The Quality Infrastructure (QI)

Quality Infrastructure
• Is a system comprising the organizations together with the
policies, relevant legal and regulatory framework and
practices needed to support and enhance the quality, safety
and environmental soundness of goods, services and
processes.
Quality Infrastructure
• Is a critical element in promoting and sustaining economic
development, as well as environmental and social
wellbeing.
• Institutions of this framework represent the scientific and
technological basis for the whole infrastructure.
Quality Infrastructure
In simple terms is the organizations (public and private) that
establish and implement …
• standardization
• metrology
• accreditation
• conformity assessment
• market surveillance
Building blocks of the QI
a ve
h
s to
Societal concerns ie
i e t
Health, Safety. Environment.
s oc
Economic wellbeing,wFair trade,
o
consumer protection, all regulation
n d
e a
Standardization Metrology a d
Conformity Accreditation Pre and post
r
t assessment market
s
a te s surveillance
i l t
i me
Development of Measurementfaand c co testing inspection
s u t
international and Traceability
r e lo certification SDOC
national c tu ica
t r u hn
standards s c
f ra n te
y in e i
lit nc
u a de
Q nf i
 co Business concerns
Trading, quality, profitability, distribution, purchasing use of specifications and contracts.
Examples of market surveillance
activities
• Market surveillance by regulator or designated body
• Pre market: a regulator or owner may require that prior to
selling medical devices the factory has a quality management
system (QMS) in place which has been certified by an
accredited certification body.
• Post market: a regulator may go to the market place and
purchase a medical devices, take it to an “accredited”
laboratory and have it tested to determine if it meets the
requirements.
 Components of the QI at the
international and national levels
1 2 3 4 5

Technical
outcomes
Measurement Documentary Claims of
Public Policy, Accreditation that society
(metrology standards, conformity,
regulation, peer can trust, and
and physical methods of validation,
contracts assessment use in
standards) test verification,
decision
certification
making
 QI at the international level
1 2 3 4 5
Technical
Measurement Claims of outcomes that
Public Policy, Documentary
(metrology and conformity, Accreditation society can trust,
regulation, standards,
physical validation, peer assessment
contracts methods of test and use in
standards) verification, decision making
certification

Public, trade Legal Performance Process used to Assessment of

measurement standards (ISO claim conformity technical
and corporate
(OIML) and IEC) (Auditing, competence
policy
Scientific/ Prescriptive Calibration, (IAF and ILAC)
Trade technical standards Evaluation,
facilitation measurement (AB’s)
Test methods Examination,
(BIPM) Development of
WTO (TBT and Many different Inspection,
TFA) Government or
standards Testing) Mutual
private Recognition
developers 1st, 2nd and 3rd
laboratories and Agreements
research party claims of
(MRA)
interests conformity and
  marking
 QI at the regional level
1 2 3 4 5
Technical
Measurement Claims of outcomes that
Public Policy, Documentary
(metrology and conformity, Accreditation society can trust,
regulation, standards,
physical validation, peer assessment
contracts methods of test and use in
standards) verification, decision making
certification

Regional Regional Regional SDOs, Process used to Regional

intergovernmen metrology e.g. COPANT, claim conformity accreditation
tal regulatory reference CEN- (Auditing, cooperative
body, e.g. laboratories e.g CENELEC, Calibration, organisations,
MERCOSUR, APLMF, EASC, ARSO Evaluation, e.g. EA, APAC,
APEC, COOMET, Examination, IAAC, SADCA,
SADAC, EU EMLM, SIM Inspection, AFRAC, ARAC
Testing)
1st, 2nd and 3rd
party claims of
conformity and
marking
Example of the Caribbean
regional approach to metrology
The slide that follows shows how the region has established
a regional Caribbean reference laboratory (CaRL) policy to
provide traceability to the national labs in states without the
resources to establish and maintain the required standards.
The standards maintained by the national labs are used to
disseminate traceability through the working standards used
by inspectors to the instruments used in measurement in
trade.
Traceability chain in Caribbean
SIDS
Regional Metrology Reference Caribbean Reference
Labs (maintaining regional Lab (CaRL)
measurements standards)

TRACEABILITY CHAIN National Metrology Lab

(maintaining national
measurement standards)

Laboratory calibrates portable National or Commercial

standards measurement Lab

Inspector uses calibrated

standards to verify instruments
used in trade
SIDS = Small Island Developing States
The QI of a country
Each country needs to have a QI that facilitates trade
internally and externally but also provides a basis for
science and technological development.

