Audit Support

Audit Support

ISO 13485:2016 certification:

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).

• Initial Certification Audits: The initial certification audits are performed in 2 stages- stage 1 audit is performed to check the readiness of organization for stage 2 audit, if the minimum criteria are met for stage 1 audit, the body will process to stage 2 audit. In stage 1 audit, the certification body will check the QMS documentation which includes your quality manual, quality procedures and formats. While in stage 2, the certification body actually check the implementation of your QMS, for eg. whether all processes and results are recorded or not.
• Surveillance Audits: The main purpose of surveillance audits is to find out whether all incidents are recorded, all measurements are recorded, proper CAPA is recorded, implemented and effective, the top management provides and inspects the system etc. in other words to check whether the documented system really works or not. The surveillance audits shall also focus on the NCs or observations of initial certification audit or previous surveillance audits.
• Recertification Audits: recertification audits are conducted before the end of validity of the certificate. In recert audits a review of QMS documentation along with results of previous surveillance audits over the period of time of certification is performed.

For CE Certification:

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.

Maven Profcon Services LLP, has a team of QMS consultants, who can help you with following:

• Conducting mock audits before the NB audit
• Updating the QMS documentation
• Support during the audit
• After audit, help you solve the non-conformities and ensure proper corrective and preventive actions are defined
• Check the effectiveness of corrective and preventive action