(Erasmus) QM - 3 - 6 - Infrastructure Management Assurance Standardization Metrology ILAC Accreditation

Quality Management
Lecture 3 Quality Costs and Control

doc.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
Concept of Quality Costs
quality costs means to quantify the total cost of quality-related efforts 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.
University of Zagreb, Faculty of Electrical Engineering and Computing, Department of Fundamentals of Electrical Engineering and Measurements, 2013
Quality Costs
Feigenbaum defined the following quality cost areas:
Cost Area Description Examples
Prevention Costs of control (or conformance) Appraisal
Efforts 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)
Test and inspection of purchased materials, final inspection, testing Maintenance of inspection equipment quality audits, laboratoriy tests Inspection documentation Quality reports Scrap, rework, material procurement costs Deviation of output quantities
Inspection test and audits are used to detect defects
Internal failure costs Costs of failure of control (non conformance) External failure costs
Defects are caught internally and dealt with by discarting or repairing defective items Defects that reach customers
In- and Out of- Warranty complaints, product service, recall, lost of reputation and customers
Cost Area and Examples ...

Cost Area Tangible costs factory accounts Examples Extra operations added because of defects; excess inspection costs; investigation of defects causes; labour, materials and burden necessary to repair od scrapp/junk products Customer complaints -> Product discounts Charges to quality guarantee account Delays and stoppages caused by defectives Customer goodwill Friction between departments
Tangible costs sales accounts Intangible costs
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

Costs of poor quality ...
Indirect poor-quality costs

Customer-incurred cost Customer-dissatisfaction cost Loss-of-reputation cost
Nonconformities and Their Economic Effects

some examples (also from the last lecture):
In 2003, Nissan recalls 2.5 mio. cars because of an engine problem
Costs: 120 m
On average, 6.2 out of 1,000 pieces of luggage dont make it to their destinations at Northwest Airlines (USA)
Costs: 250 per piece of luggage that is sent separately
The Mecedes-Benz A-Class tips over during the moose accident test
Costs: Loss of image, costs of about 300 m for remodeling
Quality 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 on process* outputs. * process any single business or manufacturing activity that contributes to final product (or service) Quality Process uses a phased approach, designed to support the entire product life cycle from inception, design and development, through rollout, to updates and support.
The Triangle of Effects

Quality manager, 1958: We manufacture high quality products that justify their price
Quality, costs and time as equal objectives
Product manager, 2013: Our products are produced at optimal costs and they fulfill all quality-related requirements
Quality responsive excellence as the most important business objective
Quality
Quality
tension triangle
Time Costs
extension of view
Time
triangle of effects
Costs
Quality of products
Quality of business and continuous process improvement
Example: OEM: End customer: Manufacturer (supplier):
The price of our brake system shall decrease by 5 % per year. The brake system shall still be free from defects in 5 years. If the innovation cant be brought to market within the next 5 months, it wont be relevant until the following series.
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 all employees! Companies should not save on necessary but instead on unnecessary things:
Work that doesn't produce additional value (if it can be avoided) Faulty work which decreases the value of a product
Tasks of Quality Controlling

Supply of information Planning and control Coordination
Provisioning information on quality and costs

that is: goal oriented relevant for planning and decision-making retrospective and prospective
Coordination of activities regarding quality through plans and programmes
Preparation of the information in the form of compressed and clear reports
Evaluation of alternative choices of action in all qualityrelevant decisions to reach an optimum of quality costs
Quality Controlling and Cost Accounting

Financial reporting
Managerial accountng
Costs and results accounting
Standard costs accounting and budgeting Difference between actual and target costs
Investment appraisal and cash-flow statement

Cost unit accounting For what are costs incurred? Financial budgeting and liquidity planning Investment appraisals and cost effectiveness studies
Accounting Annual financial statemet Balancing
Cost category accounting: Which costs are incured in which amount?
Cost centre accounting: Where are costs incurred?
Provision of data Data preparation
Coordination needed Quality controlling
Appraisal Coordination
Arithmetic mean Will-Rogers-Phenomenon
source: RWTH Aachen University
Causation and Detection of Nonconformities
source: RWTH Aachen University University of Zagreb, Faculty of Electrical Engineering and Computing, Department of Fundamentals of Electrical Engineering and Measurements, 2013
Classification of Nonconformities/Failures
Critical failure
Failures that cause dangerous or unsafe situations for persons while they use the product Total impairment of serviceability (breakdown, loss) Partial impairment of serviceability Impairment of serviceability to a minor degree No impairment of serviceability
Major failure A Major failure B

Minor failure A Minor failure B
100 % error-free products do not exist in our reality. They cannot be realized under economic aspects The objective is to consistently ensure the serviceability of the products
Traditional Quality Cost Accounting

