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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