QUALITY STANDARDISATION

A STANDARD definition !   It is a TECHNICAL DOCUMENT designed to

be used as a RULE, GUIDELINE or DEFINITION.

!   A standard may be defined as “a repeatable way of doing something”.

!   COMPANY !   SECTOR-SPECIFIC !   NATIONAL !   REGIONAL !   INTERNATIONAL

STANDARD

Types of standards !   Vocabulary standards, e.g. glossaries, signs, and

symbols; !   Basic standards, such as units of measures

(grading & classification); !   Product standards that cover specification for

dimensions, performance, health, safety, environmental protection and documentation;

!   Standards for inspection, sampling, test methods and analysis;

!   Management standards that focus on organization, such as for quality management, project management, etc.

Packaging and distribution of foods

!   ISO 3863:1989 “Cylindrical cork stoppers – Dimensional characteristics, sampling, packaging and marking”

!   ISO 4707:1981 “Cork - stoppers Sampling f o r i n s p e c t i o n o f d i m e n s i o n a l characteristics”

!   ISO 4710:2000 “Cork – Cylindrical stoppers for sparkling wines and gasified wines - Characteristics

WHAT IS A STANDARD? (1/2) !   Standards are VOLUNTARY and as such

do not impose any regulations. They provide test specifications and test methods (safety, quality, etc.).

!   Standards are consensus-based: All in te res ted par t i es (manufac ture rs , consumers and regulators) of a particular material, product, process or service are involved in the standard development.

!   Standards are approved by a recognized body.

WHAT IS A STANDARD? (1/2) !   Though the application of standards is voluntary,

laws and regulations may refer to standards and make compliance with them compulsory.

STANDARD MADE COMPULSORY !   In the EU Directives, Regulations and other EU

l e g i s l a t i o n m a y r e f e r t o E U R O P E A N STANDARDS.

!   National legislation may refer to NATIONAL STANDARDS.

!   Voluntary standardisation can support regulations concerning products on the European market.

Source: www.cen.eu

ISO

CEN

UNI

The Standardisation Bodies

•  UNI – Italian Organisation for Standardisation - 1921 •  CEI – Italian Electrotechnical Committee - 1909 •  CONCIT – “National Committee for Telecommunication Co-

ordination” - 1988 •  ITU - International Telecommunication Union

IEC

CENELEC

CEI

IEC ITU-T

ETSI

CONCIT*

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COUNTRY

REGIONAL

GLOBAL

National Standards Bodies (NSBs) !   They develop and issue standards at the country level. !   They represent their country in regional and international

bodies. !   They hold a reference library of national, regional and

international standards. !   They sell copies of standards for a reasonable fee. Standards

are not free of charge. They are PUBLICLY AVAILABLE DOCUMENTS that may be purchased.

! Some also offer conformity assessment services such the

accreditation, certification or other activities (not in Italy).

Some European NSBs ITALY UNI Ente Nazionale Italiano di Unificazione

U.K. BSI British Standards Institution

FRANCE AFNOR Association Française de Normalisation

GERMANY DIN Deutsches Institut für Normung e.V.

AUSTRIA ASI Austrian Standards Institute

DENMARK DS Danish Standards

SWEDEN SN Standards Norway

SPAIN AENOR Asociación Española de Normalización y Certificación

Source: www.cen.eu

Other NSBs USA ANSI American National Standards Institute

CHINA SAC Standardization Administration of the People's Republic of China

JAPAN JSIC Japanese Industrial Standards Committee

INDIA BIS Bureau of Indian Standards

BANGLADESH BSTI Bangladesh Standards and Testing Institution

BULGARIA BDS Bulgarian Institute for Standardization

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

European Standards Organisations (ESOs)

!   In Europe in the area of voluntary technical standardisation there are 3 Standards Organisations recognized as competent bodies:

!   CEN, CENELEC and ETSI with generally different subject areas (competence fields), but cooperating in fields of common interest (i.e. ICTs).

!   CEN is a non-profit organisation whose main fields of activity involve various sectors such as: q  Air and Space, Chemistry, q  Construction, Consumer Products, q  Energy and Utilities, q  Food, Health and Safety, q  Packaging and others.

!   CEN develops European Standards (ENs), which are also National standards in the member countries (CEN National Members).

www.cen.eu

The European Standards

!   It is the responsibility of the CEN National Members to implement European Standards as National standards.

!   The National Standards Bodies (NSBs) distribute and sell the implemented European Standard and have to withdraw any conflicting national standards.

The development of ENs !   CEN’s 31 NATIONAL MEMBERS (the

NSBs of the EU and EFTA countries) work together to develop the ENs in order to help build the European internal market, removing barriers to trade and strengthening Europe’s position in the global economy.

!   In CEN Technical Committee, experts are mandated by NSBs.

* EU Free Trade Association (Iceland, Liechtenstein,

Norway, Swiss)

ISO

!   ISO is a non-governmental organization: a bridge between the public and private sectors.

!   ISO is the world's largest developer and publisher of International Standards (over 19500 International Standards on a variety of subjects).

