ISO 13485:2016 CERTIFICATION

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), IMS Certification 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 IMS Certification’s certification authority will take decision for grant of ISO 13485 certificate

Changes Between ISO 13485:2003 & ISO 13485:2016

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.