CQP Foundation Level
Introduction to Standardization flashcards
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How does ISO/IEC Guide 2 define a standard, and which four elements of the definition are examinable?
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, aimed at the achievement of the optimum degree of order in a given context. The four elements: consensus, a recognised body, repeated use, and optimum order.
What does consensus mean in standardization?
General agreement, characterised by the absence of sustained opposition to substantial issues by any important part of the concerned interests, and by a process that seeks to take into account the views of all parties and to reconcile conflicting arguments. It is not unanimity, and it is not a majority vote: a single dissenting member does not block a standard, and a bare majority does not carry one.
How does a design standard differ from a performance standard?
Design (prescriptive): specifies the means, such as material, dimension or method. Verified by inspection and measurement; cheap to enforce, but restricts innovation and can exclude equivalent foreign solutions. Performance: specifies the result to be achieved. Verified by testing, which needs accredited laboratories; permits innovation and is preferred by Article 2.8 of the WTO TBT Agreement.
Name standards organisations at international, continental, regional and national level that matter to Kenya.
International: ISO, IEC, ITU, Codex Alimentarius, OIML, ILAC and IAF. Continental: ARSO and AFRAC. Regional: the EAC (East African Standards under the SQMT Act, 2006) and COMESA. National: KEBS, the national standards body and Kenya's ISO member body.
What are the stages of standards development, and what document goes with each?
Proposal: new work item proposal (NWIP). Preparatory: working draft (WD). Committee: committee draft (CD). Enquiry: draft standard for public comment (DKS in Kenya, DIS at ISO). Approval: final draft (FDIS at ISO), voted on. Publication: Kenya Standard (KS) or International Standard.
Which two links of the national standards body value chain turn a standard from a document into something that changes the market?
Conformity assessment: testing, inspection and certification, so compliance is demonstrated rather than asserted. Market surveillance and enforcement: checking goods on the market and at the border. Without them the honest producer bears the cost of compliance and is undercut by the dishonest one, and the mark on the pack means nothing.
Which WTO agreement covers which measures: TBT or SPS?
SPS: measures protecting human, animal or plant life or health from food-borne risks, pests and diseases. A pesticide residue limit is SPS. TBT: technical regulations, standards and conformity assessment for everything else, including quality, product performance and labelling not related to food safety. A country of origin label is TBT.
What is the difference between certification and accreditation?
Certification: third-party attestation that a product, process, system or person meets specified requirements. It is of the organisation or product. Accreditation: third-party attestation of the competence of a conformity assessment body to carry out specific tasks. It is of the certifier or laboratory. In Kenya, KEBS certifies; KENAS accredits.
What do 'shall', 'should', 'may' and 'can' mean in a standard?
Shall: a requirement. Only 'shall' statements are auditable. Should: a recommendation. May: permission. Can: possibility or capability. A nonconformity raised against a 'should' is an invalid finding.
What is the Renard R5 series, and why are preferred numbers spaced geometrically?
R5 is built on the fifth root of 10, so each step multiplies by about 1.585: 1.00, 1.60, 2.50, 4.00, 6.30, 10.00. R10 uses the tenth root of 10, about 1.259. Geometric spacing gives constant proportional steps, so every size is equally distinguishable from its neighbours. It is the mathematical basis of variety reduction.
How do a standard, a technical regulation and a specification differ?
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List the aims of standardization given in ISO/IEC Guide 2.
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What is variety reduction, and what is it not?
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What is the difference between the KEBS Standardisation Mark and the Diamond Mark of Quality?
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What happened in Kenyan and East African standardization in 1974, 2006 and 2009?
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Name the principles that govern how standardization is done.
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What are the levels at which a standard can be adopted, with a Kenyan example of each?
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What does it mean when a Kenya Standard is published as KS ISO followed by a number?
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How does a Kenya Standard become compulsory, and what follows?
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In what ways does the law reach standards in Kenya, apart from compulsory declaration?
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What authority does a company standard carry outside the company?
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What are the strength and the main risk of industry and consortium standards?
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Apart from KEBS, which Kenyan government bodies issue standards or technical requirements in their sectors?
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Why is the EAC arrangement stronger than ARSO harmonisation for a Kenyan standard?
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What happens at the enquiry stage of a Kenya Standard?
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What vote does ISO need to approve a standard?
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How often is a standard reviewed, and with what possible outcomes?
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Who does the technical drafting of a national standard, and what does that mean for the standards body's cost?
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Can standards development pay for itself from sales of the standard?
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What benefits do standards give consumers?
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How does government use standards?
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Why is certification often a question of market access rather than price?
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When is a technical regulation unlawful under the WTO TBT Agreement?
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What disciplines does the WTO SPS Agreement impose?
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A product meets an East African Standard adopted by every partner state, yet each state demands its own test. What is the barrier, and the remedy?
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What are first-party, second-party and third-party conformity assessment?
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What are the three functions of conformity assessment in ISO/IEC 17000?
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What are the limits of a certificate?
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Against which standards are conformity assessment bodies accredited?
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What conformity assessment routes are there, from lightest to heaviest, and how is one chosen?
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State the chain of confidence behind a mark on a pack.
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What goes into an organisation's standards strategy?
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Why should a firm pay for staff to sit on a standards technical committee?
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When does using standards to shape the competitive field cross the line?
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What is measurement traceability, and why does it matter?
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What do acceptance sampling standards specify, and what are the two risks?
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How should an organisation keep its standards collection current?
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What is the difference between a superseded and a withdrawn standard?
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How is a standard's designation read?
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