david hanlon - iec.ch · qm products module f product verification controls or routine test module...
TRANSCRIPT
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
David Hanlon IEC Secretary of the
Conformity Assessment Board
IEC Academy
Webinar
2018-03-13
www.iec.ch/standardsdev/resources/
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CA is assessing conformity
Basics What is CA ?
to something,
in our case IEC Standards
Standards and CA
are like two sides of a coin…
…neither side has value
without the other side
Standards + CA = Value
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certification bodies, etc
Who does CA ?
Basics
manufacturers/suppliers
end-users/customers
professional testing, inspection,
1st Party CA
2nd Party CA
3rd Party CA Independent
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Why do CA ?
Basics
end-users/customers
for assurance when providing
to ensure appropriate product development
to justify SDoC claims such as the CE marking
warranties/guaranties
material/products/equipment
quality control to check in coming
for risk management/sharing
at the request of suppliers/manufacturers to show compliance with regulations for marketing purposes
manufacturers/suppliers
certification bodies, etc
professional testing, inspection,
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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).
ISO/IEC Directives Part 2 Clause 33.1
says…
The Directives
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Standards are the basis for
designing & developing
products, processes, services, etc.
Manufacturers & suppliers then make
declarations
that their products, processes, services, etc,
are in conformity with the standards.
The story Manufacturer’s perspective
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Product
Standard
Signature
Declaration of Conformity
according to ISO/IEC 17050-1
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on a voluntary basis,
eg: as a part of a marketing strategy
eg: required by customers
The story
Why do manufacturers make
SELF-declarations of conformity ?
• Laws & regulations
• Market requirements
• Self-interest
Manufacturer’s perspective
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The story
Why do manufacturers get their
products CERTIFIED ?
Manufacturer’s perspective
on a voluntary basis,
eg: as a part of a marketing strategy
eg: required by customers • Market requirements
• Self-interest
• Laws & regulations
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The Directives
ISO/IEC Directives Part 2 Clause 33.1
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.
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• Flexibility of use neutrality principle
generic application to laws/regulations
The story Manufacturer’s perspective
Fundamental need
from standards
• Unambiguous technical requirements
• Clear & unambiguous test methods this is the limit of CA in IEC standards
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Standards are the basis for the
national requirements
that provide access to their markets.
Manufacturers & suppliers must
demonstrate compliance
that their products, processes, services, etc,
respect the national requirements.
The story National requirements perspective
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The story National requirements perspective
Requirements vary greatly
between countries • Product type / usage / risk
• Type of schemes
• Regulated aspects
• Need for a national marking or mark/label
• Need for a certification/approval license
1st Party, 3rd Party or governmental
self-declaration vs certification/approval
electrical safety, EMC, telecom, environmental, etc
whether self-declared marking or from a third party
subject to ongoing validity & associated fees
(1/2)
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(1/2)
The story National requirements perspective
Requirements vary greatly
between countries • Need for test sample to target countries
• Need for translations in local language
• Need for factory visits
• Choice of certification / approval body
• Need for in-country applicant, agent or legal entity
foreign test results not recognized
can have positive or negative effects
in-country assistance can be valuable
can be justified in limited situations
lower cost & time to market lower prices & greater choice for consumers
(2/2)
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Module A
Internal
control of
production
by
manufacturer
Module B
EU Type Examination
by
Notified Body
Module C
Conformity
to type
Internal
control of
production
by
manufacturer
Module D
QM-System
Production
by
Notified Body
Module E
QM products
by
Notified Body
Module F
Product
verification
Statistic
controls or
routine test
by
Notified Body
Module G
Unit
verification
Not suitable
for mass
production
by
Notified Body
Module H
Full quality
assurance
system
by
Notified Body
Europe Role of standards for declaration of conformity
supplier’s declaration presumption of conformity market surveillance verification
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Korea
• Products must be safe
• 11 classes with sub-categories Including, cords & cables, switches, household
appliances, power transformers, power tools, audio &
videos equipment, IT equipment, lighting, and so on.
• 3 levels of CA according to risk Safety certification
for high risk items Type 5 certification
Role of standards for KC safety scheme
Safety confirmation
for medium risk items Type 1 certification
Supplier`s confirmation of conformity (S-CoC)
for low risk items
• KC Mark national Mark
Example: Safety of electrical products
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North America
US Certification Marks
Canadian Certification Marks
Dual Country Certification Marks
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Australia
• Products must be safe
• 56 classes of declared electrical articles Typically found in residential homes,
such as dishwashers, hairdryers, room heaters,
refrigerators, and so on.
• Declared articles Require proof of compliance
through 3rd Party Certification
• Non-declared articles Require proof of compliance
through 1st Party SDoC
Role of standards for declaration of conformity Example: Safety of electrical products
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Need for Product Certification/Approval
• Europe Stable, except new East EU members. Reduced need.
• EurAsia Unstable. Possibly reduced need.
• Asia Regulations increasing in some countries, liberalising in others.
Mostly increasing need.
• North America Multiple regulation layers. Stable need.
• Oceania Regulation much like Europe. Stable need.
• Latin America, Middle East & Africa Regulations in more countries. Increasing need.
Worldwide trends
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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.
The Directives
ISO/IEC Directives Part 2 Clause 33.1
says…
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The story
Fundamental need
from standards
National requirements perspective
• Unambiguous technical requirements
• Flexibility of use neutrality principle
generic application to laws/regulations
• Should not conflict with national laws
no references to specific QMS
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www.iec.ch/standardsdev/resources/
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The Brochure
Use of this terminology is cautioned !!
Clause 3 – Checklist
Accredit, accredited, accreditation
Approval
Approving authority
Assessment
Audit
Calibration
Certificate, certification, certify, certified, certifying
Comply, compliant, compliance
Conform, conformity, conformance
Declaration
Designation, designating authority
This is a non-exhaustive list.
Evaluation
Inspection
ISO/IEC 17...
Quality
Qualification
Registration
Surveillance
Type test
Validation
Verification
Neutral, neutral party, neutral body
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Take-away
• Unambiguous technical requirements
neutrality principle
generic application to laws/regulations
• Not conflict with national laws
no references to specific QMS
IEC Standards should
• Clear & unambiguous test methods this is the limit of CA in IEC Standards
• Be written for widest possible use neutrality principle
• Be usable over time (as laws change) generic application to laws/regulations
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INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
David Hanlon IEC Secretary of the
Conformity Assessment Board
IEC Academy
Webinar
2018-03-13