ISO 13485:2016 is a specific certification standard for medical device industry. ISO 13485 certification fulfils your needs related to production control, quality management, regulatory compliances & specific needs related to production of a particular medical device. ISO 13485 is basically a QMS for medical device industry that is why it is also known as 'MD QMS'.
ISO 13485 certificate satisfies potential customers & stakeholders with the fact that a device has been manufactured following internationally recognised ISO 13485 standard. ISO 13485 audit by QCPL ensures that an organisation meets all guideline of ISO 13485:2016 & this is the reason why QCPL is an industry trusted ISO 13485 certification company. Our ISO 13485 certification process is result oriented & customer focused. We are a pioneer ISO 13485 certification body of India. All requirements of ISO 13485 are specific to organizations providing medical devices, regardless of the type or size of the organization
Now ISO 13485:2016 certification standard has come with many changes. Few important changes are as follows
New standard ISO 13485:2016 is more flexible as it allows you to make exclusions in section 6, 7 & 8 if it can be justified while in old standard ISO 13485:2013 exclusion was permissible only in section 7. In this way new standard ISO 13485:2016 is more flexible.
In old standard ISO 13485:2013 a QMS had to established based on requirements of the standard & product, while in new version ISO 13485:2006 emphasis has been given on meeting regulatory requirements. Now QMS has to be established encompassing applicable regulatory requirements.
New standard ISO 13485:2016 expects you to keeps record of supplier monitoring, evaluation & re-evaluation. Now privacy has to be maintained in maintaining confidential health information.
New standard ISO 13485:2016 says to establish procedures for storage, handling of products, traceability, measurement & revalidation in addition to requirements of old standard ISO 13485 which required procedure for verification, validation, monitoring, inspection & testing
The new standard ISO 13485:2016 says to educate / train the user about product safety & regulatory norms.