What is the primary objective of **ISO 37301**?

**ISO 37301 specifies requirements for establishing, implementing, maintaining, and improving an effective Compliance Management System (CMS).** Published on 13 April 2021, it replaces the guidance-only ISO 19600 by introducing certifiable 'shall' requirements, following the High-Level Structure (HLS) and Plan-Do-Check-Act (PDCA) cycle to systematically identify compliance obligations, assess risks, and foster a culture of integrity.

Who is legally or professionally required to comply with **ISO 37301**?

**No organization is legally required to comply with ISO 37301, as it is a voluntary international standard applicable to all sizes and sectors.** It is professionally adopted by entities seeking certification for demonstrable CMS effectiveness, driven by stakeholder demands, regulatory complexity, and reputational risk; top management must demonstrate commitment across operations.

Does **ISO 37301** require an external audit or third-party certification?

**ISO 37301 enables but does not require external audit or third-party certification.** Certification is optional via accredited bodies (e.g., ANAB-accredited), involving initial conformity assessment and surveillance audits in a typical three-year cycle, providing external validation of CMS conformance to its requirements.

How often should an assessment for **ISO 37301** be performed?

**ISO 37301 requires organizations to conduct internal audits and management reviews at planned intervals based on risk and performance needs.** Monitoring, measurement, and evaluations occur continually, with internal audits risk-based in frequency; management reviews are periodic, feeding into the PDCA cycle for continual improvement.

What are the consequences of non-compliance with **ISO 37301**?

**Non-conformance with ISO 37301 results in loss of certification, if held, but carries no direct legal penalties as it is voluntary.** Internally, it risks CMS ineffectiveness, heightened compliance breaches, reputational damage, and stakeholder distrust; certification bodies issue nonconformities requiring corrective actions during surveillance audits.

Can **ISO 37301** be mapped to other international frameworks?

**Yes, ISO 37301 follows the High-Level Structure (HLS), enabling seamless mapping and integration with other ISO management system standards.** Its clauses (context, leadership, planning, support, operation, performance evaluation, improvement) align with HLS-based frameworks, supporting Integrated Management Systems (IMS) and joint audits.

What is the first step to begin implementing **ISO 37301**?

**The first step is to determine the context of the organization, identifying internal/external issues and interested parties' needs.** This informs CMS scope, compliance obligations inventory, and a centralized compliance register, securing top management buy-in per Clause 4 requirements.

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

**ISO 13485:2016 specifies requirements for a quality management system (QMS) enabling organizations to consistently provide medical devices and related services that meet customer and applicable regulatory requirements.** This standard targets organizations involved in one or more stages of the medical device lifecycle, including design, production, distribution, installation, servicing, and decommissioning. It emphasizes documented processes, risk-based controls, validation, traceability, and post-market surveillance across Clauses 4–8 to ensure regulatory compliance and patient safety.

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

**ISO 13485 applies to organizations whose activities include one or more stages of the medical device lifecycle, such as manufacturers, suppliers, distributors, importers, and service providers.** It covers medical device manufacturers (design/manufacture), contract manufacturers, sterilization/calibration services, and entities with regulatory roles requiring complaint handling and traceability. Organizations must identify their regulatory roles and incorporate applicable requirements into the QMS; it is not legally mandatory but is expected by regulators like EU MDR notified bodies and FDA QMSR (effective February 2, 2026) for market access.

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

**ISO 13485 certification involves external audits by accredited certification bodies but is voluntary, as the standard itself does not mandate third-party certification.** Certification typically follows a Stage 1 (documentation review) and Stage 2 (implementation audit), with annual surveillance and triennial recertification. While self-declaration is possible, regulators and customers often require accredited certification as evidence of QMS conformity.

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

**Internal audits for ISO 13485 must be conducted at planned intervals as defined by the organization's risk-based audit program (Clause 8.2.4).** Management reviews occur at planned intervals (Clause 5.6), typically annually, reviewing inputs like audits, complaints, CAPA, and regulatory changes. Certification requires annual surveillance audits post-initial certification.

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

**Non-compliance with ISO 13485 can result in failed certification audits, regulatory enforcement, product holds, recalls, fines, and market access denial.** Auditors issue nonconformities requiring CAPA; persistent issues lead to certification suspension. Regulators like EU Notified Bodies or FDA may cite QMS gaps, triggering inspections, warning letters, or import alerts under aligned frameworks like QMSR.

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

**Yes, ISO 13485 can be mapped to other frameworks, as Annex B provides correspondence to ISO 9001:2015, though full ISO 9001 conformity requires additional elements.** It aligns with ISO 14971 (risk management), IEC 62366-1 (usability), and regulatory systems like EU MDR/IVDR annexes and FDA QMSR (incorporating ISO 13485 by February 2, 2026), enabling integrated QMS implementation.

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

**The first step to implement ISO 13485 is to define the QMS scope, including organizational roles, applicable regulatory requirements, processes, and any justified exclusions (Clause 4.1 and Scope).** Document this in the quality manual with process interactions, then perform a gap analysis against Clauses 4–8 to prioritize remediation.

ISO 37301 vs ISO 13485

Standards Comparison

ISO 37301

Voluntary

2021

International standard for compliance management systems

ISO 13485

Mandatory

2016

International standard for medical device quality management systems

Quick Verdict

ISO 37301 establishes certifiable compliance management systems for all organizations, embedding risk-based governance and whistleblowing culture. ISO 13485 delivers rigorous QMS for medical devices, mandating lifecycle validation and traceability. Companies adopt them for certification, risk reduction, and regulatory/market access.

