Overview of Conformity Assessment

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Overview of Conformity Assessment

• Erin Grossi
• Manager, International Affairs
• Underwriters Laboratories

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Highlights

• Characteristics of the US Conformity Assessment
  System
• Conformity Assessment Processes
• Impact of Conformity Assessment on Trade
• Hints for Success in Getting Products
  Accepted/Approved for Global Markets

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Conformity Assessment Defined

• any activity concerned with determining
  directly or indirectly that relevant requirements
  are fulfilled
• ISO/IEC Guide 2

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Evolving Definition of Safety
The Safety Equation
Health/ Environment


Fire
Shock

Casualty
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Conformity Assessment Demand Drivers

• Government (Market Access)
• through regulation
• at the federal, state, and local levels
• reflects societal needs
• Market (Market Acceptance)
• demand from consumers, retailers, distributors,
  insurers, commercial purchasers
• reflects the needs of the market

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A Public-Private Partnership
Government Regulatory Agencies
Manufacturers
Retailers/Distributors
Consumers
Insurance Providers
Standards and Certification Organizations
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Conformity Assessment Mechanisms

• Product Certification basic components
• investigation includes testing, comparing them
  to requirements, and determining compliance
• surveillance includes among other things,
  unannounced and frequent product inspections,
  witnessing of production

Suppliers Declaration of Conformity (SDoC)
Compliance is self-declared by entity
responsible for the product
Testing conduct specified tests and deliver test
results and methods
Commercial Inspection and Testing determine if
products meet a purchasers/procurement
specifications typically useful if a full
quality system is not in place or does not cover
key aspects of the product, or if confidence
needs of purchaser require inspection in addition
to quality management systems
Quality System Registration incorporates a review
of the procedure, an on-site assessment of the
implementation of the procedure, and audits to
verify continued implementation and to identify
areas that could be improved
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Designing Conformity Assessment Systems
The system should reflect the product specific
characteristics, the level of risk reduction
sought, and the resources available for
conformity assessment.
Certification 3rd party conformity assessment
Suppliers Declaration 1st party conformity
assessment
Perceived Risk
Independence and Rigor of Conformity Assessment
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Factors in CA System Design?

• The risks associated with non-compliance
• should be proportional to the rigor
• and independence of the CA system.
• System over-design will add too much cost.
• System Under-design will result in too little
  confidence of compliance.
• Penalties associated with non-compliance may
  reduce the needed rigor and independence of the
  conformity assessment system.
• Timely mechanisms that effectively remove
  non-compliant products from the market may also
  reduce the needed rigor and independence of the
  system.

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Ensuring Competence of Providers
Accreditation The procedure by which an
authoritative body gives formal recognition that
a body or person is competent to carry out
specific tasks

• Used to assess and ensure/enhance ongoing
  conformity assessment body and program for
  competence, management and technical
  requirements.
• Used to attain needed confidence in testing
  operation and results.
• Used to attain needed confidence in certification
  or registration system.

UL maintains over 200 accreditations.
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US Conformity Assessment System
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US Safety System
Installation Codes

Standards, Regulation and Certification
Inspection and Enforcement
Safe Products and Safe Installations
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US Product Safety System

• Characteristics of the US system include
• highly decentralized
• a mix of private sector (market-based) and
  government regulations
• elements of market access and market acceptance
  needs
• approaches vary by sector (including by Federal
  Agency)
• State and local regulators enforce local codes in
  parallel to federal regulation

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Federal Regulatory System (1)

• Regulation often based on locale of use
• CPSC homes, schools, places of enjoyment
• OSHA workplace
• Regulatory agencies trend toward accreditation of
  private sector laboratories and certifiers
• OSHA NRTL
• FDA Accredited Persons Program (medical)
• FCC TCB for telecom equipment

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Federal Regulatory System (2)

• Several federal agencies mandate product
  conformity, including
• Federal Communications Commission (FCC)
• Food and Drug Administration (FDA)
• Occupational Safety and Health Administration
  (OSHA)
• Consumer Product Safety Commission (CPSC)
• The U.S. Code of Federal Regulations (CFR)
  contains specific federal regulations
• National Technology Transfer Advancement Act
  (NTTAA) encourages reliance on private sector
  conformity assessment activities including
  accreditation to reduce duplication and
  complexity

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Consumer Product Safety Commission (CPSC)
The US Consumer Product Safety Commission (CPSC)
is charged with protecting the public from
unreasonable risks of serious injury or death
from more than 15,000 types of consumer products
under the agency's jurisdiction. The CPSC is
committed to protecting consumers and families
from products that pose a fire, electrical,
chemical, or mechanical hazard or can injure
children. (www.cpsc.gov)
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CPSC

