What is the primary objective of **CCPA**?

**The primary objective of the CCPA is to grant California residents enforceable rights over their personal information held by businesses, including the rights to know, delete, opt-out of sales/sharing, correct, and limit use of sensitive personal information.** Enacted in 2018 and amended by the CPRA effective January 1, 2023, it rebalances power by requiring notices at collection, data inventories, and non-discrimination.

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

**For-profit businesses doing business in California must comply with the CCPA if they meet any threshold: annual gross revenue exceeding $25 million, buying/selling/sharing personal information of 100,000+ California consumers/households/devices annually, or deriving 50%+ revenue from such sales/sharing.** This applies extraterritorially to global entities processing California residents' data, including post-CPRA elimination of employee/B2B exemptions.

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

**No, the CCPA does not mandate external audits or third-party certification.** Businesses must implement reasonable security, conduct internal data mapping and risk assessments (mandatory by 2026 for high-risk processing), and maintain records of consumer requests for 24 months, but enforcement relies on CPPA/AG investigations rather than required certifications.

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

**CCPA assessments, including data inventories and threshold evaluations, should be performed annually to confirm applicability and compliance.** Ongoing monitoring is required for evolving obligations like CPRA risk assessments (annually for high-risk activities starting 2026) and cybersecurity audits (phased for large firms by 2028), with updates triggered by business changes or regulatory amendments.

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

**Non-compliance with the CCPA incurs civil penalties of up to $2,500 per unintentional violation and $7,500 per intentional violation (adjusted to $7,988 in 2025), enforced by the CPPA and California Attorney General.** A private right of action allows $100-$750 per consumer per breach incident for unencrypted data due to inadequate security, plus examples like Zoom's $85M settlement.

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

**Yes, CCPA provisions such as consumer rights, data minimization, and vendor contracts can be mapped to frameworks like the GDPR.** Alignments include DSAR timelines (45 days), purpose limitation, and privacy impact assessments, enabling organizations to leverage unified programs for scalable compliance across jurisdictions.

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

**The first step to implement CCPA is conducting a legal applicability assessment against the three thresholds and a comprehensive data inventory mapping personal information flows, categories, and third-party recipients.** This 0-3 month scoping phase identifies gaps in notices, contracts, and rights fulfillment, producing a prioritized project plan.

What is the primary objective of **ISO 13485**?

**ISO 13485:2016 specifies requirements for a quality management system (QMS) where organizations demonstrate ability to consistently provide medical devices and related services meeting customer and applicable regulatory requirements.** It applies across device lifecycle stages including design, production, distribution, installation, servicing, and disposal, emphasizing documented processes, risk-based controls, validation, traceability, and post-market surveillance per Clauses 4–8.

Who is legally or professionally required to comply with **ISO 13485**?

**ISO 13485 applies to organizations involved in one or more stages of the medical device lifecycle, including manufacturers, contract manufacturers, suppliers of sterile services or components, distributors, importers, and service providers.** It targets those needing to demonstrate regulatory compliance, such as for EU MDR market access or FDA QMSR alignment (effective February 2, 2026), with requirements to identify applicable regulatory roles and incorporate them into the QMS.

Does **ISO 13485** require an external audit or third-party certification?

**ISO 13485 certification is voluntary but typically involves external audits by accredited certification bodies through a two-stage process: Stage 1 (documentation review) and Stage 2 (implementation verification), followed by annual surveillance and triennial recertification.** The standard itself mandates internal audits (Clause 8.2.4) but positions third-party certification as a market access enabler for regulatory maturity.

How often should an assessment for **ISO 13485** be performed?

**Internal audits for ISO 13485 must be conducted at planned intervals per Clause 8.2.4, with management reviews at planned intervals per Clause 5.6, typically annually or triggered by changes.** Certification requires annual surveillance audits post-initial certification, with full recertification every three years; frequency scales with risk, processes, and regulatory changes like new requirements or CAPA outcomes.

What are the consequences of non-compliance with **ISO 13485**?

**Non-compliance with ISO 13485 risks regulatory enforcement, including product holds, market withdrawal, fines, recalls, and loss of authorization, as it underpins QMS expectations in regimes like EU MDR and FDA QMSR.** Operationally, it leads to audit nonconformities, CAPA backlogs, supplier failures, and liability from unvalidated processes or poor traceability, with records required for at least device lifetime or two years post-release (Clause 4.2.5).

An **ISO 13485** be mapped to other international frameworks?

**Yes, Annex B of ISO 13485:2016 provides a correspondence table mapping its requirements to ISO 9001:2015, though conformity to ISO 13485 does not imply ISO 9001 compliance due to exclusions.** It harmonizes with ISO 14971 (risk management), integrates into EU MDR/IVDR QMS audits, and aligns with FDA QMSR (effective February 2, 2026), enabling shared process evidence without claiming dual certification.

What is the first step to begin implementing **ISO 13485**?

**The first step is establishing and documenting the QMS scope per Clause 4.1, including process identification, risk-based controls, outsourcing via quality agreements, and justification for any exclusions (e.g., Clause 7 design controls for contract manufacturers).** Develop the quality manual (Clause 4.2.2) detailing scope, procedures, and interactions, followed by a gap analysis against Clauses 4–8.

CCPA vs ISO 13485

Standards Comparison

CCPA

Mandatory

2020

California regulation for consumer personal data privacy rights

ISO 13485

Mandatory

2016

International standard for medical device quality management systems.

Quick Verdict

CCPA mandates consumer data rights for California businesses, enforcing privacy via fines and audits. ISO 13485 certifies medical device QMS for safety and compliance. Companies adopt CCPA to avoid penalties, ISO 13485 for market access and quality excellence.

