2021 08 16 Iec Conformity Assessment

Prof. Dr.
Thorsten IEC Academy Webinar

Arnhold 2021-08-16
Online
Harmonised Conformity Assessment, such as IEC:
More than just safety, makes economic sense
Life without Standardization – Example: movement of cargo
Pre 1960 Post 1960
2
IEC international Standards
• Represent the state of art with regard to safety and
functionality of electrical products
• Rules, guidelines or characteristics developed by
experts representing all stakeholders
• Based on international consensus
• Are a key factors for global business
3
Manufacturers: Standards are
blueprints for the safety structure
of the product design. They define
the appropriate tests.
Operators of industry plants:
Standards define safety requirements
Standards make products of different
manufactures comparable.
Regulators: Standards transform the
requirements of laws into detailed
guidelines and specifications for the
industry and public.
4
But, what happens if the
standards are not fulfilled?
5
Conformity assessment makes
standardization complete !
• Conformity assessment ensures that the standard
requirements are fulfilled not only for product
samples but for all products delivered to the
customer
• Due to mutual recognition of conformity assessment
results under the roof of IEC it is ensured that only
the necessary efforts and costs have to be covered
by the manufacturers!
Conformity assessment makes
standardization complete !
• Conformity assessment ensures that the standard
requirements are fulfilled not only for product
samples but for all products delivered to the
customer
• Due to mutual recognition of conformity assessment
results under the roof of IEC it is ensured that only
the necessary efforts and costs have to be covered
by the manufacturers!
Conformity Assessment ???
Individual Certification Marks ???
Simple Google search for “Electrical Certification Marks”, reveals:
9
Life without IEC Schemes – Non-IEC Schemes
each sets its own rules and requirements
Separate set of Rules and Agreements for each
certification Scheme
Separate set of requirements for applicants
seeking testing and certification to follow, usually
not consistent
Separate set of Operating Procedures for their
individual CB or TL to follow
Own style and format of reporting and
certificates – Is the message conveyed
understood and consistent and accepted by
others, eg “Mutual Recognition”? 10
Result: REPEAT TESTING + CERTIFICATION- WASTEFUL

DUPLICATION OF EFFORT THAT SOMEBODY HAS TO PAY
FOR, usually the customer
4 Reasons for Conformity assessment
Manufacturers/suppliers
need to assure that their 1. Safety
marketed products are
compliant with relevant
safety standards,
while governments
establish regulations
generally intended to
protect the population
against potential risks
associated with the Satory.pro
products.
Buyers/Wholesalers want 2. Quality

to ensure the quality of
purchased products and
unhindered market
access.
Manufacturers/supplier
need a neutral testimony
of the product quality.
3. Interoperability
Product manufacturers
and end users want
assurance that their
products are fit for
purpose and can interact
in harmony with other
products, services and
installations comprising Ärzte Zeitung
an overall operational
environment.
4. Consistency
Manufacturers/Suppl
iers want to ensure
that their marketed
products are
compliant with the
sample assessed.
sn.at
Conformity assessment provides tangible benefits for
the different stakeholders
It helps to reduce trade Governments
barriers caused by different
certification criteria in
various countries.
It helps countries to
meet their obligations
as stipulated in the
WTO agreement on
Technical Barriers on
Trade.
CA covers regulated and
non regulated areas
It reduces delays and Industries
costs of multiple testing
and approvals since a
product can be certified
once by a single
certification body.
Certification can than
be accepted by others
all over the world.
Broader Market access
for less time and costs!
Conformity assessment End customers
provides assurance that
the goods being
purchased will perform
to expectations and are
reasonably safe.
(People are relaying daily

on products whose
design and construction Trust building by CA
they do not understand.)
Who does Conformity Assessment ?
IEC & the Certification bodies
• IEC is providing the infrastructure of CA
− Rules, procedures, operational documents
according to the ISO 17000 series of
standards
− Standard formats and templates
− Secretary organizations for daily operations
− Homepage as the knowledge platform
− Online database, training, marketing…..
• On the basis of this infrastructure the CBs and
Test Labourites (TLs) are doing the conformity
assessment within their scopes in their own
responsibility and bills
How to become a CB/TL?
The Peer to Peer principle
• The principle is defined in ISO 17040
• A candidate CB/TL is audited by assessors
from the respective CA – system
• Assessors are dedicated experts who
come from other CBs driven by the
common interest to keep the quality level
of the CA organization appropriately high
• Once accepted the CB/TL can operate
according to the CA rules an procedures
• Re – qualification every 5 years
Who is bearing the risk of CA?
• Every member country of a
CA – System is
represented by either its
NC or a selected Member
Body MB
• By the IEC/CA rules these
organizations are
requested to take all
possible steps to exclude
any liability from falling on
the CA systems MC or IEC.
• Preferred means to
achieve this are contracts.
Quelle:IEC
How are the IEC CA systems
financed?
• Financing of the CA
systems is based on
− Membership fees
− Certificate fees
− Assessment fees
• Financial risks are
covered by piling up a
3 year financial reserve
IEC CA systems are financing their operations

completely by them self and are covering all
financial risks
IEC Structure – Conformity Assessment
Conformity
Assessment
Board (CAB)
IECEE
Conformity Assessment
IECEx
IECQ
Systems
IECRE
CA Management Committee
Important elements of a CA system
Testing Laboratory (TL):
Directly or indirectly linked to a ExCB
Carries out Type test
Issues Test reports
Certification Body (CB):

