ISO 13485:2016 Certification Consultancy
Medical Devices Quality Management System (QMS)
Since 2004, Blue Sky Management Services has been a trusted name in ISO 13485 certification consultancy for the medical device sector. Headquartered in Ahmedabad, Gujarat, we provide expert support for certification, training, and documentation required to meet ISO 13485:2016 standards.
We assist clients in obtaining certification from leading global bodies such as TÜV, BVQI, Intertek, and other UKAS, ASCB, ANAB, RVA-accredited certification agencies.
What is ISO 13485:2016?
ISO 13485:2016 is the internationally recognized Quality Management System (QMS) standard for medical devices. It is designed for manufacturers, suppliers, and service providers in the medical device industry to demonstrate compliance with regulatory and customer requirements.
This standard ensures consistent design, development, production, installation, and servicing of medical devices that meet both customer expectations and applicable legal frameworks.
Who Needs ISO 13485 Certification?
This certification is ideal for:
-
Medical device manufacturers
-
Component and accessory suppliers
-
Importers and exporters
-
Sterilization service providers
-
Software developers for medical devices
-
Regulatory affairs consultants
If you operate in the medical device supply chain and want to enhance your credibility, reduce risk, and enter new markets, ISO 13485 certification is essential.
Our ISO 13485 Certification Services Include:
We offer comprehensive support to ensure you meet every requirement of the ISO 13485 standard:
Gap Analysis
Evaluate your current systems against ISO 13485 requirements to identify deficiencies and opportunities for improvement.
Certification Coordination
We liaise with accredited certification bodies to manage audit scheduling, documentation review, and final approval.
Training & Competency Building
We conduct employee awareness and internal auditor training to support long-term compliance.
Documentation Assistance
We help you prepare and implement the essential documents:
Quality Manual
Quality Policy
Quality Procedures
Quality Objectives
Risk Management Plan
Traceability and Sterilization Records
Risk Management & Product Lifecycle Support
We guide you in conducting risk assessments as per ISO 14971 and provide input for:
Product design
Software validation
Clinical evaluations
Advisory notice handling
Service Locations
We offer our ISO 13485 certification consultancy services in:
Ahmedabad, Vadodara, Surat, Rajkot, Ankleshwar, Bharuch, Vapi, Valsad, Gandhinagar, Navsari, Bhavnagar, Gandhidham, Surendranagar, and across major cities in India including Mumbai, Delhi, Kolkata, Chennai, Pune, Jaipur, Udaipur, Jodhpur, Chandigarh, Lucknow, and more.
Key Requirements of ISO 13485:2016
To achieve ISO 13485 certification, organizations must implement the following key components:
Documentation & Planning
-
Quality Manual
-
Quality Policy & Objectives
-
Document and Record Control
-
Role-specific responsibilities in line with regulatory norms
Product Realization
-
Clean and hygienic production environment
-
Clinical evaluations for devices in development
-
Control over installation and servicing
-
Validation of sterile and non-sterile medical devices
Traceability & Risk Management
-
Complete traceability of products throughout the lifecycle
-
Risk management planning (aligned with ISO 14971)
-
Proper identification and control of non-conforming products
Legal & Regulatory Compliance
-
Adherence to local and international laws
-
Preparation and response to advisory notices
-
Review and monitoring of legal updates affecting your product
Benefits of ISO 13485 Certification
Getting ISO 13485 certified offers several strategic advantages:
✅ Access to global markets and regulatory approvals
✅ Enhanced product safety and patient satisfaction
✅ Improved internal processes and efficiency
✅ Strengthened reputation among customers and regulators
✅ Risk reduction and better incident management
✅ Competitive edge in tenders and partnerships