ISO 13485:2016
Quality Management System – Medical Devices

ISO 13485 is a stand-alone QMS standard, derived from the internationally recognized and accepted ISO 9000 quality management standard series. ISO 13485 adapts the ISO 9000 process-based model for a regulated medical device manufacturing environment. While ISO 13485 is based on the ISO 9001 process model concepts of Plan, Do, Check, Act, it is designed for regulatory compliance. It is more prescriptive in nature and requires a more thoroughly documented quality management system.

ISO 13485 was written to support medical device manufacturers in designing quality management systems that establish and maintain the effectiveness of their processes. It ensures the consistent design, development, production, installation, and delivery of medical devices that are safe for their intended purpose.

Benefits of ISO 13485:2016

Whether you are looking to operate internationally or expand locally, ISO 13485 Certification can help you improve overall performance, eliminate uncertainty, and widen market opportunities. Companies with this certification communicate a commitment to quality to both customers and regulators.

1. Increase access to more markets worldwide with certification.
2. Outline how to review and improve processes across your organization.
3. Increase efficiency, cut costs, and monitor supply chain performance.

ISO Certification Process 

The ISO certification process is comprised of a few main steps involving the filling of the application form, review of documents, and detailed auditing procedures. Below, we will look at the general outline of how to apply for and register an ISO for a business or product:

1. Applying: After having selected an appropriate ISO certification for a product or business, the applicant needs to fill in an application form for the registrar that can be submitted in form of a letter or email. The application will need to contain essential details, such as the scope of the certification, general details of the organization including its features and general information, and sought certification standards.
2. Review of Documents: After the submission of the application form, the auditor will review the various documents regarding quality control and various policies and procedures of the organization.
3. Pre-assessment: The pre-assessment stage is where the entrepreneur needs to or have a review conducted of the pre-existing quality control standards in his/her organization to identify any omissions or faults in the policies related to quality management.
4. Action Plan: After the initial review by the auditor and identification of the faults in the existing quality control standards of the organization, he/she will need to review these comments and eliminate the existing deficiencies. This accounts for the action plan.
5. First Audit: The first or initial audit stage involves a thorough inspection by the auditor regarding existing and revised quality controls and the findings of the non-conformities are categorized either as minor non-conformances or major non-conformances. Minor non-conformances constitute minor procedural faults or gaps in the system in compliance with ISO standards. Major non-conformances include the faults in the existing quality standards system that can lead to the potential collapse of the system.
6. Final Audit: By the final audit stage, all major non-conformities will need to be removed and if all the quality gaps have been addressed and rectified, the ISO auditor will prepare the final audit report and forward the ISO certification application to the ISO registrar.
7. Get ISO Certificate: After all the non-conformities are addressed, the registrar will provide the ISO Certificate.
8. Surveillance Audit: These are the periodic audits that will be conducted to ensure that the organization is maintaining ISO quality standards or not.