[Erasmus] QM - 3 - 6 - Infrastructure Management Assurance Standardization Metrology ILAC...

8/13/2019 [Erasmus] QM - 3 - 6 - Infrastructure Management Assurance Standardization Metrology ILAC Accreditation

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QualityManagementLecture 3Quality Costs and

Controldoc.dr.sc. Marko Jurevi

prof.dr.sc. Roman Malari

University of Zagreb

Faculty of Electrical Engineering and Computing

Department of Fundamentals of Electrical Engineering and Measurements, 2013


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University of Zagreb, Faculty of Electrical Engineering and Computing, Departmentof Fundamentals of Electrical Engineering and Measurements, 2013

Concept of Quality Costs

quality costsmeans to quantify the total cost of quality-relatedefforts and deficiencies (Feigenbaum, 1956.)

By classifying quality-related entries from a company's general

ledger, management and quality practitioners can evaluate

investments in quality based on cost improvement and profit

enhancement.


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Quality Costs

Feigenbaum defined the following quality cost areas:

Cost Area Description Examples

Costs of control (or

conformance)

PreventionEfforts to keep defects from

occurring

Quality planning

Statistical process control

Training and management in

Quality control (QC)

Product and design related

verification

Quality assurance (QA)

AppraisalInspection test and audits

are used to detect defects

Test and inspection of purchased

materials, final inspection, testing

Maintenance of inspection

equipment

quality audits, laboratoriy tests

Inspection documentation

Quality reports

Costs of failure of control

(non conformance)

Internal failure costs

Defects are caught internally

and dealt with by discarting

or repairing defective items

Scrap, rework, material

procurement costs

Deviation of

output quantities

External failure costsDefects that reach

customers

In- and Out of- Warranty

complaints, product service,

recall, lost of reputation and

customers


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Cost Area and Examples ...

Cost Area Examples

Tangible costsfactory accounts

Extra operations added because of defects; excess

inspection costs; investigation of defects causes;

labour, materials and burden necessary to repair od

scrapp/junk products

Tangible costssales accountsCustomer complaints -> Product discounts

Charges to quality guarantee account

Intangible costs

Delays and stoppages caused by defectives

Customer goodwill

Friction between departments


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Costs of poor quality Cost of poor quality (COPQ) or poor quality costs (PQC), are

defined as costs that would disappear if systems, processes,and products were perfect (H. James Harrington, Poor Quality

Costs, 1987)

Direct poor-quality costs / COPQ:

Controllable poor-quality cost Prevention cost

Appraisal cost

Resultant poor-quality cost

Internal error cost

External error cost

Equipment poor-quality cost


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Costs of poor quality ...

Indirect poor-quality costs

Customer-incurred cost

Customer-dissatisfaction cost

Loss-of-reputation cost


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Nonconformities and Their Economic Effects

some examples (also from the last lecture):

In 2003, Nissan recalls 2.5 mio. carsbecause of an engine problem

Costs: 120 m

On average, 6.2 out of 1,000 pieces of luggage dont make it totheir destinations at Northwest Airlines (USA)

Costs: 250per piece of luggage that issent separately

The Mecedes-Benz A-Class tips over during the moose accidenttest

Costs: Loss of image, costs of about 300 mfor remodeling


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uality assurance

systematic measurement, comparison with a standard,monitoring of processes* and an associated feedback loop that

confers error prevention.

This can be contrasted with Quality "Control" which is focused

onprocess* outputs.

* processany single business or manufacturing activity thatcontributes to final product (or service)

Quality Process uses a phased approach, designed to support theentire product life cycle from inception, design and development,

through rollout, to updates and support.


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The Triangle of Effects

Quality, costs and time as

equal objectives

Quality

Time Costs

tension

triangle

Quality manager, 1958:

We manufacture high quality products thatjustify their price

Quality responsive excellence as the most

important business objective

Quality

Time Costs

triangle

of effects

Product manager, 2013:

Our products are produced at optimal costs andthey fulfill all quality-related requirements

extension of view

Quality of products Quality of business and continuous process improvement

Example:

OEM: The price of our brake system shall decrease by 5 % per year. End customer: The brake system shall still be free from defects in 5 years.Manufacturer (supplier): If the innovation cant be brought to market within the next 5 months, it wont be relevant until the

following series.


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Increase of Process Quality through Avoidance of Waste

7 kinds of waste caused by:

Production

Stocks

Transport

Holding time

Production space

Rework (nonconformity) Transit time

Waste also includes not to use talents, skills and knowledge of allemployees!

Companies should not save on necessary but instead onunnecessary things:

Work that doesn't produce additional value (if it can be avoided)

Faulty work which decreases the value of a product


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Tasks of Quality Controlling

Supply of

informationPlanning and

control Coordination

Provisioning information on quality and coststhat is:

goal oriented

relevant for planning and decision-making retrospective and prospective

Preparation of the

information in the

form of compressedand clear reports

Evaluation of alternative choices of action in all quality-

relevant decisions to reach an optimum of quality costs

Coordination of

activities regarding

quality through plans

and programmes


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Quality Controlling and Cost Accounting

Financialreporting

Accounting

Annual financial

statemet

Balancing

Managerial accountng

Costs and results accounting

Standard costs accounting and budgeting

Difference between actual and target costs

Costcategory

accounting:

Which costs

are incured in

which

amount?

Investment

appraisal and

cash-flow

statement

Financial budgeting

and liquidity planning

Investment

appraisals and cost

effectiveness studies

Cost centre

accounting:

Where are

costs

incurred?

Cost unit

accounting

For what are

costs

incurred?

Quality controlling

Provision of data

Data preparationAppraisal

Coordination

Coordination

needed


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Arithmetic mean

Will-Rogers-Phenomenon

source: RWTH Aachen University


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Causation and Detection of Nonconformities



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Traditional Quality Cost Accounting

Quality costs are interpreted as asurchargeon manufacturing costs

It is misleadingto present the

connection between costs and

quality as a causal link. The costs

are not caused by quality, butrather bynonconformity with

quality standardsduring

production.