Quality costs are interpreted as a surcharge on manufacturing costs It is misleading to present the connection between costs and quality as a causal link. The costs are not caused by quality, but rather by nonconformity with quality standards during production. Quality costs in the traditional view deflect attention from real savings potentials.
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 to dissatisfaction, migration to competitors and decrease of the potential customers willingness to purchase.
Including Opportunity Costs (Costs of Lost Sales)
Structure und Classification of Quality Costs
Quality Management
Lecture 4 Introduction to Quality Infrastructure - Metrology and Standards
WHY A QUALITY INFRASTRUCTURE?
Storck Harbour scene
Quality infrastructure
Quality infrastructure relates to all fields of metrology, standardization and 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 combination of single elements
Recommended reading (availabe on QM moodle site): Dr. Clemens Sanetra, Roco M. Marbn: THE ANSWER TO THE GLOBAL QUALITY CHALLENGE: A NATIONAL QUALITY INFRASTRUCTURE
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 provide proof of its quality Domestic trade and export/import, which rely on testing facilities Regulators, who can rely on this infrastructure, thus avoiding duplicating facilities and services Research and development in enterprises, as they will have better access to all components of quality assurance Scientific and academic communities who are dependent on sound and internationally recognized measurements and testing procedures Financial institutions who will be more inclined to grant credits to enterprises capable of showing quality certifications Arbitration bodies in commercial disputes the entire population
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
Technical barriers to trade
The Agreement on Technical; Barriers to Trade (TBT) is one of the legal texts of the World Trade Organization (WTO) Agreement which obliges WTO Members to ensure that technical regulations, voluntary standards and conformity assessment procedures do not create 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 policy objectives, such as the protection of human health and safety, or the environment. http://www.wto.org/english/tratop_e/tbt_e/tbt_e.htm
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 greater integration of the partner countries into the international trading system Bilateral and multilateral free trade agreements make more and more 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 Bodies shall ensure acceptance of conformity assessment procedures based on adequate technical competence and verified compliance through accreditations. This is a requirement that cannot be fulfilled without having an internationally recognized QI structure in place.
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 the requirements set up by their national and international clients national metrology institute - custodian of the national measurement standards with their international traceability and it transfers this traceability to secondary and industrial measurement standards as well as eventually offering reliable calibration services at a reasonable cost accreditation body - ensure the technical competence of laboratories, of inspection bodies, and of the quality certifications granted in the country
totally independent, technical, not political
National Quality Infrastructure
National Standards Body
National Metrology Institute
National Accreditation Body
Access to international markets and preservation of domestic markets Globalization means that participation in markets is more and more decided based on quality of the products and services, rather than on their price.
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-called technical 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
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.
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.
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.
Metrology, calibration and legal metrology
The role of metrology is easily seen in the following:

No quality without quality control, no quality control without measurements, no measurements without calibration, no calibration without accredited laboratories, no accredited laboratories without traceability, no traceability without measurement standards, no measurement standards without metrology.
Metrology
metrology is the science of correct and reliable measurements a distinction is made between:
scientific metrology (development of primary measurement standards or primary methods), industrial metrology (proper maintenance and control of industrial measurement equipment including calibration of instruments and working measurement standards), and legal metrology (verification of instruments used in commercial transactions, according to criteria defined in technical regulations).
Some metrology terms

Metrology is 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 to measure, at least in principle Quantity is 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 the measurement (for electric devices, typical influence quantities may be temperature, humidity, pressure) Measurement method is a logical sequence of actions, described in general, used for measurement Measurement procedure is a detailed described sequence of actions needed for single measurement according to specific measurement method Measurement uncertainty is a non-negative parameter characterizing the dispersion of the values attributed to a measured quantity True value is the value that would be obtained by a perfect measurement, i.e. in an ideal world; value that is in conformance with the definition of a physical quantity Accuracy describes how closely a measurement comes to the true value of a physical quantity (example, a collection of resistors all marked 1 k will have a range of values, but the mean value should be 1 k. You can have more confidence in a number of measurements of a sample rather than an individual measurement. The variation enables you to identify a mean, a range and the distribution of values across the range) Precision: The closeness of agreement between replicate measurements on the same or similar objects under specified conditions.
... metrology terms

Repeatability or reproducibility (precision): The extent to which a measurement replicated under the same conditions gives a consistent result. Repeatability refers to data collected by the same operator, in the same lab/same conditions, over a short timescale. Reproducibility refers to data collected by different operators, in different laboratories/conditions. Standard is an object, system, or experiment that bears a defined relationship to a unit of measurement of a physical quantity
reference standard or prototype for the kilogram is the International Prototype Kilogram (IPK), a one kilogram mass of a platinum-iridium alloy kilogram maintained by the Bureau International des Poids et Mesures in 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 light travels in a vacuum during 1/299,792,458 of a second.
Metrological Standards
national measurement standard is often named the primary standard that is recognized by national law to serve in the country as the state basis for assigning values to other standards of the quantity concerned the custodian of national measurement standards in the USA is the NIST; and in Germany it is the PTB; in Croatia is the HMI types of metrological standards:
primary standard is a standard that is designated or widely acknowledged as having the highest metrological qualities and whose value is accepted without reference to other standards of the same quantity (Josephson device used for the realization of the unit volt is the primary standard of voltage quantity; stabilized laser used in conjunction with interferometers for the realization of one meter is the primary standard of the quantity length) secondary standards are standards whose value is assigned by comparison to a primary standard of the same quantity. Primary standards are usually used to calibrate secondary standards working standard is a standard that is used routinely to calibrate or check material measures, measuring instruments or reference materials. A working standard is usually calibrated with reference to a secondary standard and may be used to ensure that routine measurements are made correctly reference standard is a standard generally having the highest metrological quality available at a given location or in a given organization, from which the measurements made at that location are derived. Calibration laboratories maintain reference standards for calibrating their working standards
National Metrology Institute

