What It Is

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

Key Components

• Organized into Clauses 4–8: QMS/documentation (4), management responsibility (5), resources (6), product realization (7), measurement/improvement (8).
• Emphasizes documented procedures, validation, traceability, and objective evidence of implementation.
• Built on process approach, aligned with ISO 9001 but enhanced for regulatory needs like risk management (ISO 14971).
• Certification via accredited bodies with stage audits and surveillance.

Why Organizations Use It

• Enables market access (EU MDR, FDA QMSR alignment by 2026).
• Reduces risks of recalls, noncompliance fines.
• Builds stakeholder trust, supply chain assurance.
• Drives operational efficiency, scalability.

Implementation Overview

• Phased: gap analysis, documentation, training, validation, audits (9–36 months typical).
• Applies to manufacturers, suppliers, distributors globally.
• Requires eQMS tools, cross-functional teams, management reviews.

What It Is

ISO 22301:2019, titled Societal security — Business continuity management systems — Requirements, is an international certification standard for establishing, implementing, maintaining, and improving a Business Continuity Management System (BCMS). It provides a robust, risk-based framework aligned with the Annex SL high-level structure and PDCA (Plan-Do-Check-Act) cycle to protect critical operations from disruptions like cyberattacks, disasters, and supply chain failures.

Key Components

• 10 clauses, with auditable Clauses 4-10 covering context, leadership, planning (including BIA and RA), support, operations, evaluation, and improvement.
• No fixed controls; flexible, tailored requirements.
• Core principles: resilience, recovery (e.g., RTO, RPO), testing, audits.
• Certification model: two-stage external audit, 3-year validity with annual surveillance.

Why Organizations Use It

Drives reduced downtime, cost savings, regulatory compliance (e.g., NIS Directive), lower insurance premiums, enhanced stakeholder trust, and competitive advantages in sectors like finance and healthcare. Mitigates risks holistically, fostering resilience culture.

Implementation Overview

Phased: gap analysis, leadership buy-in, BIA/RA, policy development, training, testing (tabletops/drills), audits. Applicable to all sizes/sectors globally; accelerated by digital platforms (e.g., 60 days prep, 6 months certification).