Audits

An audit is usually carried out to check the status of the quality management system in relation to a standard and the internal procedures and instructions. These are called the audit criteria. In other words: does the quality management system meet the requirements of the audit criteria and is it implemented in the daily operations.
 
If you do not have enough knowledge and experience to perform internal audits yourself, I can do it for you. You also have the option to follow and auditor training to gain the required audit skills.
 
In addition, there is the possibility to conduct supplier audits. The purpose of such an audit is to assess the extent to which the agreed agreements are met. Need help? Contact me.
 
After performing the audit I will:
- Make an audit report and discuss the results with you.
- if necessary, schedule a follow-up appointment to see if the found deficiencies have been resolved.
- If desired, advise you about a possible follow-up. 
 

DEKRA Certification BV

I work as of 2010 as a contract auditor for DEKRA Certification BV in the role as Lead auditor for ISO 9001, ISO 13485 and as Notified Body Lead Auditor for the European medical devices directive. In addition, I am qualified to perform audits in accordance with the Canadian, Japanse, and Taiwanese regulatory requirements.
   

I am working as a contract auditor for SQA services Inc, USA, for the performance of supplier evaluations at European suppliers in the medical and pharmaceutical industry.