What is ISO 13485?
ISO 13485 is an international standard published by the International Organisation of Standardisation (ISO) that shares the requirements for a comprehensive Quality Management System (QMS) for the design and manufacture of medical devices. The products include medical devices in the categories of medical equipment, orthotics, functional aids, diagnostic agents, supplies for dental use, surgical, healing and hygiene products.
The latest version of the standard is ISO 13485: 2016 and meets the requirements of IEC 60601-2-25: 1993 + A1: 1999 safety of Electrocardiograms. It is has kept up with the changes in technology and regulatory requirements in the supply chain for medical devices and related services. ISO 13485: 2016 has replaced ISO 13488: 1996, ISO 13845: 2003, EN 46001: 1997 and EN 46002: 1997.
What is ISO 13485?
Accredited ISO 13485 : 2016 certification has various advantagesincluding:
- Improved Credibility in the Market: ISO 13485: 2016 is an internationally recognised standard in the medical device industry and helps you gain an edge over your competitors in the market. You can use it as a marketing tool to grab more business opportunities since customers prefer to do business with ISO 13485 certified companies.
- Happy Customers: A QMS in place for the design, production, installation and servicing of medical devices and related services ensures that the end product will be of good quality and safe for use resulting in fewer issues for customers and consequently lesser complaints.
- Continual Improvement: One of the key things to stay ahead of competition in this fast-paced world is to seek opportunities for continual improvement. With the ISO 13485 Quality Management System, it becomes a part of the organisation’s culture and everyone is always on the lookout for ways to improve on how everything is done.
How to Get the ISO 13485 Certification?
Irrespective of where you are on your ISO 13485 journey, if you want to getISO 13485 : 2016 certification in India then here is the process for it:
- Find a reputed ISO certification company for initial consultation to discuss your needs
- The ISO 13485 certification company will then audit your organisation and carry out a gap analysis
- They will find out the areas of non-conformity with the standard and give you an action plan to implement the standard
- Once your organisation has implemented the suggestions, the certification company will audit your organisation
- If there are no major non-conformities with the standard then the company will issue an ISO 13485 compliance certificate
It is important to note here that ISO 13485 certification is granted for a limited time period. If you want to retain your certification status after this time period, you will have to re-certified by an accredited certification company for compliance or implement the new version of the ISO standard, if applicable.
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