Auditing Services

Quality audits are an essential part of any effective Quality Management System (QMS). The purpose of audits is to verify the compliance of the Quality System to the applicable requirements. Applicable requirements can be the IVDR, MDR, ISO13485, ISO9001 but also and customer requirements. Companies operating in the field of (in vitro diagnostic) medical devices are required to have an internal and supplier audit program in place. QRcompliance offers auditing services to outsource these required activities.

An effective audit program can be challenging
♦ Internal auditors are required to be independent, especially in smaller companies this can be difficult.
♦ Employees need to be qualified as auditor, e.g. by internal of external training.
♦ Although well known with the company’s internal procedures internal auditors often lack knowledge of the quality and regulatory requirements.
♦ Insufficient time or resources may be available for the execution of the internal and supplier audit program..

 

In order to make internal audits an effective tool for continuously improvement of the company processes, is necessary to avoid that internal audits become a required “check box”.

 

Plan Do Check Act cycle Auditing Services

To support your quality professionals in maintaining an effective audit program, QRcompliance offers several quality audit services.  QRcompliance has a auditor with years of experience in performing quality audits conform ISO19011 “Guidelines for auditing management systems”.

Compliance Scan

Compliance Scan

A compliance scan can be performed by QRcompliance to assess if there are gaps in the company’s QMS that need to be cleared towards compliance with the ISO13485 and / or the required technical documentation for CE-marking. Check our shop for digital downloads to support the compliance of your documentation.

Internal Audits

Internal Audits

QRcompliance can execute internal audits as part of your company’s internal audit program, with the purpose to check the QMS, development and manufacturing activities for compliance with internal procedures, regulatory and customer requirements.

Inspections

Inspections

For QMS ISO certification and/or CE-marking, companies are regularly inspected regulatory and/or notified bodies A full-system audit by an independent auditor can help your company to successfully pass an inspection.

Supplier Audits

Supplier Audits

Regular audits of critical suppliers are a part of the supplier management process of the QMS, in order to gain the confidence can deliver a product conform our company’s requirements.