every country has a National Metrology Institute NMI, 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 it must 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 metrological performance and testing procedures of measuring instruments subject to legal controls, and from the point of view of manufacturers it ensures that their products meet international specifications for metrological performance and testing examples: NIST (USA), NPL (GB), CMI (Croatia), PTB (Germany), AIST, KRISS...
NMI functions
it is the primary metrology laboratory; as such it develops national measurement standards and disseminates their exactitude to industry and users in the country, it establishes and maintains the national measurements system, giving technical support to 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, reference materials, calibrations and data to establish traceability of their measurements, it participates in modernization and technology transfer between academia, industry and government, contributing to reinforce the scientific and technical infrastructure required by industry 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 worldwide metrology 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.
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 the instrument used in industry up to the national measurement standard. This regularly repeated measurement to compare a measuring instrument against a measurement standard with higher accuracy is called calibration.
Traceability
Example:
the Croatian national measurement standards of a Croatian NMI are traceable to the German national metrology institute PTB, which demonstrates 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
Example: Distribution of the Value of Mass
source: http://www.bipm.org/ University of Zagreb, Faculty of Electrical Engineering and Computing, Department of Fundamentals of Electrical Engineering and Measurements, 2013
Example: Calibration Traceability
(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 requirements exactly, measurements have to be as accurate as necessary for the purpose. Additionally, it has to be borne in mind that every measurement has an "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 themselves require traceability. other levels require traceability to a primary standard, with a descending order of uncertainties of measurement. Maintenance of some of the primary measurement standards requires quite stringent conditions. metrology institutes in countries with little demand or relatively low uncertainty requirements do not necessarily have primary standards as their national measurement standards, as long as theirs are traceable to an internationally recognized NMI with primary standards. They must guarantee reliable traceability, and intercomparison measurements will vouch for their technical competence.
MRA and key comparisons
NMI envolved in CIPM KC NMI 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
Josephson device (KRISS)
http://www.kriss.re.kr
Josephson device in Croatia
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 measurement but the highest reliability of the declared measurement capabilities. These so-called Calibration and Measurement Capabilities (CMC) are listed in a database administered by the BIPM in Paris and published on the Internet. The database is frequently updated and extended; it shows the national measurement capabilities of each country for physical quantities and it has recently been extended to chemical quantities related to analytical capabilities e.g. for the determination of heavy metals, pesticides or antibiotics. These data play an important role in international trade when it comes to the level of contaminants in agricultural or food products where internationally recognized certificates are required. free trade agreements are beginning to refer to these measurement capabilities.
OIML - International Organization of Legal Metrology

an intergovernmental treaty organization which:
develops model regulations, standards and related documents for use by legal metrology* authorities and industry, provides mutual recognition systems which reduce trade barriers and costs in a global market, represents the interests of the legal metrology community within international organizations and forums concerned with metrology, standardization, testing, certification and accreditation, promotes and facilitates the exchange of knowledge and competencies within the legal metrology community worldwide, cooperates with other metrology bodies to raise awareness of the contribution that a sound legal metrology infrastructure can make to a modern economy.
OIML is an international standard-setting body in the sense of the WTO's Technical Barriers to Trade Agreement. OIML publications should therefore be applied, when appropriate, by all signatories of the TBT Agreement when developing technical regulations http://www.oiml.org/en/about/about-oiml
* Legal metrology is the application of legal requirements to measurements and measuring instruments.
The Convention of the Metre, 1875

is a diplomatic treaty which gives authority to the General Conference on Weights and Measures (Confrence Gnrale des Poids et Mesures, CGPM), the International Committee for Weights and Measures (Comit International des Poids et Mesures, 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.
The Convention of the Metre, 1875
BIPM
BIPM - The International Bureau of Weights and Measures (BIPM) was set up by the Metre Convention and has its headquarters 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 ionizing radiation). http://www.bipm.org/en/bipm/
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/
CGPM - Confrence Gnrale des Poids et Mesures

The General Conference on Weights and Measures (Confrence Gnrale des Poids et Mesures, CGPM) is made up of delegates of the governments of the Member States and observers from the Associates of the CGPM. The General Conference receives the report of the International Committee 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 metrological determinations and various scientific resolutions of international scope; and it decides all major issues concerning the organization and development of the BIPM, including the dotation of the BIPM. The CGPM meets in Paris, usually once every four years; the 24th meeting was held from 17-21 October 2011. http://www.bipm.org/en/convention/cgpm/
SI, International System of Units

