ISO 10017:2021

ISO 10017:2021 - Overview

ISO 10017:2021, "Quality management - Guidance on statistical techniques for ISO 9001:2015", provides guidance for selecting appropriate statistical techniques to support a quality management system (QMS) in conformity with ISO 9001:2015. Intended for organizations of any size or complexity, the standard helps identify which statistical methods can assist in developing, implementing, maintaining and improving quality processes. It is important to note that ISO 10017:2021 does not teach how to apply the techniques - it guides the selection and applicability only.

Key Topics

ISO 10017:2021 maps statistical methods to QMS needs and explains benefits, limitations and typical uses for each. Major topics include:

• Descriptive statistics - summarizing data to understand central tendency and variation.
• Design of experiments (DOE) - identifying influential factors to optimize processes.
• Hypothesis testing - supporting data-driven decisions and comparisons.
• Measurement system analysis (MSA) - assessing measurement repeatability and reproducibility.
• Process capability analysis - evaluating whether processes meet specifications.
• Regression analysis - modelling relationships between variables.
• Reliability analysis - assessing product or system lifetime performance.
• Sampling - planning representative data collection to make valid inferences.
• Simulation - modelling complex systems to predict outcomes and risks.
• Statistical process control (SPC) - monitoring process stability and detecting special causes.
• Statistical tolerance and time series analysis - addressing specification limits and trend/forecasting needs.

The document also cross-references normative standards (e.g., ISO 3534 parts and ISO 9000:2015) to align terminology and concepts.

Practical Applications

ISO 10017:2021 is valuable for organizations wanting to:

• Choose the right statistical approach to improve product quality and process performance.
• Support ISO 9001:2015 clauses that require data-informed decision-making, monitoring and measurement.
• Integrate statistical thinking into corrective actions, process improvement and risk mitigation.
• Apply statistical methods across sectors - manufacturing, services, environmental management, health & safety and more.

Typical users:

• Quality managers and process engineers
• Data analysts and reliability engineers
• Internal auditors and compliance teams
• Continuous improvement and Six Sigma practitioners

Related Standards

• ISO 9001:2015 - Quality management systems - Requirements
• ISO 9000:2015 - Fundamentals and vocabulary
• ISO 3534 (parts 1–4) - Statistics - Vocabulary and symbols
• ISO/TR 10017:2003 (replaced by ISO 10017:2021)

Using ISO 10017:2021 helps organizations make informed choices about statistical tools, ensuring data-driven improvement aligned with ISO 9001:2015 requirements.