Quality costs in the traditional view

deflect attention from real savingspotentials.


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Opportunity Costs

Opportunity costs: Profit or benefit of the next best alternative

forgone as the result of making a decision.

Opportunity costs in quality control: are caused by the

behavior of the customer due to low quality, which may lead todissatisfaction, migration to competitors and decrease of the

potential customers willingness to purchase.


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Including Opportunity Costs (Costs of Lost Sales)



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University of Zagreb, Faculty of Electrical Engineering and Computing, Department

of Fundamentals of Electrical Engineering and Measurements, 2013

Structure und Classification of Quality Costs



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QualityManagementLecture 4Introduction to QualityInfrastructure - Metrology and

Standardsdoc.dr.sc. Marko Jureviprof.dr.sc. Roman Malari





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WHY A QUALITY INFRASTRUCTURE?

Storck Harbourscene


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uality infrastructure

Quality infrastructure relates to all fields of metrology,standardizationand testing, of quality management and

conformity assessment, including certification and accreditation.

In the past, the abbreviation MSTQ (Metrology, Standardization,

Testing and Quality Assurance) was used for this combinationof single elements

Recommended reading (availabe on QM moodle site):

Dr. Clemens Sanetra, RocoM. Marbn: THE ANSWER TO THE GLOBAL

QUALITY CHALLENGE: A NATIONAL QUALITY INFRASTRUCTURE


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Target groups interested in QI Businesses and producers in agriculture, forestry, fisheries, crafts and

trades who will benefit from a trade sector regulated by reliable QI

services Small and medium-sized enterprises - key factor is that they are

enabled to increase sales of their product by being able to provideproof of its quality

Domestic trade and export/import, which rely on testing facilities

Regulators, who can rely on this infrastructure, thus avoidingduplicating facilities and services

Research and development in enterprises, as they will have betteraccess to all components of quality assurance

Scientific and academic communities who are dependent on soundand internationally recognized measurements and testing procedures

Financial institutions who will be more inclined to grant credits toenterprises capable of showing quality certifications

Arbitration bodies in commercial disputes

the entire population


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Challenges from free trade and globalization

All countries should be enabled to enjoy the advantages of globalization

Standards and their enforcement can mean new entry barriers


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Technical barriers to trade

The Agreement on Technical; Barriers to Trade (TBT) is one of the legal texts of the WorldTrade Organization (WTO) Agreement which obliges WTO Members to ensure thattechnical regulations, voluntary standards and conformity assessment procedures do notcreate unnecessary obstacles to trade

The Agreement on Technical Barriers to Trade tries to ensure that regulations, standards,testing and certification procedures do not create unnecessary obstacles, while also

providing members with the right to implement measures to achieve legitimate policyobjectives, such as the protection of human health and safety, or the environment.

http://www.wto.org/english/tratop_e/tbt_e/tbt_e.htm


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Need for national quality infrastructure

A national quality infrastructure is essential in breaking down

technical barriers to trade. It is thus the key to the greaterintegration of the partner countries into the international tradingsystem

Bilateral and multilateral free trade agreements make more andmore reference to recognized technical competence through

equivalent QI structures. For instance, the WTO Agreement on Technical Barriers to

Trade (TBT) states clearly that Central Government Bodiesshall ensure acceptance of conformity assessment proceduresbased on adequate technical competence and verifiedcompliance through accreditations. This is a requirement thatcannot be fulfilled without having an internationally recognizedQI structure in place.


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National Quality Infrastructure ... requires at lest:

national standards organization - support setting up standards, give access to existing

standards and it can help entrepreneurs in the use of standards to meet therequirements set up by their national and international clients

national metrology institute - custodian of the national measurement standards withtheir international traceability and it transfers this traceability to secondary andindustrial measurement standards as well as eventually offering reliable calibrationservices at a reasonable cost

accreditation body - ensure the technical competence of laboratories, of inspectionbodies, and of the quality certifications granted in the country

totally independent, technical, not political

National

Standards Body

National

Metrology InstituteNational

Accreditation Body

National Quality Infrastructure


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Access to international markets and preservation of

domestic markets

Globalization means thatparticipation in markets is more and

more decided based on quality of

the products and services, rather

than on their price.


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Harmonizing conformity assessment procedures around the

world has far-reaching benefits for international trade in

general.

Agreements among nations or regions on the mutual

acceptability of requirements, assessment methods, inspection

or test results, etc., can all help to reduce or remove so-calledtechnical barriers to trade. These are procedures or

requirements relating to importation and to market access that

vary from country to country and may bar a foreign product


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For the domestic market, the national quality infrastructure has,

amongst other things, a protective function. It provides the

necessary structure for effective market monitoring and for

consumer protection To ensure fair trade, both imports and local production must be

strictly submitted to the same rules; this protects domestic

producers and at the same time provides incentives for their

competitiveness.


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Consumer protection (health, safety, environment)

The national legislature is responsible for the definition of the

desired level of protection of the country and its people.

it provides them with a basis for selecting products or services.They may have more confidence in products or services that

bear a mark or certificate of conformity that attests to quality,

safety or other desirable characteristics.


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National QI tasks

a national quality infrastructure shoud be capable of:

ensuring access to traceable calibrations (for instance, through a

National Metrology Institute),

ensuring internationally recognized accreditations (for instance,

through a national accreditation body), compliance with international requirements (ISO standards,

CODEX),

traceability of its national measurement standards,

participation in international intercomparisons, mutual recognition with other countries.


