ISO TR 80002-2-2017 PDF

Full title and description

ISO/TR 80002-2:2017 — Medical device software — Part 2: Validation of software for medical device quality systems. This technical report provides guidance for planning and performing validation of software that is used to support medical device quality management systems, production and service provision, and monitoring and measurement activities associated with medical device quality systems (ISO 13485 context). It is intended to help manufacturers, suppliers and auditors apply a risk-based, lifecycle approach to validating QMS- and production-related software.

Abstract

ISO/TR 80002-2:2017 gives practical, risk-based guidance on how to validate software used within a medical device quality system (for example software for design, manufacturing, labelling, packaging, distribution, complaint handling and other QMS activities). It clarifies which software is in scope (QMS/process software) and which is out of scope (software that is itself a medical device or software that is a component of a medical device) and describes lifecycle activities, validation planning, tools and evidence requirements including validation reports and release controls.

General information

• Status: Published.
• Publication date: June 2017 (effective/published 13 June 2017).
• Publisher: International Organization for Standardization (ISO).
• ICS / categories: 11.040.01 (Medical equipment in general); 35.240.80 (IT applications in health care technology).
• Edition / version: Edition 1 (2017).
• Number of pages: 84 pages.

Scope

The report applies to software used to support the medical device quality system: software used in quality management processes, production and service provision, and for monitoring and measurement of requirements. It explicitly does not apply to software that is itself a medical device nor to software that is a component, part or accessory of a medical device. The guidance covers validation planning, risk-based determination of validation depth, selection of validation tools and activities, handling legacy systems, cross-system functions (for example ERP components) and evidence expected to demonstrate validated status.

Key topics and requirements

• Risk-based scoping: determine whether a software application is in-scope for validation based on its role in the QMS and the potential impact of failures.
• Validation planning: document decisions, rationale and the level of effort required; capture chosen confidence-building activities and tools.
• Lifecycle approach: apply controlled development/implementation, testing and deployment activities consistent with the software’s intended use and complexity.
• Toolbox of activities: guidance on selecting and applying activities such as requirements definition, code review, functional and integration testing, user acceptance testing and performance checks.
• Validation evidence and reporting: prepare a validation report summarizing the objective evidence that supports the conclusion that the software is fit for intended use, and control software release to ensure the released item matches what was validated.
• Retrospective validation and revalidation: directions for handling software already in use and for revalidation after changes or repurposing.
• Partitioning and ERP/enterprise systems: advice on rationalizing scope where software includes non‑medical functions or integrated modules.
• Alignment with ISO 13485 and regulatory expectations (e.g., FDA production/process controls): use of this TR to support compliance with QMS validation requirements.

Typical use and users

Primary users are medical device manufacturers and their quality/engineering teams who must validate process and QMS software. Other users include software suppliers of QMS/production tools, regulatory and conformity assessment auditors, QA consultants and compliance engineers. The report is used to design validation procedures, risk assessments, test strategies and validation evidence packages for applications such as LIMS, MES, ERP modules, document management, complaint handling and production control systems.

Related standards

Key related documents and standards include ISO 13485 (quality management systems for medical devices), ISO/TR 80002-1 (guidance on medical device software), IEC 62304 (medical device software lifecycle processes) and ISO 14971 (risk management). Regulatory and guidance documents such as FDA software validation guidance and 21 CFR 820.70 (production and process controls) are also relevant when applying this TR in regulated jurisdictions.

Keywords

medical device software, software validation, quality management system (QMS), ISO 13485, risk-based validation, validation planning, lifecycle, ERP, MES, production software, validation report.

FAQ

Q: What is this standard?

A: ISO/TR 80002-2:2017 is a technical report that provides guidance on validating software used in medical device quality systems and production processes; it is not a certification standard but a guidance document to help achieve regulatory and standards compliance.

Q: What does it cover?

A: It covers scoping, risk-based validation planning, lifecycle validation activities (requirements, testing, release controls), producing validation evidence and reports, retrospective validation of legacy software and revalidation after changes. It explicitly excludes software that is itself a medical device or a component of a medical device.

Q: Who typically uses it?

A: Medical device manufacturers (quality, regulatory and engineering teams), suppliers of QMS/production software, auditors and consultants use it to design and judge validation activities for software that supports device manufacturing and quality processes.

Q: Is it current or superseded?

A: As published on 13 June 2017, ISO/TR 80002-2:2017 is a currently published technical report (no public indication of withdrawal or supersession as of the present). Users should always confirm status with their national standards body or the ISO catalogue before depending on the document for compliance activities.

Q: Is it part of a series?

A: Yes — it is one part of the ISO 80002 technical guidance family addressing medical device software; for example ISO/TR 80002-1 provides guidance on the application of ISO 13485 to medical device software. The TR complements lifecycle standards such as IEC 62304.

Q: What are the key keywords?

A: Key keywords include: software validation, medical device quality system, QMS software, risk-based validation, validation plan, validation report, lifecycle, ISO 13485.