ISO Certificate for Medical Device Manufacturer

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.

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Common ISO Standards

Common ISO Standards is a great post for you, if you are not sure actually which standard is fit for you. ISO has introduced more than 19,500 Standards but the most popular ISO Standards are ISO 9001, 14001, 18001, 22000, HACCP and  OHSAS. Let’s know about these standards:

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  • ISO 9001– It is also called the Quality Management System. It is most popular standard around the world. Any types and and sizes organization can adopt this standard. If you want to develop quality of your works in all departments like HR, Sales, Marketing, Purchase, Customer Care, Production, Business development, Design  etc then this is the standard for you. In a word all guidelines for management of all departments are found here. It is a great tool to manage all departments nicely. That’s why it is most used iso standard around the world. Around 1.5 million companies have adopted this standard throughout the world.
  • ISO 14001: It is for Environment. To keep your environment safe from your factory or office activities this is standard for you. It is the second  most  Popular iso standard around the world. How can you keep your land, water and air pollution pollution free that guidelines are found from this standard. Our environment is going to at risk position gradually. So, as an industrialist or as a factory owner it is your responsibility to save your environment for the next generation. By adopting this standard you can claim that you love your people, you love your country. So, just do not think about your profit. Think about your people, think about environment. think about your country. If you can love those things it will be loved your creator. It is one of the most popular standards among the common iso standards.

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  • OHSAS 18001: It is called the health safety standard. How you can protect your staffs from any accident or from health risk, that guidelines are found from this standard. As a factory owner it is your responsibility to think your worker’s health. A family is dependent on a worker’s livelihood. What happened after five or ten years if a worker dies from your bad working environment. Who will take care of that family? So, just do not think about your profit, your business only. Try to think about your responsibilities, try to think about your people who are helping you to earn money for you.  You should have a social responsibility. You will be asked to God. You will be asked to Allah after death about your responsibilities.  If you think your worker is in highly risk situation from your factory activities like heavy sound, emission of dangerous gases like CO2, CO, SO2 etc then it is your responsibility to control them, to minimize them. OHSAS 18001 can help you to do that. After 2021 this will be not valid. ISO 45001 has been placed from 2018.
  • ISO 22000: It is for food or food related packaging industry. If you want to ensure that your food is free from contamination then this is the standard for you. If you want to ensure that your food is hygiene free, free from germ, free from microbiological organ like bacteria, virus then you should adopt this standard. If you want to proof that your food is not threat for other’s health then this is the standard for your food industry.
  • ISO 27001: Information Security Management System Standard. It is also known as ISMS standard. Security of data or information is a great challenge nowadays. Specially IT Firm, financial organization are in great risk condition for growing of hackers around the world. To minimize your risk in information system it is important to adopt ISO 27001 Standard.
  • ISO 13485: It is for medical device manufacturer. To ensure your medical device quality it provides guidelines from ISO.

We understand you are thinking about the cost of ISO Certification. You are not ready to spend money. We are here for you. We do not take big money for ISO Certification. We take less money. We want to  help you. We are waiting here to help you get ISO Certified on the above mentioned standards at a low cost. Our  price is guaranteed below than other certification bodies in Bangladesh. Simply go to this page and talk to us about certification on common iso standards.

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