765/2008 - REGULATION (EC) No 765/2008 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93 Harmonized Directive
Regulation (EC) No 765/2008 establishes a comprehensive framework for accreditation and market surveillance to ensure the high level of protection of public interests such as health, safety, consumer protection, and environmental preservation, while facilitating the free movement of products within the EU. It sets uniform rules for the operation and organization of national accreditation bodies, aiming to guarantee their impartiality, technical competence, and effective peer evaluation, thereby enhancing mutual recognition of conformity assessment certificates across Member States. The Regulation mandates cooperation and information exchange between national accreditation bodies and market surveillance authorities, including controls on products from third countries and reinforced surveillance on high-risk consumer products. It integrates and complements existing sector-specific legislation by applying horizontally where no specific provisions exist. The Regulation also governs the CE marking as the sole conformity indication under EU harmonization legislation and mandates national remedies against restrictions on product marketing. Overall, it strengthens market surveillance mechanisms, supports accurate conformity assessments, and promotes a safer internal market for goods.
Purpose
Regulation (EC) No 765/2008 establishes a comprehensive framework for accreditation and market surveillance relating to the marketing of products within the European Community. Its main purpose is to ensure that products benefiting from free movement within the EU meet high levels of public interest protection-specifically health, safety (including workplace safety), consumer protection, environmental protection, and security-while preventing unnecessary restrictions on product movement. This Regulation complements existing Community legislation and aims to strengthen the operation of conformity assessment, accreditation, and market surveillance systems to foster mutual trust among Member States and enhance consumer confidence.
Key Obligations
Accreditation Framework: Member States must establish and maintain a single, national accreditation body responsible for assessing the competence of conformity assessment bodies (CABs). These accreditation bodies are to operate independently of commercial interests, safeguard impartiality and objectivity, and be recognized as exercising public authority.
Mutual Recognition and Peer Evaluation: National accreditation bodies are required to cooperate through peer evaluation schemes to ensure uniform competence across the EU. They should operate transparently and exchange relevant information within a network, coordinated by the European cooperation for Accreditation (EA), which holds the role of the first recognized body under the Regulation.
Market Surveillance: Member States must establish surveillance authorities to monitor compliance of marketed products with applicable requirements, focusing on serious risks to health and safety. Authorities are mandated to cooperate nationally and across borders to share information, investigate risks, and intervene promptly, including product withdrawal or recall when necessary.
Control of Products from Third Countries: Authorities at EU external borders must conduct adequate checks on imported products to prevent unsafe or non-compliant goods from entering the market. The Regulation incorporates and strengthens existing customs practices concerning the suspension of product release, destruction of dangerous goods, and cooperation with market surveillance authorities.
CE Marking: The Regulation sets out general principles for the CE marking as a visible indication of conformity with EU harmonisation legislation. It stipulates that the CE marking should be the sole conformity marker for regulated products, with other markings permitted only if they improve consumer protection and are not governed by EU harmonisation rules.
Legal Remedies: Member States must provide accessible means for economic operators to challenge restrictive measures related to product market placement, withdrawal, or recall in courts or tribunals.
Affected Products and Actors
Products: All products marketed within the EU requiring conformity assessment and CE marking fall under the scope of this Regulation. This includes a broad range of goods covered by Community harmonisation legislation, as well as products not yet covered by specific sectoral rules where horizontal market surveillance applies.
Economic Operators: Manufacturers, importers, and distributors are subject to market surveillance and must ensure their products comply with applicable requirements, supported by conformity certificates and test reports when available.
Conformity Assessment Bodies (CABs): Entities performing product conformity assessments must be accredited by the national accreditation body of their Member State or another if none exists locally or if competence gaps exist.
National Accreditation Bodies: Established by Member States as single, impartial, and authoritative bodies responsible for accreditation, monitoring CAB competence, and cooperating with peers and the European cooperation for Accreditation.
Market Surveillance Authorities: National authorities tasked with monitoring product safety and compliance, executing controls, and coordinating with customs and other authorities to enforce compliance and respond to market risks.