Data Privacy

CCPA

California Consumer Privacy Act (CCPA/CPRA)

Cost

€€€€

Complexity

High

Implementation Time

6-12 months

Key Features

Grants consumers rights to know, delete, opt-out of sales/sharing
Applies extraterritorially to businesses meeting revenue/data thresholds
Mandates notices at collection and comprehensive privacy policies
Requires honoring Global Privacy Control opt-out signals
Imposes fines up to $7,500 per intentional violation

Quality Management

ISO 13485

ISO 13485:2016 Medical devices Quality management systems

Cost

€€€€

Complexity

High

Implementation Time

12-18 months

Key Features

Risk-based controls for device lifecycle processes
Design development planning verification and validation
Medical device files and traceability requirements
Post-market surveillance complaint handling CAPA
Supplier evaluation monitoring and quality agreements

Detailed Analysis

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

CCPA Details

What It Is

The California Consumer Privacy Act (CCPA), amended by the California Privacy Rights Act (CPRA), is a state regulation establishing consumer privacy rights for California residents. It targets for-profit businesses meeting thresholds like $25M revenue or handling 100K+ consumers' data. Primary purpose: empower consumers with control over personal information (PI) via rights-based approach, including opt-out of sales/sharing and limits on sensitive PI.

Key Components

Core rights: know/access, delete, correct, opt-out sales/sharing, limit sensitive PI use
Obligations: notices at collection, privacy policies, DSAR handling within 45 days, vendor contracts, GPC honoring
Enforcement by CPPA and Attorney General with $2,500-$7,500 fines per violation; private breach actions
No certification; compliance via audits and documentation

Why Organizations Use It

Mandatory for qualifying businesses to avoid fines, litigation, reputational harm. Drives data governance efficiency, trust-building, market differentiation, GDPR alignment. Reduces breach risks, enables partnerships.

Implementation Overview

Phased: scoping/gap analysis (0-3 months), policies/contracts (1-4 months), technical controls (2-6 months), operationalization/training, ongoing audits. Applies globally to CA data handlers; cross-functional, tech-heavy for enterprises.

ISO 13485 Details

What It Is

ISO 13485:2016, officially Medical devices — Quality management systems — Requirements for regulatory purposes, is an international certification standard for QMS tailored to medical devices. It adopts a risk-based approach to ensure organizations consistently meet customer and regulatory requirements across the device lifecycle, from design to post-market surveillance.

Key Components

Structured into Clauses 4–8: QMS and documentation, management responsibility, resource management, product realization, measurement/analysis/improvement.
Emphasizes documented procedures, validation, traceability, risk management (linked to ISO 14971), and medical device files.
Built on process approach; certification via accredited bodies with Stage 1/2 audits and surveillance.

Why Organizations Use It

Facilitates market access (EU MDR alignment, FDA QMSR by 2026).
Mitigates product risks, ensures regulatory compliance, reduces recalls.
Builds stakeholder trust, enables supply chain partnerships, drives operational efficiency.

Implementation Overview

Phased: gap analysis, documentation build, validation, internal audits, certification.
Applies to manufacturers, suppliers globally; suits SMEs to enterprises; 9–18 months typical.

Key Differences

Aspect	CCPA	ISO 13485
Scope	Consumer privacy rights and data handling	Medical device quality management lifecycle
Industry	All businesses handling CA resident data	Medical device manufacturers and suppliers
Nature	Mandatory California privacy regulation	Voluntary international certification standard
Testing	Internal audits and consumer request processes	Certification audits and internal QMS audits
Penalties	$2,500-$7,500 per violation, private actions	Loss of certification, no direct fines

Scope

CCPA

Consumer privacy rights and data handling

ISO 13485

Medical device quality management lifecycle

Industry

CCPA

All businesses handling CA resident data

ISO 13485

Medical device manufacturers and suppliers

Nature

CCPA

Mandatory California privacy regulation

ISO 13485

Voluntary international certification standard

Testing

CCPA

Internal audits and consumer request processes

ISO 13485

Certification audits and internal QMS audits

Penalties

CCPA

$2,500-$7,500 per violation, private actions

ISO 13485

Loss of certification, no direct fines

Frequently Asked Questions

Common questions about CCPA and ISO 13485

CCPA FAQ

ISO 13485 FAQ

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CCPA

ISO 13485

Quick Verdict

CCPA

Key Features

ISO 13485

Key Features

Detailed Analysis

CCPA Details

What It Is

Key Components

Why Organizations Use It

Implementation Overview

ISO 13485 Details

What It Is

Key Components

Why Organizations Use It

Implementation Overview

Key Differences

Scope

Industry

Nature

Testing

Penalties

Frequently Asked Questions

CCPA FAQ

What is the primary objective of CCPA?

Who is legally or professionally required to comply with CCPA?

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

How often should an assessment for CCPA be performed?

What are the consequences of non-compliance with CCPA?

Can CCPA be mapped to other international frameworks?

What is the first step to begin implementing CCPA?

ISO 13485 FAQ

What is the primary objective of ISO 13485?

Who is legally or professionally required to comply with ISO 13485?

Does ISO 13485 require an external audit or third-party certification?

How often should an assessment for ISO 13485 be performed?

What are the consequences of non-compliance with ISO 13485?

An ISO 13485 be mapped to other international frameworks?

What is the first step to begin implementing ISO 13485?

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Run Maturity Assessments with GRADUM

Check out these other Gradum.io Standards Comparison Pages

LGPD vs EPA

COBIT vs NERC CIP

GMP vs WEEE