Doc Summary
Overview
ISO 13485:2016 Certification under UBIAC (United Board for International Accreditation and Certification) is an internationally recognized standard that defines requirements for a Quality Management System (QMS) specific to medical devices and related services.
It ensures that organizations involved in the design, production, installation, and servicing of medical devices consistently meet customer expectations and regulatory requirements for safety and performance.
This certification is a vital requirement for manufacturers and suppliers in the healthcare sector who aim to demonstrate product quality, reliability, and compliance with international medical standards.
Eligibility / Who Should Apply
- Manufacturers of medical devices and equipment.
- Distributors and suppliers of medical and laboratory products.
- Sterilization service providers, testing laboratories, and maintenance service firms.
- Importers and exporters of healthcare and medical devices.
- Organizations involved in design, installation, or calibration of medical equipment.
Key Features
- Focuses on quality, traceability, and regulatory compliance for medical devices.
- Ensures alignment with international standards such as EU MDR, US FDA, and WHO GMP.
- Covers the entire lifecycle — from design and production to servicing and post-market monitoring.
- Reduces risk of device failure and enhances patient safety.
- Certification valid for 3 years, with annual surveillance audits.
Step-by-Step Process
- Application Submission:
Apply through UBIAC (www.ubiac.com) or via Kanoons Law & Tax Consultants Pvt. Ltd.. - Documentation Review:
UBIAC auditors review QMS documents, production processes, and quality control measures. - Gap Analysis (Optional):
A pre-assessment identifies compliance gaps and improvement opportunities before certification. - Certification Audit:
- Stage 1 Audit: Review of documentation and process readiness.
- Stage 2 Audit: On-site evaluation of manufacturing, testing, and traceability systems.
- Certificate Issuance:
Upon successful audit, UBIAC issues the ISO 13485:2016 Certificate confirming compliance. - Surveillance & Renewal:
Annual audits ensure continued adherence to ISO requirements and regulatory consistency.
Documents Required
- Company registration certificate (Manufacturer / Importer / Supplier)
- Product design and technical documentation
- Quality policy, manuals, and standard operating procedures (SOPs)
- Equipment calibration and validation records
- Risk management and post-market surveillance data
- Supplier evaluation and purchase records
- Internal audit and management review reports
Timeline
The certification process typically takes 20–30 working days, depending on the complexity of operations and documentation readiness.
Post-Certification Requirements
- Maintain product quality records and device history files (DHFs).
- Conduct periodic internal audits and management reviews.
- Ensure compliance with changes in medical device regulations.
- Participate in UBIAC’s annual surveillance audits for continuous monitoring.
Benefits of ISO 13485 Certification
- Improves product safety, reliability, and performance.
- Increases global market acceptance for medical devices.
- Enhances compliance with international regulatory frameworks.
- Builds credibility among hospitals, healthcare providers, and distributors.
- Reduces operational risks and product recalls.
Kanoons & UBIAC Services
Kanoons Law & Tax Consultants Pvt. Ltd., through UBIAC, provides comprehensive ISO 13485:2016 Certification support for medical device and healthcare product organizations.
Our services include:
- Preparation of documentation, SOPs, and quality manuals.
- Internal audits and pre-assessment for readiness.
- Coordination with UBIAC auditors for certification and approval.
- Post-certification compliance, renewal, and surveillance support.
Kanoons ensures your organization meets the highest standards of medical device quality, safety, and international compliance.
Why Choose UBIAC (An Entity of Kanoons)
- Internationally accredited medical quality certification authority.
- Experienced auditors with domain expertise in healthcare manufacturing.
- Transparent, efficient, and globally accepted certification process.
- Continuous guidance for regulatory updates and product compliance.
- Trusted by healthcare manufacturers, exporters, and diagnostic equipment suppliers worldwide.
