A question to engage the audience immediately. Do not confirm whether they are correct or not. http://www.youtube.com/watch?v=6s01z5t4-Xs&feature=player_embedded
2011 10-26 standards and standardization
2What are standards?
Before Standardization 3• c. 3000 BC – c. 1500 BC Indus Valley Civilization – First to develop uniform weights and measures• c. 80–70 BC – c. 15 BC Marcus Vitruvius Pollio – ‘The first engineer’• 1215 Magna Carta – Clause 35 established consistent measures
4 The Birth of Standardization • Industrial Revolution • 1841 – Sir Joseph Whitworth • 1850 onwards – The birth of the railways • 1895 – Henry Skelton • 1901 – Sir John Wolfe-BarryImage: Tom Curtis / FreeDigitalPhotos.net
5 History of BSI Renamed BSI 1931 Kitemark introduced First Standards BS 1 published First laboratories opened 1903 19591900 2010 1901 1946 Engineering Standards Founder member of ISO Committee founded in London 1964 1929 Founder Member of Granted Royal Charter CEN & CENELEC
6 Types of Standard Int’l Standards (ISO) European Standards (EN) Co e Tim ntr British Standards (BS) ol Publicly Available Specifications (PAS) Private Standards Corporate Technical SpecificationsLow High
7 The Standardization Process• Proposal for new work• Project acceptance• Drafting• Public Comment• Approval• Publication• Review
European Committee forStandardization (CEN) • European standards body • Differences in process • Adoption by Weighted vote
International Organization forStandardization (ISO) • International (global) standards body • One member, one vote. • Final Draft International Standard
Standards and innovative research Standards in the research and innovation process, by Blind & Gauch Blind, K.., Gauch, S., (2007). “Standardization Benefits Researchers.” Wissenschaftsmanagement Special, 2007 (2), pp. 16-17
Bakal’s typical stages both software and hardware teams use for analysis, design, implementation, and testing. Bakal, M., (2011). Challenges and Opportunities For The Medical Device Industry: Meeting The New IEC 62304 Standard RTC, [online] Available at:<http://rtcmagazine.com/articles/view/102203>.
Concept Validation of the innovation Operation & maintenance New Standards? Quality Time Requirements & architecture Launch Terminology MeasurementDetailed design Integration & testing Measurement Testing Design Compatibility Building/creating Interface Product Specific
15 Testing and CertificationTesting Certification• Snapshot in time • More than just a test• Susceptible to or quality control system golden sampling • Many certification and• “The sample testing bodies in the UK submitted complied • UKAS ( with the requirements United Kingdom Accreditation of EN XXXX” )
Concept Validation of the innovation Operation & maintenance New Standards? Quality Time Requirements & architecture Launch Terminology MeasurementDetailed Design Integration & testing Measurement Testing Design Compatibility Building/Creating Interface Product Specific
CE and the Kitemark® Kitemark is…CE Mark • Owned exclusively by BSI • Issued under Licence• • A 3rd party voluntary mark of quality CE mark demonstrates conformity to essential requirements of all and safety• applicable New Approach Directives The CE marking is not a quality The Process mark; • Pre-Audit visit• The CE marking is mandatory in the • Initial Assessment visit EU; • Type Testing of new product• BSI cannot give authority to apply • Scheme Manager reviews, ‘Type Test’ the CE marking; results and initial assessment report• It is illegal to use the CE marking on a product that is outside the scope of • Award of Kitemark all the New Approach directives. • Continuing assessment visits • Audit testing
Type of standard Example Standards Committee Terminology BS 6100-3:2007 Building and civil engineering. B/500/-/1 Terminology Vocabulary. Civil engineering. General Measurement BS 2856:1973 Precise conversion of inch and TDW/4 Technical Product Realization metric sizes on engineering drawings Design BS 8888 Technical product specification TDW/4/8 Technical Product Realization - BS (Currently in development) 8888 Technical product specification Interface BS EN ISO 24503:2011 Ergonomics. Accessible PH/9 Applied ergonomics design. Tactile dots and bars on consumer products Compatibility BS EN 54-13:2005 Fire detection and fire alarm FSH/12/1 Installation and servicing systems. Compatibility assessment of system components Testing BS ISO 16269 Statistical interpretation of data SS/2 Statistical Interpretation of Data Quality BS EN ISO 9001:2008 Quality management QS/1 Quality management and quality assurance systems. Requirements procedures New Standard? Through the Standards Development web portal, anyone can propose a new work item. Product Specific Standards that would specifically apply to the product or industry the product will service. E.g. Eurocodes.
British Standards Online… British Standards Online