Part A: Quality infrastructure
Introduction to quality infrastructure
Key takeaways
- A national quality infrastructure is the whole institutional framework, public and private, that provides standardisation, metrology, accreditation and conformity assessment, so that products and services can be shown to meet defined requirements.
- It exists to solve an information problem: a buyer cannot check safety, composition or provenance by looking, so where claims cannot be verified buyers discount them, genuine quality earns no premium and the market degrades.
- Each pillar answers its own question: standardisation says what the requirement should be, metrology makes the measurement comparable, conformity assessment produces the evidence, and accreditation shows that the body producing it is competent.
- The pillars are a chain, not a list: with no standard there is nothing to test against, with no metrology the number is not comparable, with no conformity assessment there is no evidence, and with no accreditation the evidence is not believed.
- The standards body writes the requirement, the conformity assessment body checks against it and the accreditation body checks the checker; where one institution does two of these, as KEBS does, the impartiality risk is managed by separating the functions internally.
Quality infrastructure is the national system that allows a claim about a product to be believed by someone who did not make it. Everything in this paper is an elaboration of that sentence: standards say what the claim should mean, metrology makes the measurement comparable, testing and inspection produce the evidence, certification attests to it, accreditation attests to the attester, and technical regulation makes some of it compulsory.
What quality infrastructure is
The national quality infrastructure, commonly abbreviated NQI, is the totality of the institutional framework, whether public or private, required to establish and implement standardisation, metrology, accreditation and conformity assessment services necessary to provide evidence that products and services meet defined requirements, whether demanded by authorities or by the market.
The reason a country needs one is an information problem. A buyer cannot inspect a product's safety, composition, durability or provenance by looking at it, and a seller has every incentive to claim more than is true. Left to itself, a market in which quality is unverifiable degrades: buyers discount every claim, so producing genuine quality earns no premium, so producers stop. The quality infrastructure exists to make the claim verifiable and therefore worth making.
- It protects consumers from unsafe and substandard goods, which is why the technical regulation part of it is compulsory rather than voluntary.
- It enables trade: an export cannot enter a market whose regulator does not accept the evidence of conformity offered, so the infrastructure is what turns production capability into market access.
- It reduces the cost of doing business by removing the need for every buyer to test independently, which is precisely what mutual recognition and accreditation deliver.
- It supports industrial development by giving domestic producers a route to demonstrate that they meet international requirements.
- It protects domestic industry from dumped substandard imports, through market surveillance and import inspection.
- It supports government policy in health, environment, energy efficiency and public procurement, each of which requires measurable, verifiable specifications.
- It underpins national measurement itself, without which trade by weight, volume or energy content is not possible on fair terms.
The quality infrastructure is why an export is refused, and why an import is admitted
For a Kenyan manufacturer, this is not an abstract public good. A consignment held at a foreign port because the destination does not recognise the test report, or a competitor's substandard import undercutting you because market surveillance did not catch it, are both quality infrastructure operating or failing to operate. The whole of this paper is about that machinery.
The four pillars
The infrastructure has four technical pillars resting on a legal and policy foundation, and each pillar answers a different question. Confusing them is the commonest error in this paper, and the distinction between certification and accreditation in particular is examined every sitting.
The four pillars of a national quality infrastructure
| Pillar | The question it answers | Typical Kenyan institution |
|---|---|---|
| Standardisation | What should the requirement be? It writes down, by consensus, what an acceptable product, process or service looks like | Kenya Bureau of Standards, as the national standards body |
| Metrology | Is the measurement right, and is it comparable to everyone else's? It maintains the national measurement standards and their traceability | The national metrology function and the legal metrology service |
| Conformity assessment | Does this particular product, process, system or person meet the requirement? It produces the evidence, through testing, inspection and certification | Testing laboratories, inspection bodies and certification bodies, both public and private |
| Accreditation | Is the body producing that evidence competent to do so? It is third-party attestation of the competence of conformity assessment bodies | Kenya Accreditation Service, as the national accreditation body |
Beneath the four pillars sits the foundation: the legal and policy framework that establishes the institutions and gives their outputs force, the technical regulation regime that makes selected standards compulsory, and the market surveillance function that enforces them. Above them sit the users: manufacturers, service providers, regulators, procuring entities, consumers and trading partners.
How the four pillars combine on one consignment
SITUATION: a Kenyan processor ships 20 tonnes of packaged
honey to a buyer in Europe. The buyer requires evidence
that moisture content is within specification and that
antibiotic residues are below the limit.
STANDARDISATION
KS EAS 36, the East African Standard for honey, defines
what honey is, sets the maximum moisture content, and
specifies the test methods to be used. Without an
agreed standard, 'good honey' is an opinion and there
is nothing to test against.
METROLOGY
The laboratory's balance and its refractometer are
calibrated against reference standards which are
themselves traceable, through an unbroken chain of
calibrations, to the SI units realised nationally and
internationally. This is what makes 20.4% moisture
measured in Nairobi the same quantity as 20.4%
measured in Hamburg. Without traceability the number
is a local convention.
CONFORMITY ASSESSMENT
A testing laboratory analyses the sample and issues a
test report. An inspection body verifies the
consignment matches the sample and the documents. A
certification body has certified the processor's food
safety management system, which is what gives the
buyer confidence that the tested sample represents the
20 tonnes rather than one good drum.
