What is ISO 13485:2016 Certification?

ISO 13485:2016 is a specific certification standard for medical device industry. ISO 13485 certification fulfills 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 recognized ISO 13485 standard.
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

Why ISO 13485 Certification(MD-QMS)?

ISO 13485 is the medical device industry’s most widely used international standard for quality management. Issued by the International Organization for Standardization (ISO), the ISO 13485 standard is an effective solution to meet the comprehensive requirements for a QMS in the medical device industry. Adopting ISO 13485 provides a practical foundation for manufacturers to address the EU Medical Device Directive (MDD), the EU Medical Device Regulation (MDR), and other regulations, as well as demonstrating a commitment to the safety and quality of medical devices.

Benefits of ISO 13485:2016

The ISO 13485:2016 Medical Devices Quality Management System specifies what your organisation needs to do:
ISO 13485 certificate is universally recognized & it covers regulatory & statutory norms of most of countries, your product gets an expended market access
ISO 13485 improves performance or products & processes of a medical device company
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
After certified to ISO 13485:2016 can provide so many benefits, both for your organisation and your customers.

Changes Between ISO 13485:2003 & ISO 13485:2016

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.
Product Realization – New standard ISO 13485:2016 says to establish procedures for storage, handling of products, traceability, measurement & re-validation in addition to requirements of old standard ISO 13485 which required procedure for verification, validation, monitoring, inspection & testing
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.
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

Requirements of ISO 13485

1. Management Responsibility – Areas within the QMS that your management team need to focus on, be involved with and be accountable.
2. Resource Management – How resources such as people, infrastructure and facilities must be assigned to ensure the best possible performance?
3. Product Realization – Details on, how your business will operate in order to provide a high quality service or product?
4. Measurement, Analysis and Improvement – How you can determine if your Management System is working as expected, facilitating the continual improvement of your system?

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Certification Procedure - ISO 13485:2016

  • 1. Submission of Questionnaire & Appendix
  • 2. Issuance of Quotation
  • 3. Submission of Application
  • 4. Stage-1 Audit
  • 5. Stage-2 Audit
  • 6. Recommendation and Approval
  • 7. Issuance of Certificate
  • 8. Surveillance Audit/Re certification

THE CERTIFICATION PROCESS: HERE’S HOW IT WORKS

The audit can be conducted at whatever point you feel prepared. The length of the audit depend upon the size of the site and the multifaceted nature of the procedures, yet is consistently at any rate 1 day. After a successful certification-audit, you get a declaration with a legitimacy of three years. To keep up affirmed status, reconnaissance reviews happen in yearly interims.

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