MDSS EUROPEAN AUTHORIZED REPRESENTATIVE SERVICES MDSS CONSULTING   ENGLISH    GERMAN    CHINESE
News Updates
  • Looking for a suitable GMDN-Code?
    MDSS can assist you to determine an appropriate code for your products!
    more


  • MDSS, may support you with the process of applying for a Free Sales Certificate/Certificate of Marketability...
    more


    
HIGHLIGHTS
"The NEW CE MARKING"
Get your questions answered for the NEW REGULATION 
– THE MDR/IVDR!!!

more...


In-House Workshops
"The NEW CE MARKING"
Book now
 to make sure you’re ready to survive and thrive!


Keep up to date!

Cosmetic Products in Europe

Latest News



EVENTS
Meet us!

MEDICA
November 18-21, 2019
Dusseldorf, Germany
Booth #10B05





CONTACT

MDSS GmbH
Schiffgraben 41
30175 Hannover
Germany

Phone
(+49)-511-6262 8630
FAX
(+49) -511-6262 8633

Click here to
contact us





Internal and external audits

 

Audits basically serve to prove the effectiveness of documented processes, procedures and systems as well as whether the legal and normative requirements are fulfilled. Normally, a distinction is made between internal, external and supplier audits.

 

Certification or Surveillance Audits by Notified Bodies (External or 3rd party audits)
You have implemented your QM System successfully and now face the hurdle of an external audit? In the event of an audit by a Notified Body, a situation unfamiliar to your staff, our consultants support you with the necessary qualification and objectivity. Previously known potential deviations (e.g. those determined within the scope of an internal audit) are immediately compared with the requirements and discussed with the auditors at eye level. 

Unannounced Audits by Notified Bodies
In case of this quite new type of audit, employees of notified bodies could stand in front of your door at any time to audit your production or the one of your supplier. You are obliged to grant them access.
MDSS Consulting GmbH can prepare you and your suppliers for this situation and set up suitable procedures. During an unannounced audit we gladly offer you telephone support. For the post processing of findings you can rely on our qualified service.

Surveillance by Authorities
In case of upcoming authority surveillance actions (e.g. by federal state authorities, within the scope of recall actions or effectiveness controls) we stand on your side and offer the necessary professional support.

Internal audits (2nd party audit)
In the run-up to a regular 3rd party audit, the standard demands that all processes and procedures within the area of responsibility of a company are internally audited at least once and verified for conformity. This can be made by the company’s own employees, provided that they belong to a different department, or by external service providers like MDSS Consulting GmbH. Our auditor team conducts internal audits in all business areas, be it a scheduled yearly audit or a specific occasion (reorganization, new processes, changed responsibilities etc.). Following the audit, you will receive a documented statement on the current status of your system. 

Mock Audit
The mock audit is the simulation of an external audit or of an inspection as a preparation for such events. Various topics can be trained here, such as “unannounced audits by notified bodies”, “FDA inspections” or “Surveillance by Authorities”. 

Supplier Audit
Quality agreements with suppliers or subcontractors mostly contain extensive commitments on part of the suppliers regarding the business partner’s quality policy. We make on-site visits and provide you with an objective picture of the situation. 

Our team has a long experience at planning and conducting all type of audits worldwide. 

We support you throughout your audits or inspections and carry out different types of audits according to your wishes. MDSS Consulting GmbH concludes the audits with a report on the degree of compliance concerning the requirements and makes suggestions how to address the identified deviations.

MDSS Consulting GmbH is at your disposal to answer your questions. You can rely on our experience!