Is testing mandatory for unannounced audits?
For quality management related certificates, testing is not mandatory. However, testing may occur if the unannounced audit team has reasonable doubts about the conformity of the device type(s). The performed test(s) may include additional testing in line with Section 4 of Annex III of the European Commission Recommendation 2013/473/EU.
For product related certificates where the manufacturer has applied for a design dossier examination or for a type examination (product assessment), Notified Bodies should perform testing in line with Section 4 of Annex III of the European Commission Recommendation 2013/473/EU.
When testing a product sample, would it be sufficient that testing is done on-site with the TÜV SÜD auditor as a witness?
Yes, on-site testing with the TÜV SÜD auditor as a witness might be sufficient if tests can be performed on-site.
Other options include the testing of samples by our laboratory or by qualified personnel under one of the following:
- Under TÜV SÜD observation on TÜV SÜD premises
- On the manufacturer’s premises
- On the premises of the manufacturer’s critical supplier
- In qualified external laboratories
If an auditor decides to take an expensive product for off-site testing, will the product be returned in its original condition? Will we be reimbursed for the product?
If it is possible to perform tests on raw materials, intermediates, components or unfinished products, these tests will take place instead of destructive tests on final devices. The device acquisition and its testing will be financed by the manufacturer.
Please refer to the TÜV SÜD Testing and Certification Regulations, Module B1 Special Regulations for product testing and certification.
What criteria do Notified Bodies have for selecting the products that will be sampled?
Notified Bodies may select products which have a high likelihood of nonconformity. Other reasons may include:
- Media reports and news about malfunctions
- High risk devices
- Noncompliant products
- Information from the market based on malfunctions of similar products
- Information or inquiries from the authorities
- High rate of device noncompliance
How will sampled products be tested?
Testing of device conformity will be done in accordance to ANNEX III Section 4 of the European Commission’s Recommendation 2013/473/EU, with the main focus on the safety and performance of the device. Possible tests include:
- Microbiological safety testing
- Mechanical safety testing
- Packaging testing
- Performance testing
- Electrical safety testing
- Functional safety testing
- EMC testing
How will the manufacturer be involved in the unannounced audit during the testing of components?
When testing components on the manufacturer’s premises, the manufacturer will use its own personnel and laboratory test equipment while the personnel from TÜV SÜD will supervise the tests.
Can the manufacturer’s products, subassemblies or components be sampled at their supplier’s premises?
The European Commission Recommendation requires performing tests at the premises of critical subcontractors or crucial suppliers. Testing could even be performed on devices installed at a customer location. But samples may only be taken at the site of the supplier with the manufacturer’s consent.
What will determine whether a product will be tested on-site or off-site?
If products cannot be tested on-site during audit or if the product cannot be tested on-site for technical reasons, the following options are available:
- If samples are available and can easily be shipped to our laboratories and tested in our laboratories, the device will be sampled during an audit for later testing.
- If samples are available but difficult to be shipped out or if they are difficult to be tested in our laboratories, the tests will be performed on the selected device at the manufacturer’s, operator’s (such as a hospital), or critical supplier’s premises as arranged by the manufacturer.
- If there is no certified device type manufactured at the time of the unannounced audit. Test samples will be bought on the market and shipped to our laboratories.
How will testing be conducted on products that do not have a finalised sample?
If sampling at the manufacturer’s premises is not possible, Notified Bodies should take samples from the market, if necessary with support by the competent authorities, or should perform testing on a device installed at a customer location.
If it is possible to perform tests on raw materials, intermediates, components or unfinished products, these tests will take place instead of destructive tests on final devices.
What happens if the on-site test results are different from the results provided by the manufacturers?
If the test results play an important role in the safety and performance of the device, a recommendation of suspension of its certification will follow if the results deviate negatively when compared to the manufacturer’s data.