GDPR
EU regulation for personal data protection and privacy
ISO 17025
International standard for testing and calibration laboratory competence
Quick Verdict
GDPR mandates personal data protection for EU residents globally with hefty fines, while ISO 17025 accredits testing labs for competence and impartiality via audits. Companies adopt GDPR for legal compliance, ISO 17025 for market trust and result credibility.
GDPR
General Data Protection Regulation (GDPR)
Key Features
- Extraterritorial scope applies to non-EU entities targeting EU residents
- Fines up to 4% of global annual turnover or €20 million
- Accountability principle requires demonstrable compliance via DPIAs
- Data subject rights including erasure and portability
- Mandatory 72-hour personal data breach notification
ISO 17025
ISO/IEC 17025:2017 General requirements for competence of testing and calibration laboratories
Key Features
- Impartiality and confidentiality as core general requirements
- Personnel competence lifecycle management and authorization
- Metrological traceability and measurement uncertainty evaluation
- Method validation, verification, and result validity monitoring
- Risk-based thinking integrated across processes and management
Detailed Analysis
A comprehensive look at the specific requirements, scope, and impact of each standard.
GDPR Details
What It Is
General Data Protection Regulation (GDPR), or Regulation (EU) 2016/679, is a binding EU regulation protecting personal data of EU residents. It ensures lawful processing and free data movement, using a principles-based, accountability-driven, risk-focused approach replacing the 1995 Directive.
Key Components
- **Seven core principleslawfulness/fairness/transparency, purpose limitation, data minimisation, accuracy, storage limitation, integrity/confidentiality, accountability.
- **Data subject rightsaccess, rectification, erasure ('right to be forgotten'), portability, objection, restriction.
- Obligations include DPO appointment, DPIAs, ROPA, 72-hour breach notifications.
- One-stop-shop enforcement; fines up to 4% global turnover; no formal certification.
Why Organizations Use It
Mandatory for EU data processors worldwide to avoid severe penalties. Enhances risk management, builds trust/reputation, supports Digital Single Market. Provides competitive edge via global 'gold standard' compliance.
Implementation Overview
Gap analysis, policy/process updates, training, tech safeguards (encryption, pseudonymisation). Applies universally to controllers/processors handling EU data, any size/location. Ongoing compliance with DPA audits; two-year transition historically.
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 risk-based, performance-oriented approach integrating management and technical controls to ensure technically valid results.
Key Components
- Eight main elements: general (impartiality/confidentiality), structural, resource (personnel, facilities, equipment, traceability), process (methods, sampling, uncertainty, reporting), and management system requirements (Option A/B).
- Core principles: risk-based thinking, metrological traceability, measurement uncertainty, method validation.
- Leads to accreditation by bodies like ILAC signatories, attesting scope-specific competence.
Why Organizations Use It
- Enables market access, regulatory acceptance, and international result recognition.
- Mitigates risks from invalid results impacting safety, compliance, finance.
- Builds stakeholder trust, competitive edge via credible accreditation.
Implementation Overview
- Phased PDCA: gap analysis, documentation, training, validation, audits.
- Suits labs of all sizes in testing/calibration sectors globally.
- Requires accreditation body assessment with witnessed activities.
Key Differences
| Aspect | GDPR | ISO 17025 |
|---|---|---|
| Scope | Personal data protection and privacy rights | Laboratory competence, impartiality, testing/calibration |
| Industry | All sectors processing EU personal data, global reach | Testing/calibration labs across industries, worldwide |
| Nature | Mandatory EU regulation with fines | Voluntary accreditation standard for competence |
| Testing | DPIAs for high-risk processing, audits by DPAs | Proficiency testing, method validation, accreditation audits |
| Penalties | Up to 4% global turnover fines | Loss of accreditation, no direct financial penalties |
Scope
Industry
Nature
Testing
Penalties
Frequently Asked Questions
Common questions about GDPR and ISO 17025
GDPR FAQ
ISO 17025 FAQ
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