IS 23485:2019 "Medical Devices — Quality Management System Requirements and Essential Principles of Safety and Performance for Medical Devices 📄⚙️ [Industry Guidance]

IS 23485:2019 is an Indian standard established by the Bureau of Indian Standards (BIS) that specifies requirements for a quality management system (QMS) in the medical device industry. It ensures devices consistently meet customer and regulatory requirements and emphasizes continuous improvement, risk management, and maintaining device safety and performance. The standard includes detailed guidelines on documentation, management responsibilities, resource management, product realization, and measurement, analysis, and improvement processes.

Overview of IS 23485:2019

• Title: Medical Devices — Quality Management System Requirements and Essential Principles of Safety and Performance for Medical Devices
• Issuing Body: Bureau of Indian Standards (BIS)
• Purpose: To specify the requirements for a quality management system that can be used by an organization for the design and development, production, installation, and servicing of medical devices, as well as the essential principles of safety and performance for these devices.

Scope of the Standard

• Applicable to all organizations involved in any aspect of the lifecycle of a medical device.
• Includes both active and non-active medical devices, IVDs, and medical software.

Key Requirements of the Quality Management System (QMS)

• General Requirements: Establishment, documentation, implementation, and maintenance of a QMS.
• Management Responsibility: Leadership commitment, policy, planning, and communication.
• Resource Management: Adequate provision of resources, personnel competency, and infrastructure.
• Product Realization: Processes from design and development through to production and post-market activities.
• Measurement, Analysis, and Improvement: Monitoring and measuring QMS processes, product quality, and implementing continual improvements.

Essential Principles of Safety and Performance

• General Safety and Performance Requirements: Ensure devices meet their intended purpose without compromising safety.
• Risk Management: Implement a risk management process throughout the lifecycle of the device.
• Clinical Evaluation and Investigations: Conduct clinical evaluations and, if necessary, clinical investigations to ensure device safety and performance.
• Labeling and Instructions for Use: Provide clear and comprehensive labeling and instructions for safe use.

The documentation requirements outlined in IS 23485:2019 are closely aligned with those of ISO 13485, reflecting a similar focus on establishing a comprehensive quality management system for medical devices. Both standards emphasize ensuring the safety and performance of medical devices through rigorous documentation and compliance protocols. Below are the mandatory documentation requirements but not limited to under IS 23485:2019:

Document Title	Clause Reference	Frequency
Quality Manual	4.2.2	Initial setup and updates as needed
Quality Policy	5.3	Initial setup and review annually
Quality Objectives	5.4.1	Initial setup and review annually
Identification of Regulatory Requirements & Rationale	4.2.2, 7.2.1, 8.2.1	As needed (upon changes in regulations)
Medical Device Files	4.2.3	As Updated
Product List along with Variants	4.2.2, 7.1	As needed (upon product changes)
Device Life Cycle	7.3.7, 7.5.1, 7.5.2	Periodically, as part of design and development review
Identification of Critical Processes (Whether Carried in house or Outsourced)	7.1, 7.5, 7.5.6	Annually or upon process changes
Documented Procedures	4.2.1	Initial setup and updates as needed
Records to Demonstrate Conformity	4.2.4	Ongoing
Document Control Procedure	4.2.3	Initial setup and updates as needed
Record Control Procedure	4.2.4	Initial setup and updates as needed
Document Approval Records	4.2.3	Ongoing
Revision History Records	4.2.3	Ongoing
Management Review Records	5.6	Annually
Customer Satisfaction Records	8.2.1	Ongoing
Organizational Chart	5.5.1	Initial setup and updates as needed
Job Descriptions	5.5.1	Initial setup and updates as needed
Communication Procedures	5.5.3	Initial setup and updates as needed
Competence, Training, and Awareness Records	6.2.2	Ongoing
Training Plans	6.2.2	Initial setup and updates as needed
Resource Planning Records	6.1	Ongoing
Maintenance Records	6.3	Ongoing
Product Realization Plans	7.1	Initial setup and updates as needed
Customer Requirement Records	7.2.1	Ongoing
Contract Review Records	7.2.2	Ongoing
Design and Development Plans	7.3.1	Initial setup and updates as needed
Design Review, Verification, and Validation Records	7.3.4	Ongoing
Design Change Records	7.3.7	Ongoing
Supplier Evaluation and Selection Records	7.4.1	Ongoing
Purchasing Information Records	7.4.2	Ongoing
Production Process Control Documents	7.5.1	Initial setup and updates as needed
Service Provision Records	7.5.1	Ongoing
Identification and Traceability Procedures	7.5.3	Initial setup and updates as needed
Product Identification Records	7.5.3	Ongoing
Customer Property Management Records	7.5.4	Ongoing
Preservation Procedures and Records	7.5.5	Initial setup and ongoing
Calibration Records	7.6	Ongoing
Maintenance Records	7.6	Ongoing
Measurement and Monitoring Procedures	8.1	Initial setup and updates as needed
Internal Audit Records	8.2.2	Semi-annually
Product Inspection Records	8.2.4	Ongoing
Process Monitoring Records	8.2.3	Ongoing
Non-Conforming Product Reports	8.3	Ongoing
Corrective Action Records	8.5.2	Ongoing
Preventive Action Records	8.5.3	Ongoing
Data Analysis Reports	8.4	Ongoing
Continual Improvement Plans	8.5.1	Ongoing
Risk Management Files	ISO 14971	Initial setup and updates as needed
Clinical Evaluation Reports	MEDDEV 2.7/1	Initial setup and updates as needed
Biocompatibility Assessment	ISO 10993 series	Initial setup and updates as needed
Sterilization Validation Records	ISO 11135, ISO 11137	Initial setup and ongoing
Electrical Safety Testing Records	IEC 60601	Initial setup and updates as needed
Software Validation Records	IEC 62304	Initial setup and updates as needed
Usability Engineering Files	IEC 62366	Initial setup and updates as needed
Environmental Impact Assessment	ISO 14001	Initial setup and updates as needed

The Certification of this standard is carried out by the NABCB accredited Notified bodies, Manufacturers must verify the accreditation scope with NABCB for the notified body. 

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