective tool to evaluate if the systems in place in the organization are meeting the requirement of its own quality management system, ISO 9001, customer and regulatory requirements. ISO 9001 clearly defines internal audit requirements where these audits should be planned at defined frequencies, carried out by independent and trained internal auditors and recorded.

Management Review

The last requirement of this clause is that the Top Management of the organization should review the Organization’s Quality Management System at planned intervals. This will ensure the Quality Management System’s continuing suitability, adequacy, effectiveness and alignment with the strategic direction of the organization. The Management should review various aspects of the Quality Management System using inputs like the status of actions of last management review, changes in context, adequacy of resources, risks and opportunities, quality performance and effectiveness, etc., and derive outputs like opportunities for improvement, changes to QMS and resource needs.