PED Quality Modules — Directive 2014/68/EU

Directive 2014/68/EU establishes safety requirements for pressure equipment operating at maximum permissible pressure exceeding 0.5 bar. Manufacturers must adopt conformity assessment procedures based on equipment category classification (I through IV). Where serial production is involved, a Quality Module is typically more efficient than per-item examination.

How Quality Modules work

Manufacturers may demonstrate compliance through quality system evaluation using Quality Modules. As a Notified Body, we provide accredited assessment and certification services across the relevant modules.

ISO 9001 as foundation

A quality management system meeting ISO 9001 requirements can serve as the basis for directive compliance — provided certification is mandatory, the system demonstrates manufacturer compliance with directive requirements, and non-compliance results in corrective action requirements affecting market placement.

Module map

Module D1 — Category II applications. Module D — Categories III-IV (with design or production assessments). Module E1 — Category II applications. Module E — Category III (with production assessment). Module H — Category III applications. Module H1 — Category IV applications, with design examination.

Certification cycle

Initial 36-month cycles include two-stage initial audits and annual surveillance audits. Subsequent cycles require renewal audits before expiration. Audit duration follows IAF MD 05, IAF MD 01, Accredia Technical Regulations and organisational complexity factors.

What's included

• Modules D, D1, E, E1, H, H1
• Initial certification audit
• Annual surveillance audit programme
• Unannounced visits per current guidance
• Design examination (H1)
• Cross-mapping with ISO 9001 / 3834

Benefits to your organization

• Reduced per-item Notified Body cost on production runs
• Operational flexibility for serial manufacturers
• Single audit covers multiple product families