Type of products certifications schemes acc. PN-EN ISO/IEC 17067
The certification program can be defined as a certification system related to specified products, to which the same specified requirements, specific rules and procedures apply.
Certain certification programs may include preliminary test of the product and pre-license inspection or assessment of quality management systems at the production site, followed by surveillance including periodic testing or inspection of samples taken from production and / or the market.
Other programs consist of a preliminary test and surveillance tests, and still others may include only product type testing, limited to testing the provided sample.
For an easy and unambiguous recognition of differences between individual certification programs, PN-EN ISO / IEC 17067 introduced the concept of program type, digitally highlighted, assigning to each of them a specific share of individual functions and conformity assessment activities in the product certification system.
Types of certification programs for products have been classified from 1 to 5, whereas the type 6 program applies only in process certification.
Below, there is presented the lists of conformity assessment activities that are to be performed in a given certification program of a given type
Table 1 Type of product certification scheme PN-EN ISO/IEC 17067 | ||||||
Conformity assessment functions and activities within product certification schemes | Type of product certification scheme * | |||||
1a | 1b | 2 | 3 | 4 | 5 | |
Activities for issuing the certificate | ||||||
Product evaluation – type test acc. | X | X | X | X | X | X |
Assessment of production- pre-license inspection in factory | X | X | X | |||
Review | X | X | X | X | X | X |
Decision on certification | X | X | X | X | X | X |
Certification documents | X | X | X | X | X | X |
Certificate of conformity | X | X | X | X | X | X |
License – granting the right to use marks of conformity | X | X | X | X | X | |
Certification of a batch | X | |||||
Surveillance after issuing a certificate | ||||||
Testing of samples from the open market | X | X | X | |||
Testing of samples from the factory | X | X | X | |||
Assessment of the production, the delivery of the service | X | X | X | |||
Management system audits combined with random tests or inspections | X | |||||
* The program type 6 for processes has been omitted |
It can be seen that in all types of programs there is a product evaluation carried out by testing a product sample to demonstrate compliance with specified requirements.
In programs with the surveillance and certification of compliance of a batch, in addition to the certificate of conformity, a document entitling to use a certified certification mark for the certified product is issued. Such a document is called a license.
Scheme type 1a
In this scheme, one or more samples of the product are subject to the determination activities. A certificate of conformity or other statement of conformity (e.g. a letter) is issued for the product type, the characteristics of which are detailed in the certificate or a document referred to in the certificate. Subsequent production items are not covered by the certification body’s attestation of conformity.
The sample are representative of subsequent production items which could be referred to by the manufacturer as being manufactured in accordance with the certified type.
The certification body may grant to the manufacturer the right to use the type certificate or other statement of conformity (e.g. a letter) as a basis for the manufacturer to declare that subsequent production items confirm to the specified requirements.
Scheme type 1b
This scheme type involves the certification of a whole batch of products, following selection and determination as specified in the scheme. The proportion to be tested, which can include testing of all the units in the batch (100% testing), would be based, for example, on the homogeneity of the items in the batch and the application of sampling plan, where appropriate. If the outcome of determination, review and decision is positive, all items in the batch may described as certified and may have a mark of conformity affixed, if that is included in the scheme.
This type of certification is preferred in cases required by law, periodic nature of production and also at the recipient’s request.
Scheme type 2
In this program, the evaluation for the issuance of the certificate is limited to the product evaluation carried out by testing the product sample to demonstrate compliance with the specified requirements. The surveillance part of this scheme involves periodically taking samples of the product from the market and subjecting them to demonstration activities to check that items produced subsequent to the initial attestation fulfil the specified requirements. This program does not provide for the assessment of production. It is preferred if there is no possibility and need to carry out a factory inspection. Usually used for the certification of imported products and also in cases where legal provisions require entities to purchase equipment that has the appropriate attestations or certificates, e.g. equipment for schools and facilities.
Schemes types 3, 4 & 5
In these programs, unlike the other types, at the stage before the certificate is issued, the assessment of production process is carried out. The assessment of production, by pre-license factory inspection, is aimed at demonstrating compliance with the technical and organizational conditions guaranteeing the maintenance of repeatable production of products at the level confirmed by the type test of the product. In programs that include this action, there is always a surveillance function after issuing the certificate. The surveillance part covers both periodic sampling of products, for conducting control tests as well as periodic factory inspections, often referred to as routine inspections. Product inspection tests are performed to check whether products manufactured after the issuance of the certificate still meet the specified requirements. The purpose of the routine inspection is to confirm the maintenance of the proper production process at a level confirmed by a pre-license inspection.
It can be concluded that the certification carried out in this type of program not only confirms the conformity of the type of product identified with the specified requirements, but also gives a high degree of confidence that the subsequent manufactured products (from current production) also meet these requirements. It should be noted, however, that the type 3 certification scheme, in which a sample for control tests is taken only from the place of production, does not provide any indication of the impact the distribution channel plays on conformity.
These types of certification programs bring the best measurable benefits to all interested parties.