Although the basic requirement is one unannounced audit per certification every three years, the frequency of unannounced audits can be increased for the following reasons:
- If the device under certification bears a high risk.
- If the device is frequently noncompliant.
- If there is substantial evidence to suspect a critical non-compliance.
Therefore, it’s important for manufacturers to assess their devices to anticipate the frequency of unannounced audits a particular device category may have. We recommend that manufacturers estimate the likelihood of the frequency of these audits based on the factors mentioned above for each CE certified device category in their product portfolio.
There are a few aspects to consider when preparing for unannounced audits. A team of at least two auditors will be on site for at least one full day. An unannounced audit may last multiple days. Key processes such as design control, establishment of material specifications, purchasing and control of incoming material and components, assembling, software validation, sterilisation, batch release, packaging and product quality control will be carefully examined. This list is not an exhaustive list and other relevant processes may be examined as well.
In addition to the production process, the unannounced audits will also focus on the product. Product samples may be chosen during the unannounced audits for further inspection and testing. A specific test plan can be planned by the Notified Body prior to the unannounced audit. The Notified Body may take product samples with them for further testing. In the case where important processes are subcontracted or if important parts are purchased from a supplier, the Notified Body may also conduct an unannounced audit on the facilities of critical subcontractors and critical suppliers.
It is critically important that manufacturers are prepared for unannounced audits at any point in time. Unannounced audits will play an important role in the manufacturers ability to maintain and renew their certification. Due to the unannounced nature of the audits, the manufacturer must have policies and procedures in place when the unannounced audit team is present at their premises.
- As the unannounced audit will likely disrupt the day-to-day operational activities the manufacturers should prepare procedures to minimise impact to operational activities in the event of an unannounced audit.
- Key managers and employees that are required for the unannounced audit should be present or should be contactable or accessible in short notice.
- Manufacturers should consider establishing deputies or representatives for important roles required for the unannounced audit.
- Communication between manufacturers and critical subcontractors/suppliers should be strengthened in order to facilitate unannounced audits with critical subcontractors/suppliers.
- Manufacturers should take the responsibility to ensure that critical subcontractors/suppliers are fully aware and prepared for unannounced audit because their performance will have an impact on the manufacture’s ability to maintain and renew their CE certification.