ISO 13485 Certification

ISO 13485 certification to IVD manufacturers globally.

Sertio offers ISO 13485 quality management system certification to IVD notified body customers. 

ISO 13485 is a Quality management system standard developed to meet QMS requirements for regulatory purposes.

A condition for certification and certificate issuance is an audit to determine compliance to the specified quality management system standard 13485. The audit must conclude with a positive result. The independence, confidentiality and impartiality of the auditors is guaranteed by Sertio.

Two types certification service is available: 

Initial certification 

Certificate transfer is convenient way of changing certification body.

  • In direct certificate transfer the content of the certificate is transferred identically. No audit is required to issue certificate.
  • Certification transfer is conducted off-site based on review of documents and preparation of certification documentation for the certifier in order to transfer the existing certificates according to EN ISO 13485. Non-conformities from audits shall be closed or plan for corrective action approved by previous certification body.
  • Certification period remains the same, surveillance activities continue from where the outbounding certification body left.

Service is subject to availability.

Send your details and receive a quote

13485 certification process

1. Quotation request

  • Through a request form. Quotation request form available through contacting.

2. Quotation review

  • Performed by Sertio. We ensure that scope of certification and required competencies are available.

3. Contract and purchase order

  • Quotation detailing the services that will be provided and the associated costs.
  • The costs are also summarized

4. Stage 1 audit

 The Stage 1 audit is performed in the scope of an on-site visit at the client unless it is deemed not necessary based on the result of an in- office review of the submitted documentation

  • During the audit, the audit team evaluates the readiness of the client's quality management system for a Stage 2 certification audit.
  • Outcome of stage 1 audit is one of the following:
  1. A Stage 2 certification audit (within 3 months);

  2. Stage 2 certification audit with the condition of correcting the actual nonconformities found during the stage 2 audit;

  3. Repeat of the Stage 1 audit

5. Stage 2 audit at site(s).

  • A detailed audit report that describes the audit results and includes any nonconformities that may have been written will be provided to the client.

6. Resolution of nonconformities

  • If nonconformities are found during stage 2 audit(s), the client must propose and implement corrections and corrective actions, where necessary, and submit the completed nonconformity reports with the supporting documents (if requested) prior to the issuing of the certificate.
  • Major nonconformities shall be closed prior to issuing a certificate.
  • For minor nonconformities, the plan for corrective actions shall be accepted by Sertio prior to certificate issuance.
  • Sertio reserves the right to escalate and take necessary actions such as additional time for on-site audit prior to issuing the certification.

7. Certificate issuance

  • Final review process takes place by Sertio
  • Certification decision maker makes the certification decision
  • Certificate is issued.

Why 13485 certification?

For medical device organizations, compliance with ISO 13485 can support conformity assessment options that are used in different regulatory jurisdictions.

In many countries a quality management system is a regulatory requirement for IVD manufacturer.

ISO 13485 certification is often a prerequisite from the market point of view and serves as evidence of conformance to requirements.

The requirements of ISO 13485 are intended to act as a basis for demonstrating and supporting compliance with applicable regulatory requirements. 

Disclaimer of liability:

The certification client remains responsible for the compliance with regulatory requirements and related deadlines. ISO 13485 certification service is not accredited.  

All conformity assessment services are subject to availability.