12/06/ STANDARD QUALITY a brief look at the world of standards CAROL MOORE QUALITY MANAGER AREA LABORATORIES Crosshouse Hospital

Definition of STANDARD According to Collins Dictionary- “is an accepted or approved example of something against which others are judged or measured”  according to BSI-”defined as a document, established by consensus and approved by a recognised body, that provides, for common and repeated use, rules, guidelines, or characteristics for activities or their results”  “it can be an agreed way of doing something, can be recorded and published formally or an informal unwritten procedure”  Most are voluntary codes- not regulations 3 12/06/2016

4 Some STANDARDS  Speed limits  Exams  Recipes  Q-Busters  Call centre ring times  Baggage handling turn around times  Private standards used only by the organisation that developed them  Others including SLA’s, legislation and licensing, QIS, performance targets.  Formal Standards

Formal standards British Standards-(BS) from National Standards Body (NSB) Publicly Available Specification (PAS)- from a trade organisation European Standards (EN)- from the European Committee for Standardisation (CEN) International Standards (ISO) – from the International Organisation for Standardisation ( ISO also from Greek meaning “equal”) International Electrotechnical Committee (IEC) –works in conjunction with ISO for electrical and electrotechnical standards. 5 12/06/2016

6 WHY HAVE STANDARDS? To measure what we do against a set acceptable level (criteria) Specify requirements for the features or characteristics of a product Improve performance- product, quality, H&S, environment, communications Bring conformity and integrity to any business To demonstrate how good we are Encourage knowledge sharing Safeguards and reassures customers and users Increase world trade.

For the Customer  Ensures the quality of a product is suitable for use  Ensures things like credit cards are of the same size  Ensures the DVD you bought on holiday will fit your DVD player  Organisational standards for franchises e.g. MacDonald, Thornton's, M&S  Transport containers- fit together on boats and onto lorries and trains for ease of export logistics.

8 12/06/2016 HISTORY of STANDARDS The rut marks made from Roman carts formed the idea for railway tracks and gauges. 1900’s –steel making and tramway rails , Standards for War. 31,000 were introduced BSI established , warplane standards, war emergency standards. Also saw the start of consumer standards ISO established 1950’s and 1960’s-standards for supplying military hardware CEN established 1970’s saw many organisations with their own standards for quality 1980’s saw a rise in international trade, mainly due to better transport and technology.

British Standards Institute BSI is the oldest national standards body in the world from the  Institute of civil engineers, to the  Engineering Standards committee, to  the British Engineering Standards Association to the  BSI.1931, reduced 75 different railway gauges to 5 Created the British Standards mark in 1903 which later became the “Kitemark®” BSI became the sole organisation for issuing national standards in 1942 Held the first Commonwealth Standards Conference in 1946 which led to the start of ISO

British Standards Consumer boom of the 50’s and 60’s led to goods of dubious quality and the Kitemark®” was applied to many goods In 2010 there were over 27,000 British Standards in use over 100 countries. Include health care technology, crash test dummies, sustainability in events, food technology, French polishing, stem cell research and Neoclassical Scroll bench design to name a few.

European Standards European Committee for Standardisation (CEN) founded in 1961 by the national standards bodies of the EEC countries Has 31 members who represent the expertise from their countries. Work with  European Committee for Electrotechnical Standardisation (CENELEC)  European Telecommunications Standards Institute (ETSI)  Information Society Standardisation System (ISSS)

ISO Non governmental organisation established in 1947 from the International Federation of National Standardising Associations (ISA) and the United nations Standards Co- ordinating committee (UNSCC) Network of national standard bodies over 162 countries- co-ordinated in Geneva International agreements which are published as International Standards 1972 saw a demand for international standards due to the growth in international trade and transport End of there were 18,536 ISO standards used globally

Quality Management Standards 1950’s USA introduced quality standards for military procurement 1960’s NASA developed its quality system requirements for suppliers 1970’s saw many organisations publishing their own quality management standards and many countries developing their own national standard. 1980’s saw a requirement for an international system and the ISO 9000 series was born from BS 5750, ISO 8402 and EN Currently BS EN ISO 9001:2008 in use with over 1 million (1,064,785)certificates issued in China leads the table with 257,076 certifications.

14 12/06/2016 CLINICAL PATHOLOGY ACCREDITATION n CPA (UK) Ltd established in 1992 n Draft form of ISO was circulated for discussion and the CPA (UK) Ltd established a Standards Revision Group (SRG) n New CPA standards were approved on n Version 2.01 march 2009 incorporated more aspects of ISO n Taken under the umbrella of UKAS in 2009 and after re- location in version 2.02 November 2010 is the version in use. n Moving towards adopting BS EN ISO for criteria- currently under review. n Also BS EN ISO 22870:2006 POCT and BS EN ISO/IEC 17043:2010 for EQA schemes.

And finally Any standard is a collective work Evolve to meet the changing demands of society and technology Updated to meet and improve our quality expectations and requirements We, in turn will raise our quality to meet these standards.

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