ISO 16355-5-2017 PDF

Full title and description

St ISO 16355-5-2017 — "ISO 16355-5:2017: Determination of performance in use of products — Part 5: Guidelines for selection and use of statistical methods" (national adoption). This document provides guidance for selecting and applying statistical methods to assess and determine product performance in use, supporting evidence-based decision making in product design, verification and validation activities.

Abstract

ISO 16355-5:2017 is part of the ISO 16355 series which gives principles and requirements for the determination of product performance in use. Part 5 focuses specifically on guidelines for the selection and use of statistical methods to analyse data obtained in performance evaluation. It covers planning, sampling, measurement uncertainty, statistical modelling, hypothesis testing, confidence intervals, reliability analysis and interpretation of results to support claims about product performance under intended conditions of use.

General information

• Status: Published / In force (nationally adopted where indicated)
• Publication date: 2017
• Publisher: International Organization for Standardization (ISO) — nationally adopted as St ISO 16355-5-2017
• ICS / categories: 01.040.25 (Statistics), 13.020 (Ergonomics, human factors), 01.040.45 (Measurement and measurement methodology)
• Edition / version: ISO 16355-5:2017 (first edition of Part 5)
• Number of pages: Typically ~36 pages (final count may vary by national adoption/format)

Scope

This part of ISO 16355 provides guidelines for selecting and using appropriate statistical methods when determining product performance in use. It is intended to be used by organizations, test laboratories and practitioners involved in planning tests and experiments, collecting and analysing performance data, estimating uncertainties and making statistically justified claims about product behaviour in real-world conditions. It does not prescribe specific performance criteria for particular products but offers a framework for statistically sound evaluation across product types.

Key topics and requirements

• Planning of tests and experiments: defining objectives, requirements, performance indicators and acceptance criteria.
• Sampling strategies: representative sampling, sample size determination and considerations to avoid bias.
• Measurement and data quality: handling measurement uncertainty, repeatability, reproducibility and traceability.
• Statistical modelling and analysis: selection of models, regression, analysis of variance and treatment of covariates.
• Hypothesis testing and confidence intervals: methods to assess conformity, performance claims and significance of observed differences.
• Reliability and lifetime data analysis: techniques for failure-rate estimation, survival analysis and reliability metrics where applicable.
• Interpretation and reporting: presenting results, limits of applicability, assumptions, and communicating uncertainty to stakeholders.
• Integration with other parts of ISO 16355: alignment with performance determination principles and verification/validation processes.

Typical use and users

Users include product designers, quality engineers, test and validation engineers, statisticians, conformity assessment bodies and research organizations. The standard is used when planning and conducting performance tests, analysing experimental or field data to support product claims, comparing alternative designs, and documenting evidence for regulatory submissions or customer communications.

Related standards

Related documents include other parts of the ISO 16355 series (Part 1: Principles and general requirements, Part 2: Data collection and reporting, Part 3: Guidance on verification and validation, Part 4: Methods for determination of performance), ISO standards on measurement uncertainty and statistical methods (for example ISO/IEC 17025 for laboratory competence and guidance, and standards covering reliability and statistics), and sector-specific performance standards that require statistical evaluation.

Keywords

performance in use, statistical methods, sampling, measurement uncertainty, reliability, verification, validation, test planning, data analysis, ISO 16355

FAQ

Q: What is this standard?

A: ISO 16355-5:2017 is Part 5 of the ISO 16355 series and provides guidelines for selecting and using statistical methods to determine product performance in use.

Q: What does it cover?

A: It covers planning of experiments and tests, sampling, measurement uncertainty, statistical modelling, hypothesis testing, reliability analysis and guidance on interpreting and reporting statistical results to support performance claims.

Q: Who typically uses it?

A: Product designers, test and validation engineers, statisticians, quality and compliance professionals, laboratories and organizations performing performance evaluation and reporting.

Q: Is it current or superseded?

A: The document ISO 16355-5:2017 is the published 2017 edition. Users should check with their national standards body or ISO for any amendments or later revisions.

Q: Is it part of a series?

A: Yes — it is part of the ISO 16355 series on determination of performance in use; other parts provide principles, data collection and guidance on verification and validation.

Q: What are the key keywords?

A: Statistical methods, sampling, measurement uncertainty, performance in use, reliability, test planning, data analysis, ISO 16355.