Directive 2014/68/EU (PED) on risk control and safety for pressure equipment, provides for compliance with essential safety requirements of all plants (assemblies) and individual equipment operating at a maximum permissible pressure greater than 0.5 bar (e.g. boilers, pressure vessels, pipes and accessories) placed on the European market.
On the basis of the category in which the pressure equipment is classified (categories I to IV), the manufacturer is required to adopt a specific conformity assessment procedure.
Without prejudice to compliance with the above, the conformity assessment of pressure equipment can also pass through the assessment/audit of the manufacturer’s quality system with what are commonly identified as “Quality Modules”.
C&P S.r.l., as a Notified Body, provides these assessment and certification services under Accreditation.
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A quality management system that meets the requirements of ISO 9001 can be the basis for a consistent implementation of a quality system, subject to the following considerations:
- The certification of the quality management system under Directive 2014/68/EU is mandatory;
- The quality management system is used to certify the manufacturer’s compliance with the requirements of the directive;
- Failure to comply with a requirement of the directive is failure to comply with a mandatory requirement and will lead to the issuance of a non-compliance that may have consequences on the company’s ability to place products on the market until the non-compliance will be resolved.
The quality modules:
Module D1 = applicable up to Category II
Module D = applicable in the combinations:
- B (design) + D up to Category III
- B (production) + D up to Category IV
Module E1 = applicable up to Category II
Modulo E = applicable in combinations:
- B (production) + E up to Category III
Module H = applicable up to Category III
Modulo H1 = applicable up to Category IV
How to...
Companies that want to access QMS certification services must send a specific request for quotation to C&P S.r.l.
The request for quotation for a service can reach C&P S.r.l. in different ways:
- Telephone and/or verbal request.
- Written request via email and/or other support.
C&P S.r.l. will send the applicant (authorized representative of the customer) the Form AM021N “QMS Certification Services – Request for Quotation” to identify the requested service. The form contains the information necessary to fill it in and to send it back to C&P S.r.l.
The information that the company will have to provide concerns:
- Scope required for certification (description of activities and products services);
- Characteristics of the company (name, address, number of employees, significant aspects of its activities/processes, seasonality, applicable legal/mandatory requirements);
- The number of sites where the QMS is implemented (main office, secondary sites, temporary sites), as well as the information useful to identifying the significant aspects for each site (address, number of employees, the activities/processes implemented at them);
- Information relating to all processes outsourced to the company, which affect compliance with requirements;
- The standards or other requirements on the basis of the applicant organization wants to be certified;
- Information regarding the use of consultancy services related to the management system;
- Provisions such as security clearances required for the auditor to access specific areas and/or information and materials of the organization identified as sensitive and relevant to the purpose of certification;
- Declaration that no similar request for certification in accordance with Directive 2014/68/EU has been submitted to another Notified Body.
C&P S.r.l. will review the information received, asking the company if necessary to supplement it and formulate a service proposal/offer that will be sent together with the regulations for the provision of services to the company, (in this case to the person in reference identified in his request for proposal).
The company must re-send a copy of the offer and all the attached documentation, signed for acceptance to the following e-mail address: amministrazione@cpinspection.com.
The offer signed for acceptance by the Company Representative is considered, after review by C&P S.r.l. (offer + attached documentation signed for acceptance without modification) to all intents and purposes as a purchase order.
For the first certification cycle, which lasts 36 months, the process of planning and delivering certification services involves the definition of a verification/audit program that includes, as a minimum:
- Initial certification audit divided into two phases (Stage 1 Stage 2).
- Periodic surveillance audits at least once a year (for the “Quality Modules” aimed at assessing the conformity of pressure equipment classified in III IV for the first three years of certification, 2 surveillance audits must be completed during the first year).
The subsequent certification cycles, also lasting 36 months, the process of planning and delivering certification services involves the definition of an audit program that includes, as a minimum:
- Certification renewal audit to be carried out before the expiry of the certification (specific service contract must be confirmed before the renewal audit is performed).
The duration of the audits is determined in accordance with the procedures of C&P S.r.l. and the relevant legislation:
- IAF MD 05 “Determination of Audit time of Quality, Environmental, and Occupational Health Safety Management Systems”, IAF MD 01 “IAF Mandatory Document for the Audit and Certification of a Management System Operated by a Multi-site Organization”;
- Accredia Technical Regulations;
- Based on the size and number of locations of the client’s organization/client and the complexity of the activities and processes part of the QMS purpose/scope.
Further information can be found in our document DOC 035N “Regulations for the provision of services”, we also remain at your disposal for any clarification.