Implementation Timeline
The Regulation entered into force on 1 January 2010.
Member States were required to designate a single national accreditation body and ensure its operation in compliance with the Regulation’s principles without undue delay after enforcement.
The European Cooperation for Accreditation (EA) was to be the first recognized body at the European level to coordinate peer evaluations and cooperation.
Market surveillance frameworks and procedures, including cooperation mechanisms and rapid information exchange systems, were to be established promptly following entry into force.
The Commission committed to an in-depth analysis of consumer safety markings within one year after publication and to propose legislative measures if necessary.
By harmonizing accreditation and market surveillance provisions, Regulation 765/2008 aims to secure a safer internal market with consistent product compliance and enforcement standards across the EU.
Regulation (EC) No 765/2008 applies to the accreditation of conformity assessment bodies and market surveillance activities related to the marketing of products within the European Union. Its scope covers all products subject to Community harmonisation legislation to ensure they meet health, safety, consumer protection, environmental, and security requirements. This includes products both regulated and non-regulated by specific legislation, except where sector-specific rules already exist, such as for drug precursors, medical devices, medicinal products, motor vehicles, and aviation. The regulation establishes a framework to ensure the competence of accreditation bodies, the conformity assessment of products, and market surveillance controls, including checks on products imported from third countries. It applies to various sectors and activities involved in conformity assessment, accreditation, market surveillance, and enforcement to ensure free movement of safe and compliant products in the internal market.
Die Verordnung (EG) Nr. 765/2008 legt Vorschriften für die Akkreditierung und Marktüberwachung im Zusammenhang mit der Vermarktung von Produkten in der EU fest. Ziel ist es, ein hohes Schutzniveau für Gesundheit, Sicherheit, Verbraucher- und Umweltschutz zu gewährleisten und gleichzeitig den freien Warenverkehr nicht übermäßig einzuschränken. Die Verordnung definiert einen Rahmen für einheitliche Anforderungen an nationale Akkreditierungsstellen, die die fachliche Kompetenz von Konformitätsbewertungsstellen bestätigen, und stärkt das gegenseitige Vertrauen zwischen Mitgliedstaaten durch ein System der Beurteilung unter Gleichrangigen. Zudem regelt sie die Zusammenarbeit und den Informationsaustausch zwischen Marktüberwachungsbehörden, um gefährliche Produkte frühzeitig zu identifizieren und Maßnahmen zu koordinieren. Die Verordnung ergänzt bestehende Harmonisierungsrechtsakte und soll Doppelakkreditierungen vermeiden, indem sie vorrangig die Akkreditierung im Mitgliedstaat des Sitzes der Konformitätsbewertungsstelle vorsieht. Durch klare Anforderungen an Unabhängigkeit, Transparenz und Effizienz der Akkreditierungsstellen trägt die Verordnung zur Stärkung des Binnenmarkts und zum Schutz der europäischen Verbraucher bei.
Zweck
Die Verordnung (EG) Nr. 765/2008 zielt darauf ab, ein hohes Schutzniveau für öffentliche Interessen wie Gesundheit, Sicherheit, Arbeitsschutz, Verbraucher- und Umweltschutz sicherzustellen und gleichzeitig den freien Warenverkehr innerhalb der Europäischen Gemeinschaft nicht unnötig einzuschränken. Sie schafft einen einheitlichen Rahmen für die Akkreditierung und Marktüberwachung von Produkten, stellt Mindestanforderungen auf und regelt die Zusammenarbeit der Mitgliedstaaten sowie den Informationsaustausch. Die Verordnung ergänzt bestehende Harmonisierungsrechtsvorschriften und fördert einheitliche Standards insbesondere bei der Konformitätsbewertung von Produkten und Dienstleistungen.
