In accordance with ISO 13485: 2016 clause 8.2.4 and 21CFR820.22 a Medical Device Manufacturer’s Quality Management System must be audited in accordance to a documented procedure which must be completed impartially by competent personnel.
To help our clients remain compliant, here at Advena we offer a service whereby we can perform an internal audit either via desktop or onsite to allow an impartial audit of your system.
The benefits of impartiality are not just for continued compliance, but this also brings best practice solutions to your company, dodges intracompany politics and helps avoid the ‘we’ve always done it this way’ mentality.
In addition to Internal Audits at Advena we can also provide a service to audit your suppliers or potential suppliers on your behalf.
2nd party audits take up valuable company time and resources, here at Advena we can offer a service where one of our experienced and highly-trained auditors, all from various backgrounds, can audit the supplier. Whether it be distributor, raw material, contract manufacturing, sterilisation or packaging provider we can perform an audit to your specified criteria.
The benefits of supplier audits include not only continued compliance to your supplier control requirements but also helps avoid intercompany politics, fixing issues of quality without affecting business dynamic and develops growth.
In addition to this service Advena also offer training for internal audits and supplier audits to empower your organisation in completing these activities inhouse.
The Internal and 2nd party Audits will evaluate the QMS and regulatory documentation and assess the level of compliance, identifying any opportunities for improvement, observations or nonconformities.
After completion of the audit we will provide a full written report which can be used as a guide to upgrade the QMS, or alternatively Advena can upgrade the QMS for an agreed fee.