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 CDG ensures that an organisation meets all guideline of ISO 13485:2016 & this is the reason why CDG 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
Benefits of ISO 13485 Certification
* ISO 13485 improves performance or products & processes of a medical device company. * ISO 13485 certificate is universally recognized & it covers regulatory & statutory norms of most of countries, your product gets an expended market access. * ISO 13485 works as a brand ambassador of your medical device hence your sales & marketing cost will reduce. * ISO 13485 certification gives faith to your customers that device is safe for use & it meets requirements of most of recognized technical standards related to medical device
ISO 13485 Certification Process
* Apply for ISO 13485:2016 certificate by submitting filled in ISO 13485 application form (Soft copy or hard copy). * Application form will be reviewed by our ISO 13485 auditor / expert & if accepted a quotation for ISO 13485 certification will be issued. * Upon submission of ISO 13485 certification fee, we will send you ISO 13485 audit plan (stage-1) & subsequently audit will be conducted. * After successful stage-1 audit closure of NC’s (if any), CDG will send you stage -2 ISO 13485 audit plan. After successful audit, auditor will recommend your organization for ISO 13485 certification. * Based on auditor’s recommendation & audit findings CDG’s certification authority will take decision for grant of ISO 13485 certificate
Changes Between ISO 13485:2003 & ISO 13485:2016
Now ISO 13485:2016 certification standard has come with many changes. Few important changes are as follows-
Flexible – 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.
Regulations – 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.
Risk Based Approach – In old version risk analysis approach was applicable to ‘product realization’ only, while in new version ISO 13485:2016 risk based approach is applicable to all processes of QMS
Enhanced Record Keeping – 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.
Product Realization – 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
Training of Users – The new standard ISO 13485:2016 says to educate / train the user about product safety & regulatory norms.
