ISO 13485 Certification

ISO 13485 Certification for Medical Device

ISO 13485:2016 is an international standard for the design, manufacture, and distribution of medical devices. ISO 13485:2016 is the latest version by ISO. This standard is based on the ISO 9001:2015 process model approach. ISO 13485 Certification is a process-based approach that defines, implement, and improve the effectiveness of a quality management system that they expected by customers and regulatory requirements. The main aim of ISO 13485:2016 is to facilitate harmonized medical device regulatory requirements for quality management systems.

ISO 13485 Certificate is closely aligned to other management standards such as ISO 9001, ISO 14001, and OHSAS 18001 providing a great opportunity for integration and synergy with other quality systems.

Who can get ISO 13485 Certification?

ISO 13485:2016 is for manufacturers and their suppliers of medical devices. All medical device manufacturers, contract manufacturers, and contract packagers must meet the requirements of ISO 13485:2016 to gain certification.

What are the minimum requirements to achieve ISO 13485 Certification?

The following are the minimum requirements for ISO 13485 Certificate:

Medical devices must be manufactured in accordance with a compliant quality management system. The system’s documentation should meet the defined requirements of this standard.

The manufacturer should have an efficient quality management system that is capable of meeting all their responsibilities under the Quality System Regulations (QSR) and other applicable regulations.

Manufacturers should have a management representative who is responsible for the quality system and be fully aware of the regulatory requirements and has the authority to ensure these are fulfilled. He/she should also determine how compliance with ISO 13485:2016 will be achieved, monitored, audited, maintained, and improved through documented procedures.

The manufacturer must have a documented procedure for the product to meet ISO 13485:2016 requirements.

The manufacturer must maintain records of all their medical devices and related processes, which should be made available to the competent authority and the user of the device if required.

All personnel involved in design and development activities and service delivery should have appropriate competencies as well as knowledge of the regulatory requirements, standards, and guidelines for medical devices.

What is the process to Obtain ISO 13485 Certification?

Applying for ISO 13485 Certification can be done as per your requirement. Once you’re satisfied with the pre-assessment and wish to move ahead, we will provide you with detailed information on how you can apply for it. It usually takes around 4 weeks to complete the whole process after approval of your request.

The application for certification must include:

  • An application for ISO 13485 Certification should be completed and signed by the manufacturer’s management representative.
  • Stage1 Audit will be done in your facility by our auditors to confirm that you are compliant with the requirements of ISO 13485:2016 for your medical devices.
  • Stage2 Audit will be done in your facility to ensure the effectiveness of your ISO 13485 implementation by an ISO Lead Auditor.

ISO 13485 Certification

What are the benefits of ISO 13485 ?

  • ISO 13485:2016 certification will help medical device manufacturers to build their business by creating customer confidence, improving their market position, and increasing revenue. This standard also provides an opportunity for you to reduce costs by minimizing wastage, reducing warranty claims and recalls, reducing production failures, protecting intellectual property, and improving your time to market.
  • ISO 13485 Certificate will help you to integrate quality management processes for medical devices with other management systems so that you can reduce duplication, increase synergies and improve overall efficiency. It also helps to eliminate or minimize the risks of nonconformance of their products so that customers are satisfied with the services provided by them.
  • ISO 13485 Certification will also help you to provide better services by understanding your customer needs and meeting the requirements of ISO 13485:2016. It is an essential criterion for gaining approval, especially in the UK and Europe where medical devices manufacturers are required to be certificated under ISO 13485 or its equivalent to market their products.
  • It helps to build customer confidence and gain market recognition, reducing costs, warranty claims and recalls by improving the quality and design of products.
How to get ISO 13485:2016 Certification?

As a leading ISO 13485 Certification body in India, IAS helps organizations to ensure the effectiveness of the ISO 13485 quality management by performing the conformity assessment with standard experts who are experienced auditors in performing audits and providing the certification.

Apart from management system certification, IAS also offers product certifications against numerous certification schemes such as CE Marking, GOST-R, Green, and more.

Click here to know more about the ISO audit procedure and our Certification process! Also, refer to the frequently asked questions to get more details about the IATF 16949 certification!

Kindly contact us to have a free discussion about the certification for your organization! Request a quote now!



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