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Metrology, calibration and legal metrology

The role of metrology is easily seen in the following:

No quality without quality control,

no quality controlwithout measurements,

no measurementswithout calibration, no calibrationwithout accredited laboratories,

no accredited laboratorieswithout traceability,

no traceabilitywithout measurement standards,

no measurement standardswithout metrology.


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Metrology

metrologyis the science of correct and reliable measurements

a distinction is made between:

scientificmetrology (development of primary measurement

standards or primary methods), industrialmetrology (proper maintenance and control of industrial

measurement equipment including calibration of instruments and

working measurement standards), and

legalmetrology (verification of instruments used in commercial

transactions, according to criteria defined in technical regulations).


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Some metrology terms Metrologyis the science of measurement. Metrology includes all theoretical and practical aspects of

measurement.

Measurement(from Old French, mesurement) is the assignment of numbers to objects or events;determination or estimation of ratios of quantities, quantitative attributes are those possible tomeasure, at least in principle

Quantityis a property that can exist as a magnitude or multitude.

Measurand is a quantity intended to be measured.

Influence Quantity is a quantity that is not the measurand but that affects the result of themeasurement (for electric devices, typical influence quantities may be temperature, humidity,pressure)

Measurement methodis a logical sequence of actions, described in general, used for measurement Measurement procedureis a detailed described sequence of actions needed for single

measurement according to specific measurement method

Measurement uncertaintyis a non-negative parameter characterizing the dispersion of the valuesattributed to a measured quantity

True value is the value that would be obtained by a perfect measurement, i.e. in an ideal world; valuethat is in conformance with the definition of a physical quantity

Accuracydescribes how closely a measurement comes to the true value of a physical quantity

(example, a collection of resistors all marked 1 kwill have a range of values, but the mean valueshould be 1 k. You can have more confidence in a number of measurements of a sample rather thanan individual measurement. The variation enables you to identify a mean, a range and the distributionof values across the range)

Precision: The closeness of agreement between replicate measurements on the same or similarobjects under specified conditions.


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... metrology terms

Repeatabilityor reproducibility(precision): The extent to which ameasurement replicated under the same conditions gives a consistentresult. Repeatabilityrefers to data collected by the same operator, inthe same lab/same conditions, over a short timescale.Reproducibilityrefers to data collected by different operators, indifferent laboratories/conditions.

Standardis an object, system, or experiment that bears a definedrelationship to a unit of measurement of a physical quantity

reference standard or prototype for the kilogram is the InternationalPrototype Kilogram (IPK), a one kilogram mass of a platinum-iridium alloykilogram maintained by the Bureau International des Poids et Mesuresin

Svres, France. the reference standard for the meter is no longer defined by a physical

object. In 1983, the standard meter was redefined as the distance lighttravels in a vacuum during 1/299,792,458 of a second.


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National Metrology Institute every country has a National Metrology InstituteNMI, which is

responsible for the development and maintenance of the national

measurement standards in physical and chemical quantities. when they are declared as the national measurement standard of a

nation, they represent the countries capability

national custodian and verifier of reference standards and as such itmust obtain, conserve, develop and disseminate the basic

measurement units and the highest level of calibration standards. provides traceability to the national system and it ensures that

international technical guidelines are followed for the metrologicalperformance and testing procedures of measuring instrumentssubject to legal controls, and from the point of view of manufacturers

it ensures that their products meet international specifications formetrological performance and testing

examples: NIST (USA), NPL (GB), CMI (Croatia), PTB (Germany),AIST, KRISS...


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NMI functions

it is the primary metrology laboratory; as such it develops national measurementstandards and disseminates their exactitude to industry and users in the country,

it establishes and maintains the national measurements system, giving technical supportto the network of secondary and tertiary laboratories,

it provides traceability to the national system and through it to the international system,

it offers technical support to industry in everything related to measurements, referencematerials, calibrations and data to establish traceability of their measurements,

it participates in modernization and technology transfer between academia, industry andgovernment, contributing to reinforce the scientific and technical infrastructure required byindustry to compete in the present global markets,

it supports development of reference standards and the national system of standards,

it facilitates international harmonization and compatibility of measurements,

it represents the country in the regional metrology organization RMO and the worldwidemetrology system coordinated by BIPM,

it participates in internationally organized intercomparison measurements, and

together with the national accreditation body it organizes national intercomparison

measurements for calibration laboratories in the country.


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Traceability and calibration

International quality standards (ISO 9000, ISO/IEC 17025, etc)require traceability of measurements

concept of traceability means an uninterrupted chain of

comparison measurements with increasingly higher accuracy

instruments (smaller measurement uncertainty), starting at theinstrument used in industry up to the national measurement

standard.

This regularly repeated measurement to compare a measuring

instrument against a measurement standard with higheraccuracy is called calibration.


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Traceability

Example: the Croatian national measurement standards of a Croatian NMI are

traceable to the German national metrology institute PTB, whichdemonstrates competence through participation in worldwide

intercomparison measurements. Croatian NMI demonstrates its competence by participating in international

and/or regional intercomparison measurements.

http://www.bipm.org/en/bipm/calibrations/traceability.html


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Example: Distribution of the Value of Mass

source: http://www.bipm.org/


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Example: Calibration Traceability



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(Inter)National Measurement Traceability for example, in order to ensure that dimensions of supplied automotive parts

or threshold values of contaminants in food products meet the requirementsexactly, measurements have to be as accurate as necessary for thepurpose. Additionally, it has to be borne in mind that every measurement hasan "uncertainty", as do test results and analytical research, due to statistical,human, or technical deviations

primary measurement standards are those that are a materialized measure,measurement instrument or system, or reference material, that defines or

materializes a given measurement unit, and as such they do not themselvesrequire traceability.

other levels require traceability to a primary standard, with a descendingorder of uncertainties of measurement. Maintenance of some of the primarymeasurement standards requires quite stringent conditions.

metrology institutes in countries with little demand or relatively low

uncertainty requirements do not necessarily have primary standards as theirnational measurement standards, as long as theirs are traceable to aninternationally recognized NMI with primary standards. They must guaranteereliable traceability, and intercomparison measurements will vouch for theirtechnical competence.