Zentrale Verpflichtungen
Akkreditierung: Die Mitgliedstaaten müssen eine nationale, unabhängige Akkreditierungsstelle einrichten, die die Kompetenz von Konformitätsbewertungsstellen offiziell bestätigt und deren Tätigkeiten überwacht. Die Akkreditierung soll ein einheitliches und transparentes System sein, das gegenseitige Anerkennung und Vertrauen zwischen den Mitgliedstaaten fördert. Die Akkreditierungsstellen müssen bei der Europäischen Kooperation für Akkreditierung (EA) organisiert sein und unterliegen einem Peer-Review-Verfahren.
Marktüberwachung: Die zuständigen Behörden müssen Produkte überwachen, um sicherzustellen, dass nur sichere und konforme Waren in den EU-Binnenmarkt gelangen. Dazu gehört die Kontrolle von Produkten, die aus Drittländern eingeführt werden, sowie die Untersuchung und gegebenenfalls Unterbindung von Verstößen vor dem Inverkehrbringen gefährlicher Produkte.
Informationsaustausch und Zusammenarbeit: Mitgliedstaaten sind verpflichtet, Informationen über gefährliche oder nicht konforme Produkte untereinander und mit der Europäischen Kommission auszutauschen. Vertraulichkeit und Schutz von Geschäftsgeheimnissen sind hierbei strikt zu wahren.
Kontrollen an Außengrenzen: Die Verordnung schreibt vor, dass an den Außengrenzen der EU Eingangsstellen eingerichtet werden, um nicht konforme oder unsichere Produkte rechtzeitig zu erkennen und zu kontrollieren.
Betroffene Produkte und Akteure
Produkte: Die Verordnung gilt allgemein für Produkte, die in den EU-Binnenmarkt gelangen, und ergänzt zahlreiche spezifische Harmonisierungsrechtsakte. Sie gilt nicht für Bereiche mit speziellen besonderen Marktüberwachungsvorschriften, wie z.B. Arzneimittel, medizinische Produkte, Fahrzeuge oder Luftfahrtprodukte.
Akteure: Betroffen sind nationale Akkreditierungsstellen, Konformitätsbewertungsstellen, Marktüberwachungsbehörden, angelieferte Wirtschaftsakteure sowie die Europäische Kommission und die Europäische Kooperation für Akkreditierung (EA).
Umsetzungszeitplan
- Die Verordnung trat am 1. Januar 2010 in Kraft.
- Die Mitgliedstaaten mussten ihre nationalen Akkreditierungssysteme und Marktüberwachungsstrukturen entsprechend den Vorgaben der Verordnung einrichten und betreiben.
- Es besteht eine Verpflichtung für eine kontinuierliche Überwachung der nationalen Akkreditierungsstellen und eine regelmäßige Wiederholung der Peer-Review-Verfahren durch die EA.
- Die Verordnung ersetzt die frühere Verordnung (EWG) Nr. 339/93 und umfasst ab ihrem Zeitpunkt die Regelungen für Akkreditierung und Marktüberwachung umfassend innerhalb der Gemeinschaft.
Diese Verordnung trägt zur Harmonisierung und Verbesserung der Konformitätsbewertungsverfahren sowie der Marktüberwachung in der EU bei, um die Sicherheit von Produkten zu gewährleisten und den Binnenmarkt effizient zu gestalten.
Die Verordnung (EG) Nr. 765/2008 gilt für die Akkreditierung und Marktüberwachung im Zusammenhang mit der Vermarktung von Produkten innerhalb der Europäischen Gemeinschaft. Sie umfasst ein breites Spektrum von Produkten und zielt darauf ab, ein hohes Niveau des Schutzes öffentlicher Interessen wie Gesundheit, Sicherheit, Verbraucher- und Umweltschutz sicherzustellen. Der Anwendungsbereich schließt sowohl reglementierte als auch nicht reglementierte Produkte ein, wobei in bestimmten speziellen Bereichen wie Drogenausgangsstoffen, Medizinprodukten, Human- und Tierarzneimitteln, Kraftfahrzeugen und Luftfahrt vorrangige spezielle Vorschriften gelten. Die Verordnung richtet sich insbesondere an Konformitätsbewertungsstellen, nationale Akkreditierungsstellen und Marktüberwachungsbehörden und regelt deren Aufgaben, Zusammenarbeit und organisatorische Rahmenbedingungen zur Verbesserung der Produktkontrolle und des freien Warenverkehrs. Auch die Kontrolle von Produkten aus Drittländern wird eingeschlossen, um nicht konforme und gefährliche Waren zu identifizieren und vom Markt fernzuhalten.
