In many organizations (manufacturing or services) the processes present variability, this means they are not completely stable. The ISO 10017 standard seeks to help organizations in the identification of statistical techniques which can be useful in the development, implementation, maintenance and improvement of a quality management system, in compliance with the ISO 9001:2015 standard requirements.
Variability can be confirmed in those quantifiable characteristics of the products and processes, and can be observed at the exit of various stages in the total life cycle of the products.
The main benefit of the application of statistical techniques is they facilitate the measurement, description, analysis and interpretation of variability in the processes, even with a relatively limited amount of data. In fact, statistical analysis of this data can provide a greater understanding of the nature, extent, and causes of variability. This contributes to solve and even prevent problems that could result from such variability.
This is how statistical techniques become tools for the proper handling and use of data available for decision-making, which undoubtedly contributes to the continuous improvement of the quality of products and processes to achieve Customer Satisfaction. These techniques can be applied in various activities, such as market research, design, development, production, verification, installation and service.
ISO 10017: Guidance on statistical techniques for the ISO 9001 standard
The ISO 10017 standard is a technical report that aims to guide and assist any organization in the consideration and selection of statistical techniques appropriate to their needs. It should be noted that the criteria for determining the need for statistical techniques, and the appropriateness of the techniques selected, is a decision subject to each company. The aforementioned techniques can be useful in the development, implementation, maintenance and improvement of a quality management system in compliance with the ISO 9001 standard.
To this end, it is essential that the requirements of the ISO 9001 standard which involve the use of quantitative data are examined, and in this way, the statistical techniques that are useful in applying them to these data are identified and described.
The ISO 10017 standard clarifies that its content of statistical techniques is not complete or exhaustive, and does not exclude the use of any other technique which may be considered beneficial for the organization. It does not try to establish which techniques should be used, nor does it advise on how to implement them. Even this standard specifies that statistical techniques can be applied from qualitative data as long as they can be transformed into quantitative data.
Major statistical techniques that can be used by organizations
- Descriptive statistics
- Design of experiments
- Hypothesis test
- Measurement analysis
- Process capacity analysis;
- Regression analysis
- Reliability analysis
- Statistical process Control charts (CEP);
- Fixation of statistical tolerances;
- Time-series analysis.
From this group of techniques, descriptive techniques (including graphical methods) are an important aspect of many of these techniques.
Application of statistical techniques in accordance with ISO 9001:2015 standard
The chapters in which statistical techniques are required to be applied in accordance with ISO 9001:2015 are as follows:
Chapter 6: Planning, in number 6.1. Actions to address risks and opportunities
Chapter 7: Support, in the numeral 7.1.5. Monitoring and measuring resources
Chapter 9: Performance evaluation, in numeral 9.1. Monitoring, measurement, analysis and evaluation
Definitively, the use and application of statistical techniques is essential for organizations, because decision-making must be based on objective data.
To the novice quality manager, ISO jargon can be extremely overwhelming. What is an NCR? What do you mean by OFI? Are we certified or accredited? But before you go and pull out your hair, let’s take a moment to go over some of the most frequently used terms and their definitions with regards to ISO and Management System Certification.