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MRA and key comparisons

NMI envolved in CIPM KCNMI envolved in CIPM KC and RMO KC

NMI envolved in RMO KC

NMI envolved in BIPM KC

NMI envolved in bilateral KC

International organization signing MRA


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Josephson device (KRISS)

http://www.kriss.re.kr


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Josephson device in Croatia


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Calibration and Measurement Capabilities Assessments by peer groups and successful results of comparison

measurements are prerequisites to be accepted by the club

members. A key criterion is not the highest precision of measurementbut the highest reliability of the declared measurementcapabilities.

These so-called Calibration and Measurement Capabilities (CMC)are listed in a database administered by the BIPM in Paris andpublished on the Internet.

The database is frequently updated and extended; it shows thenational measurement capabilities of each country for physicalquantities and it has recently been extended to chemical quantitiesrelated to analytical capabilities e.g. for the determination of heavymetals, pesticides or antibiotics.

These data play an important role in international trade when it comesto the level of contaminants in agricultural or food products whereinternationally recognized certificates are required.

free trade agreements are beginning to refer to these measurementcapabilities.


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OIML - International Organization of Legal Metrology

an intergovernmental treaty organization which: develops model regulations, standards and related

documents for use by legal metrology* authorities andindustry,

provides mutual recognition systems which reduce tradebarriers and costs in a global market,

represents the interests of the legal metrology communitywithin international organizations and forums concernedwith metrology, standardization, testing, certification andaccreditation,

promotes and facilitates the exchange of knowledge andcompetencies within the legal metrology communityworldwide,

cooperates with other metrology bodies to raise awarenessof the contribution that a sound legal metrologyinfrastructure can make to a modern economy.

OIML is an international standard-setting body in thesense of the WTO's Technical Barriers to Trade

Agreement. OIML publications should therefore be applied, when

appropriate, by all signatories of the TBT Agreementwhen developing technical regulations

http://www.oiml.org/en/about/about-oiml

* Legal metrology is the

application of legal

requirements tomeasurements and

measuring instruments.


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The Convention of the Metre, 1875

is a diplomatic treaty which gives authority to the General

Conference on Weights and Measures (ConfrenceGnraledes Poids et Mesures, CGPM), the International Committee for

Weights and Measures (ComitInternational des Poids etMesures, CIPM) and the International Bureau of Weights and

Measures (Bureau International des Poids et Mesures, BIPM)to act in matters of world metrology, particularly concerning the

demand for measurement standards of ever increasing

accuracy, range and diversity, and the need to demonstrate

equivalence among national measurement standards.

Representatives of seventeen nations signed the Convention in

Paris, in 1875.


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The Convention of the Metre, 1875



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BIPM

BIPM - The International Bureau of Weights and Measures

(BIPM) was set up by the Metre Convention and has itsheadquarters near Paris, France. It is financed jointly by its

Member States and operates under the exclusive supervision of

the CIPM.

Its mandate is to provide the basis for a single, coherent system

of measurements throughout the world, traceable to the

International System of Units (SI). This task takes many forms,

from direct dissemination of units (as in the case of mass and

time) to coordination through international comparisons of

national measurement standards (as in electricity and ionizingradiation).

http://www.bipm.org/en/bipm/


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CIPM-Comit international des poids et mesures

The CIPM is made up of eighteen individuals, each of a

different nationality. Its principal task is to promote world-wide

uniformity in units of measurement and it does this by direct

action or by submitting draft resolutions to the General

Conference (CGPM).

The CIPM meets every year (since 2011 in two sessions per

year) and, among other matters, discusses reports presented to

it by its Consultative Committees.

http://www.bipm.org/en/committees/cipm/


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CGPM - Confrence Gnrale des Poids et Mesures

The General Conference on Weights and Measures (Confrence

Gnraledes Poids et Mesures, CGPM) is made up of delegates ofthe governments of the Member States and observers from theAssociates of the CGPM.

The General Conference receives the report of the InternationalCommittee for Weights and Measures (CIPM) on work accomplished;it discusses and examines the arrangements required to ensure the

propagation and improvement of the International System of Units(SI); it endorses the results of new fundamental metrologicaldeterminations and various scientific resolutions of internationalscope; and it decides all major issues concerning the organizationand development of the BIPM, including the dotation of the BIPM.

The CGPM meets in Paris, usually once every four years; the 24thmeeting was held from 17-21 October 2011.

http://www.bipm.org/en/convention/cgpm/

SI I i l S f U i


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SI, International System of Units The 11th General Conference on Weights and Measures in 1960 adopted the name

SystmeInternational dUnits(International System of Units, internationalabbreviation SI), for the recommended practical system of units of measurement

defines rules for the prefixes, the derived units, and other matters

Metal bar, Pt-Ir, 1889-1960

Modern definition of meter

SI B U i


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SI Base Units Base units are a choice of seven well-defined units, which by

convention are regarded as dimensionally independent:

the metre, the kilogram,

the second,

the ampere,

the kelvin, the mole, and

the candela

all other units of measure can be derived from the base units

Derived units are those formed by combining base unitsaccording to the algebraic relations linking the correspondingquantities

http://www.bipm.org/en/si/

SI b i


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SI base units

Unit name Unit Symbol Quantity name Definition

metre m length The distance travelled by light in vacuum in 1/299792458second.

kilogram kg mass The mass of the International Prototype Kilogram

second s time

The duration of 9192631770 periods of the radiation

corresponding to the transition between the two hyperfine

levels of the ground state of the caesium 133 atom

ampere A electric current

The constant current which, if maintained in two straightparallel conductors of infinite length, of negligible circular

cross-section, and placed 1 m apart in vacuum, would

produce between these conductors a force equal to

2107newtons per metre of length

kelvin Kthermodynamic

temperature

The fraction 1/273.16 of the thermodynamic temperature

of the triple point of water

mole mol amount of substanceThe amount of substance of a system which contains asmany elementary entities as there are atoms in 0.012

kilogram of carbon 12

candela cd luminous intensity

The luminous intensity, in a given direction, of a source

that emits monochromatic radiation of frequency 5401012hertz and that has a radiant intensity in that direction of

1/683 watt per steradian.

