ISO 13485 2016 Certification
Target Audience
ISO 13485:2016 is applicable to all manufacturers and providers of medical devices, component manufacturers, contract service providers and distributors of medical devices.
Target Audience
ISO 13485:2016 is applicable to all manufacturers and providers of medical devices, component manufacturers, contract service providers and distributors of medical devices.
ISO 13485:2016 certification provides and boosts a confidence and creates a credibility of the organization in the mind of the stakeholder, Directors and clients
An ISO 13485 Certification for Your Business Could Provide the Following Benefits:
New Version of the standard
ISO 13485 last version of 2003 is no longer valid, ABI can provide a wide range of solutions to help you to stay on top of the latest developments and ensure a smooth and transparent transition from your current ISO 13485:2003 to ISO 13485:2016 certification
Contact us to get information about the changes required to update your certificate to the new version of ISO 13485:2016
ISO 13485 Certification process/ Required Documents
Active Business international conducts an initial audit and if successful, a certificate of compliance is issued with a validity of 3 years, provided that the organization undergoes annual audit.
If you are interested to achieve ISO 13485 certification for your organization/ business, then you can contact us for further details
Four Steps to Your Certificate
We offer a global service for internationally accredited ISO 13485 certification. Our global presence means your audit will normally be carried out by local-language auditors.
We can help you:
What is ISO 13485:2016?
The ISO 13485 standard, currently ISO 13485:2016 Medical Devices – Quality Management Systems – Requirements for Regulatory Purposes, sets the basis for a quality management system for organizations involved in the life-cycle of a medical device.
ISO 13485 is a stand-alone QMS standard, derived from the internationally recognized and accepted ISO 9000 quality management standard series. ISO 13485 adapts the ISO 9000 process-based model for a regulated medical device manufacturing environment. While ISO 13485 is based on the ISO 9001 process model concepts of Plan, Do, Check, Act, it is designed for regulatory compliance. It is more prescriptive in nature and requires a more thoroughly documented quality management system
“Certification demonstrates your commitment to meeting your customers’ requirements and supports regulatory compliance in many jurisdictions”
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