Whether it is for the internal or external market an

economy should be able to demonstrate its products and
services are safe and reliable and that it has the technical
expertize within the country to do this.
The QI of a country
The national QI framework is required to establish and
implement means needed to demonstrate that products
and services meet specified requirements as required by
regulators and the market for the effective operation of
domestic markets, and its international recognition is
important to enable access to foreign markets.
QI at the national level:
Switzerland example
1 2 3 4 5
Technical
Public Policy, Measurement Claims of outcomes that
Documentary
regulation, (metrology and conformity, Accreditation society can trust,
standards,
contracts physical validation, peer assessment and use in
methods of test
standards) verification, decision making
certification

Governments, METAS, Swiss SNV, Swiss Various SAS, Swiss

industry Metrology Association for government, not- Accreditation
groups, Institute Standardization for-profit and Service
consumer and other commercial
groups standards’ bodies
writers and
professional
bodies
QI and regulation
1 2 3 4 5
Technical
Measurement Claims of outcomes that
Public Policy, Documentary
(metrology and conformity, Accreditation society can trust,
regulation, standards,
physical validation, peer assessment and use in
contracts methods of test
standards) verification, decision making
certification

Government policy and regulation can address the following:

• Organisational improvement • Market differentiation
• Public health and safety
• Regulatory compliance • Better regulatory practice
• Market failure (including externalities)
• Supply chain entry • Consumer protection
• Interconnectivity and interoperability
• Access to funding • Sustainable development
• Economic transactions
• Risk management
• Trade and market access
• Quality excellence and technically credible
results
QI and metrology
1 2 3 4 5
Technical
Measurement Claims of
Public Policy, Documentary outcomes that
(metrology and conformity, Accreditation society can trust,
regulation, physical
standards, peer assessment
validation, and use in
contracts methods of test
standards) verification, decision making
certification

“Types” of metrology
Legal metrology approves measurement devices used in daily commerce and includes scales used in
shops, gas and electricity meters, breath analysis and speed measurement. Legal metrology is
coordinated by the International Organization of Legal metrology (OIML).

Scientific and technical metrology ensures world-wide uniformity of measurements and their traceability
to the International System of Units (SI). International coordination of measurements is provided
through the International Bureau of Weights and Measures (BIPM) .

The international framework for providing reliable measurements is coordinated at the national level by
National Measurement Institutes (NMI) which provide reliable measurement.
Metrology in Daily life
Video from VSL Dutch Metrology Institute (2min)
https://www.youtube.com/watch?v=vRnT8hIxjqk
 QI and documentary standards
1 2 3 4 5
Technical
Measurement Claims of
Public Policy, Documentary outcomes that
(metrology and conformity, Accreditation society can trust,
regulation, standards,
peer assessment
physical methods of test
validation, and use in
contracts verification,
standards) decision making
certification

QI and documentary standards that specify requirements for design, performance, characteristics,
safety etc.
Documentary standards
• Standards for products, processes, services, management systems, personnel and
combination thereof
• Standards for bodies such as laboratories, certification bodies and accreditation bodies
Move to international standards (ISO, IEC)
Proprietary standards
Voluntary and mandatory standards
 QI and Conformity assessment
1 2 3 4 5
Technical
Measurement Claims of
Public Policy, Documentary Accreditation outcomes that
(metrology and conformity, society can trust,
regulation, standards, peer
physical validation, and use in
contracts methods of test verification, assessment
standards) decision making
certification

ISO and IEC have jointly developed standards (ISO/IEC 17000 series) covering:

• Principles and terminology • Suppliers declarations of conformity

• Code of conformity assessment practice • Certification – Product, Management
• systems and Persons
Testing
• Peer assessment
• Inspection
• Validation and verification
 QI and Conformity assessment
1 2 3 4 5
Claims of Technical
Measurement
Public Policy, Documentary conformity, Accreditation outcomes that
(metrology and society can trust,
regulation, standards, validation, peer
physical assessment and use in
contracts methods of test verification,
standards) decision making
certification

ISO/IEC 17000 series also covers:

• Accreditation
• Peer assessment
• Mutual recognition
The National Quality Infrastructure

Definition of units National Metrology

National Standards
(as required in standards) Institute
Body

Accreditation body National Calibration of

standards Accreditation Body reference/working
measurement
Certification body standards Inspection body standards Calibration laboratory standards standards
Testing laboratory standards

Certification Inspection Testing Calibration

Bodies Bodies Laboratories Laboratories
Standards for
products, Calibration certificate
processes and Certification Inspection report Test report
systems
ENTERPRISES

Standards for
Market surveillance
technical
regulations PRODUCTS AND SERVICES

AUTHORITIES, CONSUMERS AND GENERAL PUBLIC

Source: World Bank (see footnote 20 above)

Conclusions
Quality infrastructure components and organizations can vary from one country to
another but the following elements make up an acceptable system:

• Capability to develop standards or at least adopt them as national

• Access to physical, chemical and biological standards of measurement (physical
standards)
• Provision of a legal metrology system
• Availability of inspection, testing and calibration services required by the level of
industry needs
• Availability of third party conformity assessment services such as product
certification to meet the requirements of the regulators and others
• Mechanism to ensure all service providers are competent, such as accreditation
that is recognized via a mutual recognition arrangement or agreement.
Video
Quality Infrastructure supporting Nigeria to overcome the
trade barriers of dried beans
from United Nations Industrial Development Organization (UNIDO)

https://youtu.be/-L35Zz1F-YQ