IS 23485 Certification

Overview of IS 23485 Certification

IS 23485 is a new standard published by the Bureau of India Standards (BIS). IS 23485 is published for Medical Devices, focusing on Quality Management System requirements and essential Principles of Safety and Performance for Medical Devices.

BIS has published a new IS standard for Medical Devices by implementing this new IS 23485 guidelines, which focus on making the Organisation more agreeable with the fundamental standard of Safety and Performance and Quality Management System requirements.

This new standard has been formulated by the amalgamation of the following Indian Standards:

• ISO 13485:2016-Medical Devices- Quality Management Systems- Requirements for regulatory purposes.
• 16142-1:2016- Medical Devices- Recognised essential principles of safety and performance of medical devices- Part I: General essential principles & additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards.
• 16142-2:2017- Medical Devices- Recognised essential principles of safety and performance of medical devices- Part II: General essential principles & additional specific essential principles for all IVD medical devices and guidance on the selection of standards.

This new IS 23485, according to BIS, will become compliant with all the essential principles of safety and performance and Quality Management System requirements of medical devices, including the following:

• Risk evaluation & management for the designing and manufacturing of medical devices
• Bio-compatibility verification
• Clinical evaluation

• Environmental impacts or assessment
• Software approval
• Other safety and performance-related viewpoints liable to be experienced during the whole life pattern of a medical device.

IS 23485 specifies requirements for a Quality Management System that are used by the organisations involved in one or more stages of the lifecycle of a medical device, including design and development, production, storage and distribution, installation, servicing and final decommissioning and disposal, design and development of medical devices or provision of associated activities, such as technical support. The requirements in this Indian Standard are also used by suppliers or other external parties providing the product, like raw materials, components, subassemblies, medical devices, sterilisation services, distribution services, calibration services and maintenance services to the Organisation. This Indian Standard is also used by internal and external parties, including the certification bodies, to assess the ability of the Organisation to meet consumers and regulatory requirements applicable to the quality management system and the Organisation's own requirements. It is emphasised that the Quality Management System requirements specified under IS 23485 are complementary to the technical requirements for a product that is necessary to meet customers and applicable regulatory requirements for products that are necessary to meet customers and applicable regulatory requirements for safety and performance.

Benefits of IS 23485 Certification

The followings are the benefits of IS 23485 Certification:

• Timely observation and development of controls at the time of manufacturing of medical devices
• Helps in increasing compliance and assurance levels related to medical devices' safety and performance
• Helps in improved marketability and sales of medical devices
• Builds superior trust and transparency among the consumers
• Reduction of significant potential health hazards
• More product opportunities
• Extensive market access approval
• Manufacturers or other sub-contractors of the medical devices have a chance to leverage their certified Quality Management System (QMS) status for a smooth and seamless transition into specialised Certification.
• Meaningful feedback on the effectiveness of the Quality Management System (QMS)
• Confidence in compliance with regulations
• Identification of areas requiring attention
• Identification of areas of non-compliance and risk
• Growth and expansion in future
• Valuable and recognised reporting with Certification
• More opportunities for the organisations
• A clear understanding of medical devices

Pre-requisites for IS 23485 Certification

The list of pre-requisites required to get IS 23485 Certification is as follows:

• General requirements
• Documentation requirements
• Management responsibility
• Resource Management
• Product Realisation
• Measurement, Analysis and Improvement

Documents Required for IS 23485 Certification

Mandatory Documents needed for compliance with IS 23485 Certification are related to the followings:

• Roles undertook by the Organisation under the applicable regulatory requirements
• Quality Manual
• Medical device file
• Procedure for Documents control
• Procedure for record control
• Records for validation of the application of the computer software
• Procedure and records for data analysis
• Procedure and records for corrective action
• Procedure and records for preventive action
• Quality Policy
• Quality objectives
• Responsibilities and authorities
• Procedure and records for management review
• Procedure for training
• Requirements for infrastructure and maintenance activities
• Arrangements for control of the contaminated or potentially contaminated product
• Outputs of product realisation planning
• Requirements of the work environment
• Records of the results of customer requirements review and actions arising from it
• Arrangements for communication with the customers
• Procedure for design and development
• Process for risk management in product realisation
• Design and development planning
• Design and developments outputs
• Records of design and development review
• Design verification plans, results and conclusions
• Design validation plans, results and conclusions
• Process of transfer of design and development outputs to manufacturing
• Process and records for control of design and development changes
• Design and development file
• Procedure for purchasing
• Criteria and records for the evaluation and selection of suppliers
• Record of verification of purchased product
• Record for medical device or batch that provides traceability
• Requirements for the cleanliness of the product
• Requirements for medical device installation and verification of installation
• Process and records for servicing of the medical device
• Records of the sterilisation procedure
• Procedure and records of production as well as service provision process validation
• Procedure and records for validation of a process for sterilisation and sterile barriers systems
• Procedure for product identification
• Procedure for traceability
• Records of traceability with the name and address of the shipping package consignee
• Report on changes in customer property
• Procedure for preserving the conformity of the product
• Process of monitoring and measuring
• Record of calibration
• Procedure and records for validation of the application of computer software used for monitoring and measuring
• Procedure for customer feedback
• Procedure and records for complaint handling
• Records of reporting to regulatory authorities
• Procedure for internal audit
• Records of audits and their results
• Identity of the person authorising the release of the product
• Procedure and record of control of non-conforming product
• Record of rework

Procedure to Obtain IS 23485 Certification

Steps an applicant require to follow while getting IS 23485 Certification from the BIS are as follows:

Application

• Organisations interested in having an IS 23485 Certificate must ensure that they have the ability to provide service that consistently meets the standard of Safety and Performance and Quality Management System requirements.
• Such Organisation must apply in prescribed forms to the BIS, concerned Regional Office along with Quality Manual, a specified fee, and other required information.

Audits

• BIS conducts audits in two stages: Stage I comprises the Adequacy Audit with Preliminary Visit, while Stage II comprises the Initial (Certification) Audit.
• Stage I Audit BIS conducts an examination of the Organisation's Quality Manual to verify compliance with required standards.
• BIS Officials visit the premises to know the size, nature, location and site-specific conditions with status and level of implementation of Quality Management System requirements and Essential Principles of safety and performance for Medical Devices undertaken by the Organisation.
• Any omission or deviations from the prescribed requirements intimated by BIS is corrected and intimated to the BIS to proceed further by the applicant.
• A formal report is sent to the applicant by the Audit team leader of BIS.
• Stage II Audit-An Audit team of BIS officers goes for the Initial (Certification) Audit to evaluate the implementation, effectiveness, and Organisation's Quality Management System requirements and safety and performance complying with the set BIS standards, procedures and activities as stated in the Documented management system.
• The audit team leader conducts a meeting with the management head and all other heads of different departments of the Organisation. This is called an open meeting which is conducted to confirm the audit plan, and then the audit is carried out as per the same audit plan.
• The audit team records observations after conducting the audit.
• A closing meeting is conducted with the same members who were there at the opening meeting by the audit team of BIS.

Certification

• BIS makes a decision related to granting IS 23485 Certification to the applicant based on the evaluation of the audit's findings and conclusion.
• BIS grants Certifications if it is satisfied with the actions taken by Organisation for its Quality Management System requirements and safety and performance.
• The Certification is granted for three years.

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