Ente Certificazione Macchine is an independent certification, inspection, testing and training body. Over the years, ECM has expanded its areas of expertise and the portfolio of services offered, by obtaining accreditations and notifications.
The accreditations as notified body have been issued by Accredia, and as testing laboratory have been issued by Perry Johnson Laboratory Accreditation Inc. (PJLA).
Accredia, as the only national accreditation body designated by the Italian government, i.e. the only body recognized in Italy to certify that the certification and inspection bodies have the skills to assess the compliance of products, processes and systems with the reference standards, operates under the supervision of the Ministry of Economic Development. Visit the website www.accredia.it
Perry Johnson Laboratory Accreditation Inc. (PJLA), as International Accreditation Body for Testing and Calibration Laboratories, is recognized to attest that laboratories have the competence to assess the compliance of products to national and international reference standards. PJLA is among the MRA Signatories of the International Laboratory Accreditation Cooperation (ILAC) and the Asia Pacific Accreditation Cooperation (APAC) for both testing and calibration. Visit the website www.pjla.it
NB: For requests of information or to find out how to submit reports, complaints, appeals and reserves, please visit the following page.
To view the Declaration of the direction on independence – impartiality – confidentiality, click on the following link.
Notified Body for product certification
Ente Certificazione Macchine is a Notified Body (n. 1282) authorized to carry out conformity assessments and issue product certifications according to ISO 17065, with respect to the requirements of the following directives (to view the relevant authorization decree of the competent Ministry, click on the number of each directive):
– Directive 2014/33/UE Lifts and Safety Components for Lifts
– Directive 2006/42/CE Machinery
– Directive 2014/34/EU Apparatus and protection systems intended for use in potentially explosive atmospheres (Atex)
– Directive 2000/14/CE Noise
– Directive 2014/30/UE Electromagnetic Compatibility (EMC)
– Directive 2014/68/EU Pressure Equipment (PED)
– Direttiva 2014/53/UE Radio Equipment Directive (RED)
ECM is also a Notified Body authorized by the Italian Ministry of Health to issue product certifications according to Medical Device Regulation (EU) 2017/745 (MDR) and responsible for the surveillance of all requirements for devices it has certified according to the Medical Device Directive 93/42/EEC (MDD) before 26 May 2021.
See the notification on the European Commission’s database NANDO.
For MDR certification requests, you can download and complete the form Medical Device Certification Application – MDR 2017/745.
To communicate changes to legacy devices, it is possible to download and fill in the following form Communication of changes to legacy devices.
You can see the Regulations for Medical Device Certification (MDR) and the Regulation of Legacy Medical Devices (MDD).
Accredited body for the certification of Quality Management Systems
Ente Certificazione Macchine is accredited by Accredia for the certification of Quality Management Systems according to ISO 17021-1, for the following international standards:
– EN ISO 13485: 2016
For QMS certification requests, it is possible to download and fill in the following form QMS Certification Application
PJLA Accredited Testing Laboratory ISO 17025
Ente Certificazione Macchine is PJLA Accredited Testing Laboratory – ISO/IEC 17025:2017 – Accreditation No. 121697 – Certificate Mr. L23-821 by Perry Johnson Laboratory Accreditation Inc. (PJLA).
Periodic verifications of work equipment
(Annex VII Legislative Decree 81/2008 and DM 11.04.2011)
ECM is a private qualified subject pursuant to the D.M. April 11, 2011 for the verification of work equipment of Annex VII of Legislative Decree 81/2008 and as amended. To view the decree authorising periodic inspections of work equipment, referred to in Annex VII of Legislative Decree No. 81/2008, click on the following link.
The matrix of territorial and verification staff skills and the Organigram Flowchart Procedures are available. You can also consult the Regulation of Periodic Verification D. Lgs. 81/2008 (RTVP 81-2008).
For the communication of commissioning and the request for the first periodic check, you can access the INAIL portal.
For periodic verification requests, you can download the forms available below:
- form for requesting periodic verification of groups SC (Lifting Things) and SP (Lifting People);
- form for requesting periodic verification of the GVR group (Gas, Steam, Heating).
Electrical systems verification
ECM is a private subject that performs periodic and extraordinary inspections pursuant to Presidential Decree 462/2001 and subsequent amendments of electrical earthing systems and protection systems against atmospheric discharges. In particular, it checks:
- installations and devices for protection against atmospheric discharges;
- earthing systems for systems powered up to 1000 V;
- earthing systems for systems powered above 1000 V.
To request a quotation for periodic and extraordinary inspections according to D.P.R. 462/2001, please download and fill in the document Request Form for Quotation D.P.R. 462/2001.
Ente Certificazione Macchine provides the following voluntary services (for services provided in the mandatory area, see the Mandatory section).
Audits and Inspections
Inspection activities on products and equipment, at local and international level, according to specific voluntary international standards or requirements voluntarily defined by the customer.
Third party EC conformity assessment activities
ECM acts as an independent third party to carry out EC third party conformity verifications on machinery and equipment in order to assess that all safety requirements of the relevant standards are met. These activities include:
- Verification of technical documentation supporting the EC compliance,
- Onsite inspection and assessment of the machinery,
- Execution of laboratory tests deemed necessary.
ECM has a highly qualified technical staff and instruments for carrying out safety, quality and performance tests in accordance with various international standards or with customer-defined requirements.
ECM testing skills include performing laboratory tests, debugging actions to solve any problems, research and development activities.
Among the tests that ECM can perform are:
- electromagnetic compatibility
- electric safety
- endurance tests
- stability tests
- verification of the IP rating
- nondestructive tests
- climatic tests.
It is available the Regulation on Voluntary Non Notified Certification (RGVOL01).