8.4 Analysis of data

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 organisation 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 corrective or preventive action.

Why should I analyse data?

The purpose of analysing data is to:

  • Assess organisational performance against established plans and stated quality objectives
  • Identify areas for improvement
  • Help determine the cause of problems
  • Provide guidance for determining the most appropriate corrective or preventive action to take

How do I collect data for analysis?

Data collected for analysis includes:

  • Results from customer surveys
  • Results from employee surveys
  • Customer, supplier and employee feedback
  • Results from internal audits
  • Results from process monitoring and measurements
  • Results from product monitoring and measurements
  • Non-conformance reports
  • Warranty claims and returned products

How do I analyse data?

Effective data analysis is an essential part of any quality management system:

  • Use statistical techniques where appropriate (e.g. Statistical Process Control)
  • Data should be analysed by designated, competent personnel
  • Use data feedback for continuous product and process improvement

Should I document our analysis of data process?

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.

How's best to document the process?

Develop and implement a procedure that defines the roles and responsibilities for analysing quality management system data in order to drive continual improvement and to facilitate a factual approach to decision making:

  • Data collection
  • Data analysis
  • Information output
  • Reporting

Looking for help documenting the process?

We provide an Analysis of Data Procedure template to help you manage this process in many of our ISO Templates.

Measuring analysis of data process effectiveness

The effectiveness of the analysis of data process is often determined by looking for evidence that the organisation has sufficiently utilised data from the outputs of its activities and has used that data to drive continual improvement and enhance customer satisfaction.