BSI Unannounced Audits - Trial Outcome and next steps

Enews - April 22, 2014

EU Commission Recommendation (2013/473/EU) Unannounced Audits


BSI continues to progress with the introduction of unannounced audits. Following our Customer Webinar on the 11th February 2014, (see link to webinar recording), we have now completed our "trial phase" of conducting several unannounced audits.  A number of companies contacted us and volunteered to be considered for inclusion in this trial phase.  Although we were not able to include everyone who volunteered to receive a trial unannounced audit, the results achieved were very positive.

Trial Outcome

From the analysis and review of the audits conducted the results were extremely helpful, and where appropriate, our processes have been reviewed and amended in order to improve and further develop our approach to unannounced audits. Feedback from the companies involved has been very positive and helpful, overall the trial provided benefits for both parties. We would like to take this opportunity to thank all of the companies involved in these audits and also the companies who volunteered but were not audited.

Introduction to unannounced audit program – BSI's approach to meeting the European Commission expectations

We have now moved into the next phase and the full introduction of the unannounced audit program, we had previously agreed with the UK MHRA and in Germany with ZLG that as of the 1st April 2014 we will begin to undertake unannounced audits.

For High Risk devices, (including MDD Class III, AIMD & IVD List A) the frequency is once every two years, for all other devices it is once every three years, or should the situation require it, more frequently.

The EU Commission Recommendation 2013/473/EU was published 24th September 2013, we have provided you with details of this Recommendation, so our expectation is that by now you are aware of the requirements and have started to plan and develop appropriate processes for receiving an unannounced audit within your company (and any critical subcontractors and crucial suppliers), to allow the fulfilment of the obligations placed on you, as the legal manufacturer.

Next steps for implementation

Please be aware that with immediate effect future planned audits supporting BSI EC Certification will contain an element with respect to unannounced audits, in order to check your state of preparedness. The outcome of this inclusion will be;

  • If you are not aware of the Commission Recommendation and/ or there is no evidence of planning to receive unannounced audits, then a minor non-conformity will be raised which would then require an appropriate corrective action plan to be developed in the normal manner.
  • If there is evidence of awareness, but limited evidence of plans being developed etc., or those are found to be lacking, then an Observation will be raised.

Fee structure, sanctions and penalties

Our fee structure for unannounced audits has now been finalized and will be circulated along with revised BSI Terms & Conditions of Contract by the middle of May 2014.

Should you have any questions or comments in relation to unannounced audits please refer to our specific unannounced audit webpage, which has a selection of FAQ’s, or your BSI Scheme Manager.

Thank you for your continuing support and participation.

Yours faithfully

John Howlett, BSI UK Head of Notified Body

Dr Gert Bos, BSI Germany Head of Notified Body