• Publishes comprehensive accident data on consumer
  products and issues recalls for unsafe consumer
  products
• Adopts voluntary product safety standards into
  regulations
• Issues mandatory federal regulations when
  voluntary standards do not exist or are
  inadequate
• Participates in private standards development
  organization activities

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CPSC UL Parallels
UL Private Sector
CPSC Public Sector
Standards Development Product Testing/
Certification Public Education Campaigns Internati
onal Outreach Field Inspections/ Market
Surveillance Public Notices
Technical Regulations Product Testing
(Research) Public Education Campaigns Internationa
l Outreach Field Inspections/ Compliance Product
Recalls
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Occupational Safety Health Administration (OSHA)

• Occupational Safety Health Administration
• US Government agency US Department of Labor
• Products used in the American workplace
• Program regulations are in 29 CFR 1910.7

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OSHA
OSHA's mission is to assure the safety and health
of America's workers by setting and enforcing
standards providing training, outreach, and
education establishing partnerships and
encouraging continual improvement in workplace
safety and health.
www.osha.gov
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OSHAs Jurisdiction

• Typical Office Settings
• Petroleum Refineries
• Aircraft Hangars
• Textile Mills
• Grain Elevators
• Factories
• Utility Gas Plants

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What is OSHAs Nationally Recognized Testing
Laboratory Recognition Program?

• The NRTL Program
• In 1988, OSHA established the NRTL Program
• 18 Laboratories in 54 locations
• Foreign-based NRTLs (e.g., CSA, TUV)
• Objective
• Seeks to prevent accidents through assuring the
  safety of products
• Recognizes Certification Bodies to test and
  certify products for workplace safety

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Products Requiring NRTL Approval

• Electrical conductors equipment
• Automatic sprinkler systems
• Mechanical ventilation systems
• Employee alarm systems
• LPG consuming appliances
• Elevators and Escalators
• Automatic shut-off devices
• X-Ray Equipment

A complete list of all 37 product categories is
available on the OSHA website at www.osha.gov
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Basic NRTL Product Certification Process

• NRTL tests products to verify conformance to the
  standards contained in its NRTL scope (standards
  that OSHA has deemed appropriate for products
  used in the workplace).
• If the product complies with the relevant
  standards, NRTL lists the product and allows the
  manufacturer to apply its Mark to the product.
• NRTL conducts follow-up surveillance assessments
  both at the manufacturers location and in the
  marketplace to ensure ongoing compliance.

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ANSIs Roles and Responsibilities

• to accredit U.S. Technical Advisory Groups and
  Conformity Assessment programs
• to ensure integrity of the U.S. voluntary
  consensus standards system
• to provide regional and international access
• to offer a neutral policy forum
• to accredit certification programs

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ANSI Accreditation Programs
Conformity Assessment (ISO/IEC 17011)
Standards
ISO/IEC Guide 65
ISO/IEC Guides 62 and 66
ISO/IEC17024
ANSI Procedures Essential Requirements
PersonnelCertifiers
ProductCertifiers
Standards Developing Organizations and U.S. TAGs
ISO 9001 / 14001Certifiers




Diagram courtesy of ANSI
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Overview / History

• ANSI Program issued first accreditation in 1972
• ISO/IEC Guide 65 accreditation criteria
• Accreditation of Telecom Certification Bodies
  started in the year 2000 (FCC-linked)
• Recognized by NIST/NVCASE since June 2000 to
  accredited TCBs
• Recognized by NIST/NVCASE since October 2003 to
  Accredited TCBs in accordance with Industry
  Canada Requirements under APEC TEL MRA

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ANSI Accreditation Process

• Preliminary Letter of Application
• Application
• Preparation for Assessment
• Initial Assessment
• Assessment Report
• Accreditation Committee Renders Decision
• 2-year cycle -- Surveillance Reassessment

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US Laboratory Accreditation History

• Sector-specific programs go back 60 years
• National programs started in the 1970s
• NVLAP, 1976
• A2LA, 1978
• NIST has identified
• Over 30 federal government programs
• Over 50 state and local government programs
• Over 20 professional/trade association programs

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Sector-based LaboratoryAccreditation Programs

• Government (all levels)
• environmental
• medical
• food safety
• animal health
• calibration
• construction materials
• firearms
• manure

• Private-sector
• automotive
• building materials
• environmental
• medical
• forensic science
• industrial hygiene
• steel construction
• solar equipment
• safety equipment
• kitchen cabinets

