What is the primary objective of **ISO 17025**?

**ISO/IEC 17025:2017 specifies general requirements for the competence, impartiality, and consistent operation of testing and calibration laboratories.** It ensures technical validity of results through metrological traceability, measurement uncertainty evaluation, validated methods, and controlled processes under Clauses 6 (resources) and 7 (processes), enabling global acceptance via ILAC mutual recognition.

Who is legally or professionally required to comply with **ISO 17025**?

**No organizations are legally mandated to comply with ISO/IEC 17025:2017, but accreditation is professionally required for testing and calibration laboratories seeking market acceptance.** Suppliers, regulators, and customers in regulated sectors (e.g., manufacturing, environmental) reject non-accredited results, as accreditation bodies like ANAB or A2LA attest to competence within a defined scope.

Does **ISO 17025** require an external audit or third-party certification?

**ISO/IEC 17025:2017 requires accreditation by an ILAC-signatory body through external assessments, not certification.** Assessments include document review, on-site evaluation with witnessed testing, proficiency testing review, and scope-specific technical competence verification under Clauses 4–8.

How often should an assessment for **ISO 17025** be performed?

**ISO/IEC 17025:2017-accredited laboratories undergo initial assessment followed by annual surveillance and full reassessment every 2 years.** Internal audits occur at planned intervals (Clause 8.8), with management reviews at least annually (Clause 8.9) to ensure ongoing impartiality, competence, and process validity.

What are the consequences of non-compliance with **ISO 17025**?

**Non-compliance with ISO/IEC 17025:2017 results in accreditation suspension, scope reduction, or withdrawal by the body.** This leads to market exclusion, rejected results by regulators/customers, contract losses, and rework costs; common findings include inadequate uncertainty budgets (Clause 7.6) and impartiality risks (Clause 4.1).

Can **ISO 17025** be mapped to other international frameworks?

**Yes, ISO/IEC 17025:2017 management system requirements (Clause 8, Option B) map directly to ISO 9001:2015.** This allows integration while retaining unique technical elements like method validation (7.2), traceability (6.5), and proficiency testing (7.7) not covered by ISO 9001.

What is the first step to begin implementing **ISO 17025**?

**The first step for ISO/IEC 17025:2017 implementation is a clause-by-clause gap analysis against current practices.** Prioritize high-risk areas like impartiality (Clause 4), competence records (6.2), and uncertainty evaluation (7.6), followed by executive sponsorship and a scoped remediation plan.

Who is legally or professionally required to comply with **AS9100**?

**AS9100 applies professionally to organizations designing, developing, manufacturing, or servicing aviation, space, and defense products and services.** Major OEMs and primes require certification as a supplier qualification condition, with visibility via IAQG's OASIS database; it covers manufacturers, material suppliers, design centers, and quality organizations, but distributors use AS9120 and MRO uses AS9110.

Does **AS9100** require an external audit or third-party certification?

**Yes, AS9100 requires third-party certification through accredited bodies via a two-stage audit process.** Stage 1 assesses documentation and readiness; Stage 2 verifies implementation and effectiveness using AS9101 guidance; certification is maintained with annual surveillance audits and recertification every three years.

How often should an assessment for **AS9100** be performed?

**AS9100 requires internal audits at planned intervals per a risk-based program (Clause 9.2), with annual surveillance audits and full recertification every three years post-certification.** Management reviews occur periodically (Clause 9.3), focusing on performance data, risks, and improvements.

What are the consequences of non-compliance with **AS9100**?

**Non-compliance with AS9100 results in certification suspension or revocation, loss of supplier approval, and exclusion from OEM contracts.** Audits identify nonconformities requiring corrective actions within 60-90 days; persistent issues lead to major findings, market access denial via OASIS, and potential safety incidents or contractual penalties.

Can **AS9100** be mapped to other international frameworks?

**Yes, AS9100D aligns with ISO 9001:2015's Annex SL 10-clause structure (Clauses 4-10), enabling integrated management systems.** It supports mapping to frameworks sharing this structure through common elements like risk-based thinking (Clause 6.1), leadership (5), and performance evaluation (9).

What is the first step to begin implementing **AS9100**?

**The first step to implement AS9100 is conducting a gap analysis against AS9100D clauses and ISO 9001:2015 requirements.** Define QMS scope (Clause 4.3), identify processes, internal/external issues, and interested parties, then prioritize aerospace additions like product safety and configuration management.

ISO 17025 vs AS9100

Q: What is the primary objective of **AS9100**?

**AS9100's primary objective is to establish a quality management system (QMS) for aviation, space, and defense organizations that ensures product safety, configuration integrity, and supply chain reliability.** It builds on ISO 9001:2015 with over 100 aerospace-specific requirements, including operational risk management (Clause 8.1.1), configuration management (8.1.2), product safety (8.1.3), and counterfeit parts prevention (8.1.4), to mitigate catastrophic failure risks in high-consequence environments.

Standards Comparison

ISO 17025

Voluntary

2017

International standard for testing and calibration laboratory competence

AS9100

Mandatory

2016

International standard for aerospace quality management systems.

Quick Verdict

ISO 17025 accredits testing labs for technical competence and impartiality, ensuring valid results. AS9100 certifies aerospace QMS with safety, configuration controls. Labs adopt 17025 for credibility; aerospace firms use AS9100 for market access, risk mitigation.