The 11th General Conference on Weights and Measures in 1960 adopted the name Systme International dUnits (International System of Units, international abbreviation SI), for the recommended practical system of units of measurement defines rules for the prefixes, the derived units, and other matters
Modern definition of meter Metal bar, Pt-Ir, 1889-1960
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 units according to the algebraic relations linking the corresponding quantities http://www.bipm.org/en/si/
SI base units
Unit name metre kilogram second Unit Symbol m kg s Quantity name length mass time Definition The distance travelled by light in vacuum in 1/299792458 second. The mass of the International Prototype Kilogram 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 The constant current which, if maintained in two straight parallel 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 2107 newtons per metre of length The fraction 1/273.16 of the thermodynamic temperature of the triple point of water The amount of substance of a system which contains as many elementary entities as there are atoms in 0.012 kilogram of carbon 12
ampere
electric current
kelvin mole
K mol
thermodynamic temperature amount of substance
The luminous intensity, in a given direction, of a source that emits monochromatic radiation of frequency 5401012 candela cd luminous intensity hertz and that has a radiant intensity in that direction of watt per steradian. University of Zagreb, Faculty of Electrical Engineering and Computing,1/683 Department
of Fundamentals of Electrical Engineering and Measurements, 2013
Named units derived from SI base units

Name radian steradian hertz newton pascal joule watt coulomb Symbol rad sr Hz N Pa J W C angle solid angle frequency force, weight pressure, stress energy, work, heat power, radiant flux electric charge or quantity of electricity voltage (electrical potential difference), electromotive force electric capacitance electric resistance, impedance, reactance electrical conductance magnetic flux magnetic field strength inductance temperature relative to 273.15 K luminous flux illuminance radioactivity (decays per unit time) absorbed dose (of ionizing radiation) equivalent dose (of ionizing radiation) catalytic activity J/kg J/kg cdsr lm/m2 W/A C/V V/A A/V V s Wb/m2 Wb/A Quantity Expressed in terms of other SI units 1 1 Expressed in terms of SI base units m/m m2/m2 s1 kgms2 kgm1s2 kgm2s2 kgm2s3 sA
N/m2 N m J/s
volt farad ohm siemens weber tesla henry degree Celsius lumen lux becquerel gray sievert katal
V F S Wb T H C lm lx Bq Gy Sv kat
kgm2s3A1 kg1m2s4A2 kgm2s3A2 kg1m2s3A2 kgm2s2A1 kgs2A1 kgm2s2A2 K cd m2cd s1 m2s2 m2s2 s1mol
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 be used 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, nautical mile, barn, knot, neper and [deci]bel ) Non-SI units associated with the CGS and the CGS-Gaussian system of units (erg, dyne, poise, stokes, stilb, phot, gal, maxwell, gauss and rsted)
Scientific notation
Importance of units
Mars Climate Orbiter, 1998 due to complications arisen from human error, the spacecraft encountered Mars at a lower than anticipated altitude and disintegrated due to atmospheric stresses. the flight system software on the Mars Climate Orbiter was written to take thrust instructions using the metric unit newtons (N), while the software on the ground that generated those instructions used the Imperial measure pound-force (lbf). This error has since been known as the "metric mixup" and has been carefully avoided in all missions since by NASA.
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), in Latin America it is the SIM Sistema Interamericano de Metrologa; Inter-American Metrology System.
http://www.bipm.org/en/practical_info/useful_links/rmo.html
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) of Europe in fields like research in metrology, traceability of measurements to the SI units, international recognition of national measurement standards and related Calibration and Measurement Capabilities (CMC) of its members. Through Knowledge Transfer and cooperation among its members EURAMET facilitates the development of the national metrology infrastructures. responsible for the elaboration and execution of the European Metrology Research Programme (EMRP) which is designed to encourage collaboration between European National Metrology Institutes (NMIs) and partners in industry or academia. The programme funds joint research projects in specific fields of metrology with over 50 projects selected for funding so far and many more expected over the coming years.
EURAMET
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)

mutual recognition agreement (MRA) is an international agreement by which two or more countries agree to recognize one 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 international organizations 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
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 assessment through the Agreement on Mutual Recognition in Relation to Conformity Assessment (Signed July 4, 2000)
Certification
certification confirms conformity with requirements defined in written standards. recognition can be achieved by using standards and assessment procedures which are implemented worldwide (ISO-Standards, Codex Alimentarius recommendations, etc.). a third party assessment of the competence of the Certification Body and regular surveillance visits by an accreditation body will confirm reliability and facilitate international recognition 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 and management 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 Point HACCP
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
Accreditation and Certification are often confused or seen as equivalent, which is a misconception. much more than a certification Accreditation is 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?
Example: various telephone plugs

Standardization and International standards

standard (another similar definition) is a document, established by consensus and approved by a recognized body, that provides, for common and repeated use, rules, guidelines or characteristics for activities or their results, aimed at the achievement of the optimum degree of order in a given context. International standards:
developed by international standards organizations. International standards are available for consideration and use worldwide. may be used either by direct application or by a process of modifying an international standard to suit local conditions if adopted, result in the creation of national standards that are substantially the same as international standards in technical content, but may have
(i) editorial differences as to appearance, use of symbols and measurement units, substitution of a point for a comma as the decimal marker, and (ii) differences resulting from conflicts in governmental regulations or industry-specific requirements caused by fundamental climatic, geographical, technological, or infrastructural factors, or the stringency of safety requirements that a given standard authority considers appropriate