!   ISO is a network of the national standards bodies of 161 countries (one member per country) with a Central Secretariat in Geneva (CH) that coordinates the system.

Source: www.iso.org

The ISO SYSTEM

!   The ISO Sys tem i s f inanced thanks to the MEMBERSHIP SUBSCRIPTIONS. Each national member pays in proportion to the country's Gross National Income and trade figures).

!   Another source of revenue is the SALE of STANDARDS. However, the operations of ISO Central Secretariat represent only about one fifth of the cost of the system's operation. The main costs are borne by: !   the member bodies that manage the development projects

for specific standards !   and the business organizations that provide experts to

participate in the technical work. Source: www.iso.org

In the definition of new standards are involved 3238Technical Bodies: 210 Technical Committees (TCs) 519 Subcommittees (SCs) 2443 working groups (WGs) 66 ad hoc study groups.

The Technical Bodies

44

The ISO Standards… !   make the development, manufacturing and supply of

products and services more efficient, safer, reliable and cleaner;

!   facilitate trade between countries; !   provide governments with a technical base for health,

safety and environmental legislation, and conformity assessment ;

!   share technological advances and good management practice;

!   disseminate innovation; !   safeguard consumers, and users in general, of products

and services; !   make life simpler by providing solutions to common

problems. Source: www.iso.org

An ISO Standard for… !   All the credit cards look very much alike,

and can only be used worldwide thanks to their dimensions and thickness based on ISO/IEC 7810, Identification cards – Physical characteristics.

An ISO Standard for… !   Alimentary pasta produced from durum wheat

semolina – Estimation of cooking quality by sensory analysis – Part 2: Routine methods

Source: www.iso.org

A TEST METHOD FOR LABS to determine a

minimum of cooking time for pasta.

An ISO Standard for ensuring Customer Satisfaction

!   Designed to encourage HARMONIZATION

of the complaints handling processes practised in different countries and by different businesses worldwide.

!   The standard provides the essential elements for handling complaints within an organization - from initial receipt to the final assessment of complaint satisfaction.

ISO 10002 Guidelines for complaints handling

ISO Standards for ensuring quality & safety

!   ISO 18416:2007 helps to reduce cases of infection from cosmetic with guidelines for microbiological examination for labs (in particular, for Candida Albicans).

!   I S O 2 2 7 1 6 : 2 0 0 7 p r o v i d e s g o o d

manufacturing practices for cosmetic products: it gives guidelines for the production, control, storage and shipment of cosmetic products.

ISO Management Standards (1/4) !   The ISO 14000 family of standards are

c o n c e r n e d w i t h e n v i r o n m e n t a l management . This means what an organization does to:

– minimize the negative effects on the environment caused by its activities, and to

– achieve continual improvement of its environmental performance.

!   ISO 14001:2004 gives the requirements for environmental management systems (EMS) for organizations wishing to operate in an environmentally sustainable manner.

!   The ISO 22000 family of standards for FOOD SAFETY management are aimed to ensure safe food supply chains worldwide by providing a framework of internationally harmonized requirements.

!   Organizations can choose to be independently certified as conforming to the requirements of ISO 22000:2005, or may be required to do so by their customers or regulators.

ISO Management Standards (2/4)

!   ISO/IEC 27001, Information technology – Security techniques – Information security management systems – Requirements, specifies the processes to enable a business to

!   establish, implement, review and monitor, manage and maintain an effective Information Security Management System (ISMS).

!   A systematic approach to managing sensitive company information so that it remains secure.

!   A standard published by ISO and the International Electrotechnical Commission (IEC).

ISO Management Standards (3/4)

!   ISO 26000:2010, Social Responsibility

! Thi standard provides guidance rather than requirements, so it cannot be certified.

! It helps clarify what social responsibility is,

! It helps businesses and organizations translate principles into effective actions

! It shares best practices relating to social responsibility, globally.

! It is aimed at all types of organizations regardless of their activity, size or location.

ISO Management Standards (4/4)

The development of ISO Standards !   ISO launches the development of new

standards in response to the industrial, technical and business sectors that express a clearly established need for them to one of ISO's national members.

!   The latter then proposes a new work item to ISO.

!   If accepted, the work item is assigned to an existing technical committee.

Please note ! ISO does not perform certification

!   ISO doesn’t provide CERTIFICATION or CONFORMITY ASSESSMENT.

!   It is not involved in the certification process to any of the developed and published standard.

!   Certification* is performed by external certification bodies, which are largely provate.

* In North America certification is very ofeten referred to as REGISTRATION.

Certification

!   The provision by an independent body of WRITTEN ASSURANCE (a certificate) that

!   The PRODUCT, SERVICE or SYSTEM in question

! meets SPECIFIC REQUIREMENTS.

CONFORMIY ASSESSMENT

Accreditation

!   The formal recognition by an independent body (the ACCREDITATION BODY) that a CERTIFICATION BODY is capable of carrying out certification.

!   It is not obligatory but it adds another level of confidence.

!   An accredited certification body has been independently checked tio make sure it opeates according to specific standards.