Medical devices and their quality systems with ICMED 13485 certification
The association of the Indian medical industry is nowadays improving themselves in bringing the robust medical device approval systems and in order to assist with the same, the AIMED – the association of Indian medical device Industry has collaborated with the quality council of India (QCI) and with the National accreditation board for certification bodies (NABCB) to bring up this scheme of ICMED 13485 to aim for the quality certification scheme for medical devices in India.
This is actually an international quality management system standards with some customized add ons that can be brought to the market. The commonly used forms of this scheme are:
ICMED 13485 – This is comprised of the ISO 13485 internationally harmonized standard of the quality management systems for medical devices along with some additional features to it.
ICMED 9000 – This is comprised of the ISO 9000:2008 and the quality management systems only
Eligible medical equipment organisations to apply for this ICMED 13485 certification:
The exporters and the manufacturers from the Indian medical device industry
The distributors and the local authorized representatives of the medical device manufacturers
Once you successfully complete this certification and the program, the UL – which is a certification body under ICMED, will honour you with this certificate and they will add your company name to the publicly accessible database wherein the customers and the distributors can view and verify.
The bodies that are approved under the medical devices manufacturer facility certification scheme has been operated by the QCI (quality council of India) for ICMED 9000, ICMED 13485 and ICMED 13485 plus and these were provided as per the specification for each scheme type.
After the complete due verification of manufacturing facility with the prescribed criteria, the certification will be provided. While applying for the certification, you need to clearly mention for which type of certification you are applying for. Also you need to mention about the information regarding the manufacturing facility that needs to be certified.
Documents needed and the application information:
The applicant must be needed to enlist all the activities that are needed to be certified or needed to be audited. This information will cover single or multiple location and sites and if any overlap is happening, that information is also captured.
With the type of certification that is sought, the programs will change. This may include:
For all the ICMED 9000, ICCMED 13485 and the ICMED 13485 plus certification, the audit cycle will be as follows:
- Firstly, the initial certification audit that is happening in two stages as in stage 1 and stage 2 as per the standards of ISO 17021: 2011 for ICMED 9000 and ICMED 13485 certification is performed
- Then, the initial certification audit in two stages as in stage 1 and stage 2 as per the ISO 17021: 2011 and ISI 17021: 2012 for ICMED 13485 plus certification will be performed.
- If you have a 3 year validity and before the end of that validity, the recertification audits will also be performed
Every CBs will individually audit the manufacturing facility and the time duration will be calculated individually only. The audit time shall take around 8 hours a day which is a one man-day hours for the on-site audit. While performing the certification audit, the main objective of doing the audit at manufacturing facility is to verify and effectively implement the criteria that are listed in the ICMED 9000, ICMED 13485 and the ICMED 13485 plus certification. The audit plans can be modified further if necessary.
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