ISO 13485:2016 Medical Devices Quality Management Systems Certification

ISO 13485:2016 Certification is an independent certification service that evaluates an organization’s Quality Management System for medical devices against the requirements of ISO 13485:2016, supporting consistent product quality, regulatory compliance, and patient safety throughout the medical device lifecycle.

Sustainable Management System Inc. delivers ISO 13485 certification through a structured, impartial, and evidence-based certification process, aligned with internationally recognized certification principles and applicable regulatory and accreditation requirements.

This service provides independent third-party certification of an organization’s Medical Devices Quality Management System against the requirements of ISO 13485:2016. The certification process assesses whether the QMS is established, implemented, maintained, and effective in meeting applicable regulatory requirements and managing risks associated with medical devices.

Certification activities typically include application review, Stage 1 audit (system readiness and documentation review), Stage 2 audit (implementation and effectiveness assessment), certification decision, and ongoing surveillance audits during the certification cycle. Audit conclusions are based on objective evidence, documented findings, and defined certification rules.

Certification is granted and maintained subject to continued conformity with ISO 13485 requirements and successful completion of surveillance audits.

Benefits

Demonstrates compliance with internationally recognized medical device QMS requirements
Supports regulatory compliance and market access
Strengthens risk management and product safety controls
Improves consistency and traceability across the product lifecycle
Enhances confidence of regulators, customers, and business partners

Applicable Scope

The certification is applicable to organizations involved in one or more stages of the medical device lifecycle, including design, development, production, storage, distribution, installation, servicing, and related support activities.

The certification scope is defined based on:

Medical device products and related services
Regulatory responsibilities and applicable markets
Organizational activities, processes, and locations

The final certification scope is confirmed during the certification application and audit process.

Why Choose Us

Sustainable Management System Inc. provides professional and impartial certification services supported by competent auditors with medical device sector expertise and robust certification processes.

Our ISO 13485 certification services are delivered in accordance with defined certification rules, structured audit methodologies, and strong internal quality controls. We emphasize independence, objectivity, confidentiality, and consistency, ensuring credible and reliable certification outcomes.

Contact Us

For ISO 13485:2016 certification, application guidance, audit planning, or certification cycle details, please contact us through our enquiry form or official communication channels. Service arrangements are planned based on organizational size, scope, regulatory complexity, and market requirements.