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standards

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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
  • Sampling
  • Simulation
  • 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.

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Accreditation bodies allow organizations seeking accreditation can demonstrate to their customers that they have been successful at meeting the requirements of international accreditation standards.

An accreditation body (AB) is an organization that provides accreditation services, which is a formal, third party recognition of competence to perform specific tasks. In other words, it means that organizations seeking accreditation can demonstrate to their customers that they have been successful at meeting the requirements of international accreditation standards.

In the last few decades many specified standards have been developed, and with them the number of organizations that check conformity and compliance with these standards has grown. These organizations provide services such as testing, inspection, calibration and certification and they may be laboratories, inspection bodies, certification bodies or other types of organizations. Anything or anyone can be evaluated (products, equipment, people, management systems or organizations) and the role of an accreditation body is to assess the technical competence and integrity of the organizations offering these kinds of evaluation services by:

  • Ensuring that certification bodies, inspection agencies, calibration/testing laboratories and other conformity assessment bodies meet established standards that will enable them to provide a service in an objective and independent manner.
  • Ensuring compliance with codes of ethics/conduct when providing assessment services.
  • Examining the competence of the organization’s staff.
  • Verifying the scope of an organization’s services. There are many sector specific standards and because not all organizations perform the same work or have similar capabilities, accreditation bodies can help identify and qualify those that are competent to perform a defined scope of work.

Regarding the quality of products and services, accreditation bodies play an important role because many are motivated to define and measure quality in a particular field. In their vision and mission statements, most accreditation bodies include quality improvement in their respective field. This helps keep accredited programs constantly focused on quality improvement as one of their own measures of success.

When an organization has been accredited by an accreditation body it means that they have been assessed against internationally recognized standards to demonstrate their competence, impartiality and performance capability. This serves as a means to identify a proven, competent evaluator so that the selection of a laboratory, inspection or certification body is an informed choice.  Most accreditation bodies provide a list of the organizations they have accredited, facilitating the search of these accredited organizations.