ISO 13485:2016 Certification
Medical Devices Quality Management System
ISO 13485 certification is awarded following the successful completion of a structured, independent audit and inspection process that evaluates your Medical Devices Quality Management System against international requirements.
Once certified, the validity of the certification depends on continued compliance, supported through periodic surveillance audits to ensure your system remains effective, consistent, and aligned with the standard.
What is ISO 13485?
In an environment shaped by strict regulatory expectations and increasing demands for patient safety, quality management must go beyond basic compliance.
The ISO 13485 Certificate is the globally recognised benchmark for Quality Management Systems for medical devices, enabling organisations to ensure product safety while strengthening operational control and regulatory confidence.
At TQV, we support organisations in achieving the ISO 13485 Certificate by implementing a practical, business-focused management system. Through certification, inspection, testing, and training, we help you manage quality risks, meet regulatory requirements, and enhance trust across healthcare markets.
Why is ISO 13485 important?
With medical device regulations evolving worldwide, ISO 13485 is the most widely accepted quality management standard specific to the medical devices sector. Built on principles such as risk management, regulatory compliance, and continual improvement, ISO 13485 provides a framework through which organizations can achieve formal certification (although certification itself is voluntary).
Key business benefits include:
- Strengthened risk management:
Establishes a structured approach to identifying, assessing, and controlling risks across the entire product lifecycle, helping ensure patient safety and product reliability - Regulatory alignment:
Supports compliance with stringent medical device regulations and applicable legal requirements, enabling smoother approvals and access to regulated markets. - Improved operational performance:
Optimizes workflows and quality processes, minimizing inefficiencies, reducing waste, and improving productivity. - Global market readiness:
Aligns organizations with internationally accepted standards, supporting expansion into global markets and strengthening competitive positioning. - Increased credibility and trust:
Demonstrates commitment to quality and safety, reinforcing confidence among regulators, customers, partners, and end users through certified compliance.
Quality Management Toolkit
Our ISO 13485 Services
Training
Structured training programs to enhance understanding of ISO 13485 for different roles, experience levels, and organisational needs.
Gap Analysis
An optional pre-audit assessment where auditors review your system to identify gaps or potential non-conformities before the certification audit.
Audit & Certification
A two-stage independent audit evaluating your Medical Devices Quality Management System against ISO 13485. Accredited certification builds stakeholder confidence and supports market access.
Integrated Audits
For organizations with multiple certifications, we offer integrated audit programmes that align standards, improving efficiency and reducing audit time and costs.
ISO 13485 Certification Process with TQV
Application Review
Once TQV will review and accept your application for ISO 13485, the stage l audit dates will be set ( along with your team to review your documents.)
Stage 1 Audit
This audit is mainly for documentation review; where our auditors will assess and verify your QMS documentation to ensure they are prepared effectively in accordance with the ISO (Medical Devices QMS) standard requirements. If the documents under observation are in order, then we move to stage 2 Audit.
Stage 2 Audit
TQV auditors will visit your office premises and conduct the external audit to ensure that the documentation reviewed and verified in stage 1 Audit are actually being implemented effectively within your organization.
Successfully Certification Issue
After successful completion of stage 2 Audit, TQV auditors will submit their findings and report to the Audit Manager who will verify the effectiveness and compliance to the Medical Devices QMS standard and finally TQV will grant your organization with the ISO 13485 certification.
Certification & Surveillance
Certification valid for three years, supported by periodic surveillance audits to ensure continued compliance and improvement.
Why Work with TQV
Global recognition, local execution
We support organizations across more than 120 countries, with qualified auditors available wherever you operate. This ensures consistent certification quality, backed by responsive, location-specific support delivered both on-site and remotely.
Business-focused approach
ISO 13485 provides a solid foundation for managing medical device quality. At TQV, we look beyond checklists and assess it in the context of your real business challenges, helping you understand how quality systems support compliance, performance, and patient safety.
Experienced professionals
At TQV, our auditors and trainers bring years of cross-industry experience and hands-on expertise. They provide insights at every step of certification and training, turning compliance requirements into practical, real-world improvements for your organization.
Alignment with Sustainable Development Goals (SDGs)
ISO 13485 also supports global sustainability efforts by contributing to these UN Sustainable Development Goals:
SDG 3:
Good Health and Well-Being – Ensure healthy lives and promote well-being for all ages by improving access to healthcare, disease prevention, and overall health outcomes.
SDG 10:
Reduced Inequalities – Ensuring equal protection, safety, and fair treatment for all employees.