ISO 9001 Quality Management System requires the organization to use factual information as a basis for decision making. The clause 9.1 monitoring, measurement, analysis and evaluation in ISO 9001 caters to this requirement.
Monitoring means observing the status of a system, process or activity.
Measurementis the process to determine a value.
For your Quality Management System (QMS)to work effectively, you need evidence on the basis of which you make your decisions and for continuous improvement. Measurement and Monitoring is the process in ISO 9001with which you can collect that evidence.
ISO 9001 requires you to generally determine
- What is needed to be monitored and measured?
- What methods shall be used for the monitoring, measurement, analysis and evaluation needed to ensure valid results?
- When the monitoring and measuring shall be carried out?
- When results from monitoring and measurement be analyzed and evaluated?
It is a requirement that the organization shall evaluate the performance and effectiveness of the Quality Management System. It is also required that the records for monitoring, measurement, analysis and evaluation shall be kept.
Your ISO 9001 Consultant will advise you broadly to
First, plan how you are going to monitor, measure, analyze and evaluate your organizationâ€™s quality management system .
Second, to monitor, measure, analyze and evaluate the QMS performance and its effectiveness.
The objective of the organization is to have happy and contended customers. It is a requirement that the organization shall monitor the customerâ€™s perception of the level to which their needs and expectations have been met.Â So, how are we going to know that the customer is happy? The organization will have to determine the methods for obtaining, monitoring and reviewing the information relating to customer satisfaction.
Some ways of collecting this information can be customer surveys, customer feedback on delivered products and services, meetings with customers, market-share analysis, compliments, warranty claims and dealer reports.
An effective Quality Management System is based on the foundation of processes that ensure that customerâ€™s expectations are met and exceeded. Letâ€™s take an example of an organization that is manufacturing air-conditioners for a customer and see where the definition of monitoring & measurements goes in:
- The air-conditioner is made to customerâ€™ documented and agreed specification. Can the organization provide the resources and take the measurements initially to make sure that the specified and actual products are the same? If yes then has the organizationthe resources and processes to make sure that the output remains constant through the process of ongoing monitoring to protect our performance and reputation and satisfy the customer?
- The air-conditioner is ready for the final testing before its shipment to the customer. Now can the organization provide the resources and also design the process to make sure that the performance as well as characteristics of the manufactured air-conditioner matches the expected performance of the customerâ€™s specification? Measurements shall be taken of the parameters and monitoring shall be carried out if the answer is yes.
Analysis and evaluation
The factual information and data arising from the monitoring and measuring activities shall be analyzed and evaluated.The ISO Consultant can advise the organization to use appropriate statistical techniques to analyze and evaluate the information.
This analysis is of great benefit to the organization and shall be used in various ways to evaluate:
- Conformity of products and services to specifications.
- Level of customer satisfaction.
- Performance and evaluation of the quality management system.
- If the planning has been implemented effectively.
- Have the actions to address risks and opportunities been effective.
- The level of performance of external providers.
- Any need for improvement of the quality management system.
These factors can be used as inputs to the management review to improve the products, processes and the quality management system.
Root Cause Analysis is a technique used to find the reason for problems. It is used by the organization to find out the main reasons for the defects or other problems. The general steps involved are first identifying a problem, second performing a diagnosis, third, selecting and implementing solutions and finally leveraging and sustaining the results.
Fish bone diagram(a form of root cause analysis) also called cause-and-effect diagram or Ishikawa Diagram identifies many possible causes for a problem or effect. It can be used for a brainstorming session. It is used when the organization is identifying possible causes for a problem and when the thinking of the team falls into ruts. The main quality problem is labeled as the head of the fish. The major categories of potential causes are written down as bones and the likely specific causes as ribs.
The Scatter Diagram makes a graph of pairs of numerical data and is also called the X-Y graph. If you want to analyze one variable with another variable, then scatter diagram is the right statistical tool for you. The scatter diagram shows whether two variables are related. It is used when managers suspect that a certain factor is causing a particular quality problem.
Organisation are looking to achieve ISO 9001 Certification for several reasons eg: getting pre qualified for tenders, Customer request, etc,. To develop and Implement systems quickly and have a systems that adds value to your organisation you may need the services of specialist ISO 9001 Consultants who can guide you through the requirements of the ISO 9001 Quality management system and help you identify activities that need to be monitored, measured and analyzed correctly as it has an huge impact on the organizationâ€™s strategy for survival and growth.