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The standard ISO 13485:2016, requires the manufacturers of medical device to perform internal audits at planned intervals. Internal audit supports the effectiveness of the QMS and ensure that the products manufactured are safe and effective. The qualified internal auditors of an organization can perform these audits but a professional, third party involvement is more objective when accessing the effectiveness of QMS and process with an independent and unbiased perspective. Appointing a third party auditor can curb the requirement of permanently hiring additional qualified team or training an entire team from existing employees.
Maven Profcon Services LLP, has a team of qualified internal auditor and the team can perform the internal audit to ensure the effectiveness of QMS with scrutiny, identify the gaps that disturb the flow of regular production and post production activities. If you do not wish to outsource this process, Maven also provides ISO 13485 internal auditor training and certification to qualify the medical device manufacturers and their employees as Internal auditors.
The certification cycle is for three years. Hence this cycle has initial certification audit, followed by surveillance audit next year, followed by recertification audit.
Maven performs a systematic review of the scientific literature, checks the adequacy of existing testing performed and develops performance evaluation plan along with a compliant Performance Evaluation Report (PER).
The certification cycle is of five years- Initial certification audit, followed by 3 surveillance audits annually and a recertification audit.
Notified bodies once in five years shall perform at least 1 unannounced audit onsite. Where appropriate manufacturer’s suppliers or sub-contractors are also audited which may be combined with CE surveillance audits.
During the CE certification and CE surveillance audit, assessment of technical documentation and its update will be performed along with the verification of effective QMS implementation. The manufacturing facility will be closely observed and the man-material movement will be scrutinized.