Overview
ISO 13485:2016 is the latest internationally recognized Quality Management System (QMS)
standard developed specifically for organizations involved in the life cycle of
medical devices. The standard establishes requirements for organizations to
consistently design, develop, manufacture, install, and service medical devices
that are safe, effective, and compliant with applicable regulatory requirements.
ISO 13485:2016 places enhanced emphasis on risk-based decision making, regulatory
compliance, process validation, and documented controls, aligning closely with
global medical device regulations such as EU MDR, FDA, and other international frameworks.
Why ISO 13485:2016 Certification is Important
- Ensure consistent quality, safety, and performance of medical devices
- Meet international regulatory and statutory requirements
- Strengthen confidence among regulators, customers, and stakeholders
- Implement risk-based controls throughout the product life cycle
- Improve traceability, documentation, and change management
- Enhance access to global medical device markets
Who Can Be Certified?
ISO 13485:2016 is applicable to organizations of all sizes operating within the
medical device supply chain, including:
- Medical device and equipment manufacturers
- In-vitro diagnostic (IVD) device manufacturers
- Manufacturers of components, raw materials, and accessories
- Sterilization, calibration, and testing service providers
- Importers, distributors, and authorized representatives
- Organizations providing installation, servicing, and maintenance of medical devices
Key Requirements of ISO 13485:2016
- Quality management system documentation and regulatory alignment
- Management responsibility and risk-based quality objectives
- Resource management and personnel competence
- Product realization and validated manufacturing processes
- Risk management throughout the product life cycle (ISO 14971)
- Design and development controls with verification & validation
- Supplier evaluation and outsourced process control
- Monitoring, measurement, and calibration of equipment
- Control of nonconforming products and field safety actions
- Corrective and preventive actions (CAPA) and continual improvement
Benefits of ISO 13485:2016 Certification
- Globally accepted medical device quality management system
- Improved patient safety and regulatory preparedness
- Reduced risk of recalls, complaints, and nonconformities
- Enhanced customer confidence and brand reputation
- Improved operational control and regulatory compliance
- Strong competitive advantage in international markets
Certification Process
- Application submission and scope definition
- Optional gap analysis and system implementation
- Stage 1 audit – documentation and readiness review
- Stage 2 audit – certification assessment
- Certification decision and issuance of ISO 13485:2016 certificate
- Annual surveillance audits to ensure ongoing compliance
Why Choose Us as Your Certification Partner?
- Internationally experienced and qualified medical device auditors
- Independent, impartial, and globally aligned certification process
- Timely audits with efficient certification timelines
- Transparent and cost-effective certification solutions
- Dedicated technical support and responsive client service
Get Certified with Confidence
Achieve global recognition and demonstrate your commitment to quality,
patient safety, and regulatory compliance with ISO 13485:2016 certification.
Partner with us to strengthen your medical device quality management system
and expand your presence in international markets.
Contact Us
Email: iso@psacertification.com