You must be able to show, through meaningful and relevant data, that your quality management system is effective. This will allow you to determine where targeted improvements can be made. Data used for this purpose should be gathered from within your organization and from any relevant external sources. Since each company is different, the data you gather will be unique.
ISO 9001 Analysis of Data must include:
Where the analysis shows unacceptable performance then those items should become Quality objectives 5.4.1 and where appropriate, become subject to preventice or corrective action.
The purpose of analyzing data is to:
Data collected for analysis includes:
Effective data analysis is an essential part of any quality management system:
It is not a mandatory requirement to document your analysis of data process. However, you should always look to adequately define and control any operational processes that generate information on the performance of your quality management system. Therefore, the implementation of an analysis of data procedure will be appropriate to the majority of businesses.
Develop and implement a procedure that defines the roles and responsibilities for analyzing quality management system data in order to drive continual improvement and to facilitate a factual approach to decision making:
We provide an Analysis of Data Procedure template to help you manage this process in many of our ISO Templates.
The effectiveness of the analysis of data process is often determined by looking for evidence that the organization has sufficiently utilized data from the outputs of its activities and has used that data to drive continual improvement and enhance customer satisfaction.