ISO 13485:2016 Certification

ISO 13485:2016 Certification is an international standard that specifies requirements for a Quality Management System (QMS) specifically for organizations involved in the design, production, installation, and servicing of medical devices and related services.

ISO 13485:2016– Built on Principles That Drive Long-Term Success

  • Patient Safety First
    ISO 13485 puts patient health at the center by ensuring medical devices are consistently safe, effective, and high in quality.

  • Strong Quality Management
    A structured Quality Management System (QMS) helps organizations maintain process control, reduce errors, and improve device reliability.

  • Regulatory Compliance
    The standard aligns with global regulatory requirements, helping manufacturers meet legal obligations and enter international markets confidently.

  • Risk-Based Thinking
    Proactively identifying and addressing risks in product design, manufacturing, and distribution reduces failures and enhances trust.

  • Traceability and Documentation
    Robust record-keeping and traceability systems ensure transparency and support corrective actions when needed.

  • Supplier and Process Control
    Ensures suppliers and outsourced processes meet the same high-quality standards, maintaining consistency across the supply chain.

Steps to Get ISO 13485:2016 Certified

Step 1

Gap Analysis

Assess current system against ISO 13485:2016.

Step 2

Planning

Define QMS scope, regulatory requirements, and objectives.

Step 3

Documentation

Create policies, manuals, procedures, and risk files.

Step 4

Implementation

Integrate QMS processes across departments, train staff.

Step 5

Internal Audit

Regularly audit QMS, address non-conformities.

Step 6

Management Review

Top management reviews performance and improvement actions.

Step 7

Certification Audit

Accredited auditor evaluates QMS compliance.

Step 8

Certification Issued

Accredited auditor evReceive certification after successful audit, valid for 3 yearsaluates QMS compliance.

Benefits of ISO 13485:2016 Certification

Regulatory Compliance – Ensures alignment with global medical device regulations.

Improved Product Quality – Enhances consistency and safety of medical devices.

Risk Management – Identifies, reduces, and manages quality-related risks.

Customer Trust – Builds confidence with patients, clients, and partners.

Global Market Access – Facilitates entry into international markets.

Operational Efficiency – Streamlines processes and reduces waste.