Stricter controls on the Certification process
The impressive product offer in terms of quantity, diversity and provenance has repeatedly led the EU Commission to set as its objective the reinforcement and the standardizing of consumer protection and safeguarding across Europe, with a consequent strengthening of the internal market control and surveillance measures.
Specifically, stricter criteria are currently being applied for the accreditation of Notified Bodies (NB), which are called to play their part in assessing the safety of products, with a particular attention paid to II and III Category PPE (Personal Protective Equipments). EA and Accredia latest trends are also heading towards increased strictness in the quality standards of their practices.
However, it should be pointed out how the requests made by the Notified Body contribute to effectively reduce the risk for the Manufacturer of finding themselves in an untenable position in judicial disputes initiated by harmed or damaged users.
Such requests can be summarized as follows:
- Particularly close attention will be paid to the documentation submitted to the Notified Body so to verify its completeness and thoroughness for the purposes of Certification procedures;
- In order to prevent abuses, it will not be possible to modify previously issued Test Reports so that they would refer to different products: test need to be repeated every time;
- Quality plans provided by Manufacturers will be thoroughly examined taking into account the specificities of each particular product: if the quality plan is not deemed exhaustive and/or comprehensive enough, objective evidences of the sampling and the control methods referring to the tested products will be required;
- The monitoring contract of III Category PPE provides for an obligation to store different production batch samples, manufactured in the period intercurring between two inspections;
- When it is not possible to gather PPE produced over time, ISO 9001 certificates may be a favorable element in proving the homogeneity of a particular product. If the certification process refers to manufacturing activities – and not only commercial ones -, it is nevertheless necessary to scrutinize the employed means and methods of control;
- If III Category PPE should result noncompliant on the occasion of the periodic inspection, the Notified Body will be forced to request information regarding the nature and the number of production batches that have been placed on the market since the last inspection and to test samples of said production batches;
- If the concerned PPE cannot be traced, are not available for new testing or they prove once again noncompliant, the Notified Body shall notify the competent Supervisory Authorities which will assess the risks involved and adopt the possible countermeasures;
- The withdrawal of a certificate or a formal refusal of an application are promptly communicated to the Supervisory Authority (MoED) and to all European Notified Bodies that certify that type of PPE, in order to prevent the commercialization of noncompliant PPE in the first place, and the presentation of an application for those same PPE to another Notified Body in the second place.