FAQ: How to understand module C2
(so-called supervised product check of personal protective equipment category III)
What does module C2 mean?
Module C2 means that finished specimens of the certified product are randomly sampled and tested once a year. The term Module C2 refers to the procedure for annual product checks as stated in Regulation (EU) 2016/425 Annex VII.
Why do I need module C2?
According to the regulation for personal protective equipment EU 2016/425 Annex I some specific products are so-called category III. This means that they are designed to protect the user from serious injury or death. As a precaution the European Commission has therefore decided that such products shall be checked and verified at least once per year by a notified body.
How do I get module C2?
You get module C2 by signing a standard agreement between your company and FORCE Certification A/S (see attachment to this FAQ). You will then receive your own signed copy of the agreement, a special module C2-certificate, and a list of the products which are covered by the agreement.
Certification of personal protective equipment (PPE)
FORCE Certification offers certification of personal protective equipment (PPE) in accordance with the current EU regulation PPE(EU) 2016/425.
Learn more about certification of personal protective equipment (PPE) and how we can help you: Certification PPE
When will the products be sampled for the first time/the following years?
The product(s) covered by a new agreement are required to be sampled for the first test immediately after the products are certified. The module C2-certificate will be issued upon positive results during this first test. Similarly, products added to an existing agreement are required to be sampled for the first test before they can be added to the C2-certificate. The following years, the product(s) will be sampled with about 1 year interval.
Who will make the random sampling?
The random sampling is performed by an inspector from FORCE Certification A/S, or an inspector representing FORCE Certification A/S. The sampling process itself may be sub-contracted by FORCE Certification A/S to one of our suppliers. The manufacturer will be duly informed.
Where will the random sampling take place?
The random sampling will take place at a location agreed upon between the manufacturer and FORCE Certification A/S. Usually it shall be a location with an easy access to a stockpile of the product. Most often this is at the factory, a production line, warehouse, importer, retail, or other suitable place.
You will receive a sampling report stating where and which specimens have been sampled.
Can we just ship the random specimens to you instead?
No, according to the regulations sampling shall be performed by an inspector.
How many specimens are sampled?
The number of sampled specimens mainly depends on the produced amount since last sampling (i.e. the production number of the previous year). As a rule of thumb FORCE Certification A/S rely on a receding sampling rate for higher production numbers:
| Production number: | Number of sampled specimens for test: |
| 1-100 | 1-3 |
| 101-500 | 1 pr. 100 |
| 501-3000 | 1 pr. 500 |
| 3001-10.000 | 1 pr. 1000 |
| 10.001-100.000 | 1 pr. 10.000 |
| 100.001-1.000.000 | 1 pr. 100.000 |
| Etc. | Etc. |
Sampling is accumulated, e.g. a production of 500.000 will result in a sampling of 30 specimens.
Table is for guidance only because some tests require a minimum of specimens to perform.
What happens with the sampled specimens?
The inspector will make sure that the sampled specimens are transported to the laboratory appointed by FORCE Certification A/S. The specimens are then tested according to the standard of the product. Testing of the sampled specimens will usually be in accordance with parts of the standard (not necessarily all the tests according to the complete standard). Not all sampled specimens are necessarily tested. The testing process itself may be sub-contracted by FORCE Certification A/S to one of our suppliers. The manufacturer will be duly informed. Even in the event of sub-contracting (parts of) the tests, the overall assessment and evaluation of the obtained test results will always be conducted by FORCE Certification A/S.
Once the tests are completed you will receive a test report.
What is expected of the manufacturer?
It is expected that the manufacturer will take all measures necessary so that the manufacturing process and internal production control ensure the homogeneity of the production.
The manufacturer shall keep the documents connected to the supervised product check for at least 10 years after the personal protective equipment has been placed on the marked.
The manufacturer shall grant access to the location of sampling specimens, and supply FORCE Certification A/s with all necessary documents and information that may be needed to conduct the sampling and the tests.
The manufacturer shall affix FORCE Certification A/S’s identification number (0200) during the manufacturing process to each individual item of personal protective equipment.
What will FORCE Certification A/S do?
- FORCE Certification A/S will once per year arrange and send the inspector to perform the sampling.
- FORCE Certification A/S will arrange the testing of the sampled specimens.
- FORCE Certification A/S will provide you with a test report and an overall conclusion of the product check.