Monitoring,Measurement, required by ISO 9001
ISO 9001 Quality Management System requires the organization to use factual information as a basis for decision making. This requirement is met by clause 9.1 monitoring, measuring, analyzing and evaluating in ISO 9001.
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.
Let â€™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 customer â€™ 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 organization the 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 customer â€™s specification? Measurements shall be taken of the parameters and monitoring shall be carried out if the answer is yes.