N d it d i d f SI b it


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Named units derived from SI base unitsName Symbol Quantity

Expressed in

terms of

other SI units

Expressed in

terms of

SI base units

radian rad angle 1 m/m

steradian sr solid angle 1 m2/m2

hertz Hz frequency s1

newton N force, weight kgms2

pascal Pa pressure, stress N/m2 kgm1s2

joule J energy, work, heat Nm kgm2s2

watt W power, radiant flux J/s kgm2s3

coulomb Celectric charge or quantity of

electricitysA

volt Vvoltage (electrical potential

difference), electromotive forceW/A kgm2s3A1

farad F electric capacitance C/V kg1m2s4A2

ohm electric resistance, impedance,

reactanceV/A kgm2s3A2

siemens S electrical conductance A/V kg1m2s3A2

weber Wb magnetic flux Vs kgm2s2A1

tesla T magnetic field strength Wb/m2 kgs2A1

henry H inductance Wb/A kgm2s2A2

degree Celsius C temperature relative to 273.15 K K

lumen lm luminous flux cdsr cd

lux lx illuminance lm/m2 m2cd

becquerel Bq radioactivity (decays per unit time) s1

gray Gy absorbed dose (of ionizing radiation) J/kg m2s2

sievert Svequivalent dose (of ionizing

radiation)J/kg m2s2

katal kat catalytic activity s1mol

N SI it t d f ith SI


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Non-SI units accepted for use with SI

the CIPM has recognised that some non-SI units still appear in the

scientific, technical and commercial literature, and will continue to beused for many years to come

Non-SI units accepted for use with the SI (minute, hour, day,

degree of arc, minute of arc, second of arc, hectare, litre and tonne)

Non-SI units whose values in SI units must be obtained

experimentally(electronvolt, dalton/unified atomic mass unit,

astronomical unit, speed of light, Planck constant and electron mass)

Other non-SI units (bar, millimetre of mercury, ngstrm, nauticalmile, barn, knot, neper and [deci]bel )

Non-SI units associated with the CGS and the CGS-Gaussiansystem of units (erg, dyne, poise, stokes, stilb, phot, gal, maxwell,

gauss and rsted)


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Importance of nits


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Importance of unitsMars Climate Orbiter, 1998

due to complications arisen from

human error, the spacecraftencountered Mars at a lower thananticipated altitude anddisintegrated due to atmosphericstresses.

the flight system software on the

Mars Climate Orbiter was writtento take thrust instructions usingthe metric unit newtons (N), whilethe software on the ground thatgenerated those instructions usedthe Imperial measure pound-force(lbf). This error has since beenknown as the "metric mixup" andhas been carefully avoided in allmissions since by NASA.

Regional metrology organizations (RMOs)


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Regional metrology organizations (RMOs)

Apart from the internationally operating CIPM the continents

have set up Regional Metrology Organizations (RMO), to

compare and harmonize their metrological systems.

The relevant RMO for the Europe is EURAMET, for Asian

countries is called Asia Pacific Metrology Program (APMP), inLatin America it is the SIMSistema Interamericano deMetrologa; Inter-American Metrology System.

http://www.bipm.org/en/practical_info/useful_links/rmo.html

EURAMET


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EURAMET

http://www.euramet.org/

The European Association of National Metrology Institutes(EURAMET) is a Regional Metrology Organisation (RMO) of Europe

coordinates the cooperation of National Metrology Institutes (NMI) ofEurope in fields like research in metrology, traceability ofmeasurements to the SI units, international recognition of nationalmeasurement standards and related Calibration and Measurement

Capabilities (CMC) of its members. Through Knowledge Transfer andcooperation among its members EURAMET facilitates thedevelopment of the national metrology infrastructures.

responsible for the elaboration and execution of the EuropeanMetrology Research Programme (EMRP)which is designed toencourage collaboration between European National Metrology

Institutes (NMIs) and partners in industry or academia. Theprogramme funds joint research projects in specific fields of metrologywith over 50 projects selected for funding so far and many moreexpected over the coming years.

EURAMET
http://www.euramet.org/http://www.euramet.org/http://www.euramet.org/


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EURAMET

EURAMET


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EURAMET

12 Technical Commitees (TC)

TC-AUV: Acoustics, Ultrasound and Vibration TC-EM: Electricity and Magnetism

TC-F: Flow

TC-IR: Ionising Radiation

TC-L: Length

TC-M: Mass and Related Quantities

TC-MC: Metrology in Chemistry

TC-PR: Photometry and Radiometry

TC-T: Thermometry

TC-TF: Time and Frequency TC-IM: Interdisciplinary Metrology

TC-Q: Quality

Mutual recognition agreement (MRA)


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Mutual recognition agreement (MRA)

mutual recognition agreement (MRA)is an international

agreement by which two or more countries agree to recognizeone another's conformity assessments.

