Certification stages

The Certification Process – from application to certification

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 8 – 10 months 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 6 – 8 months in advance of the desired audit date.

Pre-Audit (optional)

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 and Product List

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 2 – 3 months 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 Quality 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 Quality-Management-System are examined and evaluated and the result is presented in an audit report to contracting party.