Posted by Mike Brown on 27-Apr-2017 08:30:00

What's the Notified Body's role under the Pressure Equipment Directive

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Under Article 10 of the Pressure Equipment Directive (PED 2014/68/EU), “before placing pressure equipment on the market, the manufacturer shall subject each item of equipment to one of the conformity assessment procedures described in Annex III”.

With the exception of “Module A – Internal Production Control”, all of the conformity assessment modules require involvement of a Notified Body. In the UK these are approved by BEIS (Department for Business, Energy and Industrial Strategy), which are based on UKAS audits (United Kingdom Accreditation Service).

Notified Bodies only help organisations achieve compliance with the directive and confirm this has been achieved; the organisation must CE mark equipment, put in place Quality Systems where required and undertake other tasks such as drawing up technical documentation and a Declaration(s) of Conformity.

The Notified Body’s involvement according to the conformity assessment module

The degree of the Notified Body’s involvement will depend on the conformity assessment module that is required and will also be determined by the hazard category level, whether quality systems are involved and whether an individual unit or series of units are being manufactured.

To find out which conformity assessment modules are available for your specific pressure equipment requirements in just a few easy steps, use our handy Pressure Equipment Calculator.

The Notified Body’s role for each conformity assessment module is listed below.

  • Module A - Internal Production Control: No involvement required.
  • Module A2 - Internal Production Control with Monitoring of Final Assessment: Final inspection and test (may be statistical)
  • Module B Design and Production - EU Type Examination: Examine documentation, design review, assessment of joining procedures and NDT, ensure ESRs have been met, and witness of manufacture
  • Module C2 – Monitoring of Final Assessment: Ensure Module B Type examination is in place and monitor final assessment (statistical basis)
  • Module D – QA for Production, Final Inspection & Testing, Module D1 – QA for Production, Final Inspection & Testing, Module E – QA for Final Inspection & Testing, and Module E1 – QA for Final Inspection & Testing*: Assess Quality System, annual surveillance (triennial reassessment), and assess proposed changes to Quality System

*Auditor must have pressure equipment experience

  • Module F – Product Verification: Assess Module B/B1, assessment of joining procedures and NDT, and examine and test each item (staged inspections)
  • Module G – Unit Verification: Assess design, assessment of joining procedures and NDT, and examine and test each item (staged inspections)
  • Module H – Full Quality Assurance*: Assess Quality System, annual surveillance (triennial reassessment), and assess proposed changes to Quality System

*Auditor must have pressure equipment experience

  • Module H 1– Full Quality Assurance: with Design Examination and Final Inspection and Test: Design approval and monitor final assessment, with increased surveillance

If you need to know the steps that manufacturer’s must follow for each conformity assessment module, use our Pressure Equipment Calculator.

How to find a suitable Notified Body

A manufacturer can use any accredited Notified Body established in a Member State to verify that they have achieved compliance with the Pressure Equipment Directive. You can use either UKAS’s search facility  or the European Commission’s Nando database. However, it is important to consider whether or not the Notified Body can assess all classes of products in addition to the specific product type if you wish to save time and effort in complying with numerous directives across your product range or for combination products.

British Engineering Services is a UKAS accredited Notified Body that sits on UK and international standards committees and bodies, with a team of technical consultants that have a wealth of experience and knowledge across many different disciplines. If you need help with Pressure Equipment Directive conformity then why not  speak to one of our experts and get a quote?

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Topics: PED

Mike Brown

Written by Mike Brown

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