At a meeting held in Paris on 14 October 1999, the directors of

the national metrology institutes (NMIs) of thirty-eight Member

States of the BIPM and representatives of two internationalorganizations signed a Mutual Recognition Arrangement (CIPM

MRA) for national measurement standards and for calibration

and measurement certificates issued by NMIs. A number of

other institutes have signed since then.

http://www.bipm.org/en/cipm-mra/

Conformity assessment


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Conformity assessment Conformity assessment, also known as compliance assessment is any

activity to determine, directly or indirectly, that a process, product, or service

meets relevant technical standards and fulfills relevant requirements

Conformity assessment activities may include:

Testing

Surveillance

Inspection Auditing

Certification

Registration

Accreditation

the World Trade Organisation (WTO) governs conformity assessmentthrough the Agreement on Mutual Recognition in Relation to Conformity

Assessment (Signed July 4, 2000)

Certification


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Certification certificationconfirms conformity with requirements defined in written standards.

recognition can be achieved by using standards and assessment procedures which areimplemented worldwide (ISO-Standards, Codex Alimentarius recommendations, etc.).

a third party assessment of the competence of the Certification Body and regularsurveillance visits by an accreditation body will confirm reliability and facilitate internationalrecognition

Different kinds of certifications are known: Certification of management systems - management systems demonstrate that the enterprise in

question has implemented procedures to structure and document its administration andmanagement processes:

Quality Management Systems according to the ISO 9000 series Environmental Management Systems according to the ISO 14000 series

Occupational Health and Safety Systems according to the OHSAS 18000 series

Hygienic Systems: Hazard Analysis and Critical Control PointHACCP

Certification of products proves that production processes, contents, properties, etc. of a product comply with the

requirements of a written standard CE: European Union Compliance Mark

VDE: Electrical Equipment Quality Mark GS: Safety Certification

Organic or Bio product certification

GMO (Genetically Modified Organisms)

Halal (Muslim food requirements)

Kosher (Jewish Food requirements)

Accreditation


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Accreditation Accreditation and Certification are often confused or seen as

equivalent, which is a misconception.

much more than a certification

Accreditationis the procedure by which an authoritative body

gives formal recognition that a body or person is competent to

carry out specific tasks.

accreditations are granted in many different fields.

a typical structure of an accreditation body might comprise

departments for the accreditation of:

Testing and calibration laboratories according to ISO/IEC 17025

Inspection Bodies according to ISO/IEC 17020

Certifying Bodies for Environmental Management Systems

according to ISO/IEC 17021

Standards?


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Standards?

Example: various

telephone plugs

Standardization and International standards


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standard(another similar definition) is a document,established by consensus and approved by arecognized body, that provides, for common andrepeated use, rules, guidelines or characteristics foractivities or their results, aimed at the achievement ofthe optimum degree of order in a given context.

International standards: developed by international standards organizations.

International standards are available for considerationand use worldwide.

may be used either by direct application or by a process ofmodifying an international standard to suit local conditions

if adopted, result in the creation of national standards thatare substantially the same as international standards intechnical content, but may have (i) editorial differences as to appearance, use of symbols

and measurement units, substitution of a point for acomma as the decimal marker, and

(ii) differences resulting from conflicts in governmentalregulations or industry-specific requirements caused byfundamental climatic, geographical, technological, orinfrastructural factors, or the stringency of safetyrequirements that a given standard authority considersappropriate



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International standards are one way of overcoming technical

barriers in international commerce, caused by differencesamong technical regulations and standards developedindependently and separately by each nation, nationalstandards organization, or company

standards can vary in two major respects:

the typeof agreement

the numberof people, organizations or countries who wereinvolved in making the agreement.

In some standards, the type of agreement essentially amounts

to advice and guidance; others are much more prescriptive andset out absolute requirements that have to be met if a userwishes to make a claim of compliance with the standard.



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Croatian (HR), British (BS), German (DIN) ... other national

European (EN) and

internationalstandards (ISO/IEC) are developed according to

strict rules to ensure that they are transparent and fair private/internalcompany standards

The standards infrastructure is responsible for producing:

full consensus documents, i.e. standards; and partial consensus documents

Examples of full consensus standards


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Examples of full consensus standards

Examples of full consensus standard:

British Standard (BS), which can take the form of a specification,

method of test, vocabulary, code of practice or guide

European standard (EN)

international standard International Organization forStandardization (ISO) or International Electrotechnical

Commission (IEC)

Related publications:

Draft for development (DD)

Guide European Committee for Standardization CEN/CLC, or

ISO Technical specification CEN/CLC/TS, ISO or IEC/TS

Technical report CEN/CLC/TR, ISO or IEC/TR

Standards Hierarchy


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Standards Hierarchy

Companies

Industry

R

ecognized

contractors suppliers

APIEEMUA UKOOA

ASME

National ANSI BS

Regional CEN /CENELEC

International ISO / IEC

Vienna agreementon technical cooperation

between ISO and CEN

operators

OGP

otherEuropean

HRN

Categories of standards - function


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Categories of standards - function standards can be categorized according to the function they need to

perform:

most common is the Specification(a highly prescriptive standard settingout detailed absolute requirements) commonly used for product safety purposes or for other applications

where a high degree of certainty and assurance is required by its usercommunity

Codes of practice recommend sound good practice as currentlyundertaken by competent and conscientious practitioners. drafted to incorporate a degree of flexibility in application, whilst offering

reliable indicative benchmarks.

commonly used in the construction and civil engineering industries.

Methods- highly prescriptive, setting out an agreed wayof measuring,testingor specifyingwhat is reliably repeatable in different circumstancesand places, wherever it needs to be applied.

Vocabulary- a set of terms and definitions to help harmonize the use oflanguage in a particular subject or discipline.

Guides- published to give less prescriptive advice which reflects thecurrent thinking and practice amongst experts in a particular subject.

