ISO 13485 Certification About

ISO 13485 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), International Quality Assessment Service (IQAS) 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 International Quality Assessment Service (IQAS)’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.