What It Is

ISO 13485:2016 is an international certification standard specifying quality management system (QMS) requirements for medical devices. Designed for regulatory purposes, it ensures organizations consistently meet customer and regulatory requirements across the device lifecycle, using a risk-based process approach.

Key Components

• Clauses 4–8 cover QMS, management responsibility, resources, product realization, and measurement/improvement.
• Emphasizes documented procedures, medical device files, validation, traceability, and post-market surveillance.
• Builds on process approach like ISO 9001 but adds device-specific regulatory focus.
• Certification via accredited bodies with stage 1/2 audits and surveillance.

Why Organizations Use It

• Enables market access (EU MDR, FDA QMSR alignment by 2026).
• Reduces risks like recalls via robust controls.
• Builds stakeholder trust and supply chain assurance.
• Drives operational efficiency and competitive edge.

Implementation Overview

• Phased: gap analysis, documentation, training, validation, audits.
• Applies to manufacturers, suppliers, distributors globally.
• Requires eQMS tools, cross-functional teams; 9–18 months typical.

What It Is

GRI Standards (Global Reporting Initiative Standards) is a voluntary, modular framework for sustainability reporting. Its primary purpose is to enable organizations to disclose significant economic, environmental, and social impacts using an impact-centric materiality approach, focusing on effects on stakeholders rather than just financial materiality.

Key Components

• Universal Standards (GRI 1, 2, 3): Foundation, general disclosures, material topics (baseline for all reporters).
• **Sector StandardsSector-specific material topics (e.g., Oil & Gas, Mining).
• **Topic StandardsSpecific disclosures (e.g., GRI 403 Occupational Health & Safety, GRI 308 Supplier Environmental Assessment).
• Built on principles like accuracy, balance, verifiability; requires GRI Content Index for compliance.

Why Organizations Use It

Drives accountability, regulatory alignment (e.g., EU CSRD), risk management, stakeholder trust, and benchmarking. Enhances credibility for investors, regulators, and civil society.

Implementation Overview

Phased: materiality assessment, data systems, management approaches, content index. Applies universally; no certification but supports assurance. Involves governance, stakeholder engagement, supply-chain due diligence.