Analyzing data is an essential activity for improving your system and its processes, as well as, your products and services. Data collection has no purpose if the data isn’t examined, evaluated, analyzed, and converted into proposals for decision making.
To judge conformity to the audit criteria, you must clearly understand the requirement.
Clause 8.4 begins, “The organization shall determine, collect, and analyze appropriate data to demonstrate the suitability and effectiveness of the quality management system and to evaluate where continual improvement of the effectiveness of the quality management system can be made.”
Therefore, we analyze the data to show the quality management system is effective (achieving planned results) and to spot where improvements can be made. It is not enough to just collect the data, we must analyze it and reach some conclusions.
Also, Clause 8.4 links back to Clauses 4.1.e and 4.1.f, which state, “The organization shall monitor, measure, and analyze these processes, and implement actions necessary to achieve planned results and continual improvement of these processes.”
Clause 8.4 continues, “This shall include data generated as a result of monitoring and measurement and from other relevant sources.”
This requirement emphasizes that the data we collect, especially numerical facts, are to be included in the analysis.
Clause 8.1 also states, “This shall include determination of applicable methods, including statistical techniques, and the extent of their use.” So, you must consider and identify the methods to be used for analysis. And, you may find that statistical techniques are useful tools for the analysis process.
Clause 8.4 concludes, “The analysis of data shall provide information relating to:
a) customer satisfaction (see 8.2.1),
b) conformity to product requirements (see 7.2.1),
c) characteristics and trends of processes and products including opportunities for preventive action, and
We help you to identify the tools that can be effectively used to analyze your QMS data and gain knowledge on improvement of your product and system.