Standards Comparison

    ISO 17025

    Voluntary
    2017

    International standard for competence of testing/calibration laboratories

    VS

    AS9120B

    Mandatory
    2016

    Aerospace QMS standard for parts distributors.

    Quick Verdict

    ISO 17025 accredits testing labs for technical competence and valid results in regulated sectors, while AS9120B certifies aerospace distributors for traceability and counterfeit prevention. Labs gain market trust; distributors secure OEM supply chains.

    Laboratory Quality

    ISO 17025

    ISO/IEC 17025:2017 General requirements for testing/calibration labs

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

    Key Features

    • Impartiality via ongoing risk identification and mitigation
    • Metrological traceability and measurement uncertainty evaluation
    • Personnel competence lifecycle with authorization records
    • Proficiency testing for results validity assurance
    • Risk-based management system Option A or B
    Quality Management

    AS9120B

    AS9120B Quality Management Systems - Distributors

    Cost
    €€€€
    Complexity
    High
    Implementation Time
    6-12 months

    Key Features

    • Traceability and chain-of-custody controls for split lots
    • Counterfeit and suspected unapproved parts prevention
    • Risk-based external provider evaluation and flowdown
    • Configuration management via sales orders
    • Product safety and ethical behavior awareness

    Detailed Analysis

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

    ISO 17025 Details

    What It Is

    ISO/IEC 17025:2017 is the international standard specifying general requirements for the competence, impartiality, and consistent operation of testing and calibration laboratories. It applies a performance-based, risk-based approach linking management systems to technical validity of results, covering testing, calibration, and sampling.

    Key Components

    • Eight main clauses: general (impartiality/confidentiality), structural, resource, process, and management system requirements.
    • Core elements include metrological traceability, measurement uncertainty, method validation/verification, personnel competence, and proficiency testing.
    • Built on risk-based thinking; management system via Option A (standalone) or Option B (ISO 9001-aligned).
    • Leads to accreditation by bodies like ILAC signatories, attesting technical scope-specific competence.

    Why Organizations Use It

    • Enables market access, regulatory acceptance, and international result recognition.
    • Mitigates risks of invalid results impacting safety, compliance, finance.
    • Builds stakeholder trust through demonstrated impartiality and traceability.
    • Provides competitive edge via credible, defensible outputs.

    Implementation Overview

    • Phased PDCA: gap analysis, documentation, technical validation, audits, accreditation assessment.
    • Suits labs of all sizes in regulated industries globally.
    • Involves training, equipment calibration, LIMS controls; requires ongoing surveillance audits.

    AS9120B Details

    What It Is

    AS9120B is the IAQG quality management system standard for aerospace distributors, built on ISO 9001:2015's 10-clause structure. It targets organizations procuring, storing, splitting, and reselling parts without alteration, emphasizing risk-based thinking to mitigate supply chain risks like traceability loss and counterfeits.

    Key Components

    • Over 100 aerospace-specific requirements beyond ISO 9001.
    • Core areas: context analysis, leadership, planning, support, operations (traceability, counterfeit prevention, external providers), performance evaluation, improvement.
    • Built on PDCA cycle; requires documented information, not full procedures.
    • Certification via accredited bodies, OASIS listing.

    Why Organizations Use It

    • Commercial necessity for OEM/Tier 1 supply chains.
    • Reduces risks of nonconformities, counterfeits, recalls.
    • Enhances market access, customer trust, efficiency.
    • Builds resilience via KPIs, audits, continual improvement.

    Implementation Overview

    • Phased: gap analysis, process design, training, audits (6-12 months).
    • Applies to aviation/space/defense distributors globally.
    • Involves cross-functional teams, internal audits, Stage 1/2 certification.

    Key Differences

    Scope

    ISO 17025
    Testing/calibration lab competence, technical validity
    AS9120B
    Aerospace parts distribution, traceability, counterfeit prevention

    Industry

    ISO 17025
    Testing/calibration labs, all regulated sectors globally
    AS9120B
    Aerospace distributors/stockists, aviation/space/defense

    Nature

    ISO 17025
    Accreditation standard for lab competence
    AS9120B
    Certification standard based on ISO 9001

    Testing

    ISO 17025
    Proficiency testing, witnessed technical assessments
    AS9120B
    Internal audits, surveillance certification audits

    Penalties

    ISO 17025
    Loss of accreditation, rejected results
    AS9120B
    Loss of certification, supply chain exclusion

    Frequently Asked Questions

    Common questions about ISO 17025 and AS9120B

    ISO 17025 FAQ

    AS9120B FAQ

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