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The ISO 9001 Standard requires collecting data from the processes and analyzing them in order to maintain improvement. So does his cousin the ISO 13485 Standard but with some crucial differences:
ISO 9001
| ISO 13485
| The data analysis should apply whether the organization complies with the quality management policy and objectives and the how much effective the quality management system is. The analysis must indicate opportunities for improvement.
| The data analysis should demonstrate whether the organization complies with the quality management policy and objectives and must indicate about the quality management effectiveness and to evaluate where improvement of the effectiveness is required.
| The organization is required to determine which type of data would be gathered, the resources of this data, the frequent of collecting the data, and the way they should be analyzed. Of course the data should refer to the quality policy and the quality objectives.
| The organization is required to maintain a documented procedure describing which type of data would be gathered, the resources of this data, the frequent of collecting the data, and the way they should be analyzed. Records of gathering the information and analyzing it would be documented and kept as a quality record.
| The data analysis must refer to the next issues:
| The data analysis must refer to the next issues:
| Customers' satisfaction
| Customers' feedback gathered according to the requirement in paragraph 8.2.1
| Conformity to products requirements
| Conformity to products requirements
| Information about the realization of processes and products.
| Information about the realization of processes and products.
| Information regarding suppliers
| Information regarding suppliers
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Data analysis shall indicate some kind of a status report regarding processes, products, quality objective and any other quality management system element that may have an effect on your products and can be measureable.
Determining the information required The ISO 13485 Standard requires a documented procedure that describes the whole data analysis process: - Which information is required (the type of the data)? Of course the data must be appropriate to the quality management system's objectives. It is one of the top management bad habits to analyze information that is not related or relevant to the quality management system because it is not so interesting. Numbers and profits are much more interesting than customer's returning if you sit at the top management.
- Where this information exists (what documentation is relevant to the data analysis)? Forms, information system etc.
- How frequently the data is gathered? Daily, weekly, monthly, quarterly, yearly etc.
- Who is responsible to perform the analysis?
The effectiveness of your quality management system The data gathered and analyzed should indicate the effectiveness of the quality management system. In fact, data analysis is the most obvious tool to measure the quality management system effectiveness. Why? Because you have a clear numerical picture of your quality management system versus the requirements: quality objectives, customers' requirements, regulatory requirements. Effectiveness: The extent to which planned activities are realized and planned results achieved. Looking at the numbers you may say "Our quality management system is effective because we accomplished…." Or you may say "We failed. Numbers are showing that we wasted our time and resources…" or "The numbers are not sufficient to get a clear picture, but it shows that we are the on right track." While the ISO 9001 Standard requires analyzing customer's satisfaction the ISO 13485 Standard requires analyzing customer's feedback. What is the difference? The ISO 13485 Standard gives less scale to customer's satisfaction,as for achieving the customer's requirements. This is due to the nature of medical devices and the requirement for competing to regulatory requirements of some kind. The ISO 13485 Standard requires also that results of the data analysis would be included within the records control. That means that your records control procedure must include reference to the results of data analysis.
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