International standards are one way of overcoming technical barriers in international commerce, caused by differences among technical regulations and standards developed independently and separately by each nation, national standards organization, or company standards can vary in two major respects:
the type of agreement the number of people, organizations or countries who were involved in making the agreement.
In some standards, the type of agreement essentially amounts to advice and guidance; others are much more prescriptive and set out absolute requirements that have to be met if a user wishes to make a claim of compliance with the standard.
Croatian (HR), British (BS), German (DIN) ... other national European (EN) and international standards (ISO/IEC) are developed according to strict rules to ensure that they are transparent and fair private/internal company standards
The standards infrastructure is responsible for producing:
full consensus documents, i.e. standards; and partial consensus documents
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 for Standardization (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
R e International c o g Regional n i z ANSI e National d Industry Companies
API
ISO / IEC
Vienna agreement
on technical cooperation between ISO and CEN
CEN /
CENELEC
HRN
BS
other European
ASME
OGP
EEMUA
UKOOA
operators
contractors
suppliers
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 setting out 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 user community Codes of practice recommend sound good practice as currently undertaken 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 way of measuring, testing or specifying what is reliably repeatable in different circumstances and places, wherever it needs to be applied. Vocabulary - a set of terms and definitions to help harmonize the use of language in a particular subject or discipline. Guides - published to give less prescriptive advice which reflects the current thinking and practice amongst experts in a particular subject.
Some technical standard organisations

International standards organizations
ANSI American National Standards Institute BIPM, CGPM, and CIPM Bureau International des Poids et Mesures and the related 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

International Organization for Standardization - an international standard-setting body composed of representatives from various national standards organizations ISO was founded on 23 February 1947 the organization today known as ISO began in in 1906. as International Electrotechnical Commission; 1926 as the International 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 on standards, each one representing one country products: international standards technical reports, technical specifications, publicly available specifications, technical corrigenda, and guides
ISO structure
http://www.iso.org/
CASCO Conformity assessment COPOLCO Consumer Policy DEVCO Developing country matters REMCO Committee on reference materials
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, with members drawn from the membership as a whole. The ISO Council meets three times a year, and its members are rotated to ensure that it is representative of ISO's membership. Operations are managed by the Secretary-General, whose appointment is permanent. The Secretary-General reports to the President, who is a prominent figure 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 provides administrative and technical support to ISO members, coordinates the decentralized standards' development programme and publishes the output.
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 is accepted for membership in the ISO. Member bodies are entitled to participate and exercise full voting rights on any technical committee or policy committee of ISO. Correspondent members - usually an organization in a country that does not yet have fully developed national standards activities. Correspondent members do not take an active part in the technical and policy development work, but are entitled to be kept fully informed about the work of interest to them. Subscriber membership has been established for countries with very small economies. Subscriber members pay reduced membership fees that nevertheless allow them to maintain contact with international standardization activities. http://www.iso.org/iso/home/about/iso_members.htm
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 IEC is 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 for standards 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?

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 new scopes of technological activity. In order to use resources most efficiently, ISO only launches the development of new standards for which there is clearly 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 and business sectors who have requested the standards, and will subsequently put them to use. The experts may be joined by others with relevant knowledge, such as representatives of government agencies, testing laboratories, consumer associations, environmentalists, .... They participate as national delegations, chosen by the ISO national member institute for the country concerned.
How does ISO develop standards?

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 the preparation of a working drafts Subcommittees may have several working groups, which can have several Sub Groups (SG) http://www.iso.org/iso/home/standards_development.htm http://www.iso.org/iso/home/standards_development/resources-fortechnicalwork/stages_of_the_development_of_international_standards.htm
National contribution in global standardization
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 in the development of any standard which is judged to be important to its country's economy voluntary
ISO has no legal authority to enforce their implementation. Some ISO standards (mainly concerned with health, safety or environment) have been adopted in some countries as part of their regulatory framework, or are referred to as the technical basis for legislation. Using ISO standards is a sovereign decision made by the regulatory authorities or governments; ISO itself does not regulate or legislate. they may become a market requirement (example: the case of ISO 9000 quality management systems or of dimensions of freight containers and bank cards).
market-driven - ISO develops only those standards for which there is a market requirement consensual - the fact that they are developed in response to market demand and are based on consensus among the interested parties ensures widespread applicability of the standards. international - ISO standards are technical agreements that provide the framework for compatible technology worldwide
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