ACCREDITATION
The buyer's regulator does not know the Kenyan
laboratory. What it knows is that the laboratory is
accredited to ISO/IEC 17025 by an accreditation body
that is a signatory to the ILAC mutual recognition
arrangement. That single fact is what makes the test
report acceptable abroad without re-testing.
TECHNICAL REGULATION AND MARKET SURVEILLANCE
In Kenya, the same standard applied domestically
through a compulsory technical regulation is what
stops adulterated honey being sold locally, enforced
by market surveillance rather than by the buyer.
REMOVE ANY ONE PILLAR AND THE SHIPMENT FAILS
No standard: nothing to test against.
No metrology: the number is not comparable.
No conformity assessment: no evidence exists.
No accreditation: the evidence is not believed.
The pillars are not a list. They are a chain.
The institutions
Learn the separation of roles, because the examination tests it
The standards body writes the requirement. The conformity assessment body checks against it. The accreditation body checks the checker. Where one institution performs two of these roles, as national standards bodies commonly do by both writing standards and certifying against them, an impartiality problem arises which must be managed by separating the functions internally. A candidate who can explain that tension is answering the question properly.
Self-check
Define a national quality infrastructure, explain its four technical pillars, and explain why the removal of any one of them defeats the whole. (12 marks)
Explain the economic argument for why a country needs a quality infrastructure at all, rather than leaving quality to be settled between buyer and seller. (8 marks)
Show worked answer
Definition, pillars and interdependence (12 marks).
A national quality infrastructure is the totality of the institutional framework, public and private, required to establish and implement standardisation, metrology, accreditation and conformity assessment services necessary to provide evidence that products, processes and services meet defined requirements, whether those requirements are imposed by authorities or demanded by the market.
Standardisation writes down, by consensus among interested parties, what an acceptable product, process or service is, together with the methods by which conformity is to be determined. In Kenya this is the function of the Kenya Bureau of Standards as the national standards body under the Standards Act (Cap 496).
Metrology maintains the national measurement standards and the unbroken chain of calibrations by which a measurement made anywhere in the country is traceable to the international system of units. It comprises scientific metrology, which establishes and maintains the standards; industrial metrology, which applies them in production and calibration; and legal metrology, which controls measuring instruments used in trade, health, safety and enforcement.
Conformity assessment produces the evidence that a particular item meets the requirement, through testing, inspection, certification of products, systems and persons, and supplier's declaration of conformity.
Accreditation is third-party attestation of the competence of conformity assessment bodies. In Kenya this is the function of the Kenya Accreditation Service, which accredits laboratories, inspection bodies and certification bodies against the relevant international standards and holds international recognition through the ILAC and IAF arrangements.
The four are a chain rather than a list, and removing any link defeats the rest. Without a standard there is nothing to test against, and a claim of quality has no agreed meaning, so no evidence can be produced about it. Without metrology the measurement is not comparable, so a result of 20.4 per cent obtained in Nairobi cannot be equated with the same figure obtained abroad, and the test report is a local convention rather than a fact. Without conformity assessment no evidence exists at all, and the standard is a document nobody applies. Without accreditation the evidence exists and is not believed, because the receiving party has no basis for knowing whether the body that produced it was competent, and it will therefore require its own testing, which reimposes the entire cost the infrastructure was built to remove. Each pillar is necessary and none is sufficient.
The economic argument (8 marks).
The argument rests on an information asymmetry that markets cannot solve unaided. A buyer generally cannot determine a product's safety, composition, durability, hygiene or provenance by inspecting it at the point of purchase. Many of the attributes that matter most are credence attributes: they cannot be verified even after use, since a consumer who eats adulterated honey or uses a substandard electrical fitting may never connect the eventual harm to the product. The seller, by contrast, knows these attributes, and has a commercial incentive to claim more than is true.
The consequence, where nothing corrects the asymmetry, is adverse selection. Because buyers cannot distinguish genuine quality from claimed quality, they rationally discount every claim and are willing to pay only the price appropriate to average quality. At that price, producing genuine quality is unprofitable, because the extra cost is real and the extra revenue is not obtainable. Genuine producers therefore either reduce quality or leave the market, which lowers average quality further, which lowers the price buyers are willing to pay again. The market degrades towards the lowest quality that can be sold, and this occurs even though buyers would willingly pay more for quality they could verify and producers would willingly supply it. Both sides are made worse off by the absence of verification.
A quality infrastructure corrects this by making the claim verifiable by a party the buyer has reason to trust. A standard gives the claim an agreed meaning; metrology makes the measurement comparable; conformity assessment produces evidence; and accreditation gives the buyer a reason to believe the evidence without investigating the body that produced it. Quality then commands a price, and producing it becomes rational.
Three further economic benefits follow. First, transaction cost falls: without a trusted infrastructure every buyer must test independently, and the same test is repeated many times over the same product. Second, market access is created: an export is admitted or refused on whether the destination accepts the evidence offered, so the infrastructure converts production capability into trade. Third, externalities are addressed: unsafe products impose costs on people who were not party to the transaction, and no purely private arrangement between buyer and seller will price those costs, which is the justification for the compulsory element in technical regulation as distinct from voluntary standards.