Procedures in order to obtain and uphold a certificate include:
- initial assessment of application documents
- initial inspection at production plant
- manufacturer's quality control
- periodical external inspections
Type testing, initial assessment of documents and initial inspection is performed to obtain initial validation of materials, products, production processes and manufacturer's quality control. After successfully passing these procedures, a certificate will be issued by the certification body.
If all the results of type tests and inspections are not satisfactory for issuing a certificate, the applicant shall apply corrective actions. After that those parts of tests and/or inspections considered necessary by the certification body shall be repeated.
A manufacturer shall submit an application to the certification body.
The application for certification shall be made in writing on a special form (annex 3) and be accompanied by:
- technical data (type test reports, drawings, etc.) according to chapter 6.3.1
- description of the supplier's quality control (procedures, test items and frequencies, documentation) according to chapter 6.5
The same form shall also be used to apply for an extension of scope of existing certificate and in case of changing the place of manufacture of the certified product.
6.3 Initial assessment of application documents
In the initial assessment the certification body examines the submitted documents against the requirements set out in these rules.
6.3.1 Technical data
The applicant should present technical data for the product, which includes, as applicable:
- product description
- product norm or reference to a standard
- type test report
- quality control plan
- information about the intended marking
184.108.40.206 Product description
The product description should carry the designation or number as well as the date and the last revision date.
220.127.116.11 Type test report
Type test report shall show that all the technical requirements set out in annex 1 are fulfilled. The report shall not be older than two years at the time of application.
Type testing is to be carried out in an accredited test institute to the extent stated in annex 1.
Type test results only apply to products made of same materials as the type tested products were manufactured of.
The supplier is responsible for sending the samples to the test institute and for the related costs.
18.104.22.168 Quality control plan
The quality control plan shall describe the methods and minimum test frequencies applied in manufacturer’s internal quality control for items according to annex 1.
Manufacturers have the right to mark the certified products with a certification label (quality mark) consisting of an EHP logo and a certificate number as set out in annex 5. The certificate number is made up of a unique certification body number denoted with two digits and a serial number from 01 to 99.
6.4 Initial inspection at production plant
The initial inspection shall provide evidence that the manufacturer meets all the requirements of these certification guidelines. The initial inspection includes inspections and checks included in “manufacturer’s type test” and a check of procedures to perform “manufacturer’s quality control” in accordance with annex 1 (inspections and tests according to “external inspection” are not carried out during initial inspection but only during periodical inspections)
6.5 Manufacturer’s quality control
Manufacturer’s quality control is performed in order to ensure that certified products continuously satisfy requirements in EN 488. The quality control shall consist of tests, measurements and inspections according to annex 1.
The minimum requirements of quality control (items to be tested and test frequencies) are given in annex 1. The quality control shall be described in a quality manual or the like.
The quality control tests and measurements can be performed by the manufacturer itself or they can be outsourced to a subcontractor or test laboratory.
Test equipment used for internal inspection shall be well-maintained, adjusted and calibrated.
All quality control tests and measurements shall be documented, giving the information of the samples, results, dates, name of controller and measures implemented due to results. These documents together with documents on manufactured products and received materials and components shall be maintained for at least 6 years and the certification body shall have access to them.
6.6 Periodical external inspections
External inspections are performed in order to evaluate the certificate holder’s continued compliance with all the specified requirements for certification, especially the minimum extent and proper functioning of the manufacturer's quality control.
The inspection is made by the certification body once a year through a visit to the manufacturer at times determined by the body.
Checks will be made during the visit that the manufacturer's quality control works and is documented by the manufacturer as required. Furthermore, testing and inspections and sampling by the certification body of certified products will be carried out according to annex 1.
In order to facilitate the follow up of the quality of the delivered products the certificate holder shall keep record of the quality reclamations they receive from the field and the actions they have consequently taken. These records can be checked during external inspections.
If the manufacturer employs a quality system according to ISO 9001 certified by an accredited certification body the audit of quality control can be limited to the inspection of conformity of the quality control plan to these guidelines (annex 1) and the ISO 9001 audit and revision reports.
The results of the inspection shall be reported in writing to the manufacturer and - if the certificate holder is not the same as the manufacturer - also to the certificate holder.
If inspections, testing and/or the audit of the manufacturer's quality control result in non-conformity, the certification body initiates an investigation into the causes. The investigation can result in a note, request for corrective acts, new inspection visit, retesting or requirements for changes to the quality control.
6.7 Modification of a certified product
The holder of a certificate is obliged to notify the certification body before modifications to the design, material or implementation are made. The certification body then determines whether the modifications are of a type that can be accepted without renewed testing, inspection or revision of the certificate based on the principle described in annex 2.
6.8 Modification of standards and certification guidelines
In case of amendment or revision to the relevant EN standards or these certification guidelines a supplementary inspection and/or type testing of the changed element(s) will be required by the certification body in order to prove compliance with the changed requirements in order to re-issue the certificate. The certificate holder should be given reasonable time to adapt to the revised regulations, unless there are special motives for other action.