Measuring processes was already mentioned many times throughout the standard: quality manual, quality objectives, management responsibility, and control of production and service provision. Until this paragraph the ISO 13485 Standard specified where he expects to find monitoring and measurement of processes activities. On paragraph 8.2.3 he specifies how it expects us to perform monitoring and measurement of processes.

The main ideas are:

• Analyzing realized outputs compared to planned outputs
• Avoiding the possibility of realizing a defect product

The organization must evaluate its performances compared to planned objectives. The medical device must conform to its specification. Measuring and monitoring the processes shall achieve it. The measurements must also provide the information about the ability of the processes to deliver the desired medical device. It is a kind of a status report regarding the processes with implications over the product.

The measurement of processes should include different aspect of the processes. The processes are the ones mentioned in the quality manual; both quality processes and the product realization processes. Processes mentioned here include all the realization processes:

• Development processes
• Acceptance processes
• Production and realization processes
• Delivering processes

In order to make it easier to measure and analyze, set a quantitative criteria to the realization processes. The status report would be much clearer and usable.

Pay attention. When evaluating quality processes, you are required not only to verify that they are defined and had been performed, but also evaluating the results, and whether the processes achieved their objectives. For example, when you are evaluating the management review process, you are required to evaluate whether the decisions were carried out according to schedules. When you are evaluating the internal audit process, you are required to verify that non-conformities are left open.  

The measurement shall be conducted according to defined methods for monitoring and measurements. The methods are not required to be documented (as procedures or work instructions). The defined method shall include all the requirements:

• Definition of the measured processes
• The method for measuring every process
• Results required
• The responsible party for conducting the measurements
• The treatment for any detected non conformity.    

Evaluating and monitoring processes would obtain an effective quality management system. It is mainly because the ISO 13485 Standard (as well as the ISO 9001  Standard ) requires a corrective action for every deviation from planned results.

The most common measurements are:

• Planned duration of processes compared to achieved duration of processes -
• Planned costs of processes compared to achieved costs
• Measurements of substructures and their performances - malfunctions, capacity, utilization etc.
• Measurement of Resource utilization - material, rework, human resources etc.
• Deviations from production requirements – production cycles, resources, scrap
• Control over measuring devices

After defining conducting controlling measuring and monitoring the organization shall define a process to ensure appropriate corrective actions to non conformities detected following the measurements. The corrective actions must be designated to achieve the products specifications. It is not required to document it on a procedure. When it occurs that process provides an inappropriate output, the organization is required to set the measures to eliminate these inappropriate outputs and prevent them from reoccurring. The most recommended way is to introduce such cases to the corrective action process.