Le règlement (CE) n° 765/2008 établit un cadre communautaire pour l'accréditation et la surveillance du marché afin d'assurer la conformité des produits commercialisés dans l'Union européenne. Son objectif est de garantir un haut niveau de protection des intérêts publics tels que la santé, la sécurité, la protection des consommateurs et de l'environnement, tout en favorisant la libre circulation des marchandises. Il impose aux États membres de désigner un organisme national unique d'accréditation chargé d'évaluer la compétence technique des organismes d'évaluation de la conformité, afin d'assurer la qualité et la fiabilité des certificats délivrés. Le règlement renforce la coopération entre les autorités nationales et encourage l’échange d’informations, notamment concernant les produits présentant un risque grave, en s’appuyant sur des systèmes d’évaluation par les pairs et de reconnaissance mutuelle. Il complète la directive 2001/95/CE relative à la sécurité générale des produits et vise à éviter les accréditations multiples, en promouvant une harmonisation et une transparence accrues au sein du marché intérieur.
Objet
Le règlement (CE) n° 765/2008 du Parlement européen et du Conseil du 9 juillet 2008 établit les règles relatives à l'accréditation et à la surveillance du marché pour la commercialisation des produits au sein de la Communauté européenne. Il vise à garantir que les produits circulant librement en Europe respectent les exigences assurant un haut niveau de protection des intérêts publics, notamment en matière de santé, sécurité, environnement et protection des consommateurs. Ce règlement complète la législation spécifique existante et instaure un cadre général qui organise l'accréditation des organismes d'évaluation de conformité et renforce la surveillance du marché.
Obligations clés
Accréditation des organismes d'évaluation de la conformité : Les États membres doivent désigner un unique organisme national d'accréditation responsable de l'attestation de compétence technique des organismes qui évaluent la conformité des produits. L'accréditation vise à assurer l'objectivité, la compétence et l'impartialité dans l'évaluation, et doit fonctionner sur la base de règles harmonisées au niveau européen.
Fonctionnement des organismes nationaux d'accréditation : Ceux-ci doivent être organisés pour préserver leur indépendance, ne pas fonctionner en recherche de profit et sont considérés comme représentant l’autorité publique. Ils doivent également participer à un système d’évaluation par les pairs et assurer une coopération mutuelle entre eux.
Reconnaissance mutuelle : Un certificat d’accréditation délivré par un organisme national doit être reconnu sur l’ensemble du territoire de l’Union européenne, afin d’éviter des accréditations multiples et de renforcer la confiance dans la qualité des évaluations.
Surveillance du marché : Le règlement instaure un cadre européen de surveillance du marché, précisant les exigences minimales pour contrôler la conformité et la sécurité des produits, y compris ceux importés de pays tiers. Il encourage la coopération transfrontalière et l’échange d’informations entre autorités nationales et avec la Commission européenne.
Gestion des risques graves : En cas de risques sérieux liés à un produit, les autorités doivent intervenir rapidement, notamment en retirant le produit du marché, le rappelant ou en interdisant sa mise sur le marché. Un système d’échange rapide d’informations (existant dans la directive 2001/95/CE) est utilisé pour coordonner ces actions.
Contrôle aux frontières extérieures : Les autorités doivent contrôler les produits aux points d’entrée dans l’UE afin d’identifier les produits non conformes ou dangereux, y compris ceux dont le marquage CE est abusif ou trompeur.
Respect de la confidentialité : Les échanges d’informations entre autorités bénéficient de strictes garanties de confidentialité, conformément aux règles nationales et européennes applicables.
