UNIDOWAITRO

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UNIDO/WAITRO Workshop on Significance of Testing
and Conformity Assessment in GlobalTrade
- Challenges for Research Technology
Organisations (RTOs) 18-22 April 2005
STANDARDS AND CONFORMITY ASSESSMENT THEIR ROLES
IN SCIENCE AND TECHNOLOGY
By Khalidah Mustafa SIRIM Berhad
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STANDARDS AND CONFORMANCE INFRASTRUCTURE
MEASUREMENT
STANDARDS
CONFORMANCE
  Primary Standards   Calibration   Legal
Weights Measures
  Voluntary standards  Regulatory standards
Accreditation  Certification   Testing
Inspection
   
The components of the standards and conformance
infrastructure
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BUILDING BLOCKS FOR RECOGNITION AND ACCEPTANCE
REGULATORY MRAs
Product Certification
Product Certification
TECHNICAL MRAs
Accreditation System
Accreditation System
Quality System Certification
Quality System Certification
Inspection, Testing Calibration
Inspection, Testing Calibration
National Measurement System
National Measurement System
Economy A
Economy B
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THE ROLE OF STANDARDS IN ST
Enhance Innovation
STANDARDS
Facilitate Technology Transfer
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THE ROLE OF STANDARDS IN ST
Enhancing innovation facilitating technology
transfer

• German study- positive correlation between patent
  application standards
• Providing a rich source of information
• Transfer current technology
• Act as a catalyst for spread of innovation

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THE ROLE OF STANDARDS IN ST
Enabling human resources development

• Growing awareness on the importance of standards
  in academic communities
• Building a strong foundation for scientists,
  engineers, businessmen
• Standards grasp the practicalities in industry,
  manufacturing, technologies and management.

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THE ROLE OF STANDARDS IN ST
Support high technology industry

• Standards applied from design, test and
  evaluation to management of business
• ensure interchangeability and interoperability
  of
• parts and components.
• determine level of performance and quality
• efficient and cost effective operation
• Activate and enhance research and development
  activities

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IMPLEMENTATION OF STANDARDS
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CONFORMITY ASSESSMENT
Accreditation Body
Competence
Conformity Assessment Bodies
Certification Bodies
Testing/ Calibration Laboratories
Inspection Bodies
Compliance
Products/ Services
Suppliers/ Manufacturers
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DEFINITIONS

• Conformity
• fulfillment by a product, process or service to
  specified requirements
• Conformity assessment
• demonstration that specified requirements
  relating to a product, process, system, person or
  body are fulfilled
• Subject field of conformity assessment includes
  testing,inspection evaluation, certification, as
  well as accreditation of conformity assessment
  bodies.
• Object of conformity assessment encompasses any
  particular material, product, installation,
  process, system, person or body to which
  conformity assessment is applied. A service is
  covered by the definition of a product
• Mark of conformity
• protected mark indicating that the relevant
  object of conformity assessment (product,
  process, system, person or organisation) is in
  conformity with a specific standard or other
  normative documents.
• Note
• 1. A specified standard/normative document may be
  a standard, guides, technical specifications or
  regulations
• 2. A protected mark is a mark legally protected
  against unauthorised use

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CONFORMITY ASSESSMENT ORGANISATIONS

• FIRST PARTY
• declaration/ attestation by a manufacturer or
  supplier of a product, process or service
  complies with specified requirements -
  suppliers declarations/ manufacturers
  declarations
• also known as declaration
• SECOND PARTY
• evaluation of a product, process or service
  (including management systems) by the purchaser
  or end user
• Note Second parties include e.g.
  purchasers/users of products, or potential
  customers seeking to rely on a suppliers
  management system, or organisations representing
  those interests.
• THIRD PARTY
• evaluation of a product, process or service
  (including management systems) by an organisation
  that is independent of the supplier and end-user
• also known as certification

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CONFORMITY ASSESSMENT

• MAIN ACTIVITIES
• Testing
• Inspection
• Management systems certification
• Product certification
• Accreditation
• ORGANISATIONS
• First party
• Second party
• Third party

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CONFORMITY ASSESSMENT HIERARCHY
Cooperation ILAC MRA
Government Industry Recognition
Cooperation IAF MRA
Mutual Recognitions EA, APLAC
Mutual Recognitions EA, PAC
Accreditation Bodies Accredit Labs Inspection
bodies
Accreditation Bodies Accredit Certification
Bodies
Laboratories Test Products materials ISO IEC
17025
Inspection Bodies Inspect Products,items
structures ISO IEC 17020
Certification Bodies Certify Products ISO IEC
Guide 65
Certification Bodies Certify Management Systems
ISO IEC Guide 62,66
Products Marked per specifications, safety
requirements
QMS or EMS Certified ISO 9001, TS 16949 ISO 14001
Products Tested per specifications
Products Inspected per specifications
Confidence regarding Compliance with Regulations
Suppliers ISO IEC 17050
Second parties
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TECHNICAL INFRASTRUCTURE INTER-RELATIONSHIPS
Agreement on Technical Barriers to Trade
International
Regional
METROLOGY (PHYSICAL STANDARDS) SCIENTIFIC
LEGAL
DOCUMENTARY STANDARDS
CERTIFICATION ACTIVITIES
GOVERNMENT ACCREDITATION
POLICY
Malaysia
MOSTI
National Standards Body
Standards Development Agency
Measurement Standards Laboratory
Trade
ST
Regulator
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THE ROLE OF TESTING CERTIFICATION in ST
Compliance to standards/ specifications
Technical basis for judgement
Testing/ Certification
Independent assurance
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PRODUCTS ( industry/national/international )
MAJOR CERTIFICATION PROGRAMMES
OCCUPATIONAL HEALTH SAFETY MANAGEMENT
SYSTEM (OHSAS 18000)
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THE ROLE OF TESTING IN ST
Testing to standards

• Sound technical basis for decision making
• Competent and reliable test houses
• Reproducible and repeatable
• Facilitate communications and agreement

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THE ROLE OF CERTIFICATION IN ST
Certification ensures compliance

• Reducing risk for business and decision making by
  customers
• Independent assurance of compliance
• Provides common technical basis for agreement
• Instills customer confidence
• Sound technical basis for demonstration

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THE ROLE OF ACCREDITATION in ST
Test reports/data
Accreditation
Integrity of quality and standards
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THE ROLE OF ACCREDITATION IN ST
Test Reports/Data

• Increasing confidence in data that are used to
  established baselines for key analyses and
  decisions
• Reducing uncertainties
• Increasing public confidence
• Eliminating redundant reviews
• Improving efficiency of assessment process

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THE ROLE OF ACCREDITATION IN ST
Ensure integrity of quality and standards

• Reducing risk for business and decision making by
  customers
• Accreditation bodies operate at the highest
  standards
• Accredited Testing/Calibration/Certification
  bodies comply with International standards and
  guidance

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THE ROLE OF ACCREDITATION IN ST
Greater prospect for International trade

• Reduce/remove technical barriers to trade
  resulting in
• Harmonizing conformity assessment procedures
• Being signatory to APLAC, ILAC, IAF, PAC
  MLAs/MRAs provides confidence in credibility
  competency
• A nations goods and services to enter foreign
  market

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CONCLUSION

• Accreditation ensures the competency, credibility
  and reliability of data and the bodies producing
  the data.
• Standards put ST results into practice and
  activate RD.

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