ISO TR 80001-2-7:2015

Application of risk management for IT-networks incorporating medical devices -- Application guidance -- Part 2-7: Guidance for Healthcare Delivery Organizations (HDOs) on how to self-assess their conformance with IEC 80001-1

Название (английский):

Статус документа:: Отменён
Формат:: Электронный (PDF)
Количество страниц:: 102
Дата публикации:: 17 марта 2015 г.
Издание:: IEC TR 80001 edition 1 version 1
ICS:: 11.040.01

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Описание (английский):

ISO/TR 80001-2-7:2015 is to provide guidance to HDOs on self-assessment of their conformance against IEC 80001-1.

Abstract

Похожие стандарты

Стандарты, упомянутые в описании

Overview

ISO/TR 80001-2-7:2015 provides practical guidance for Healthcare Delivery Organizations (HDOs) to self-assess conformance with IEC 80001-1 - the international framework for risk management of IT-networks that incorporate medical devices. The technical report presents an exemplar assessment method, supporting materials (a Process Reference Model - PRM and a Process Assessment Model - PAM) and aligns assessment practices with ISO/IEC 15504 process-assessment concepts.

Key topics and technical elements

Purpose: Guidance for HDOs to evaluate their implementation of IEC 80001-1 processes and identify improvement opportunities.

Assessment Method: A repeatable, seven-stage assessment lifecycle:

Stage 1 - Define assessment scope
Stage 2 - Stakeholder involvement
Stage 3 - Information collection and evaluation
Stage 4 - Findings report
Stage 5 - Presentation of findings
Stage 6 - Improvement plan (optional)
Stage 7 - Follow-up assessment (optional)

PRM & PAM: Included annexes define a Process Reference Model and an example Process Assessment Model that satisfy ISO/IEC 15504-2 requirements and provide standard process purposes, outcomes and indicators.

Processes covered: The PAM groups 14 processes (examples include Medical IT Network Risk Management, Change/Release & Configuration Management, Monitoring, Event Management, Documentation & Planning, Responsibility Agreements).

Assessment mechanics: Uses process attribute rating scales and capability levels (per ISO/IEC 15504) to evaluate how well risk-management processes are performed.

Prerequisites: Recommends trained assessors (lead assessor where multiple assessors are used), stakeholder engagement, and access to relevant documentation and evidence.

Tailoring: The exemplar method is intended to be tailored to the HDO context - enabling lightweight or more rigorous assessments as needed.

Practical applications and users

Who benefits:

Healthcare Delivery Organizations (HDOs) seeking to validate or improve risk management for medical IT-networks.

Clinical engineering, IT managers, risk managers and compliance teams conducting internal assessments.

Assessors and auditors performing capability evaluations or preparing for external review.

Vendors and medical device manufacturers collaborating in responsibility agreements or preparing evidence for HDO assessments.

Common uses:

Self-assessment for IEC 80001-1 conformance.

Baseline measurement of risk-management process capability and maturity.

Identifying weaknesses and creating targeted improvement plans.

Supporting change/release planning, go-live decisions, monitoring and event management practices.

Related standards

IEC 80001-1:2010 - Roles, responsibilities and activities for risk management of medical IT-networks (normative reference).

ISO/IEC 15504-1 / 15504-2 - Process assessment concepts and performing assessments (used for PRM/PAM alignment and capability rating).

Keywords: ISO TR 80001-2-7, IEC 80001-1, healthcare delivery organizations, HDO self-assessment, Medical IT-Network risk management, PRM, PAM, ISO/IEC 15504, process capability, assessment method.

ISO TR 80001-2-7:2015

Abstract

Похожие стандарты

Overview

Key topics and technical elements

Practical applications and users

Related standards

Технические детали

IEC 80001-1:2010

Application of risk management for IT-networks incorporating medical devices - Part 1: Roles, responsibilitie…

BS ISO/IEC 15504-1:2004

Information technology. Process assessment. Concepts and vocabulary.

ISO/IEC 15504-2:2003

Information technology — Process assessment — Part 2: Performing an assessment