ISO 15198:2004

Overview

ISO 15198:2004 - "Clinical laboratory medicine - In vitro diagnostic medical devices - Validation of user quality control procedures by the manufacturer" - defines a manufacturer-focused process to validate quality control (QC) procedures recommended for users of in vitro diagnostic (IVD) medical devices. The standard applies to all IVD devices and is intended to ensure that QC procedures in the instructions for use effectively detect device performance failures and support the device’s intended use and claims.

Key topics and requirements

• Manufacturer responsibility: Manufacturers must design, validate and document QC procedures they recommend to users as part of design control and risk management.
• Risk analysis: Conducted per ISO 14971 principles to identify hazards, sources of variability and residual risks not eliminated by design. QC procedures are required to mitigate remaining risks.
• Validation objective: Demonstrate that QC procedures can detect results that fail to meet the device’s performance specifications (accuracy, precision, sensitivity, specificity, etc.).
• Performance evaluation: Use internal and external study data that reflect intended use and user environments when developing and validating QC procedures.
• Instructions for use: Provide clear guidance on acceptable control materials, testing frequency, acceptability criteria, user actions for out-of-spec results, and limitations of the QC procedure.
• Detection methods: Validation may cover use of control materials, electronic monitoring systems, or on‑board chemical/biological controls. Acceptability criteria and failure-detection capabilities must be defined.
• Statistical and metrology references: Terms and evaluation approaches reference ISO 3534-1, ISO 5725-1 and the International Vocabulary of Metrology (VIM).

Practical applications - who uses this standard

• IVD manufacturers (R&D, quality, regulatory affairs): to design and validate manufacturer-recommended QC procedures and to prepare compliant instructions for use.
• Clinical laboratory managers and laboratory directors: to understand manufacturer-provided QC validation data and select appropriate local QC systems.
• Regulatory and quality auditors: to assess manufacturer conformity with design validation and risk mitigation expectations.
• Product development teams: to integrate QC validation into design control and to demonstrate traceability of QC recommendations.

Related standards (for implementation)

• ISO 13485:2003 - medical device quality management and design control
• ISO 14971 - risk management for medical devices
• ISO 3534-1, ISO 5725-1, VIM - statistical terms, precision and accuracy guidance
• Relevant EN standards referenced for control materials and lab information

ISO 15198 supports robust QC practices by aligning manufacturer validation with risk management and user needs, improving the reliability of IVD results and facilitating compliance across regulatory and accreditation frameworks.