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Government Laboratory Accreditation Programs

• Serve specific regulatory needs for health,
  safety, and environmental issues
• Some agencies are beginning to recognize
  accreditation by others (e.g., NRC, DOD, HUD,
  DOE)
• Some agencies are considering how accreditation
  can be used to support their programs (e.g.,
  USDA, FDA)

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International Laboratory Accreditation System
ILAC International Laboratory Accreditation
Cooperation
Peak international Mutual Recognition Arrangement
(MRA) Relies on Regional Bodies to perform
evaluations
Regional bodies Evaluate ABs using ISO/IEC 17011
APLAC Asia Pacific Laboratory Accreditation
Cooperation
EA European cooperation for Accreditation
Assess labs using ISO/IEC 17025, additional
requirements, and test methods
Government or Industry Define additional
criteria for evaluating ABs and assessing
laboratories
Accreditation Bodies A2LA, IAS, NVLAP
Specifiers
Perform tests using test methods
Laboratories
Laboratory Users
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US Laboratory Accreditation System
NACLA National Cooperation for Laboratory
Accreditation
National Mutual Recognition Arrangement (MRA)
Evaluates ABs using ISO/IEC 17011
Not-NACLA recognized Accreditation Bodies The
100 others
Specifiers
Recognized Accreditation Bodies A2LA, AIHA, IAS,
LAB, PRI, NFSTC, NVLAP
Government or Industry Define additional
criteria for evaluating ABs and assessing
laboratories
Not approved no independent evidence that they
operate according to ISO/IEC 17011 may assess
labs to 17025 or other requirements
Laboratories
Laboratory Users
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Conformity Assessment Process
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Closed-Loop Conformity Assessment
Certification Decision
Testing
Declaration of Conformity
Ongoing Compliance
Corrective Action
On-site Factory Inspection
Market Surveillance
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US Electrical Product System

• Certification process has four primary steps
• Product evaluation and report phase
• Initial factory audit
• Authorization of certification agreement and
  continued follow-up inspections
• Re-evaluation of the product if the manufacturing
  process has changed

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Impact of Codes

• Code Requirements
• Drive demand for product testing/certification
• Drive demand for accreditation of organizations
  performing testing/certification
• Provide a minimum outline of the conformity
  assessment process

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Local Regulators

• Local regulators are required to
• Review Construction Plans
• Issue permits
• Conduct on-site inspections
• Verifies compliance to Code requirements
• To referenced standards
• Testing of product
• Product Certification

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Local Regulators

• Local regulators
• Are required to determine type of conformity
  assessment that is acceptable.
• Handle appeals
• Issue Certificate of Occupancy
• Conduct annual inspections

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Hints for Manufacturers

• Identify target markets early in design and
  development
• Identify and monitor regulations, standards and
  conformity assessment processes needed for market
  access and market acceptance
• If third party conformity assessment required or
  desired, determine what organization(s) are
  able (accredited, recognized and/or notified)
• Design products and services to comply with the
  super set of target country requirements if
  possible
• Choose most effective able conformity
  assessment organization for needed/desired
  services
• Work with conformity assessment organization(s)
  early in the design and development process

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Conformity Assessment and Trade
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The Safety and Trade Connection
Standards and Conformity Assessment
Assuring Safety
Facilitating Trade
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Who Needs What?
The market needs Confidence that a product or
system meets requirements safety, performance,
EMC, etc.
The manufacturer needs Effective conformity
assessment that is seamless, quick and
cost-effective.
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Evolution of Conformity Assessment
1970s Common Standards for Conformity Assessment
Bodies
2000-2010 Growth of National Treatment ?
1980s IECEE CB Scheme for Electrical Equipment
and Test Certificate Recognition
1990s Mutual Recognition Agreements and Free
Trade Agreements
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What Is National Treatment?
Enables testing and certification (in a given
market) by an organization, regardless of its
location, provided it has successfully completed
the local markets accreditation (or recognition)
process.
The accreditation or recognition process itself
is the same, regardless of whether the applying
organization is domiciled in the host country.
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Why National Treatment?
Countries accredit/recognize conformity
assessment organizations outside their territory
under the same system as local organizations.
Regulators get the needed confidence that
products meet their requirements.
Manufacturers are able to streamline the process
for market access, saving time and money.
Consumers and users get faster, more economical
access to new products.
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Contact Information

• Erin Grossi
• Manager, International Affairs
• Ph 202-296-7841
• Email Erin.Grossi_at_us.ul.com