ISO Certificate for medical device manufacturer is available from AAS. To maintain quality for medical device 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. AAS is the authorized channel partner of the certification body IQS Audits and ITCC International which are located in the UK.
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