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 to Geneva, Switzerland http://www.iec.ch/
CENELEC - European Committee for Electrotechnical Standardization
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
fr. Comit Europenne de 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 European Standards (ENs) http://www.cen.eu
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) carries with it the obligation, in accordance with IR Part 2, to be implemented at national level, by being given the status of a national standard and by withdrawal of any conflicting national standards must be transposed into a national standard in all member countries guarantees that a manufacturer has easier access to the market of all these European countries when applying European Standards Member countries must also withdraw any conflicting national standard: the EN prevails over any national standard http://www.cen.eu/cen/products/en/pages/default.aspx
ETSI - European Telecommunications Standards Institute

produces globally-applicable standards for Information and Communications Technologies (ICT), including fixed, mobile, radio, converged, broadcast and internet technologies produces standards and specifications supporting EU and EFTA policy issues such as the New Approach, other EU legislation (e.g. Electronic Fee Collection, the interoperability regulation under the Single European Sky (SES) initiative, the Electronic Communication Network and Services Framework Directives), mandated activity and other EU initiatives (e.g. Strategy 2020 and Digital Agenda) recognized by the European Union as a European Standards Organization not-for-profit organization with more than 700 ETSI member organizations drawn from 62 countries across 5 continents world-wide http://www.etsi.org/
ANSI American National Standards Institute

founded on October 19, 1918 as a private, not-for-profit organization is the official U.S. representative to the International Organization for Standardization (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
Quality Management
Lecture 6 Laboratory Accreditation and Mutual Recognition
The Influence of Metrology on Trade

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, the value 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 fundamental work of metrology and the most important part of legal metrology
Accreditation
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 Accreditation provides a means of determining the competence of laboratories to perform specific types of testing, 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) Of course, laboratory accreditation requirements go beyond just ISO/IEC 17025
Benefits of Laboratory Accreditation

by obtaining accreditation, a laboratory will gain following benefits:
enhancing the laboratory competence in order to be recognized nationally 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 accredited laboratories 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 testing unit by the regulator
ISO/IEC 17025
ISO/IEC 17025 General requirements for the competence of testing and calibration laboratories main ISO/CASCO standard used by testing and calibration laboratories specifies the general requirements for the competence of laboratories to carry out tests and/or calibrations contains management requirements and technical requirements many commonalities with the ISO 9000 standard, but ISO/IEC 17025 is more specific in requirements for competence covers testing and calibration performed using standard methods, nonstandard methods, and laboratory-developed methods applicable to all organizations performing tests and/or calibrations. (includes first-, second- and third-party laboratories, and laboratories where testing and/or calibration forms part of inspection and product certification) for use by laboratories in developing their management system for quality, administrative and technical operations not intended to be used as the basis for certification of laboratories
ISO/IEC 17025
originally known as ISO/IEC Guide 25, ISO/IEC 17025 was initially issued by the International Organization for Standardization in 1999 predecessor was the EN 45001 (withdrawn after ISO/IEC 17025 was adopted as EN ISO/IEC 17025) a second release in 2005 (after it was agreed that it needed to have its quality system words more closely aligned with the ISO 9001:2000)
ISO/IEC 17025
accreditation is simply formal recognition of a demonstration of that competence prerequisite for a laboratory to become accredited is to have a documented quality management system laboratories use ISO/IEC 17025 to implement a quality system aimed at improving their ability to consistently produce valid results basis for accreditation from an accreditation body
ISO/IEC 17025
comprises five elements that are
Scope, Normative References, Terms and Definitions, Management Requirements and Technical Requirements
main sections are Management Requirements (related to the operation and effectiveness of the quality management system within the laboratory) and Technical Requirements (includes factors which determines the correctness and reliability of the tests and calibrations performed in laboratory)
online preview: https://www.iso.org/obp/ui/#iso:std:iso-iec:17025:ed2:v1:en
ISO/IEC 17025
allows laboratories to carry out procedures in their own ways, but an auditor (assessor) may require the laboratory to justify using a particular method requires continual improvement regular internal audits are expected to indicate opportunities to make the test or calibration better than it was. the laboratory is expected to show scientific and technological advances in relevant areas third party auditing (assessment) of the laboratory is normally carried out by the national organization responsible for accreditation laboratories are accredited under ISO/IEC 17025, rather than certified or registered (as with ISO 9000 series)
Accreditation bodies
ILAC worked to establish methods of evaluating accreditation bodies against ISO/CASCO standard (ISO/IEC Guide 58 which became ISO/IEC 17011) in Croatia, Croatian Accreditation Agency (HAA) is national accreditation body complying with all requirements of the international and European standard for accreditation bodies adopted in the Republic of Croatia as the Croatian Standard HRN EN ISO/IEC 17011: 2005.
ISO/IEC 17025
During an ISO/IEC 17025 assessment, technical competence must be demonstrated (showing appropriate calibration and/or testing procedures) ISO/IEC 17025 assessor will evaluate many aspects of your technical program (interact with the technicians, gathering necessary competence information, and will expect each technician to not only perform calibration and/or testing methods correctly but also understand why particular methods are followed. Also the assessor can analyze training records for competence information) During the accreditation process, your accreditation body is required to approve and issue a "scope of accreditation. scope of accreditation is a supplementary certificate document that outlines laboratories technical capabilities. laboratories are required to document each calibration or testing parameter, parameter range, the best measurement uncertainty for each parameter and the calibration/testing equipment or standard(s) used for each parameter labs are required to represent their capabilities honestly on their issued scope
Accreditation vs. certification
accreditation differs from certification by adding the concept of a third party (Accreditation Body - AB) attesting to technical competence within a laboratory in addition to its adherence and operation under a documented quality system (specific to a Scope of Accreditation)
ILAC - International Laboratory Accreditation Cooperation

