Standards Comparison

    ISO 31000

    Voluntary
    2018

    International guidelines for enterprise-wide risk management

    VS

    ISO 17025

    Voluntary
    2017

    International standard for competence of testing and calibration laboratories.

    Quick Verdict

    ISO 31000 provides voluntary risk management guidelines for all organizations, embedding risk into governance. ISO 17025 mandates accreditation for labs, ensuring technical competence and impartiality. Companies adopt ISO 31000 for strategic resilience; ISO 17025 for credible, accepted test results.

    Risk Management

    ISO 31000

    ISO 31000:2018, Risk management — Guidelines

    Cost
    €€€
    Complexity
    Medium
    Implementation Time
    12-18 months

    Key Features

    • Defines risk as effect of uncertainty on objectives
    • Eight principles for integrated, customized risk management
    • Framework embeds risk into governance and leadership
    • Iterative process: assess, treat, monitor, review risks
    • Non-certifiable guidelines for any organization or sector
    Laboratory Quality

    ISO 17025

    ISO/IEC 17025:2017 General requirements for laboratory competence

    Cost
    €€€€
    Complexity
    High
    Implementation Time
    12-18 months

    Key Features

    • Ensures impartiality and confidentiality via risk management
    • Requires metrological traceability and uncertainty evaluation
    • Manages personnel competence lifecycle with authorizations
    • Validates methods and ensures result validity via PT
    • Supports accreditation for global result acceptance

    Detailed Analysis

    A comprehensive look at the specific requirements, scope, and impact of each standard.

    ISO 31000 Details

    What It Is

    ISO 31000:2018, Risk management — Guidelines is a non-certifiable international standard providing principles, framework, and process for managing risk as the effect of uncertainty on objectives. It applies universally to any organization, emphasizing leadership integration and value creation/protection through systematic risk practices.

    Key Components

    • **Three pillars8 principles (integrated, customized, dynamic, etc.), framework (leadership, design, implementation, evaluation, improvement), and 6-step process (communication, scope/context/criteria, assessment, treatment, monitoring/review, recording/reporting).
    • No fixed controls; flexible, iterative PDCA-aligned approach.
    • Guidelines only, no certification model.

    Why Organizations Use It

    Enhances decision-making, resilience, and governance; reduces losses, captures opportunities. Builds stakeholder trust via transparent practices. Strategic benefits include better resource allocation and agility in volatile environments; aligns with regulations indirectly.

    Implementation Overview

    Phased roadmap: leadership commitment, gap analysis, pilot process, integration, monitoring. Tailored to size/sector; involves policy, training, tools like risk registers. Internal audits ensure effectiveness; applicable globally to enterprises, projects, SMEs.

    ISO 17025 Details

    What It Is

    ISO/IEC 17025:2017, titled "General requirements for the competence of testing and calibration laboratories," is an international accreditation standard specifying requirements for labs to produce valid, impartial results. It adopts a risk-based, performance-oriented approach, integrating management and technical controls.

    Key Components

    • Eight main elements: general (impartiality/confidentiality), structural, resource, process, and management system requirements.
    • Focuses on competence lifecycle, metrological traceability, measurement uncertainty, method validation.
    • Option A/B for management systems (standalone or ISO 9001-aligned).
    • Emphasizes ILAC-recognized accreditation attesting to technical scope.

    Why Organizations Use It

    • Enables market access, regulatory acceptance, and cross-border result validity.
    • Mitigates risks from invalid results, enhances trust with customers/regulators.
    • Drives efficiency, continual improvement, competitive edge in tenders.

    Implementation Overview

    • Phased PDCA: gap analysis, documentation, training, validation, audits.
    • Applies to labs of all sizes in testing/calibration; requires accreditation body assessment with witnessed activities.

    Key Differences

    Scope

    ISO 31000
    Enterprise risk management guidelines
    ISO 17025
    Laboratory testing/calibration competence

    Industry

    ISO 31000
    All sectors, any organization size
    ISO 17025
    Testing/calibration labs, technical sectors

    Nature

    ISO 31000
    Non-certifiable guidelines, voluntary
    ISO 17025
    Accreditation standard, competence-based

    Testing

    ISO 31000
    Internal audits, management reviews
    ISO 17025
    Proficiency testing, witnessed assessments

    Penalties

    ISO 31000
    No formal penalties, loss of alignment
    ISO 17025
    Loss of accreditation, market exclusion

    Frequently Asked Questions

    Common questions about ISO 31000 and ISO 17025

    ISO 31000 FAQ

    ISO 17025 FAQ

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