Auditing Process Overview

Scope

Swiss Certification Services is providing certification for Quality Management Systems according to ISO 13485:2016.

Detailed Auditing Process

Process when compliance is established

After stage I and stage II audit and providing that non-conformities have been adequately handled, the certification board will grant certification

After surveillance 1 or surveillance 2 audit and providing that non-conformities have been adequately handled, the certification board will decide maintain the validity of the certification

After the renewal audit and providing that non-conformities have been adequately handled, the certification board will renew the certification

If the customer submit proof of proper handling of major non-conformities, within 6 months, the certification board will restore the certification

If a scope extension is requested by the customer, the certification board will decide if an audit needs to be conducted prior to grant the extension and upon completion of the required activities, the scope extension will be granted

Process when compliance is not proved

The certification will be refused if the client failed to resolve major non-conformities, within 3 months after the second stage II audit

The certification will be suspended in the following cases:

  • The QMS has persistently or seriously failed to meet certification requirements (including requirements for the effectiveness of the QMS)
  • The client doesn’t allow surveillance/recertification audits to be conducted at the required frequencies
  • The client has made a voluntary requested suspension.

The certification will be withdrawn in the following cases:

  • The client has failed to resolve the issues that have resulted in the suspension in the allocated time (in some cases, the scope can be reduced)
  • The client created repeated obstacles to surveillance/recertification audits scheduling.
  • The client has made a voluntary requested for withdrawal.
  • The client has deliberately lied / hide information from the audit team to cover fraud / illegal actions.

The certification scope will be reduced in the following cases:

  • The client has failed to resolve the issues that have resulted in the suspension in the allocated time.
  • The client has made a voluntary request for scope reduction.

Geographical Areas

Switzerland

Germany

Austria

Luxemburg