ISO 13485:2016

Structure of ISO 13485
ISO 13485 is an internationally recognized standard that defines quality management system (QMS) requirements for manufacturers, suppliers, contract service providers, and distributors of medical devices and equipment. The primary objective of the standard is to establish harmonized QMS requirements for regulatory compliance within the medical device sector.
ISO 13485 is based on the requirements of ISO 9001 and follows a similar clause structure. Some clauses of ISO 13485 also reference ISO 9001. It serves as the foundation for regulatory compliance in local and global markets, making ISO 13485 certification essential for organizations exporting medical devices. Certification provides objective evidence of compliance with the standard’s requirements.

Validating Your Quality Management System

Certifications build trust, which is crucial in the medical device industry. EN ISO 13485 is the international standard for QMS in medical devices. It evaluates quality management practices in design and development, production, customer service, and assembly. Implementing a QMS under ISO 13485 enhances operational efficiency, ensures compliance, and improves international market access.

Mandatory Procedures in ISO 13485

ISO 13485:2016 mandates 10 documented procedures in addition to ISO 9001:2008 requirements to define and control various operational areas. These include:
1. Design & Development – Ensures a controlled, consistent design and development process (Clause 7.3.1).
2. Purchasing Process – Ensures purchased products meet specified requirements (Clause 7.4.1).
3. Particular Requirements for Sterile Medical Devices – Validates sterilization processes (Clause 7.5.2.2).
4. Identification – Ensures returned devices are identified and distinguished from conforming products (Clause 7.5.3.1).
5. Traceability – Defines product traceability and required records (Clause 7.5.3.2.1).
6. Preservation of Product – Ensures product conformity during processing and delivery (Clause 7.5.5).
7. Control of Monitoring and Measuring Devices – Ensures consistency in measurement and monitoring (Clause 7.6).
8. Feedback – Establishes an early warning system for quality issues (Clause 8.2.1).
9. Analysis of Data – Evaluates QMS effectiveness through data collection and analysis (Clause 8.4).
10. Advisory Notices & Improvement – Implements advisory notices and regulatory notifications (Clause 8.5.1).
Additionally, specific clauses require documented procedures under certain conditions, such as infrastructure, work environment, product realization planning, customer requirements, production control, cleanliness, installation, validation of processes, and risk management.

Benefits of ISO 13485 Certification

By obtaining EN ISO 13485 certification from TNV Certification Pvt. Ltd., organizations can:
• Expand market access and increase device sales.
• Meet regulatory requirements in various global markets.
• Enhance brand equity by demonstrating safe medical device production.
• Gain a competitive edge.
• Reduce operational costs.
• Strengthen business credentials.
• Improve stakeholder relationships.
• Ensure legal compliance.
• Boost customer satisfaction.
• Improve risk management.

Integrated Services

Organizations can integrate ISO 13485 certification with other standards, such as:
• ISO 9001 (Quality Management)
• ISO 14001 (Environmental Management)
• OHSAS 18001 / ISO 45001 (Occupational Health & Safety)
• CE Compliance for Medical Devices

Certification Process – Four Steps to Certification

1.Application & Agreement – Initial consultation, financial terms, and contractual agreement.
2. Stage-1 Audit – Assessment of site and review of QMS documentation.
3. Stage-2 Audit – On-site evaluation of QMS implementation and effectiveness.
4. Certification – If all criteria are met, the organization receives certification confirming compliance with ISO 13485.

Risk Management According to ISO 14971

ISO 14971 defines the risk management process for identifying and controlling risks associated with medical devices. Organizations must document a risk management process that includes risk analysis, evaluation, control, and post-market surveillance.

ISO 13485 Quality Management System

ISO 13485 evaluates an organization’s ability to meet customer expectations and regulatory requirements. It is a process standard, not a product standard, meaning organizations must comply with relevant product and service-oriented technical regulations.
ISO 13485:2016 follows the ISO 9001:2015 process model and is structured based on Annex SL. Unlike ISO 9001:2015, it focuses more on regulatory compliance than business improvement. The standard requires detailed documentation and emphasizes risk management as a critical element.
Although the FDA has not fully adopted ISO 13485:2016, the standard aligns with FDA regulations to ensure compliance with global market requirements. Additionally, ISO 13485 is compatible with other management systems such as ISO 14001 and ISO 45001.