To begin with: Information / Preparation / Clarification of open questions / Offer
In this stage, the necessary data concerning the company are collected including, all further facilities and all critical subcontractors including.
These information describe the current status of the company and the intended scope of the certification process. Based on the data given
in the questionnaire, MEDCERT prepares a quotation of the estimated certification extent.
Time frame recommendation: at least 5 – 7 month in advance of the desired audit date
Step 1: Order and Application review
Upon filing of the application by the client, MEDCERT initiates the certification process. The Lead Auditor, whose know-how and
experience corresponds to the company´s profile, will be named.
Time frame recommendation: at least 4 – 6 month in advance of the desired audit date
If requested by the contracting body, MEDCERT can carry out a pre-audit. This optional examination is an optimal preparation
for a future certification audit. Our auditor conducts a preliminary evaluation; vulnerabilities and ideas for improvements will be
identified. This way, you know exactly where the action points are, and you can prepare your company well in advance of
the actual certification audit.
Step 2: Examination of Documentation
Before an audit commences, the documentation has to be verified. The contracting party has to provide the following documents
to the responsible MEDCERT auditor:
• complete QM-Manual including SOP´s (Standard Operating Procedures)
• Organisational Chart
• Management Review and reports on the internal audits
• if applicable also Product Documentation
The documentation will be examined according to the industry standards, respectively legal requirements.
After the documentation review, the client gets a report thereof.
Time frame recommendation: at least 8 weeks in advance of the desired audit date
Step 3: Time frame and Audit planning based on the submitted documents
The contracting party will receive a detailed audit plan, which depicts which areas are monitored at what time.
Step 4: Certification Audit
The certification audit is conducted based on the coordinated audit plan. The auditor examines on site, whether and how the
Quality Management System is put into practice. Concluding the audit, an evaluation of remarks and potential Non-Conformities
will be discussed and documented.
Simultaneously it is to be determinated how and when the corrective action has to be submitted.
The audit results will be summarized later in the form of an audit report.
Step 5: Evaluation of corrective action
The corrective actions will be evaluated by the responsible Lead Auditor.
Step 6: Harmonization of the Scope of Certificate
After a positive evaluation of the corrective actions, the text of the certificate is concerted between MEDCERT and the
contracting party. The drafts are prepared and for release by customer.
Step 7: Assessment by the certification body of audit results and corrective actions
In this stage, the entire certification process is evaluated in summary. The results of the audit are exhibit to the MEDCERT
certification body that reviews the fulfilment of the requirements. If all criteria are accomplished, the contracting party receives
the certificate that verifies the conformity of the Management System with the stated requirements.
Step 8: Issue of certificate
Congratulations! You successfully completed the process to obtain the required certificate. You have reached your destination!
Step 9: Surveillance Audit (annual)*
To sustain the validity of the issued certificate, regular annual surveillance audits are conducted. Here, the essential parts of the
QM-System are examined and evaluated and the result is presented in an audit report to contracting party.
* Audit costs are lower than for the initial audit