ISO 17025
International standard for testing/calibration laboratory competence
ISO 13485
International standard for medical device quality management systems
Quick Verdict
ISO 17025 accredits testing labs for competent, impartial results trusted globally, while ISO 13485 certifies medical device QMS for regulatory compliance and lifecycle safety. Labs seek 17025 for market acceptance; device firms adopt 13485 for approvals and risk control.
ISO 17025
ISO/IEC 17025:2017 General requirements for laboratory competence
Key Features
- Ensures competence, impartiality, consistent lab operations
- Mandates ongoing impartiality risk identification/mitigation
- Requires metrological traceability and uncertainty evaluation
- Integrates risk-based thinking across processes
- Enables global result acceptance via ILAC accreditation
ISO 13485
ISO 13485:2016 Medical devices Quality management systems
Key Features
- Risk-based QMS process controls
- Design and development validation
- Supplier evaluation and monitoring
- Post-market complaint handling
- Documented traceability and records
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 accreditation standard specifying general requirements for the competence, impartiality, and consistent operation of testing and calibration laboratories. It applies a risk-based, performance-oriented approach tying management controls to technical validity of results, covering testing, calibration, and sampling activities.
Key Components
- Eight core elements: general (impartiality/confidentiality), structural, resource, process, and management system requirements.
- Focuses on personnel competence, metrological traceability, measurement uncertainty, method validation, and proficiency testing.
- Built on risk-based thinking; offers Option A (standalone) or B (ISO 9001-integrated) management systems.
- Leads to scope-specific accreditation by ILAC-recognized bodies.
Why Organizations Use It
- Ensures results are globally accepted, enabling market access and regulatory compliance.
- Mitigates risks from invalid data, enhances trust with customers/regulators.
- Provides competitive edge via demonstrated technical credibility and efficiency gains.
Implementation Overview
- Phased approach: gap analysis, documentation, technical validation, audits.
- Suits labs of all sizes in regulated industries; requires witnessed assessments for accreditation.
ISO 13485 Details
What It Is
ISO 13485:2016 is the international standard titled Medical devices — Quality management systems — Requirements for regulatory purposes. It provides a certifiable framework for organizations in the medical device lifecycle, emphasizing risk-based controls to ensure devices meet customer and regulatory requirements consistently.
Key Components
- Structured into Clauses 4–8: QMS, management responsibility, resources, product realization, measurement/improvement.
- Over 20 documented procedures covering design controls, validation, supplier management, complaints, CAPA.
- Built on process approach, ISO 9001 compatibility, ISO 14971 risk integration.
- Third-party certification via staged audits.
Why Organizations Use It
- Enables market access (EU MDR, FDA QMSR alignment by 2026).
- Mitigates risks of recalls, liabilities via traceability, post-market surveillance.
- Builds stakeholder trust, reduces costs through operational efficiency.
- Competitive edge in supply chains, partnerships.
Implementation Overview
- Phased: gap analysis, documentation, training, validation, audits.
- Applies to manufacturers, suppliers globally; scalable by size.
- Involves eQMS, cross-functional teams; certification every 3 years.
Key Differences
| Aspect | ISO 17025 | ISO 13485 |
|---|---|---|
| Scope | Testing/calibration lab competence, impartiality, technical validity | Medical device QMS lifecycle, regulatory compliance, risk management |
| Industry | Testing, calibration labs across industries worldwide | Medical device manufacturers, suppliers, global healthcare |
| Nature | Voluntary accreditation standard for lab competence | Voluntary certification standard for regulatory QMS |
| Testing | Proficiency testing, witnessed technical assessments, surveillance | Internal audits, process validation, management reviews, certification audits |
| Penalties | Loss of accreditation, rejected results, market exclusion | Loss of certification, regulatory non-compliance, market access denial |
Scope
Industry
Nature
Testing
Penalties
Frequently Asked Questions
Common questions about ISO 17025 and ISO 13485
ISO 17025 FAQ
ISO 13485 FAQ
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