Internal Audit for a Medical Device
Internal audits are crucial for maintaining the effectiveness of a Quality Management System (QMS) in medical devices. According to ISO 13485:2016 – Clause 8.2.4, Manufacturers must conduct Internal audits at planned intervals to ensure Medical Device safety and effectiveness.
While internal teams can perform Internal Quality Audit (IQA), involving a professional third party brings an objective and unbiased perspective. This Internal Audit (IQA) approach helps assess the QMS and processes more accurately. Additionally, hiring third-party auditors eliminates the need for training existing employees or hiring new staff for medical device auditing, ensuring a thorough evaluation of your QMS for medical devices and supporting CE certification and performance evaluation reports.
ISO 13485 Certification Audits and its Certification Cycle
To clear an ISO 13485:2016 audit, a medical device manufacturer must have a clear understanding of the frequency and intervals at which the notified body conducts the ISO 13485 audit.
- Initial Certification Audit: These audits are conducted at the very initial stage of ISO 13485 Certification. The purpose of this medical device QMS audit is to check the documentation of various medical device manufacturing procedures and the implementation of those documented procedures. These QMS audits are conducted in two stages:
- Stage 1: In the first stage, the Auditor reviews QMS documentation, including the quality manual, procedures, and formats and the readiness of the Medical Device Manufacturer for the prepared documents.
- Stage 2: In the second stage, the Auditor ensures the QMS procedures documented are implemented at the Medical Device Manufacturing Site and the results are recorded properly by performing a thorough Evaluation of each of them.
Surveillance Audit: Once the initial certification audit is done and certification has been awarded, surveillance audits are conducted starting next year till the certificate validity to ensure continuity of implementation as per ISO 13485. These ISO 13485 annual audits ensure that incidents and measurements are recorded, CAPA is implemented effectively, and top management is involved in inspecting the system. They also address non-conformities from previous audits. The aduits ensure that the organisational objectives and policies are continuously monitored.
Recertification Audit: The Validity of an ISO 13485 certificate is usually 3 years from the dat of certificate being awarded. Recertification Audit occurs before the ISO 13485 certificate expires, the auditors review the QMS documentation of the Medical Device Manufacturer and check continued effectivity along with the results of prior surveillance audits.
Certificate Cycle: The ISO 13485:2016 Certificate is valid for three years including the surveillance audits in the subsequent years and the recertification audit.
CE Certification Audits and the Certificate Cycle
Similar to ISO 13485 audits, CE certification also involves an Initial Certification Audit, Surveillance Audits, and Recertification Audits.
- Initial Certification Audit is conducted in two stages:
- Stage 1 Audit: The first stage is all about preparation. The auditor checks if your organization has the necessary documentation and if your team is ready for the next step. If any issues are found, they need to be fixed before moving to Stage 2. This stage should be completed within six months; otherwise, it must be repeated.
- Stage 2 Audit: In the second stage, the auditor looks at how your system works in practice. This is a full audit of your medical device QMS. If significant issues are found, they must be corrected before you can get certified. Minor issues can be addressed as planned.
Surveillance Audit: After you receive your certificate, a surveillance audit happens within 12 months to ensure everything is still in compliance. This isn’t as thorough as the full system audit but is essential to maintain your certification.
Recertification Audit: Every few years, a recertification audit is conducted to confirm that your QMS for medical devices continues to meet the necessary standards, like ISO 13485:2016. This audit is comprehensive, ensuring that your system remains effective and relevant.
Certificate Cycle: The CE certification is valid for five years, with Surveillance Audits conducted by the notified body for consecutive years till the certificate validity. During this period, the Notified Body also carries out one unannounced audit, often combined with CE Certification Surveillance Audits.
Maven Profcon Services LLP offers expert audit support for your Internal Quality Audits (IQA), Medical Device CE and ISO 13485 Audit. We ensure your QMS for medical devices aligns with ISO 13485:2016 standards, facilitating smooth performance evaluation reports and CE certification processes. Trust Maven Profcon to help you maintain compliance and enhance the quality of your medical device’s QMS.
To have Audit Support for ISO 13485 and CE Certification, contact us at enquiry@mavenprofserv.com or call +91-7490017774 / +91 7940026222