Produits et acteurs concernés
Produits : Tous produits destinés à la commercialisation sur le marché intérieur européen, incluant ceux soumis à des législations d'harmonisation spécifiques ainsi que les produits non régulés par des règles particulières.
Acteurs économiques : Les fabricants, importateurs, distributeurs, et notamment les organismes chargés de l’évaluation de conformité (laboratoires, organismes certificateurs) qui doivent être accrédités.
Autorités nationales : Organismes nationaux d’accréditation, autorités chargées de la surveillance du marché, services de contrôle aux frontières extérieures.
Coopération européenne : L’organisme European Cooperation for Accreditation (EA) est reconnu comme acteur majeur pour assurer la coordination et l’évaluation par les pairs des organismes nationaux d’accréditation.
Calendrier de mise en œuvre
Le règlement est entré en vigueur le 1er janvier 2010.
Les États membres ont dû désigner leur organisme national unique d’accréditation selon les principes définis et assurer son fonctionnement conformément au règlement.
La coopération entre organismes nationaux d’accréditation et la participation à la European Cooperation for Accreditation (EA) devaient être mises en place et maintenues.
Les autorités nationales ont été tenues de renforcer la surveillance du marché, y compris via des échanges d’informations et des mesures coordonnées au niveau européen.
Les contrôles aux frontières extérieures ont dû être organisés pour détecter les produits non conformes ou dangereux avant leur mise sur le marché.
Ce cadre réglementaire vise à créer un système harmonisé, transparent et efficace d’accréditation et de surveillance du marché des produits à l’échelle de l’Union européenne pour assurer la sécurité des consommateurs et la fluidité du marché intérieur.
Le règlement 765/2008 s'applique à tous les produits bénéficiant de la libre circulation des marchandises au sein de l'Union européenne, en vue de garantir leur conformité aux exigences légales assurant un haut niveau de protection des intérêts publics tels que la santé, la sécurité, la protection des consommateurs et de l'environnement. Ce cadre général établit des règles concernant l'accréditation, la surveillance du marché, le contrôle des produits importés de pays tiers et le marquage CE. Toutefois, il ne s'applique pas lorsque des dispositions spécifiques de la législation communautaire d'harmonisation existent déjà, notamment dans les secteurs tels que les précurseurs de drogues, les dispositifs médicaux, les médicaments à usage humain et vétérinaire, les véhicules à moteur et l'aviation. Le règlement couvre aussi bien les secteurs réglementés que non réglementés, et vise à renforcer la confiance dans les certificats délivrés par les organismes d'évaluation de la conformité.
Uredba Evropskega parlamenta in Sveta št. 765/2008 določa zahteve za akreditacijo in nadzor trga v zvezi s trženjem proizvodov znotraj Evropske unije. Namenjena je zagotavljanju visoke stopnje varnosti in zaščite javnih interesov, kot so zdravje, varnost, varstvo potrošnikov in okolja, ter uveljavljanju prostega pretoka proizvodov brez nepotrebnih ovir. Uredba vzpostavlja enoten okvir za delovanje nacionalnih akreditacijskih organov, ki potrjujejo strokovno usposobljenost organov za ugotavljanje skladnosti. Nacionalni akreditacijski organi morajo delovati neprofitno, neodvisno in zagotavljati verodostojnost svojih ocen. Prav tako uredba krepi mehanizme nadzora trga, vključno s hitrim ukrepanjem ob nevarnih proizvodih, ter določa pravila za sodelovanje med državami članicami in Komisijo. Posebno pozornost namenja oznaki CE kot oznaki skladnosti proizvodov ter vzpostavlja sistem izmenjave informacij in sodelovanja za učinkovito odkrivanje in preprečevanje trženja neskladnih ali nevarnih proizvodov. Namen je izboljšati varnost na trgu in zaupanje potrošnikov v proizvodih znotraj EU.
