Stage 1: Information / Preparation (Quesstionnaire) Clarification of inquires (Quotation)

In this stage all the information and data concerning the company and each facility is collected. All data specifies the present situation of the company and the intended scope of the certification process. Based on the data given in the questionnaire, MEDCERT prepares a quotation with the planned scope of the certification.

Time frame recommendation: 3 -4 months in advance of a desired audit date

Stage 2: Placing an order

Placing an order initiates the certification process. The lead auditor will be named whose know-how and experience is related to the company's profile.

Time frame recommendation: 2 -3 months in advance of a 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 the future certification audit. Our auditors conduct a preview; weak points and areas for improvement will be identified. In this way, you know exactly where the action points are and can prepare your company well in advance for the actual certification audit.

Stage 3: Examination of documentation

Before an actual audit commences, the documentation has to be verified. The contracting party has to provide the MEDCERT auditor with the following documentation:

• complete QM-Manual
• SOP's (Standard Operating Procedures)
• Organisational Chart
• Management Review and reports on the internal audits
• Product documentation

Time frame recommendation: at least 8 weeks in advance of a desired audit date

Stage 4: Certification audit

The certification audit will be carried out on the basis of the agreed audit plan, so you know when and which fields will be examined. The auditor will examine on site if and how the recorded Quality Management System is being put into practice.

Stage 5: Evaluation of corrective action

The corrective actions will be evaluated by the designed Lead Auditor.

Stage 6: Issue of ceritifcate

In the final stage the complete certification process is subject to verification. The review is submitted to the MEDCERT Certification Body which examines compliance with the requirements. If all criteria have been fulfilled, then the contracting party receives a certificate which certifies that the management system conforms to standard requirements. A MEDCERT certificate is valid for 5 years.

Stage 7: Pre-Surveillence audit

To maintain the validity of the certificate, the contracting party has to undergo periodical, annual pre-surveillance audits. In these processes all essential parts of the management system are examined and evaluated. The results are presented to the contracting party in an audit report.

Stage 8: Re-Certification

Before the expiry of the certificate (valid for 5 years), a re-certification audit is conducted.