Issues IEC CA Certificates
Issues Quality Assessment Reports
Endorses IEC Test Reports
IECEx – Assessor
Assessment of CBs
Assessment of TLs
Basis is ISO/IEC 17065
(former ISO/IEC Guide 65)
26
IECEE – The CB System
Multilateral certification
system based on IEC
standards.
Its members use the
principle of mutual
recognition (recipro-
cal acceptance) of
test results to obtain
certification or appro-
val at national levels
around the world.
23 Categories
covered
Special programs for
• Industrial
automation
• Cyber security
• Energy efficiency
• Electrical Vehicles
• Global Motor
Energy efficiency
IECEx products & services for
hazardous areas
IECEx Equipment
IECEx EquipmentScheme
Scheme
Certification ofofEx
Certification ExEquipment
Equipment
IECEx Conformity Mark License

Scheme
IECEx Services Scheme

Certification of Ex Service Providers, eg
Repair and overhaul workshops + Install.
IECEx Certified Persons

Scheme (CoPC)
Competency to work in Ex field (New)
IECEx Competency scheme
IECEx Competency scheme
Appropriate Mix of Ex CB examines: IECEx Cerified Person
Competences to be
certified
Knowledge
Skills
Experience
Surveillance – Re Assessment
IECQ: CA in Supply chains
World wide approval
and certification
system, covering the
supply of electronic
components,
associated materials,
assemblies and
processes.
Ihlemann.de
IECQ is about
assurance and cost
cutting.
To minimize incoming
inspection costs and
eliminating the quality amsde.com
auditing of suppliers.
Three main schemes:
• Approved Process
• Approved Component
• Independent Testing Lab.
Special Programs
• Hazardous Substances Process Management
• Automotive Qualification Program
• others
IECRE Renewable Energies
• Reliability depends on integrated system design
of many components
• Each individual component contributes to the
successful interaction of the system:
• Wind: Blades, bearings, gearboxes, generators,
towers, foundations, controllers, etc.)
• PV: Panels, actuators, support structures,
inverters, cables
• Marine: Wave/current/tidal energy converters
36
A RE power plant is just like any power plant,
a complex system…
• “RE systems” are assembled from many Wind power plant
large and small components, which all

have to work harmoniously to
produce reliable energy
• Depending on technology:
PV power plant
Blades, gears, towers, panels, cables,

controllers, etc.
• Requires field assembly, commissioning Marine power
plant
and O&M
• Interconnection compliance
• Every turnkey system is a unique field
installation
37
…however, unlike conventional power plants,
RE power plants face unique exposures
• Components and systems cannot be tested to design specifications
(specific to wind applications)
• Power driving components are immediately exposed to the environment
• The “energy sources” are not continuously available 24/7
• The variables of the power sources vary constantly, and with this, loads
and degradation
• Min. 20 years design life may result in challenges given the direct
environmental exposure to power generation devices
• Each installation is unique as it must fit the particular geology and
geography of its location, and in addition, the design criteria need to
meet demand (one size does not fit all!)
• Assessment must depend on design analysis and model validation
through testing
• Turn key system reliability and performance depend on upstream
38 component certifications AND installation / maintenance quality
Finally:
• How can standardization
support the CA – Systems?
CA friendly standardization
IEC Standards should
• Unambiguous technical requirements

• Clear & unambiguous test methods
→ this is the limit of CA in IEC Standards
• Be written for widest possible use
→ neutrality principle
• Not conflict with national laws
→ neutrality principle
→ generic application to laws/regulations
→ no references to specific QMS
• Be usable over time (as laws change)
→ generic application to laws/regulations
The Directives
ISO/IEC Directives Part 2 Clause 33.1
says…
All documents containing requirements for
products, processes, services, persons,
systems and bodies shall be written in
accordance with the "neutrality principle",
such that conformity can be assessed by a
manufacturer or supplier (first party), a user
or purchaser (second party), or an
independent body (third party).
The Directives
says…
Such documents shall not include
requirements related to conformity
assessment other than requirements which
are necessary to provide repeatable and
reproducible conformity assessment results.
The Directives
says…
No document containing requirements for
products, processes, services, persons,
systems and bodies shall make conformity
dependent on a quality management
systems standard, i.e. it shall not, for
example, make normative reference to ISO
9001.
Prof. Dr. Thorsten IEC Academy Webinar
Arnhold 2021-08-16
Online

2021 08 16 Iec Conformity Assessment

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Prof. Dr.

Thorsten IEC Academy Webinar

Life without Standardization – Example: movement of cargo

Pre 1960 Post 1960

Simple Google search for “Electrical Certification Marks”, reveals:

Result: REPEAT TESTING + CERTIFICATION- WASTEFUL

Buyers/Wholesalers want 2. Quality

(People are relaying daily

IEC CA systems are financing their operations

Certification Body (CB):

IECEx Conformity Mark License

IECEx Services Scheme

IECEx Certified Persons

large and small components, which all

Blades, gears, towers, panels, cables,

• Unambiguous technical requirements

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