ISO 13485
International standard for medical device quality management
APRA CPS 234
APRA prudential standard for information security resilience.
Quick Verdict
ISO 13485 provides QMS certification for global medical device makers, ensuring lifecycle compliance. APRA CPS 234 mandates information security for Australian financial firms, demanding board oversight and rapid incident reporting. Companies adopt them for market access and regulatory resilience.
ISO 13485
ISO 13485:2016 Medical devices Quality management systems
Key Features
- Risk-based controls for device lifecycle safety
- Mandatory medical device files for traceability
- Explicit post-market surveillance and complaints
- Process and software validation requirements
- Regulatory integration with FDA QMSR, EU MDR
APRA CPS 234
APRA Prudential Standard CPS 234 Information Security
Key Features
- Board ultimate responsibility for information security
- 72-hour notification for material incidents to APRA
- Covers third-party managed information assets
- Systematic independent testing of controls required
- Asset classification by criticality and sensitivity
Detailed Analysis
A comprehensive look at the specific requirements, scope, and impact of each standard.
ISO 13485 Details
What It Is
ISO 13485:2016 is an international certification standard titled "Medical devices — Quality management systems — Requirements for regulatory purposes." It provides a risk-based framework for organizations in the medical device lifecycle, from design to post-market surveillance, ensuring consistent conformity to customer and regulatory requirements.
Key Components
- Organized into Clauses 4–8: QMS/documentation, management responsibility, resources, product realization, measurement/improvement.
- Emphasizes documented procedures, validation, traceability, and risk management per ISO 14971.
- Requires medical device files, supplier controls, CAPA, and internal audits.
- Certification via accredited bodies with stage audits and surveillance.
Why Organizations Use It
- Enables market access (EU MDR, FDA QMSR alignment by 2026).
- Mitigates risks like recalls and liabilities.
- Builds stakeholder trust and supply chain assurance.
- Drives operational efficiency and competitive differentiation.
Implementation Overview
- Phased approach: gap analysis, process design, validation, audits.
- Applies to manufacturers, suppliers, distributors globally.
- Timelines 9–36 months; involves eQMS, training, certification audits.
APRA CPS 234 Details
What It Is
APRA Prudential Standard CPS 234 (Information Security) is a binding prudential regulation issued by the Australian Prudential Regulation Authority. Effective from 1 July 2019, it mandates APRA-regulated entities (banks, insurers, super funds) to maintain information security capabilities commensurate with threats to minimize impacts on confidentiality, integrity, and availability of information assets, including those managed by third parties. It adopts a risk-based, assurance-driven approach emphasizing governance, testing, and notification.
Key Components
- 11 core requirements spanning governance, capability maintenance, asset classification, controls, incident response, testing, and internal audit.
- Pillars include Board accountability, systematic testing, third-party assessments, and strict APRA notifications (72 hours for material incidents, 10 business days for control weaknesses).
- Built on CIA triad principles; no fixed controls but commensurate with risk.
- Compliance via evidence-based assurance, no formal certification.
Why Organizations Use It
- Mandatory for APRA entities to avoid penalties, enforcement.
- Enhances cyber resilience, protects stakeholders, integrates with CPS 220/230.
- Builds trust, reduces incident impacts, enables proportional implementation.
Implementation Overview
- Phased: gap analysis, policy framework, asset register, controls, testing.
- Applies to all sizes in Australian financial sector; audits via internal/APRA review. (178 words)
Key Differences
| Aspect | ISO 13485 | APRA CPS 234 |
|---|---|---|
| Scope | Medical device QMS lifecycle | Financial sector information security |
| Industry | Global medical devices | Australia financial services |
| Nature | Voluntary certification standard | Mandatory prudential regulation |
| Testing | Internal audits, process validation | Systematic independent control testing |
| Penalties | Loss of certification | Regulatory enforcement, fines |
Scope
Industry
Nature
Testing
Penalties
Frequently Asked Questions
Common questions about ISO 13485 and APRA CPS 234
ISO 13485 FAQ
APRA CPS 234 FAQ
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