Laboratory Quality

ISO 17025

ISO/IEC 17025:2017 General requirements for competence of testing and calibration laboratories

Cost

€€€€

Complexity

High

Implementation Time

12-18 months

Key Features

Ensures competence, impartiality, consistent lab operations
Mandates metrological traceability and uncertainty evaluation
Risk-based thinking across processes and management
Dedicated impartiality and confidentiality requirements
Accreditation enables global results acceptance

Quality Management

AS9100

AS9100D Quality Management Systems Requirements

Cost

€€€€

Complexity

High

Implementation Time

12-18 months

Key Features

Configuration management for product integrity
Product safety processes across lifecycle
Counterfeit parts prevention and detection
Operational risk management in Clause 8
Enhanced supplier controls and traceability

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 provides a performance-based framework tying management system controls to technical validity of results, using risk-based thinking.

Key Components

Eight main clauses: general, structural, resource, process, and management system requirements.
Focus on impartiality/confidentiality (Clause 4), personnel competence, metrological traceability, measurement uncertainty, method validation.
Option A/B for management systems (standalone or ISO 9001-aligned).
Leads to accreditation by bodies like ILAC signatories, attesting technical competence within scope.

Why Organizations Use It

Ensures globally accepted, traceable results reducing trade barriers.
Meets customer/regulatory demands; mitigates legal, safety risks.
Builds trust, enables market access, operational efficiency.

Implementation Overview

Phased approach: gap analysis, documentation, technical validation, audits. Applies to labs of all sizes in testing/calibration; requires witnessed assessments, proficiency testing, ongoing surveillance.

AS9100 Details

What It Is

AS9100D (AS9100:2016) is the international quality management system (QMS) standard for aviation, space, and defense organizations. It extends ISO 9001:2015 with over 100 aerospace-specific requirements, focusing on risk-based thinking, product safety, and supply chain integrity using a process-based approach.

Key Components

10-clause structure aligned with ISO Annex SL.
Core additions: configuration management (8.1.2), product safety (8.1.3), counterfeit parts prevention (8.1.4), operational risk management, enhanced supplier controls.
Built on PDCA cycle; requires documented processes, KPIs, audits.
Certification via accredited third-party audits (Stage 1/2, surveillance).

Why Organizations Use It

Mandatory for OEM supplier approval and market access.
Reduces defects, improves delivery, ensures traceability.
Mitigates safety risks, counterfeit threats; builds stakeholder trust.
Drives cost savings, competitive edge via OASIS visibility.

Implementation Overview

Phased: gap analysis, process design, training, internal audits, certification.
6-18 months typical; suits all sizes in ASD sectors globally.
Evidence-driven audits emphasize operational effectiveness.

Key Differences

Aspect	ISO 17025	AS9100
Scope	Testing/calibration lab competence, impartiality, technical validity	Aerospace QMS with product safety, configuration, counterfeit prevention
Industry	Testing/calibration labs all sectors globally	Aviation, space, defense manufacturing/supply chain
Nature	Accreditation standard for lab competence	Certification standard extending ISO 9001
Testing	Proficiency testing, witnessed activities, accreditation body assessments	Stage 1/2 audits, surveillance, recertification every 3 years
Penalties	Loss of accreditation, rejected results	Loss of certification, contract exclusion

Scope

ISO 17025

Testing/calibration lab competence, impartiality, technical validity

AS9100

Aerospace QMS with product safety, configuration, counterfeit prevention

Industry

ISO 17025

Testing/calibration labs all sectors globally

AS9100

Aviation, space, defense manufacturing/supply chain

Nature

ISO 17025

Accreditation standard for lab competence

AS9100

Certification standard extending ISO 9001

Testing

ISO 17025

Proficiency testing, witnessed activities, accreditation body assessments

AS9100

Stage 1/2 audits, surveillance, recertification every 3 years

Penalties

ISO 17025

Loss of accreditation, rejected results

AS9100

Loss of certification, contract exclusion

Frequently Asked Questions

Common questions about ISO 17025 and AS9100

ISO 17025 FAQ

AS9100 FAQ

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ISO 17025

AS9100

Quick Verdict

ISO 17025

Key Features

AS9100

Key Features

Detailed Analysis

ISO 17025 Details

What It Is

Key Components

Why Organizations Use It

Implementation Overview

AS9100 Details

What It Is

Key Components

Why Organizations Use It

Implementation Overview

Key Differences

Scope

Industry

Nature

Testing

Penalties

Frequently Asked Questions

ISO 17025 FAQ

What is the primary objective of ISO 17025?

Who is legally or professionally required to comply with ISO 17025?

Does ISO 17025 require an external audit or third-party certification?

How often should an assessment for ISO 17025 be performed?

What are the consequences of non-compliance with ISO 17025?

Can ISO 17025 be mapped to other international frameworks?

What is the first step to begin implementing ISO 17025?

AS9100 FAQ

What is the primary objective of AS9100?

Who is legally or professionally required to comply with AS9100?

Does AS9100 require an external audit or third-party certification?

How often should an assessment for AS9100 be performed?

What are the consequences of non-compliance with AS9100?

Can AS9100 be mapped to other international frameworks?

What is the first step to begin implementing AS9100?

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SOC 2 Audit Survival Guide: First 5 Steps to Ace Your Type 2 Audit with Infographic

Proving CIS Controls v8.1 Works: A KPI & Evidence Framework for Board Reporting, Audits, and Continuous Assurance

Run Maturity Assessments with GRADUM

Check out these other Gradum.io Standards Comparison Pages

DORA vs C-TPAT

OSHA vs FISMA

OSHA vs ISO 17025