Medical device manufacturers are required to carry out a regular ISO 13485 audit of their quality management system to ensure it complies with the requirements of the ISO 13485 standard. Internal audits serve to verify that the quality system is suitable, efficient and effective.
A professional external auditor is more objective when assessing the status of your quality management system and processes. At EmasConsultors, we carry out fully independent ISO 13485 audits that review the quality system in companies with ISO 13485 certification, or companies that are about to undergo their initial ISO 13485 certification audit by a notified body.
ISO 13485 audit services
The purpose of ISO 13485 quality audits is to ensure that the relevant manufacturing, development and control facilities comply with current Good Manufacturing Practice (GMP) and meet the requirements of the ISO 13485 standard.
An ISO 13485 management system audit includes:
- A review of the current quality system and regulatory documentation prior to the on-site ISO 13485 audit by a notified body or registrar.
- A systematic and independent process audit to determine compliance or non-compliance with the ISO 13485 requirements of your quality system.
- A review of internal and external documentation to verify compliance with ISO 13485 requirements.
- A practical verification of ISO 13485 requirements through a review of objective evidence during the audit.
- Physical verification of compliance with requirements, through interviews and fact-based observations to confirm compliance with the quality management system requirements.
- An assessment of current special controls and validated processes. The auditors have knowledge and experience in various processes such as cleanrooms or software programming.
We can also carry out an ISO 13485 process audit, focusing on specific areas where non-compliance issues have arisen, as well as areas that your internal auditors cannot audit due to conflicts of interest.