by Abdul Halim | Jun 30, 2020 | ISO 13485
ISO 13485 Certification in Bangladesh post will help you to know who needs this certificate, cost of the certificate and how to obtain this iso 13485:2016 certificate.
ISO 13485 is the certificate for medical device manufacturers. Who wants to develop the quality of the medical devices including face mask, surgical mask, gown as well as other PPE they need this standard. If you have this certificate you can export your medical items to many countries.
To export your mask or other medical PPE in EU market CE mark is necessary. But due to lack of lab test facility in Bangladesh it is difficult to obtain CE marking certificate from notified body of EU. Considering this problem obtaining ISO 13485 certificate is easier and cost savvy.
To know the cost and procedure you may call 01742125232 for ISO 13485 Certification in Bangladesh.
by Abdul Halim | Jul 30, 2019 | ISO 13485
ISO Certificate for medical device manufacturer in Bangladesh is available from AAS. To maintain quality for medical devices there is a standard which is ISO 13485. The latest version of this standard is 13485:2016. The first version of this standard was 13485:1996 and the second version was 13485:2003. Now all those two versions have been expired.
There is a good similarity between the two standards of ISO 9001 and ISO 13485. However, some differences are still there. Like ISO 9001 is focused on Continual improvement approach but ISO 13485 requires only that the certified organization demonstrate the quality system is effectively implemented and maintained.
The second requirement is customer satisfaction for 9001 but 13485 does not require it.
For both the standards regulatory body’s requirement is must. In the USA FDA approval is must and for the EU market Medical Devices Directives 93/42/EEC is required. Many developing countries they do not have any specific guideline from their government end. In that case they can follow the above mentioned two guidelines.
6.4.2 Contamination control is mandatory for 13485:2016 but in 9001 there is no such clause. 5.2 indicates about the Cleanliness of product for 13485.
There is many similarities in both the standards like SOP, procedures, Design, preservation of products, identification of production process, corrective and preventive action, monitoring and measurement of equipment, calibration for the monitoring devices, Internal audit, data analysis etc are common for both the standards.
In Bangladesh there are many medical device manufacturers who are exporting those devices in abroad. They need certificate on ISO 13485 to export those products like face mask, medical face mask, gown, coverall, surgical face mask etc. AAS is the authorized channel partner of the certification body IQS Audits and ITCC International which are located in the UK. If you have this certificate you can export your products worldwide.
To get quotation in the shortest time you may contact this page