Namen
Uredba (ES) št. 765/2008 določa zahteve za akreditacijo in nadzor trga v zvezi s trženjem proizvodov znotraj Evropske unije. Namen uredbe je zagotoviti visoko stopnjo zaščite javnih interesov, kot so zdravje, varnost na delovnem mestu, varstvo potrošnikov in okolja, hkrati pa preprečiti neupravičene omejitve prostega pretoka blaga. Uredba vzpostavlja splošni pravni okvir, ki dopolnjuje in krepi obstoječa pravila usklajevalne zakonodaje, ter ureja postopke akreditacije, nadzora trga, pristop do proizvodov tretjih držav in uporabo oznake CE.
Ključne obveznosti
Akreditacija: Države članice morajo imenovati eno nacionalno telo za akreditacijo, ki deluje neprofitno, zagotavlja strokovnost, nepristranskost in neodvisnost ter je zadnja stopnja nadzora v verigi ugotavljanja skladnosti proizvodov. Akreditacijski organ presoja usposobljenost organov za ugotavljanje skladnosti in izdajanje certifikatov. V primeru, da država članica ne vzpostavi lastnega akreditacijskega organa, mora uporabiti organ druge države članice.
Nadzor trga: Države članice morajo zagotoviti učinkovit nadzor proizvodov na trgu, vključno s preiskavami in sankcijami. Organi za nadzor trga morajo imeti pravice umika ali odpoklica nevarnih proizvodov ter ukrepati hitro v primeru resnih tveganj za zdravje ali varnost. Prav tako morajo tesno sodelovati med seboj in s carinskimi organi za preprečevanje nedovoljenega uvoza neskladnih proizvodov.
Oznaka CE: Oznaka CE je edina oznaka skladnosti, ki dokazuje, da je proizvod skladen z usklajevalno zakonodajo Skupnosti. Uredba določajo splošna načela uporabe oznake, da se zagotovi njena enotnost in verodostojnost na trgu.
Medsebojno sodelovanje in izmenjava informacij: Nacionalni organi morajo sodelovati tako znotraj države kot čez mejo, izmenjevati informacije, izvajati skupne preiskave in sodelovati v sistemih hitre izmenjave podatkov o nevarnih proizvodih.
Pravne sankcije: Države članice morajo določiti učinkovite, sorazmerne in odvračne sankcije za kršitve določb uredbe, z možnostjo za strožje kazni v primerih ponavljajočih se kršitev.
Financiranje: Uredba priznava potrebo po finančni podpori dejavnostim za izvajanje politik na področju akreditacije in nadzora trga, vključno z možnostjo donacij in drugih finančnih spodbud.
Zadevni izdelki in akterji
Izdelki: Vse vrste proizvodov, ki se dajo na trg Evropske unije, razen tistih, za katere obstajajo posebni zakonodajni predpisi s posebnimi določbami o akreditaciji in nadzoru trga (npr. medicinski pripomočki, motorna vozila, letalstvo).
Aktarji:
- Države članice EU, ki morajo vzpostaviti nacionalne akreditacijske organe in organe za nadzor trga.
- Nacionalni akreditacijski organi, ki izvajajo postopke akreditacije organov za ugotavljanje skladnosti.
- Organi za ugotavljanje skladnosti, ki izvajajo ocene in izdajo certifikate skladnosti proizvodov.
- Organi za nadzor trga, ki izvajajo nadzor nad proizvodnimi izdelki na trgu in ukrepajo ob nezakonitostih.
- Carinski organi, odgovorni za nadzor proizvodov, ki prihajajo iz tretjih držav.
- Evropsko združenje za akreditacijo (EA), ki upravlja sistem medsebojnega strokovnega vrednotenja in sodeluje pri razvoju shem sektorjev akreditacije.
Rok za izvedbo
- Uredba je bila sprejeta 9. julija 2008 in velja neposredno v vseh državah članicah od takrat.
- Nacionalne države so odgovorne, da čim prej vzpostavijo ali priznajo nacionalne akreditacijske organe v skladu z določbami uredbe.
- Komisija najkasneje v enem letu po objavi v Uradnem listu EU predloži analizo o označevanju varnosti proizvodov za potrošnike in po potrebi zakonodajne predloge.