first started as a conference in 1977 develop international cooperation for facilitating trade by promotion of the acceptance of accredited test and calibration results ILAC was formalized as a cooperation in 1996 when 44 national bodies signed a Memorandum of Understanding (MOU) in Amsterdam on 2 November 2000, ILAC's 36 full members, consisting of laboratory accreditation bodies from 28 economies worldwide, signed a mutual recognition arrangement (the ILAC Arrangement) in Washington DC, to promote the acceptance of technical test and calibration data for exported goods aim is to increase use and acceptance by industry and government of the results from accredited laboratories and inspection bodies, including results from facilities in other countries. in this way, the free-trade goal of 'product tested or inspected once and accepted everywhere' can be realized www.ilac.org
International Mutual Recognition

Mutual Recognition Arrangement (MRA) is an arrangement between two or more parties to mutually recognise or accept some or all aspects of one anothers conformity assessment results (e.g. test reports, certificates of compliance) products that are tested and/or certified before export can enter the importing country directly without having to undergo similar conformity assessment procedures in the importing country In the agreement, the accreditation institutes (government or individuals) are required to operate according to the ISO/IEC rules every accreditation institution must show that its operations are effective (it can ensure that the ability of a laboratory that it has accredited is in accordance with the ISO/IEC 17025 criteria)
Benefits of Mutual Recognition

to achieve international mutual recognition, the metrological benchmark and the criterion of every country must be equivalent or accordant. method in use is to compare the national metrological institutions of different countries. key comparison is carried out by choosing the main physical quantities in a field ILAC mutual recognition agreement is an important cooperation tool that serves to promote international free trade when products are sold from one country to another, there is no need to inspect them again. This promotes the international free traffic of goods by decreasing costs, minimizing technical barriers and promoting the globalization of trade
The European Standardization System

differences between national laws, standards, and conformity assessment procedures made trade between the member states difficult, expensive and time-consuming creation of the Single Market in Europe was laid down in four basic principles commonly identified as the 4 freedoms, free movement of goods, services, capital and workers goal of the Single Market was to eliminate all barriers to trade existing between the Member States new legislative technique and strategy was established: The New Approach
New Approach
New Approach to Technical Harmonization and Standardization was passed as a Council Resolution on May 7th 1985 (OJ 85/C136/1) to "harmonize" the health, safety, and environmental requirements of Member States into one single European legislative package New Approach Directives are broad regulatory requirements to which confronted products must conform one piece of legislation replaced existing ones in every State Member States are obliged to adopt the New Approach Directives because European legislation always prevails over national one, which must be replaced represents a major change in policy for it makes reference to voluntary European Standards as the most appropriate method for technical implementation of legally-imposed requirements for products under European law products placed on the market must comply with legislation but not necessarily with standards
Old Approach
the Old Approach that caused slow development of the Internal Market until 1985 prior to this harmonization, each country developed its own standards through a National Standards Body. Different sets of standards were not only costly, but also created major difficulties to trade between European countries. It became necessary to create a new, integrated, European system of standardization civil servants at the Commission used to draft detailed technical specifications that were annexed to the Directives. This was a long process and required the continuous updating of documents three European Standards Bodies were asked to plan, draft, create and adopt standards Europe-wide: CEN, CENELEC and ETSI Global Approach to Testing, Certification and Conformity Assessment, adopted in 1989, supplements the New Approach Global Approach provided for the establishment of harmonized procedures to assess the conformity of products with the requirements of the New Approach Directives and the placing of the CE Marking to such products. Notified Bodies (officially recognized organizations within Member States) certify conformity on the basis of the New Approach, if required by the appropriate Directive
New Approach Directives

New Approach Directives are based on the following principles: Legislation is restricted to regulatory specifications that must be met before products can be placed on the European market place. These specifications are outlined in the New Approach Directives and mainly refer to essential requirements that are of public interest (health and safety) necessary standards ensuring that products meet these regulatory requirements are created by the CEN, CENELEC or ETSI, depending on the work field. They are called harmonized standards application of harmonized standards or other technical specifications remains voluntary. Manufacturers are always free to choose any technical solution that provides compliance with the essential requirements set by the Directive only products fulfilling the essential requirements may be placed on the European market and put into service national authorities must acknowledge that products manufactured in conformity to harmonized standards are presumed to conform to all the necessary legal requirements established by the Directives manufacturers may choose between different conformity assessment procedures provided for in the applicable Directive
European Conformity - CE Marking