Compliance Management

ISO 37301

ISO 37301:2021 Compliance management systems – Requirements

Cost

€€€€

Complexity

High

Implementation Time

12-18 months

Key Features

Certifiable requirements standard replacing guidance-only ISO 19600
High-Level Structure enables integration with ISO 9001/14001/27001
Risk-based planning identifies obligations and compliance risks
Leadership commitment fosters compliance culture and whistleblowing protections
PDCA cycle drives performance evaluation and continual improvement

Quality Management

ISO 13485

ISO 13485:2016 Medical devices Quality management systems

Cost

€€€€

Complexity

High

Implementation Time

12-18 months

Key Features

Risk-based QMS for medical device lifecycle
Mandatory design controls and validation
Supplier evaluation and outsourcing controls
Traceability and medical device files
Post-market surveillance and CAPA processes

Detailed Analysis

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

ISO 37301 Details

What It Is

ISO 37301:2021 is a certifiable international standard specifying requirements with guidance for establishing, implementing, maintaining, and improving Compliance Management Systems (CMS). Applicable to all organization sizes and sectors, it uses a risk-based approach and Plan-Do-Check-Act (PDCA) cycle aligned with ISO High-Level Structure (HLS).

Key Components

Core clauses: context, leadership, planning, support, operation, performance evaluation, improvement.
Emphasizes leadership commitment, compliance culture, whistleblowing channels, risk assessment, internal audits, and continual improvement.
Built on HLS for integration; supports companion standards like ISO 37302 (effectiveness) and ISO 37303 (competence).
Certification via accredited bodies (e.g., ANAB).

Why Organizations Use It

Demonstrates systematic compliance to stakeholders, reduces risks, fines, and reputational damage.
Meets regulatory, ESG, and investor demands; enhances trust and market access.
Drives efficiency through integrated management systems.

Implementation Overview

Phased: gap analysis, obligation register, controls, training, audits.
Scalable for SMEs to enterprises; 3-year certification cycle with surveillance audits.
Global applicability; 2024 amendment adds climate action focus.

ISO 13485 Details

What It Is

ISO 13485:2016, titled "Medical devices — Quality management systems — Requirements for regulatory purposes," is a certifiable international standard establishing a risk-based QMS framework for organizations in the medical device lifecycle, from design to post-market surveillance. It ensures consistent delivery of safe, compliant devices meeting customer and regulatory needs.

Key Components

Core clauses (4–8): QMS/documentation, management responsibility, resources, product realization, measurement/improvement.
Emphasizes validation, traceability, risk management (per ISO 14971), medical device files, supplier controls, CAPA.
Built on process approach; requires documented procedures/records.
Third-party certification via accredited bodies with stage audits.

Why Organizations Use It

Facilitates market access (EU MDR, FDA QMSR by 2026).
Mitigates risks, reduces recalls/costs, ensures supply chain resilience.
Builds regulator/partner trust, competitive edge in global markets.

Implementation Overview

Phased: gap analysis, documentation/process design, validation/training, internal audits/management review, certification.
Applies to manufacturers/suppliers globally; scalable for SMEs to enterprises.

Key Differences

Aspect	ISO 37301	ISO 13485
Scope	Compliance obligations, risks, culture, whistleblowing	Medical device lifecycle, QMS, safety, validation
Industry	All sectors, all sizes, global applicability	Medical devices, healthcare supply chain, global
Nature	Certifiable CMS requirements standard, voluntary	Certifiable QMS requirements standard, regulatory-oriented
Testing	Internal audits, management reviews, certification audits	Internal audits, process validation, certification audits
Penalties	Loss of certification, no legal penalties	Loss of certification, regulatory enforcement risks

Scope

ISO 37301

Compliance obligations, risks, culture, whistleblowing

ISO 13485

Medical device lifecycle, QMS, safety, validation

Industry

ISO 37301

All sectors, all sizes, global applicability

ISO 13485

Medical devices, healthcare supply chain, global

Nature

ISO 37301

Certifiable CMS requirements standard, voluntary

ISO 13485

Certifiable QMS requirements standard, regulatory-oriented

Testing

ISO 37301

Internal audits, management reviews, certification audits

ISO 13485

Internal audits, process validation, certification audits

Penalties

ISO 37301

Loss of certification, no legal penalties

ISO 13485

Loss of certification, regulatory enforcement risks

Frequently Asked Questions

Common questions about ISO 37301 and ISO 13485

ISO 37301 FAQ

ISO 13485 FAQ

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ISO 37301

ISO 13485

Quick Verdict

ISO 37301

Key Features

ISO 13485

Key Features

Detailed Analysis

ISO 37301 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

ISO 37301 FAQ

What is the primary objective of ISO 37301?

Who is legally or professionally required to comply with ISO 37301?

Does ISO 37301 require an external audit or third-party certification?

How often should an assessment for ISO 37301 be performed?

What are the consequences of non-compliance with ISO 37301?

Can ISO 37301 be mapped to other international frameworks?

What is the first step to begin implementing ISO 37301?

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?

Can ISO 13485 be mapped to other international frameworks?

What is the first step to begin implementing ISO 13485?

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Using CIS Controls v8.1 as a ‘Compliance On-Ramp’: Map One Security Program to NIST CSF, ISO 27001, PCI DSS, and NIS2

5 Ways Modern Compliance Software Makes Evolving Regulations Your Strategic Advantage

Run Maturity Assessments with GRADUM

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ISO 37301 vs CMMI

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