Internal Audit

More effectiveness, less resources

INTERNAL AUDIT

Internal Audit of your QMS

As a medical device manufacturer, you are obliged, according to the ISO 13485 standard, to audit your quality management system (QMS) on a regular basis. This is called the Internal Audit and is an evaluation of the effectiveness of your QMS. Your certification body will, during their audit, verify the responsibilities and requirements for planning and conducting audits and the recording and reporting of the audit results. 

 

 

Important is to show you take all necessary corrective actions to eliminate detected non-conformities and their causes. To show the follow-up of CAPA's, including verification of actions taken and a report of the verification results.   

Our experts, most of them worked at a Notified Body, have a lot of experience with internal auditing in a wide scope of business areas within the medical device industry. We offer a transparent process and make sure that the report is in compliance with ISO13485 and will be accepted by the certification body.

An Internal Audit is an effective tool to monitor, control and improve your performance. Qserve's Internal Audit services can make your life easier in the following situations:

  • Your internal auditors are too busy with other important tasks
  • Your internal audit results do not yet improve your effectiveness
  • Your internal auditor suddenly moved to another job or is long-term ill
  • You are not in compliance according to your certification body
  • No internal resources available
  • You want to set up templates to increase the efficiency of your internal audit.

 

INTERNAL AUDIT

Searching for methods to maintain your QMS?

Quality Management System (QMS) Maintenance, to make sure that your QMS conforms with the latest internal and external updates.

Read more

Set up and report on an effective Management Review Meeting to comply with the management review requirements of the ISO 13485.  

Contact us

Train your staff with our Internal Auditor Training to make sure your Internal Audits improve your effectiveness.

Read more