Notified Body Pressure Equipment Audit checklist

Directive and ADR/RID/TPED

Pressure Equipment Directive
TÜV SÜD Industrie Service GmbH
– Pressure equipment manufacturer –
Dok.: Rev. 5, 19.07.16

Manufacturer:

Module:

Certification audit - date:

1st Surveillance Audit - date:

2nd Surveillance audit - date:

Auditor(s) Certification audit:

Signature auditor(s)
Auditor(s) 1st Surveillance
audit
Signature auditor(s)
Auditor(s) 2nd Surveillance
audit
Signature auditor(s)

This audit questionnaire is a practical implementation and basis for a quality system audit per the
requirements of the Pressure Equipment Directive 2014/68/EU.
This is intended to be a mixture of checklist and audit notes.

During the certification audit or re-certification audit all applicable sections of the audit questionlist need to be
addressed.
During surveillance audits only certain aspects may be audited.
Within 3 years a full evaluation of the quality system needs to be achieved.
The cover page of the audit questionnaire needs to be filled out and signed by the auditor.

Review of quality system documentation:

Document, section, page, as applicable need to be recorded in the column „quality system documentation“

During the on-site audit

The applicable questions have to be answered as follows:
 1 = fulfiled
 2 = minor nonconformity (non-critical nonconformity, corrective actions will be verified during next on-site
audit)
 3 = nonconformity (re-audit on-site or submittal of additional documentation to be set date are necessary)
Randomly check documents and records as well as product-, object- or gage-numbers may be recorderd in the
column „audit notes“. A process oriented audit approach is to be preferred.

Notes need to be legible to enable others to review and evaluate.

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Notified Body Pressure Equipment Audit checklist
Directive and ADR/RID/TPED
Pressure Equipment Directive
TÜV SÜD Industrie Service GmbH
– Pressure equipment manufacturer –
Dok.: Rev. 5, 19.07.16

Nr. n/a Quality system E Audit notes E

Questions to the quality system * document

1 general information about the

company:
1.1 Quality manual, revision:
1.2 Registered by (ISO 9001):
1.3 Org.-chart, revision:

1.4 Contact for Notified Body:

1.5 Management / quality representative:
1.6 Number of employees:
Total: for PED:
1.7 Number of sites:

1.8 Requirements for welding / permanent

joining of metallic materials per EN
ISO 3834-3 oder -2

Information about the product:

Products to be covered by PED
approval:

1.9 Hazard category:

1.10 Fluid group:

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Notified Body Pressure Equipment Audit checklist
Directive and ADR/RID/TPED
Pressure Equipment Directive
TÜV SÜD Industrie Service GmbH
– Pressure equipment manufacturer –
Dok.: Rev. 5, 19.07.16

Nr. n/a Quality system E Audit notes E

Questions to the quality system * document

2 Changes since the last audit:

2.1 organizational:

2.2 manufacturing (new equipment, new

processese, etc.):
2.3 number of pressure equipment
manufactured:
2.4 new customers:
2.5 business situation

2.6 customer complaints

3 implementation of corrective
actions since the last audit:
3.1 have the non-conformances from the
last audit been corrected and
respective corrective action effectively
implemented?

4 Management responsibility
4.1 Internal communication
4.2 Commitment to fulfill the requirements
of the PED
4.3 Resource management, e.g.
regarding equipment, personnel

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Notified Body Pressure Equipment Audit checklist
Directive and ADR/RID/TPED
Pressure Equipment Directive
TÜV SÜD Industrie Service GmbH
– Pressure equipment manufacturer –
Dok.: Rev. 5, 19.07.16

Nr. n/a Quality system E Audit notes E

Questions to the quality system * document

5 Management responsibility
5.1 Management review from:
5.2 Customer satisfaction:
5.3 Process effectiveness and product
conformity:
5.4 Status of corrective and preventive
actions:
5.5 actions from former reviews:
5.6 changes to the quality system:
5.7 quality goals:

5.8 pressure equipment manufactured

and conformity assessment procedure
applied

6 Approvas per PED Annex I,

sections 3.1.2, 3.1.3
6.1 Personnel approvals for permanent
joining:
6.2 Procedure approvals for permanent
joining:
6.3 Weld samples during production:
6.4 Approvals for NDT personnel:

7 Internal Audits
7.1 Internal Audits (plan/exectution)
8 Marking and labeling per PED
annex I, Section 3.3:
8.1 Proper -marking
8.2 Information about the manufacturer
(Name and Address)
8.3 Year of manufacture
8.4 Series or batch identification or serial
number

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Notified Body Pressure Equipment Audit checklist
Directive and ADR/RID/TPED
Pressure Equipment Directive
TÜV SÜD Industrie Service GmbH
– Pressure equipment manufacturer –
Dok.: Rev. 5, 19.07.16

