They mainly affect the CE marking of pressure equipment D 2014/68/UE.
ENAC has published in October 2022 the evaluation procedure “Notified Bodies: accreditation requirements” CGA-ENAC-OCP Rev. 9 Series 13. The most substantial changes are found in the qualification of welders (WPQ) and in the qualification of welders. welding procedures (WPQR).
The most important changes refer to the need for companies that qualify welders to be certified in accordance with ISO 17024 and that companies that standardize procedures must be accredited in accordance with ISO 17020.
The term that ENAC has given to carry out the adaptation has expired in April 2023, so we can affirm that, if an organization issues approvals and has not adapted to these changes, the qualifications issued would not be valid.
On the other hand, dated 1/11/2023, UNE has updated the UNE-EN ISO 9712:2023 standard “Non-destructive tests. Qualification and certification of personnel who carry out non-destructive tests” (ISO 9712:2021).
As the most relevant change, EN 9712 establishes the need, for D 2014/68/UE category III and IV pressure equipment, for non-destructive testing (NDT) inspectors to be qualified by notified bodies in accordance with UNE-EN ISO/IEC 17024:2012.
We manufacture pressure equipment with CE D 2014/68/UE marking. Does this update of the standard affect us?
ISO 9712, in its annex ZA, establishes that it is the responsibility of notified bodies to qualify END inspectors for CE Marking of category III and IV R.D. pressure equipment. 709/2015 (D 2014/68/UE). Therefore, it affects level 2 and level 3 test inspectors of:
For the CE Marking of pressure equipment Directive 2014/68/UE, ISO 17024 accreditation is also required for companies in charge of welding procedures (WPQ) and ISO 17020 for those that perform WPQR.
We are a laboratories that certify welders and welding procedures. How does it affect us?
As we have said before, it affects laboratories that work with manufacturers of pressure equipment with CE marking under Directive 2014/68/UE.
ISO 17024 is a standard that is responsible for defining the criteria and procedures for the certification of people.
ISO 17020 contains the requirements that inspection bodies have to meet if they wish to demonstrate that they have a management system, that they are technically competent and that they are capable of generating technically valid results.
It includes the requirements of the UNE-EN ISO 9001 standard and therefore if the inspection bodies meet the requirements of the ISO 17020 standard, they will act under a quality management system for their inspection activities that will also comply with the principles of the ISO 9001 standard.
We manufacture metal structures with CE marking. Do these regulatory changes affect us?
The regulatory changes outlined do not affect manufacturers of metal structures EN 1090-1:2009+A1:2011. However, it is common for regulatory variations to occur continuously (eg UNE-EN ISO 3834). It is essential to update the protocols and systematics of the Factory Production Control System (SCPF).
Regulatory outdatedness generates various problems:
We provide solutions
At OAK, we have extensive experience with companies that are dedicated to producing pressure equipment under Directive 2014/68/UE. We develop the entire documentary base of the project, training for the implementation, follow-up and monitoring of the project, carrying out internal audits and support in periodic regulatory inspections.
Our work, in companies that require CE Marking, is the design and development of the SCPF in accordance with the applicable standards (eg EN 3834-2, UNE-EN 508-1:2022, UNE-EN 14782:2006, …) . Our experience and knowledge of the EN 1090-1, EN 1090-2 and EN 1090-3 standards give us a great advantage in this phase of the project.
OAK works in the field of CE Marking UNE-EN 1090-1 and R.D. 709/2015 (D 2014/68/UE) since 2012, years before it became mandatory. We are one of the few engineering firms in Spain with a technical area specialized in CE Marking and that works throughout the peninsula.
Since 2002 our Firm develops projects in the construction sector. Currently, we are one of the leading engineering firms in the application of industry standards in accordance with Regulation (UE) 305/2011 and D 2014/68/UE.