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ISO 13485:2016 is the globally recognized standard for implementing a Quality Management System (QMS) specifically tailored to the medical device industry. It supports manufacturers, importers, and service providers in maintaining product safety, compliance, and customer satisfaction.
AccordMed is a trusted ISO 13485 Certification Consultant in India, helping medical device companies ensure global compliance and regulatory readiness—so you can meet CDSCO, USFDA, EU MDR, and other regulatory requirements with confidence.
What is ISO 13485:2016?
ISO 13485:2016 certification sets out the criteria for a QMS where an organization must demonstrate its ability to consistently design, produce, install, and deliver medical devices that meet customer expectations and regulatory obligations.
This standard is based on the process approach and incorporates risk management, documentation control, and regulatory alignment throughout the product lifecycle.
Who Needs ISO 13485 Certification?
ISO 13485:2016 is applicable to:
- Medical Device Manufacturers
- Importers, Exporters, and Distributors
- OEM/Contract Manufacturers
- Design & Development Firms
- Sterilization Service Providers
Certification is often a prerequisite for:
- CDSCO approval in India
- CE Marking in Europe
- USFDA 510(k) and PMA pathways
International tenders and hospital procurement
Key Benefits of ISO 13485:2016
- Regulatory Alignment – Ensures compliance with global regulations (CDSCO, EU MDR, USFDA QSR)
- Risk Reduction – Integrates risk management into product and process design
- Operational Efficiency – Streamlines workflows, reduces nonconformities and recalls
- Market Access – Essential for product registrations and international exports
- Customer Confidence – Improves brand image and trust among buyers and health professionals
The 8 Clauses of ISO 13485:2016 Explained
ISO 13485 consists of 8 structured clauses that define the complete framework for an effective QMS:
Clause 1: Scope
Defines the applicability of ISO 13485 to organizations involved in the design, development, production, installation, and servicing of medical devices.
It clarifies that the standard is applicable regardless of the organization’s size or type.
Clause 2: Normative References
Lists documents that are indispensable for applying ISO 13485. In this case, it refers to ISO 9000:2015, which provides fundamental QMS vocabulary and principles.
Clause 3: Terms and Definitions
Establishes the terminology used throughout the standard. Familiarity with these terms ensures consistency in interpretation and implementation.
Clause 4: Quality Management System
Outlines the general QMS requirements, including:
- Document control
- Record management
- Process interaction
- Regulatory compliance
- Quality Manual development
This clause forms the foundation of your ISO 13485 system.
Clause 5: Management Responsibility
Focuses on top management’s role in establishing, implementing, and maintaining the QMS. Key elements include:
- Quality policy and objectives
- Management review
- Customer focus
- Resource provision
Leadership commitment is critical for ISO 13485 success
Clause 6: Resource Management
Addresses the provision and management of resources required for an effective QMS, including:
- Human resources and training
- Infrastructure and environment
- Equipment maintenance and calibration
Only a trained and well-resourced team can ensure product quality.
Clause 7: Product Realization
This is the core operational clause, covering:
- Design and development
- Purchasing and supplier control
- Production and service provision
- Device traceability and cleanliness
- Validation of sterilization and software
- Complaint handling and post-market surveillance
Clause 7 ensures your product lifecycle—from design to delivery—is compliant and controlled.
Clause 8: Measurement, Analysis and Improvement
Focuses on continual improvement and regulatory oversight. It includes:
- Internal audits
- Monitoring and measurement of processes
- Nonconformance handling
- CAPA (Corrective and Preventive Action)
- Data analysis and trend reporting
This clause ensures long-term QMS effectiveness and regulatory readiness.
ISO 13485 Certification Consultant in India
We offer end-to-end consulting for ISO 13485:2016, customized to your operations:
Gap Analysis
We evaluate your existing QMS and regulatory readiness.
Documentation Support
We help create or update SOPs, Quality Manuals, risk files, and more.
Training & Implementation
We train your team to understand, implement, and maintain ISO-compliant practices.
Internal Audit & Pre-Assessment
We conduct mock audits and prepare you for certification.
Certification Body Coordination
We connect you with an accredited certifying body and guide you through the audit.
Post-Certification Maintenance
We offer continual compliance audits, surveillance readiness, and document updates.
ISO 13485 Certification Process in India
Initial Consultation & Planning
Understand requirements, define scope, and create a roadmap for implementation.
Documentation and QMS Implementation
Develop Quality Manual, SOPs, records, and implement the Quality Management System.
Internal Audit and Management Review
Conduct internal audits and hold a formal management review to evaluate system effectiveness.
Certification Audit by Notified Body
Undergo Stage 1 (documentation review) and Stage 2 (implementation audit) with a certifying body.
Surveillance Audits and Improvements
Participate in annual surveillance audits and ensure continual improvement of the QMS.
Frequently
Asked Questions
While not legally required in all cases, ISO 13485 is highly recommended and often expected during CDSCO audits and Form MD submissions.
ISO 13485 is specific to medical devices and includes regulatory, sterilization, and traceability requirements that ISO 9001 does not cover.
No, but it forms the foundation for meeting those regulations. It is often required for CE marking, FDA QSR compliance, and international registrations
Only accredited certification bodies like TÜV SÜD, BSI, DNV, or Intertek can issue valid ISO 13485:2016 certificates.
ISO 13485 certificates are valid for 3 years, with annual surveillance audits.
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