- Redno medsebojno strokovno vrednotenje nacionalnih akreditacijskih organov in nadzornih organov za ugotavljanje skladnosti mora biti vzpostavljeno in izvajan tekom obdobja po uveljavitvi uredbe.
Uredba zagotavlja okvir za stalno izboljševanje nadzora nad izdelki na trgu EU in usklajeno akreditacijo, kar pripomore k varnosti uporabnikov in nemotenemu delovanju notranjega trga.
Uredba 765/2008 se uporablja za izdelke, ki se tržijo znotraj Evropske unije, da zagotovi zahteve za akreditacijo in nadzor trga ter s tem visoko raven varstva zdravja, varnosti, potrošnikov in okolja. Poudarja potrebo po splošnem okviru za akreditacijo in tržni nadzor, ki dopolnjuje obstoječo usklajevalno zakonodajo EU. Uredba velja za različne vrste izdelkov, razen tam, kjer obstajajo posebne zakonodajne določbe, na primer za predhodne sestavine, medicinske pripomočke, motorna vozila in letalstvo. Cilj je zagotoviti skladnost z varnostnimi zahtevami in preprečiti dajanje nevarnih izdelkov na trg EU. Pravila urejajo akreditacijske organe, nadzor trga, kontrolne dejavnosti na mejah ter označevanje skladnosti z oznako CE, s čimer se omogoča prost pretok blaga po notranjem trgu.
General Information
This document specifies the requirements for a measurement management system when an organization:
needs to demonstrate its ability to consistently ensure confidence in validity and reliability of measurement results and thereby to provide a consistent level of measurement quality for an organization’s products and services;
aims to rely on reliable and valid measurement results useful to enhance customer satisfaction and effectively apply its measurement management system processes;
implements processes for a measurement management system that enhance conformity with customer, statutory and regulatory requirements.
All the requirements of this document are generic. This document is applicable to any organization, regardless of its type or size, or the products and services it provides. This includes organizations manufacturing products and providing engineering services (except for calibration and test services included within the scope of ISO/IEC 17025).
This document is not intended to substitute requirements for, or to add requirements to, the general requirements for the competence of testing and calibration laboratories specified in ISO/IEC 17025.
NOTE For organizations that operate internal testing and calibration laboratories, the competence of those functions can be evaluated in accordance with ISO/IEC 17025.
- Standard55 pagesEnglish languagee-Library read for1 day
This document specifies the requirements for a measurement management system when an organization:
needs to demonstrate its ability to consistently ensure confidence in validity and reliability of measurement results and thereby to provide a consistent level of measurement quality for an organization’s products and services;
aims to rely on reliable and valid measurement results useful to enhance customer satisfaction and effectively apply its measurement management system processes;
implements processes for a measurement management system that enhance conformity with customer, statutory and regulatory requirements.
All the requirements of this document are generic. This document is applicable to any organization, regardless of its type or size, or the products and services it provides. This includes organizations manufacturing products and providing engineering services (except for calibration and test services included within the scope of ISO/IEC 17025).
This document is not intended to substitute requirements for, or to add requirements to, the general requirements for the competence of testing and calibration laboratories specified in ISO/IEC 17025.
NOTE For organizations that operate internal testing and calibration laboratories, the competence of those functions can be evaluated in accordance with ISO/IEC 17025.
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- Amendment4 pagesEnglish languagee-Library read for1 day
- Amendment4 pagesEnglish languagee-Library read for1 day
This document establishes principles and specifies general requirements that are applicable to all types of product-related environmental statements and environmental statement programmes. Environmental statements result from environmental statement programmes and include self-declared environmental claims, ecolabels, environmental product declarations (EPDs) and footprint communications.
This document is intended to be used in conjunction with other standards in the ISO 14020 family.
NOTE Those other standards contain additional terms and definitions, principles and requirements that are relevant to their specific scopes.