CE Marking was chosen as an easily identifiable label to indicate compliance with the requirements of the New Approach The CE Marking is a declaration of conformity with European legislation designed to show all parties concerned that a product meets all the appropriate requirements specified by New Approach Directives a passport for entrance into the EU market CE in the term CE Marking stands for Conformit Europenne (European Conformity)
CE Marking
Which Directives apply to some product

first step to compliance is the responsibility of the manufacturer to determine which Directives apply to the product (note: product may be regulated by more than one Directive)
solution: CENELEC publishes every year in June the CD-ROM Links between Products, Directives and Standards in the Electrotechnical Field
after the Directives and the requirements have been identified, the manufacturer must them apply the appropriate standards and/or elaborate his product on the basis of the essential requirements depending on the individual Directive, he may have to undertake a method of Conformity Assessment
CE Marking
the manufacturer or his Authorized Representative, established in the European Union, affixes the CE Marking to the product CE marking must be affixed visibly, legibly and indelibly to the product, to its data plate or, where this is not possible, to its packaging
Declaration of Conformity
CE Marking does not provide any information about the Directives or Standards that apply to the product nor about the method of Conformity Assessment used to bring the product into compliance. this information is provided by other accompanying documents such as the Declaration of Conformity manufacturer may fill out the Declaration of Conformity, sign it and affix the CE Marking to products or equipment only if he can prove conformity to the applicable requirements set in the Directives or to harmonized standards other products (involving higher risks for both consumers and workers) cannot be certified by the manufacturer only. they must undergo one or more of the modules for Conformity Assessment foreseen in the Global Approach to Conformity Assessment involving the intervention of an independent third party: a Notified Body
Notified Bodies
independent test houses or certification bodies that carry out the Conformity Assessment procedures referred to in the applicable New Approach Directive designated and notified by each Member State and must have the necessary qualifications (technical, but also independence, impartiality and integrity) to meet the testing and/or certification requirements set by the Directives Certificates issued by a Notified Body in one Member State must be accepted throughout the European Union list of Notified Bodies is published in the Official Journal of the European Communities and provided by European Organization for Conformity Assessment
References
ISO: International standards and private standards, http://www.iso.org/iso/private_standards.pdf, 2013 Paul Ingallinera, What You Should Know About Laboratory Accreditation, www.qualitydigest.com/feb03/articles/03_article.shtml www.etsi.org www.NewApproach.org CENELEC, Primer on Standards - Uncovering the mysteries of standardization in Europe, 2002

(Erasmus) QM - 3 - 6 - Infrastructure Management Assurance Standardization Metrology ILAC Accreditation

Hochgeladen von

Dokumentinformationen

Originaltitel

Copyright

Verfügbare Formate

Dieses Dokument teilen

Dokument teilen oder einbetten

Freigabeoptionen

Stufen Sie dieses Dokument als nützlich ein?

Sind diese Inhalte unangemessen?

Copyright:

Verfügbare Formate

(Erasmus) QM - 3 - 6 - Infrastructure Management Assurance Standardization Metrology ILAC Accreditation

Hochgeladen von

Copyright:

Verfügbare Formate

Quality Management

Lecture 3 Quality Costs and Control

Concept of Quality Costs

Prevention Costs of control (or conformance) Appraisal

Efforts to keep defects from occurring

Inspection test and audits are used to detect defects

Cost Area and Examples ...

Tangible costs sales accounts Intangible costs

Costs of poor quality

Resultant poor-quality cost

Equipment poor-quality cost

Costs of poor quality ...

Indirect poor-quality costs

Nonconformities and Their Economic Effects

The Triangle of Effects

Quality of business and continuous process improvement

Example: OEM: End customer: Manufacturer (supplier):

Increase of Process Quality through Avoidance of Waste

Tasks of Quality Controlling

Provisioning information on quality and costs

Coordination of activities regarding quality through plans and programmes

Preparation of the information in the form of compressed and clear reports

Quality Controlling and Cost Accounting

Investment appraisal and cash-flow statement

Accounting Annual financial statemet Balancing

Cost category accounting: Which costs are incured in which amount?

Cost centre accounting: Where are costs incurred?

Provision of data Data preparation

Coordination needed Quality controlling

Arithmetic mean Will-Rogers-Phenomenon

source: RWTH Aachen University

Causation and Detection of Nonconformities

Major failure A Major failure B

Traditional Quality Cost Accounting

Including Opportunity Costs (Costs of Lost Sales)

Structure und Classification of Quality Costs

WHY A QUALITY INFRASTRUCTURE?

Storck Harbour scene

Target groups interested in QI

Challenges from free trade and globalization

Technical barriers to trade

Need for national quality infrastructure

National Quality Infrastructure

totally independent, technical, not political

National Quality Infrastructure

National Standards Body

National Metrology Institute

National Accreditation Body

Consumer protection (health, safety, environment)

Metrology, calibration and legal metrology

The role of metrology is easily seen in the following:

Some metrology terms

... metrology terms

National Metrology Institute

Traceability and calibration

Example: Distribution of the Value of Mass

Example: Calibration Traceability

(Inter)National Measurement Traceability

MRA and key comparisons

Josephson device (KRISS)

Josephson device in Croatia

Calibration and Measurement Capabilities

OIML - International Organization of Legal Metrology