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:
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:
- 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:
Pre-requisites for IS 23485 Certification
The list of pre-requisites required to get IS 23485 Certification is as follows:
Documents Required for IS 23485 Certification
Mandatory documents needed for compliance with IS 23485 Certification are related to the followings:
Procedure to Obtain IS 23485 Certification
Steps an applicant require to follow while getting IS 23485 Certification from the BIS are as follows:
- 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.