This lecture will explore the definition of standards and the theory of standardization, focusing on how both the economy through innovation and knowledge management. The intent of this work is to show students how important an understanding of standardization is when they enter the workplace, have an innovation that they would like to bring to the market or become involved in the standardization process. It is recommended that this lecture is accompanied by the following: The handout “Standards and Standardization” The article “BS 8888: Gain from Improved Specification” The article “Developments and Initiatives: Cutting manufacturing and production costs” It is also recommended that this lecture is followed up by a seminar or tutorial which simulates the conditions of a standardization committee to either write a response to a standard at the public comment stage or to create a new work proposal, both of which would be submitted through the relevant BSI websites. Support material for these simulation sessions can be supplied by BSI.
ISO/IEC defined a standard as: “ [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 NOTE: Standards should be based on the consolidated results of science, technology and experience, and aimed at the promotion of optimum community benefits.” This is a definition that has been accepted and repeated by many standardization organizations, including in BSI’s BS 0. If we were to go beyond the definition and look as standardization conceptually and theoretically, it could be said that it transcends being simple guidelines, specifications or best practice; standardization is a knowledge management tool in its basic form. These documents ensure that knowledge gained by practitioners is captured and made available to be the building blocks of further innovation. As previous research points out, “ Where higher education is more focused on training a new generation how to understand and use knowledge, standardization is concerned with distributing the knowledge from previous generations to ensure it is not lost. At its purest definition, standardization is a knowledge creation tool and, if participation in the process by knowledge workers was high within an economy, a vitally positive tool for that economy.”
There are 6 commonly considered levels of standardization, the first 2 of which are not produced by BSI but by individual companies. Corporate Technical Specifications are explicit sets of requirements to be satisfied by a material, product, or service. An example could be the product specifications of your laptop or iPod. These standards are quick to write because they are highly controlled by the company producing them. As we move up the diagram below, you’ll notice that each level takes longer to write as it requires consensus from a wider spectrum of stakeholders. Private standards are private documents owned and written by an organization or corporation. These are used and circulated as they determine necessary or useful. A simple example of this could be a company’s branding guidelines or the equality/health & safety policies which add a level to previously existing legislation or standards, tailored to the explicit needs of the company. The Publicly Available Specification (PAS) is a consultative document where the development process and written format is based on the British Standard model. Any organisation, association or group who wish to document standardized best practice on a specific subject, can commission a PAS, subject to the BSI acceptance process. The main difference is in the area of consensus; a British Standard must reach full consensus between all stakeholders on technical content, whilst a PAS invites comments from any interested party but does not necessarily incorporate them. This means that the timescale for the development of a PAS can be shorter, typically around 8 months. British Standards are the formally produced standards from BSI, the UK’s National Standards Body. The standards are written by consensus with input from industry, experts and other stakeholder groups like consumer representatives and academia where required. The different types of British Standards available (Specification, Code of Practice, Test Method, Guide, etc.) are detailed in the tables with your handouts. As, I said in the previous slide, there are also European and International standards bodies and these bodies produce, respectively, European standards and international standards . BSI, like most NSBs, adopts the standards at European and International level, so that these are effectively British standards as well (e.g. BS EN, BS ISO). In the case of European standards, we are obliged to adopt these and any UK work must stop (at ‘standstill’) if equivalent European work commences. This is why, for example, the international standards for quality management systems’ full registration in the UK is BS EN ISO 9000.
The BSI process for standardization is quite simple; based on consensus between stakeholders. The process starts with the proposal of a new work item. Most work items may be born within the committee, but new work can be proposed by anyone through BSI’s New Proposals website. If it is accepted, a small group of experts will draft the standard and then present the draft to the technical committee for wider consultation. Once the committee has approved the draft, it goes out for public comment — this is when anyone is free to propose changes or additions to the draft document. The public comment stage ensures that every national, European and international standard is transparent and accepted by the wider public. Once the public comments have been considered and appropriate actions taken, the draft goes forward for final approval . At the national level, this would be done by committee consensus; however European and international standards are also subject to voting by the member bodies of the organizations. The secretary or chairperson of the committee then gives endorsement to publish and the standard becomes available to the public. Standards are not just one-off declarations. They are reviewed at least once every 5 years to ensure the information within them is still relevant.
CEN is a major provider of European Standards and technical specifications. It is the 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). CEN's 31 National Members work together to develop voluntary European Standards (ENs). There are differences in the standardization process. There is still the public consultation process after which, taking into consideration the comments resulting from the CEN Enquiry, a final version is drafted. This draft is then submitted to the CEN Members for a weighted formal voting. After ratification by CEN, each of the National Standards Bodies adopts the European Standard as an identical national standard and withdraws any national standards which conflict with the new European Standard. Hence one European Standard becomes the national standard in the 31 member countries of CEN.
