ISO 13485:2016 is the internationally recognized standard for Quality Management Systems (QMS) specific to the medical device industry. It outlines requirements for the design, development, production, installation, and servicing of medical devices and related services, ensuring product safety and regulatory compliance.
Certification under ISO 13485:2016 is suitable for manufacturers, suppliers, and service providers involved in the medical device lifecycle. It demonstrates a strong commitment to regulatory compliance, patient safety, and consistent quality in healthcare products.
Purpose of ISO 13485:2016 Certification
- Ensure safety and performance of medical devices
- Comply with international regulatory requirements (e.g., EU MDR, FDA)
- Improve product traceability and defect prevention
- Enhance risk management and process control
- Build confidence among customers, regulators, and stakeholders
- Foster a culture of quality and continuous improvement in healthcare
Our ISO 13485:2016 Certification Process
We follow a step-by-step certification process to ensure clarity, objectivity, and transparency:
1. Application Submission
The organization submits a completed Certification Request Form including:
- Company profile
- Number of employees
- Locations of operations
- Scope of certification
2. Application Review & Quotation
We review the details to:
- Verify audit feasibility
- Define the certification scope
- Provide a formal quotation
3. Audit Planning
Once confirmed, we plan the certification audit including:
- Audit team assignment
- Timeline and logistics
- Client coordination
4. Stage 1 Audit – Documentation Review
Assessment of the organization’s QMS documentation for:
- Conformance with ISO 9001:2015
- Readiness for on-site audit
- Identification of potential gaps
5. Stage 2 Audit – On-site Assessment
Comprehensive audit of the implemented QMS:
- Process evaluation
- Staff interviews
- Objective evidence verification
- Identification of nonconformities (if any)
6. Audit Report & Certification Decision
- Audit team submits findings and recommendations
- Independent decision-maker reviews the report
- Certification granted if requirements are met
7. Certification Issuance
- Valid for 3 years
- Certificate includes scope, standard, issue/expiry dates
8. Surveillance Audits (Year 1 & 2)
- Annual on-site surveillance audits
- Verification of continued conformity and improvements
9. Recertification Audit (Year 3)
- Full system reassessment before certificate renewal
Key Features
- ✅ Independent & Impartial Audits by Medical Device Experts
- ✅ Deep Knowledge of Regulatory & Industry Requirements
- ✅ Transparent, Structured, and Process-Oriented Approach
- ✅ Quick Turnaround on Reporting and Certification
- ✅ Full Compliance with ISO/IEC 17021-1 and Relevant ISO Standards
About Quality HUB India
Quality HUB India(QHI) is a NABCB, IAF accredited third-party certification body (CB) offering independent and impartial certification services for a range of ISO management systems. Quality HUB India(QHI) is a trusted name in the field of quality, management system training, and certification support. With a strong focus on empowering organizations to achieve operational excellence. We specialize in ISO 9001:2015 (Quality Management), ISO 14001:2015 (Environmental Management), and ISO 45001:2018 (Occupational Health & Safety Management) certifications.
We follow globally accepted auditing practices in strict compliance with ISO/IEC 17021-1, ensuring fair, transparent, and unbiased assessments across diverse industries and sectors.
How to Get Started
Step 1: Submit the ISO Certification Request Form
Step 2: Our team will contact you for review and audit scheduling.
📞 Contact Us: +91- 7073111630
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