How to get ISO 13485 certification

In the previous article, we learned about ISO 13485. In this article, we will explore how to get certified in ISO 13485.

First of all, what is the certification process for ISO 13485?
ISO 13485 certification includes initial certification, annual surveillance checks, and recertification. Here are the details:

1. Initial Certification
– The company fills out the “ISO 13485 Certification Application Form and Certification Contract.” After receiving the certification application materials, the certification center will conduct an initial review of the documents. If they meet the requirements, a “Acknowledgment Notice” will be issued.
– Submit system-related qualifications and materials for review by the organization one week before the on-site inspection.
– After the audit is passed by the certification organization, they will issue an audit notification and arrange for the company’s first-stage audit.
– After the first-stage audit is passed, the certification organization will schedule the second-stage audit.
– Rectify any non-conformities found during the audit.
– The certification organization’s technical committee will review and issue the certificate.
– Annual surveillance audits are conducted once a year.

2. Annual Surveillance Checks
– The certification center will develop an annual inspection plan based on the company’s certification certificate issuance date and will send an inspection notification to the company in advance.
– The company will pay the annual surveillance management fee as required by the contract, and the certification center will form an inspection team to conduct on-site inspections at the company.
– Rectify any non-conformities found during the audit.
– The certification organization’s technical committee will review and issue the certificate.
– Annual surveillance checks are conducted once a year.

3. Recertification
– Companies whose certification is due to expire in 3 years should re-fill out the “ISO 13485 Certification Application Form” along with relevant materials to the certification center. The rest of the certification process is similar to the initial certification.

The above has provided a brief introduction to what the ISO 13485 medical device management system is all about. For friends who frequently undergo various certifications, the most frustrating aspect is likely to be preparing the documents. It often happens that everything is ready, but the documents are incomplete. So today, let’s talk about the materials needed for ISO 13485 system certification. Take out a notebook and jot down the following:

1. Authorization letter signed by the authorized representative of the applicant for medical device system certification application and contract.
2. Medical device management manual and procedural documents of the applicant.
3. Copy of the medical device product registration certificate and filing certificate.
4. Summary of the entire product production process, explanation of product production process, special processes, and key processes.
5. Product sales data and user feedback information for the past 6 months.
6. List of major outsourced and subcontracted components.
7. Records related to personnel, production, quality, and research and development.

In conclusion, ISO 13485 medical device management system certification is of great significance to organizations involved in the production and sale of medical devices. It not only improves product quality and customer satisfaction but also helps to reduce risks and costs, enhance the organization’s competitiveness, and promote sustainable development.