CQP Advanced Level

Quality Infrastructure and Legal Framework flashcards

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What are the four pillars of a national quality infrastructure, and what question does each answer?

Standardisation: what should the requirement be? Metrology: is the measurement right, and comparable to everyone else's? Conformity assessment: does this product, process, system or person meet the requirement? Accreditation: is the body producing that evidence competent? They are a chain: remove any one and the claim of quality is not believed.

Why is 'ISO certified' the wrong expression?

ISO writes standards and does nothing else: it does not certify, accredit or enforce. A certification body assesses the organisation and issues the certificate, and that body may itself be accredited by a national accreditation body. Correct form: 'certified to ISO 9001 by a certification body accredited by KENAS'.

What does consensus mean in standards development?

General agreement, characterised by the absence of sustained opposition to substantial issues by any important part of the concerned interests, with a process that seeks to take account of all views and reconcile conflicting arguments. It is not unanimity: a standard can be adopted over one participant's objection, but not over the sustained objection of an entire interest group.

What are first-party, second-party and third-party conformity assessment?

First-party: performed by the organisation that provides the object; a supplier's declaration of conformity is its output. Second-party: performed by a party with a user interest, typically a customer auditing a supplier. Third-party: performed by a body independent of both provider and user, such as a certification body or an independent laboratory.

What is metrological traceability, and which three elements of the definition matter?

The property of a measurement result whereby it can be related to a stated reference through a documented unbroken chain of calibrations, each contributing to the measurement uncertainty. Unbroken: no link rests on an uncalibrated instrument. Documented: it can be demonstrated, not just asserted. Uncertainty: each link contributes to a stated uncertainty.

How does accreditation differ from certification?

Object: accreditation attests to a conformity assessment body; certification to a product, process, service, system or person. Subject matter: accreditation assesses technical competence, with assessors witnessing the work. Structure: one national accreditation body without commercial competition, while certification bodies compete. Position: accreditation is one level higher, the assessment of the assessors.

How do you decide whether a measure falls under the TBT Agreement or the SPS Agreement?

By the purpose of the measure, not the product or its form. SPS: protection from food-borne risks, pests, diseases and disease-carrying organisms. Must rest on scientific principles and sufficient evidence. TBT: technical regulations, standards and conformity assessment for any other legitimate objective. Based on relevant international standards. Milk fat labelling is TBT; freedom from a pathogen is SPS.

How does a standard differ from a technical regulation?

Standard: voluntary, made by a recognised standardising body by consensus, adopted by choice or contract. Non-compliance costs a customer or a market. Technical regulation: mandatory, made by a public authority with legal power, enforced by inspection and market surveillance. Non-compliance means seizure, penalty or prosecution. A Kenya Standard becomes a technical regulation when declared compulsory under the Standards Act.

What is the economic argument for a national quality infrastructure?

Information asymmetry: buyers cannot verify safety, composition or provenance, and sellers have an incentive to overclaim. Adverse selection follows: buyers discount every claim and pay for average quality, so genuine quality earns no premium and producers cut it or leave. The infrastructure makes the claim verifiable, so quality commands a price. It also cuts transaction cost, creates market access and addresses externalities.

Why must KENAS be institutionally separate from KEBS?

KEBS operates testing, inspection and certification services, which are among the bodies requiring accreditation. Inside KEBS, the accreditor would be assessing its own colleagues, its decisions would not be credible to competing private bodies, and peer evaluation under ISO/IEC 17011 would not accept it. Separation is the condition of international recognition.

How is a national quality infrastructure (NQI) defined?