Some technical standard organisations


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Some technical standard organisations International standards organizations

ANSI American National Standards Institute

BIPM, CGPM, and CIPM Bureau International des Poids et Mesures and therelated organizations established under the Metre Convention of 1875. DCMI Dublin Core Metadata Initiative Ecma International Ecma International (previously called ECMA) IEC International Electrotechnical Commission IEEE Institute of Electrical and Electronics Engineers

IEEE-SA IEEE Standards Association

IETF Internet Engineering Task Force ISO International Organization for Standardization ITU The International Telecommunication Union TIA - Telecommunications Industry Association

WMO World Meteorological Organization W3C World Wide Web Consortium

Regional (European) standards organizations CEN European Committee for Standardization CENELEC European Committee for Electrotechnical Standardization ETSI European Telecommunications Standards Institute

ISO International Organization for Standardization


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ISO - International Organization for Standardization

International Organization for Standardization - an internationalstandard-setting body composed of representatives from variousnational standards organizations

ISO was founded on 23 February 1947

the organization today known as ISO began in in 1906. asInternational Electrotechnical Commission; 1926 as theInternational Federation of the National Standardizing

Associations (ISA) (focus: mechanical engineering) currently headquartered in Geneva, Switzerland

WWW: http://www.iso.org

voluntary organization; members are recognized authorities onstandards, each one representing one country

products: international standards

technical reports, technical specifications, publicly availablespecifications, technical corrigenda, and guides

ISO structure


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ISO structure

CASCOConformity assessmentCOPOLCOConsumer Policy

DEVCODeveloping country matters

REMCOCommittee on reference materials

http://www.iso.org/

ISO organization


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ISO organization

strategic decisions are referred to ISO members, who meet for an

annual General Assembly Members review proposals developed by the ISO Council, which

resembles the board of directors of a business organization, withmembers drawn from the membership as a whole.

The ISO Council meets three times a year, and its members arerotated to ensure that it is representative of ISO's membership.

Operations are managed by the Secretary-General, whoseappointment is permanent.

The Secretary-General reports to the President, who is a prominentfigure in standardization or in business and is elected for two years.

The Secretary-General is based at the ISO Central Secretariat in

Geneva, Switzerland, with a compact staff, which providesadministrative and technical support to ISO members, coordinates thedecentralized standards' development programme and publishes theoutput.

Member categories of ISO


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Member categories of ISO Membership in ISO is open to national standards institutes or similar

organizations that are most representative of standardization in their country(one member in each country).

ISO members are divided into three categories: Member bodies - "full member", is the national body "most representative of

standardization in its country". Only one full member for each country isaccepted for membership in the ISO. Member bodies are entitled toparticipate and exercise full voting rights on any technical committee or policycommittee of ISO.

Correspondent members - usually an organization in a country that doesnot yet have fully developed national standards activities. Correspondentmembers do not take an active part in the technical and policy developmentwork, but are entitled to be kept fully informed about the work of interest tothem.

Subscriber membership has been established for countries with very smalleconomies. Subscriber members pay reduced membership fees thatnevertheless allow them to maintain contact with internationalstandardization activities.

http://www.iso.org/iso/home/about/iso_members.htm

ISO standards designation


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ISO standards designation

International standards are designated with the format ISO[/IEC][/ASTM] [IS] nnnnn[-p]:[yyyy] Title

nnnnn - number of the standard

p - optional part number

yyyy - year published

Title - describes the subject

IECis included if the standard results from the work of ISO/IEC JTC1(the ISO/IEC Joint Technical Committee)

ASTM(American Society for Testing and Materials) is used forstandards developed in cooperation with ASTM International

Examples:

ISO/IEC TR 17799:2000 Code of Practice for Information Security

Management ISO/TR 19033:2000 Technical product documentation Metadata for

construction documentation

How does ISO develop standards?


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How does ISO develop standards? If an industry or business sector needs a new standard, it should

communicate the requirement to one of ISO's national members.

The member then proposes the new work item to the ISO. If accepted, the work item is assigned to an existing technical committee.

Proposals may also be made to set up technical committees to cover newscopes of technological activity. In order to use resources most efficiently,ISO only launches the development of new standards for which there isclearly a market requirement.

ISO standards are developed by technical committees (TC), subcommittees(SC), working groups (WG) and study groups (SG).

These groups are comprised of experts on loan from industrial, technical andbusiness sectors who have requested the standards, and will subsequentlyput them to use.

The experts may be joined by others with relevant knowledge, such asrepresentatives of government agencies, testing laboratories, consumerassociations, environmentalists, .... They participate as national delegations,chosen by the ISO national member institute for the country concerned.



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International Standards are developed by a process with six steps: Stage 1: Proposal stage

Stage 2: Preparatory stage

Stage 3: Committee stage

Stage 4: Enquiry stage

Stage 5: Approval stage

Stage 6: Publication stage

TC/SC may set up working groups (WG) of experts for thepreparation of a working drafts

Subcommittees may have several working groups, which can haveseveral Sub Groups (SG)

http://www.iso.org/iso/home/standards_development.htmhttp://www.iso.org/iso/home/standards_development/resources-for-technical-work/stages_of_the_development_of_international_standards.htm

National contribution in global standardization


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National contribution in global standardization

Characteristics of ISO standards


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Characteristics of ISO standards key criteria for ISO standards are that they should be

equal- every participating ISO member institution has the right to take part inthe development of any standard which is judged to be important to itscountry's economy

voluntary ISO has no legal authority to enforce their implementation.

Some ISO standards (mainly concerned with health, safety or environment) havebeen adopted in some countries as part of their regulatory framework, or arereferred to as the technical basis for legislation.

