ISO 13485 Measurement analysis and improvement

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ISO 13485 Measurement, analysis and improvement general requirements

The purpose of the measuring processes is to collect, analyze and report data relevant to the medical devices and the realization processes. The analysis shall strive to support the processes, maintain the effectiveness of your quality management system, the quality of the medical devices. The Measurement, analysis and shall promote the organization on a effectively course towards improvement. Pay attention, I use the word "effective" all the time. If I t was a web site that deals with the ISO 9001 Standard, I would have written "continually". But the ISO 13485 Standard demands an effective quality management system. This is one of the, main differences throughput the standard. In order to improve effectively the organization must prepare an improvement plan with objectives, control the execution of the plan, and the results regarding the objectives.

The organization is required to plan implement and monitor the processes for measurements, monitoring and improvements. The purposes are:

ISO 13485 Monitoring and Measurement - Feedback Requirments

In the general flowchart of the ISO standard, the customer is always at the final stage: that means that the organization exists to serve its customers.

The organization is required to constantly assess whether it has achieved the customer's requirements. While the ISO 9001 Standard give large scale to customers' satisfaction, the ISO 13485 Standard does not consider customer's satisfaction as much as customer's feedback about the medical device:

ISO 13485 Monitoring and Mesruement - Internal Audit requirements

One of the most effective acts that organization may conduct in order to monitor, analyze control and improve is the internal audit. I am a big fan of it. This article would last too long if I had to go into most specific details about its significance.
The audit main goal is to give a status report. The tactic of an audit (external or internal) is to evaluate the organization's performances with reference to the requirements. In plain words, it is required from your organization to maintain several activities. The audit evaluates whether the activities are performed and how well they are performed.

The organization is required to perform the internal audit in defined periodical intervals in order to assess the quality management system and to confirm that:

ISO 13485 Monitoring and Measurement of Processes requirements

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.

ISO 13485 Monitoring and Mesurement of Product requirement

The organization is required to measure and monitor the competence of the medical devices to its requirements: customer, quality and regulatory. The purpose is to prevent the organization form realizing with a status report about the quality. Now, there is no chance on earth that we could allow that

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