ISO 9001:2015 Clause 9.1.1 – Monitoring, Measurement, Analysis and Evaluation for QMS Success
Introduction
Unlock the power of performance evaluation with our guide to ISO 9001:2015 Clause 9.1.1. This clause is all about planning what to monitor, how to measure it, and when to analyze the results. Learn how to determine the effectiveness of your Quality Management System, using real-world examples from diverse industries to make your QMS a tool for continuous improvement. With Maxicert’s expertise in ISO certification and implementation support, organizations can establish practical monitoring frameworks that not only meet compliance requirements but also drive smarter decision-making and measurable business growth.
9 Performance Evaluation
This section requires organizations to regularly check how well their Quality Management System (QMS) is performing. It ensures that the QMS is effective, meets quality goals, and supports continual improvement by using data and reviews.
9.1 Monitoring, Measurement, Analysis and Evaluation
This clause focuses on planning and carrying out activities to monitor and measure important aspects of the QMS. It requires deciding what to monitor, how and when to measure, analyzing the results, and using the information to evaluate the QMS’s overall effectiveness and make improvements.
9.1.1 General
The organization shall determine:
- what needs to be monitored and measured;
- the methods for monitoring, measurement, analysis and evaluation needed to ensure valid results, the system:
- when the monitoring and measuring shall be performed;
- 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.
Planning Your Monitoring and Measuring Activities
This clause addresses the wider monitoring, measurement, analysis and improvement of the performance of the quality management system. You need to plan how you intend to carry out the monitoring and measuring activities that you are going to use.
ISO 9001:2015 Clause Guide Panel
- Clause 1
- Clause 2
- Clause 3
- Clause 4 – Sub-clause 1
- Clause 4 – Sub-clause 2
- Clause 5 – Sub-clause 1
- Clause 5 – Sub-clause 2
- Clause 5 – Sub-clause 3
- Clause 6 – Sub-clause 1
- Clause 6 – Sub-clause 2
- Clause 7 – Sub-clause 1
- Clause 7 – Sub-clause 2
- Clause 7 – Sub-clause 3
- Clause 7 – Sub-clause 4
- Clause 8 – Sub-clause 1
- Clause 8 – Sub-clause 2
- Clause 8 – Sub-clause 3
- Clause 8 – Sub-clause 4
- Clause 8 – Sub-clause 5
- Clause 8 – Sub-clause 6
- Clause 8 – Sub-clause 7
- Clause 8 – Sub-clause 8
- Clause 8 – Sub-clause 9
- Clause 8 – Sub-clause 10
- Clause 8 – Sub-clause 11
- Clause 8 – Sub-clause 12
- Clause 9 – Sub-clause 1
- Clause 9 – Sub-clause 2
- Clause 9 – Sub-clause 3
- Clause 9 – Sub-clause 4
- Clause 10
Examples of Monitoring and Measurement Activities
A 2-person Manufacturer of Jams, Jellies and Associated Preserves
The manufacturer established monitoring and measurement at the following stages in the systems:
- Visual inspection of incoming raw fruit for spoilage, disease, etc.
- Weighing of fruit and reconciling the masa introduced into the manufacturing process
- Visual inspection of fruit after peeling, where applicable, for defects which may not have been previously visible
- Monitoring the condition of the fruit as during heating to ensure that it is not over- or under-cooked (checking the texture, colour, aroma and other characteristics of the fruit based on experience and skill)
- Measuring and recording the quantity of sugar and other ingredients added to the batch of fruit being heated
- Visual monitoring of fill levels in jars as an indicator of mass for the specific product being transferred
- Checking the mass of the finished product to ensure that it complies with the legal tolerance for the printed mass of the jar of jam or similar product
- Visual checks on the number of jars packed per case of product
A 6-person Inspection Company for the Oil & Gas Sector
The company identified the following methods:
- Monitoring of technical competence for inspectors is periodically done by the Team Leader or a subcontracted expert
- Inspectors use a calibrated light meter to measure the level of illumination to determine whether there is adequate ambient illumination available, or whether additional light is needed to carry out the inspections
- Analysis of the number of inspections carried out by inspectors each month is done to determine whether customer requirements relating to the volume of inspections are being met
- Evaluation of the degree of kink in the wire rope by comparison with a template with a known angle at the vertex
A Regulatory Inspection Agency
Based on its experience:
- Monitoring of imported electrical items from a new supplier shall be done for the first batch, and for every batch thereafter for the next year.
- Subsequently monitoring shall be relaxed to once every three months if there are no nonconforming electrical items detected.
- If nonconformities are detected then monitoring shall be done on a per shipment basis for another calendar year.
A Printing Company Using an Offset Process
- Measurement of the print dimensions for full-colour A3 posters shall be done on one out of every one hundred (1% inspection) prints.
A Shipping Agency of 15 Employees
A Construction Company Providing Excavation, Supply and Compaction of Structural Fill Material and Load-Bearing Concrete
The company applies the following methods to ensure implementation of monitoring and measurement activities:
- Supervisors are provided with the approved Inspection and Test plans for the job
- The Quality Control person assigned to the job ensures that inspection of stage completion is done prior to the job being allowed to progress to the next stage, e.g., the depth of excavation is verified based on reports from the civil surveyors before approved structural fill is allowed to be placed into the excavated hole
- As the pouring of load-bearing concrete is a process requiring validation (a “special process”), the Quality Control personnel ensure the following records are retained:
- The design mix and actual quantities for the concrete from the batching plant
- Certificates of analysis for the raw materials (cement, water, sand, gravel, etc.) used in preparing the batch of concrete
- Approved procedures for the mixing and delivery (pouring) of concrete
- Competence records for the batch plant operator and the concrete pour operator
- Certification for the batch plant and the concrete pour equipment (e.g., the concrete mixer and pump)
- Records of the characteristics of the concrete at the time of the pour (e.g., a Pour Card) such as slump test result, temperature, water added and quantity of water added.
A Supplier of Technical Services to the Oil and Gas Sector
- Reviews the performance of parts of its QMS on a monthly basis at management meetings.
- The overall effectiveness of the QMS is evaluated twice a year.
A Regulatory Agency
- Evaluates quality performance through the use of a “Balanced Scorecard” approach on a quarterly basis.
- The overall effectiveness of the QMS is evaluated once a year.
Conclusion
Ultimately, ISO 9001:2015 Clause 9.1.1 is the compass for your quality management system. It’s not enough to simply have a system in place; you must actively monitor and measure its performance. By systematically determining what, how, and when to evaluate your processes, you gain the data needed to make informed decisions. This proactive approach ensures your QMS remains effective, allows you to proactively identify areas for improvement, and provides the clear evidence needed to demonstrate your commitment to quality. With Maxicert as a trusted partner, businesses can transform evaluation practices into a powerful driver of continual improvement and long-term customer satisfaction.
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FAQ
What is Clause 9.1.1 about in ISO 9001:2015?
Clause 9.1.1 explains how organizations should decide what to monitor and measure in their quality management system, how to do it properly, and when to review the results to check if the system is working well.
Why is monitoring and measuring important for a Quality Management System?
Monitoring and measuring help businesses see if they are meeting their quality goals, find areas that need improvement, and make better decisions to keep customers happy and the system effective.
What are some examples of monitoring activities an organization might do?
Examples include checking raw materials for defects, measuring production output, surveying customer satisfaction, or reviewing service delivery to ensure everything meets set standards.
How often should an organization analyze and evaluate quality data?
The frequency depends on the organization and its processes. It can range from daily checks on important steps to quarterly or annual reviews of overall system performance, ensuring timely improvements.
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