What are the mandatory procedures as per ISO 13485:2016?
The new ISO 13485:2016 certification in Iraq is based on ISO 9001:2008, which means that the requirements for documentation are based on the requirements of the previous version of ISO 9001, with the addition of documents specific to the medical device industry.
• Roles undertaken by way of the employer underneath relevant regulatory necessities
• Procedure and files for the validation of the software of pc software program
• Quality Manual
• Medical system file
• Procedure for record manipulate
• Procedure for file manipulate
• Quality coverage
• Quality targets
• Responsibilities and authorities
• Procedure and information for administration assessment
• Procedure for education
• Requirements for infrastructure and preservation things to do
• Requirements for work surroundings
• Arrangements for manage of contaminated or doubtlessly contaminated product
How to get ISO 13485 Certification in Iraq?
If you are thinking about how to get ISO 13485 Certification in Iraq, I would gladly prefer Certvalue with no apprehension. You can easily achieve Certvalue by just visiting www.certvalue.com where you can chat with a specialist or you can also compose an inquiry to email@example.com, so that one of our experts will get in touch with you at the earliest to gives best possible solution available in the market.
Iraq, Baghdad, Mosul
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contact no: +91 7760173623
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Last Update : Jul 02, 2021 6:20 AM
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