Using ISO standards is a sovereign decision made by the regulatory authorities orgovernments; ISO itself does not regulate or legislate.

they may become a market requirement (example: the case of ISO 9000 qualitymanagement systems or of dimensions of freight containers and bank cards).

market-driven- ISO develops only those standards for which there is amarket requirement

consensual- the fact that they are developed in response to market demandand are based on consensus among the interested parties ensureswidespread applicability of the standards.

international- ISO standards are technical agreements that provide theframework for compatible technology worldwide

Some popular ISO standards


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Some popular ISO standards

ISO 9000 - Quality management

ISO 14000 - Environmental management

ISO 22000 - Food safety management

ISO 20121 - Sustainable events

ISO 26000 - Social responsibility

ISO 31000 - Risk management

ISO 50001 - Energy management

ISO 27001 - Information security

ISO 3166 - Country codes

ISO 4217 - Currency codes

ISO 639 - Language codes

http://www.iso.org/iso/home/standards.htm

IEC - International Electrotechnical Commission


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IEC International Electrotechnical Commission

the leading global organization that prepares and

publishes international standards for all electrical,electronic and related technologies

cooperates closely with the International Organization for

Standardization(ISO) and the International

Telecommunication Union(ITU) officially founded in June 1906, in London, England

in 1938, IEC produced the first edition of the International

Electrotechnical Vocabulary(IEV)

in 1948, the IEC Central Office moved from London toGeneva, Switzerland

http://www.iec.ch/

CENELEC - European Committee for Electrotechnical Standardization


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p

European Committee for

Electrotechnical Standardization

a non-profit technical organization

created in 1973 as a result of the merger of two previous European

organizations: CENELCOM and CENEL

is responsible for standardization in the electrotechnical engineering

field creates market access at European level but also at international

level, adopting international standards wherever possible, through its

close collaboration with the International Electrotechnical Commission

(IEC), under the Dresden Agreement

composed of the National Electrotechnical Committees of 22

European countries

http://www.cenelec.eu

CEN - European Committee for Standardization


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CEN European Committee for Standardization

fr. ComitEuropennede Normalisation

officially created as an international non-profit association based in

Brussels on 30 October 1975

major provider of European Standards and technical specifications

only recognized European organization according to Directive

98/34/EC for the planning, drafting and adoption of European

Standards in all areas of economic activity with the exception of

electrotechnology (CENELEC) and telecommunication (ETSI)

33 National Members work together to develop voluntary EuropeanStandards (ENs)

http://www.cen.eu

EN, the European Standard


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EN, the European Standard European Standards (EN) are documents that have been ratified by one of

the 3 European Standards Organizations, CEN, CENELEC or ETSI

designed and created by all interested parties through a transparent,consensual process

key component of the Single European Market

Internal Regulations, Part 3, states that the EN (European Standard) carrieswith it the obligation, in accordance with IR Part 2, to be implemented atnational level, by being given the status of a national standard and bywithdrawal of any conflicting national standards

must be transposed into a national standard in all member countriesguarantees that a manufacturer has easier access to the market of all theseEuropean countries when applying European Standards

Member countries must also withdraw any conflicting national standard: theEN prevails over any national standard

http://www.cen.eu/cen/products/en/pages/default.aspx

ETSI - European Telecommunications Standards Institute


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ETSI European Telecommunications Standards Institute

produces globally-applicablestandards for Information

and Communications Technologies (ICT),including fixed, mobile, radio, converged, broadcast and internettechnologies

produces standards and specifications supporting EU and EFTApolicy issues such as the New Approach, other EU legislation (e.g.Electronic Fee Collection, the interoperability regulation under theSingle European Sky (SES) initiative, the Electronic CommunicationNetwork and Services Framework Directives), mandated activity andother EU initiatives (e.g. Strategy 2020 and Digital Agenda)

recognized by the European Union as a European StandardsOrganization

not-for-profit organization with more than 700 ETSI memberorganizations drawn from 62 countries across 5 continents world-wide

http://www.etsi.org/

ANSIAmerican National Standards Institute


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S e ca a o a S a da ds s u e

founded on October 19, 1918 as a private, not-for-profit organization

is the official U.S. representative to the International Organization forStandardization (ISO) and, via the U.S. National Committee, the

International Electrotechnical Commission (IEC)

a member of the International Accreditation Forum (IAF)

regionally, the Institute is the U.S. member of the Pacific Area

Standards Congress (PASC) and the Pan American Standards

Commission (COPANT). ANSI is also a member of the Pacific

Accreditation Cooperation (PAC) and via the ANSI-ASQ National

Accreditation Board (ANAB), a member of the Inter American

Accreditation Cooperation (IAAC)

http://www.ansi.org

Q li


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Quality

ManagementLecture 6Laboratory Accreditationand Mutual Recognition

doc.dr.sc. Marko Jurevi

prof.dr.sc. Roman Malari




The Influence of Metrology on Trade


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gy

Metrology = foundation of quality; has a very close relation to

standardization

Metrology (includes testing instruments, testing methods and

testing standards) plays a very important role in international

trade

The process of the dissemination of the value of quantity is to

transmit gradually, through the different grade standards, thevalue reproduced by the national or international primary

standard to the measuring instruments and tools in the

laboratory

dissemination of the value of quantity is the fundamentalwork of metrology and the most important part of legal

metrology

Accreditation


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laboratory is an institute that calibrates and tests the procedure

of experimental certification The aim of the existence of laboratory is to provide society with

accurate and credible testing data and results

Laboratory Accreditationprovides a means of determining

the competence of laboratories to perform specific types oftesting, measurement and calibration.

general requirements for laboratory accreditation are contained

in ISO/IEC 17025 (contains quality system requirements and

technical requirements that the laboratories must meet) Ofcourse, laboratory accreditation requirements go beyond just

ISO/IEC 17025

Benefits of Laboratory Accreditation


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by obtaining accreditation, a laboratory will gain following

benefits:

enhancing the laboratory competence in order to be recognizednationally and internationally;

increasing the confidence in and the reliability of test results or

calibration results generated by the accredited laboratory

acceptance of testing and calibration certificates from accreditedlaboratories in countries who are members of APLAC and ILAC

Mutual Recognition Arrangements;

facilitating trade in national and international markets;

reducing technical barriers to trade, by eliminating the need for

repeated testing in the importing country;

the accredited laboratory will be used as a testi

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