ISO (International Organization for Standardization) is the world's largest developer and publisher of International Standards. ISO is a network of the national standards institutes of 163 countries, one member per country, with a Central Secretariat in Geneva, Switzerland, that coordinates the system. ISO is a non-governmental organization that forms a bridge between the public and private sectors. On the one hand, many of its member institutes are part of the governmental structure of their countries, or are mandated by their government. On the other hand, other members have their roots uniquely in the private sector, having been set up by national partnerships of industry associations. Therefore, ISO enables a consensus to be reached on solutions that meet both the requirements of business and the broader needs of society. Decisions are taken within ISO on the basis of votes cast by ISO member bodies, on the basis of one country, one vote. At the enquiry stage, a draft International Standard (DIS) is made available to all ISO member bodies and all of them are entitled to vote and comment on the document during a five month period. If the DIS receives 100% approval, it may proceed directly to publication once any comments received have been addressed. Otherwise, a final draft International Standard (FDIS) is sent to all ISO member bodies for voting for a period of two months, together with the report of voting on the DIS which includes all the comments received and how these have been addressed.
It is commonly misconstrued that standards could become inhibitors of innovation, perceiving to add layers of beaurocracy. In truth, the opposite is true if standards are used effectively. An innovative product can be created one of two ways. In the case of disruptive technologies, the product is completely designed from scratch. New innovations are created for every aspect of it and creating or redefining the market it’s in. Alternatively, an incremental technology approach could be taken, where an idea would be incorporated to add a unique perspective on an existing product. These products are similar to icebergs in that only 10% of an iceberg can be seen above the waterline; similarly only 10% of an innovative product would be affected by the innovative idea that inspired it. In either case, standards could make the research and design process quicker, more efficient and more successful if integrated effectively.
In the cases of both disruptive and incremental innovations, research is vital to creating the first concept. Standards can seamlessly integrate into research processes to assist the work and strengthen its reliability. Blind and Gauch explored how standards can integrate into the research process and mapped where certain standards could make a positive difference at relevant stages in the process. Blind and Gauch found different standard types perform different roles, bringing different benefits to the process. Understanding basic terminology early is vital in order to ensure the ideas ore communicated correctly. Measuring and testing standards reinforce the legitimacy of any results found as well as ensure the correct tests are done to ascertain the most accurate results. Interface standards ensure ease of use in the final product and can widen accessibility to more non-mainstream areas of the market. Compatibility standards ensure that the innovation can work with any products or complimentary tools that would enhance it or be vital to its operation. Quality standards manage the overall process, ensuring the best possible work is created. This model was designed specifically for the purpose of mapping standards to academic and innovative research and, though it perfectly exhibits where certain standards could make a positive difference in that process, a certain amount of adaption would be needed in order for it to work in a more practical environment.
In a 2011 article for RTC Magazine , IBM’s Martin Bakal discussed how IEC 62304 medical device software – software life cycle processes , has affected IBM’s work in the medical devices industry. Bakal understands the importance of standards, stating: “ By applying best practices guidance and process automation, companies have a new opportunity to improve on their fundamental business goals, while getting through regulatory approvals faster.” Bakal uses what he calls “the standard V diagram” to detail the hardware and software device life cycles in the industry, looking at the typical stages for analysis, design, implementation and testing. This particular diagram, like Blind & Gauch’s research model, was created for a specific criteria, however is open to being adapted in a way that can help show how standards can fit into the design and engineering of any innovation.
Combining the two to creates a possible cycle which outlines the relationship between standards and the innovation process, showing how standards can be a catalyst, rather than an inhibitor for innovation. The concept stage is purely borne by the inception of an innovative idea. Once the concept is formed, the requirements & architecture need to be detailed so that others can share the broader vision. Firstly, terminology standards will need to be used in order to communicate the vision effectively and-once the first rough design drafts are written-measurement standards will need to come in to play. These standards will also be vital in the detailed design stage. On any project, a mistake in measurement could be disastrous-especially on larger projects, like bridges or public buildings. Design standards for engineering projects would be vital at this stage as well. Once the project has reached the building or physical creation stage interface standards are important for the same reason they are for research but-more importantly-standards which are specific to the industry will also be vital. Standards can be found for a range of specific areas, like civil engineering, agriculture and food and information technology. Discovering which standards will specifically affect the design and building of your project and deciding which are non-pertinent could be just as important as the innovation itself. Testing of the product requires the relevant standards be followed to ensure success.
Testing has a number of issues that must be considered before going down that route. Firstly, testing is a snap shot in time . A sample might work at that moment, in those conditions, but will they work in a year’s time? You will also need to re-test if you make any design or operational changes to the product. Test subjects can also susceptible to golden sampling , so a company can choose its best products to go through the testing process, already assured it will pass. These issues mean that the wording of the final certificate is very specific, saying not that the product meets a standard, but instead, “ The sample submitted complied with the requirements of EN XXXX” . Certification is a system of continual assessment to the standard, which means that any issues that might arise in testing are removed. This means that certification is more than just a test and more than just a quality control system. There are a number of certification bodies in the UK. If you are interested in getting your products or services certified, you should check whether the company has been accredited by the United Kingdom Accreditation Service. This will give you and your stakeholders peace of mind over the results.
using compatibility standards to integrate the innovation with pre-existing technology makes the product easier to use for a wider audience. Post-launch quality standards can ensure the systems in place to either mass produce or, in the case of larger one-off projects, maintain the final product can mitigate the risks of system or process failures which could harm users or be detrimental to the long-term success of the innovation. It’s at this stage that the possibility of a Kitemark scheme may be relevant.
