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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. 

For any query and clarification feel free to connect with us. 

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