Nr. n/a Quality system E Audit notes E

Questions to the quality system * document

8.5 Essential maximum/minimum

allowable limits:
8.6 Additional information / marking (as
applicable):
Volume of the pressure equipment in
L
Nominal size for piping DN
Test pressure PT applied in bar and
date
Safety device set pressure in bar
Output of the pressure equipment in
kW
Supply voltage in V (volts)
Filling ratio kg/l
Maximum filling mass in kg
Tare mass in kg
Fluid group
warnings

9 Traceability
9.1 Material identification:
9.2 Welds:
9.3 Filler materials:

10 Procurement
10.1 Materials according PED Annex I,
section 4
10.2 Procurement specification:

10.3 Material certificates per EN 10204:

10.4 Material manufacturer certification

10.5 Supplier evaluation and monitoring

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Notified Body Pressure Equipment Audit checklist
Directive and ADR/RID/TPED
Pressure Equipment Directive
TÜV SÜD Industrie Service GmbH
– Pressure equipment manufacturer –
Dok.: Rev. 5, 19.07.16

Nr. n/a Quality system E Audit notes E

Questions to the quality system * document

10.6 Specifications, e.g. AD 2000, ASME

10.7 Receiving inspection performed?

11 Design

11.1 Specifcation / standards applied:

11.2 Standards applied available?

11.3 Design method: calculation or

experimental

11.4 Consideration of the operating

conditions like internal/external
pressure, temperature, hydrostatic
pressure, fill weight, environmental
loads (wind, snow,...), corrosion,
erosion, fatigue / creep..

11.5 example:

hazard analysis

applied harmonized standards

drawing nos.

Serial-no.

Calculation software used

Categorization of the pressure

equipment

Release of design drawings (checks,

reviews, 4-eyes-principle) (Module
H/H1)

Information for the design calculation for

sufficient strength considering e.g.

Loads on piping

Proof of stability

Cyclic loading

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Notified Body Pressure Equipment Audit checklist
Directive and ADR/RID/TPED
Pressure Equipment Directive
TÜV SÜD Industrie Service GmbH
– Pressure equipment manufacturer –
Dok.: Rev. 5, 19.07.16

Nr. n/a Quality system E Audit notes E

Questions to the quality system * document

Test and inspection plan available

Test pressure PT according Annex I

Section 7.4

Operating conditions sufficiently

described

Joint efficiency

Welding information on design drawings

sufficient

11.6 Design review / examination performed

through Notified Body for Category IV
pressure equipment (Module H1)

12 Manufacturing
12.1 Processes and techniques applied in
manfacturing to ensure that pressure
equipment is manufactured according to
the design documentation
12.2 Heat treatment?
12.3 Repair procedure?
13 Inspection
13.1 Final inspection (visual und document /
record control) performed on all
pressure equipment
13.2 Proof test performed on all pressure
equipment (exception: series-produced
pressure equipment in category I)
13.3 Inspection of safety devices
(for pressure assemblies)
13.4 Monitoring and measuring equipment

13.5 work instructions / test plans available?

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Notified Body Pressure Equipment Audit checklist
Directive and ADR/RID/TPED
Pressure Equipment Directive
TÜV SÜD Industrie Service GmbH
– Pressure equipment manufacturer –
Dok.: Rev. 5, 19.07.16

Nr. n/a Quality system E Audit notes E

Questions to the quality system * document

14 Document control
14.1 Document / record retention
14.2 Document and record retention in years

15 Documentation accompanying the

pressure equipment

15.1 Declaration of Conformity (sample)

15.2 Operating instruction:….including

mounting, putting into service, use and
maintenance including checks by the
user

16 Interface manufacturer – notified

body
16.1 Communication of changes - planned
and executed - to the quality system

16.2 How is communication defined?

17 Module D
17.1 Valid approval for module B (EU-type
examination – production type)

17.2 Valid approval for module B (EU-type

examination – design type)

18 Unexpected Visits
18.1 Number of unexpected visits performed
18.2 Number of unexpected visits to be
performed

19 Next Audit
19.1 Next audit date (consider validity of
current certificate)

20 Issuance of Certificate

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Notified Body Pressure Equipment Audit checklist
Directive and ADR/RID/TPED
Pressure Equipment Directive
TÜV SÜD Industrie Service GmbH
– Pressure equipment manufacturer –
Dok.: Rev. 5, 19.07.16

Nr. n/a Quality system E Audit notes E

Questions to the quality system * document

20.1 Sample according to order form

20.2 Scope verification
20.3 Manufacturer information – changes?

21 Supervision of the market

21.1 where documented who supplied
pressure equipment? (Art. 11)
21.2 where documented to whom pressure
equipment was supplied to? (Art. 11)
21.3 Process in place to remain in conformity
with the Directive if there are changes
in design or characteristics of the
pressure equipment or if there are
changes in the harmonized standards
or in other technical specifications ?
(Art. 6, chapt. 4)
21.4 Process in place for what will be done,
if pressure equipment does not meet
the requirements of the PED. E.g.
recall, communication with national
authorities? (Art. 6, chapt. 8)
21.5 Process in place for providing technical
documentation to authorities upon
request? Language? (Art. 6, chapt. 9)
22 Open points / action items

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