Both the CE mark and Kitemark are widely recognized symbols connected to standardization, however there are many misconceptions about both The CE mark demonstrates compliance to the EU New Approach Directives, which is a legal requirement for all products sold within the EU. As the CE mark shows compliance with the law, rather than working to an industry standard, it is fair to say that it is not a quality mark. Standards bodies like BSI do not have the authority to give the CE marking; in some cases a company can self-declare that a product conforms to these Directives. They have to carry out a 1st Party conformity assessment (self-conformity) and keep documentary proof for authorities to access as and when they wish. The Kitemark is a term and mark owned by BSI which is issued under license and, unlike the CE, is a mark of certified quality and safety . The process for obtaining a Kitemark is much more stringent than the CE mark, as it involves 3rd Party assessment . There are a number of schemes, but not one for every standard, so the company will need to choose the correct scheme that applies to them. A pre-audit visit is required, which is followed up by an initial assessment visit . The product is then type tested against the relevant standard, followed by a review by that specific Kitemark scheme manager. Once all these stages are passed, the Kitemark is awarded . That’s not where the process ends, though. There are continuing assessment visits and audit testing to ensure that the requirements continue to be met.
In the case of overwhelming and influential success an innovative project or product could inspire a new standard as others in the industry realize the advantages of following suit. Therefore, as the innovation becomes imbedded in the industry and validated as successful a new standard may be written. This could, in turn, be a catalyst to inspire new ideas and concepts, beginning the innovation process once more.
The RMS Titanic was the most ambitious engineering feat of its time, using advanced technologies and safety features and the expertise of experienced engineers to create the largest passenger liner of it’s time. However, despite all these positives, research shows that vital areas were overlooked or ignored. It could be argued that, by not complying with standards of the time, Titanic’s chances of survival were compromised. The advert overleaf for an exhibition at the Denver Museum of Nature & Science lists some of the common standards not followed by the Titanic. Hull sections were built with zinc, known to go brittle in freezing temperatures Basic safety standards were not followed due to the confidence in the ships unsinkability. Wireless operators after the liner hit the iceberg sent outdated CQD signals, rather than the new-standard SOS signals. In addition to these issues, research by David G. Brown (2000) noted that the rudder was also an issue. It met the legal requirements for ships of its size, but was closer to the minimum rather than looking at what the standard rudder size for such a large liner would be. This meant the turning circle of the liner was smaller and the iceberg harder to avoid. Many projects will rightly be concerned about meeting legal minimums, but this example shows that complying with standards can add an extra, vital layer of safety and reassurance.
Using the mapping above, the following are examples of standards that could be relevant in the innovation process. You will also see the committee that wrote the standard. The best way to keep up to date with standards is through keeping track of the committee’s work, not keeping track of any changes to the standard itself. This can be done through the Standards Development website https://standardsdevelopment.bsigroup.com – this website doesn’t just help follow the work of standards; it also provides access to the public comment and draft proposal online portals as well as giving you access to other methods you could be involved in the standardization process which are discussed later in this document.
2011 11-30 standardization standards and inovation
Standardization, Standards, InnovationNewell Hampson-Jones,Education Sector Representative, British Standards Institution7th December, 2011Produced in Collaboration with:Gill Whitney, BSc, MSc, FRSA, MIET, PGCert HE, CEngMiddlesex University
3 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
4The 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
Using Standards to Design & Engineer InnovationBakal’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>.
Using Standards to Design & Engineer Innovation
11Testing and CertificationTesting Certification• Snapshot in time • More than just a test or quality control system• Susceptible to golden sampling • Many certification and testing bodies in the UK• “The sample submitted complied with the • UKAS ( requirements of EN United Kingdom Accreditation Se XXXX” )
Using Standards to Design & Engineer Innovation
CE and the Kitemark®CE Mark Kitemark is… • Owned exclusively by BSI• Conformity to New Approach • Issued under Licence Directives • 3rd party voluntary mark of quality and safety• Not a quality mark The Process• Mandatory in the EU • Pre-Audit visit• BSI cannot give authority to • Initial Assessment visit apply the CE marking • Type Testing of new product• It is illegal to use the CE • Initial assessment report marking on a product that is outside the scope of all the • Award of Kitemark New Approach directives. • Continuing assessment visits • Audit testing
Using Standards to Design & Engineer Innovation
…could Standards have saved the Titanic? Source:http://codyrapol.com/internet/images/it-wasnt-an-iceberg-that-sank-the-titanic/