- Standard35 pagesEnglish languagee-Library read for1 day
- Amendment4 pagesEnglish languagee-Library read for1 day
- Amendment4 pagesEnglish languagee-Library read for1 day
This document specifies general requirements for the competence and impartiality of proficiency
testing (PT) providers and consistent operation of all proficiency testing schemes. This document can
be used as a basis for specific technical requirements for particular fields of application.
Users of proficiency testing schemes, regulatory authorities, organizations and schemes using peer-
assessment, accreditation bodies and others can use these requirements in confirming or recognizing
the competence of proficiency testing providers.
- Standard47 pagesEnglish languagee-Library read for1 day
This document specifies general requirements for the competence and impartiality of proficiency
testing (PT) providers and consistent operation of all proficiency testing schemes. This document can
be used as a basis for specific technical requirements for particular fields of application.
Users of proficiency testing schemes, regulatory authorities, organizations and schemes using peer-
assessment, accreditation bodies and others can use these requirements in confirming or recognizing
the competence of proficiency testing providers.
- Standard47 pagesEnglish languagee-Library read for1 day
This document specifies requirements for quality and competence in medical laboratories.
This document is applicable to medical laboratories in developing their management systems and assessing their competence. It is also applicable for confirming or recognizing the competence of medical laboratories by laboratory users, regulatory authorities and accreditation bodies.
This document is also applicable to point-of-care testing (POCT).
NOTE International, national, or regional regulations or requirements can also apply to specific topics covered in this document.
- Standard72 pagesEnglish languagee-Library read for1 day
- Standard – translation102 pagesSlovenian and English languagee-Library read for1 day
This document establishes principles and specifies general requirements that are applicable to all types of product-related environmental statements and environmental statement programmes. Environmental statements result from environmental statement programmes and include self-declared environmental claims, ecolabels, environmental product declarations (EPDs) and footprint communications.
This document is intended to be used in conjunction with other standards in the ISO 14020 family.
NOTE Those other standards contain additional terms and definitions, principles and requirements that are relevant to their specific scopes.
- Standard35 pagesEnglish languagee-Library read for1 day
This document gives guidance on how to conduct an environmental due diligence (EDD) assessment through a systematic process of identifying environmental aspects, issues and conditions as well as determining, if appropriate, their business consequences.
This document does not provide guidance on how to conduct other types of environmental assessment, such as:
a) environmental audits;
b) environmental impact assessments;
c) environmental performance, efficiency, or reliability assessment;
d) intrusive environmental investigations and remediation.
- Standard37 pagesEnglish languagee-Library read for1 day
This document specifies requirements for quality and competence in medical laboratories.
This document is applicable to medical laboratories in developing their management systems and assessing their competence. It is also applicable for confirming or recognizing the competence of medical laboratories by laboratory users, regulatory authorities and accreditation bodies.
This document is also applicable to point-of-care testing (POCT).
NOTE International, national, or regional regulations or requirements can also apply to specific topics covered in this document.
- Standard72 pagesEnglish languagee-Library read for1 day
- Standard – translation102 pagesSlovenian and English languagee-Library read for1 day
This document gives guidance on how to conduct an environmental due diligence (EDD) assessment through a systematic process of identifying environmental aspects, issues and conditions as well as determining, if appropriate, their business consequences.
This document does not provide guidance on how to conduct other types of environmental assessment, such as:
a) environmental audits;
b) environmental impact assessments;
c) environmental performance, efficiency, or reliability assessment;
d) intrusive environmental investigations and remediation.
- Standard37 pagesEnglish languagee-Library read for1 day
This document specifies principles and requirements for bodies performing validation and verification of environmental information statements.
Any programme requirements related to bodies are additional to the requirements of this document.
This document is a sector application of ISO/IEC 17029:2019, which contains general principles and requirements for the competence, consistent operation and impartiality of bodies performing validation/verification as conformity assessment activities.
This document includes sector-specific requirements in addition to the requirements of ISO/IEC 17029:2019.
- Standard40 pagesEnglish languagee-Library read for1 day
This document specifies the requirements for competence to carry out reference measurement procedures in laboratory medicine, using the requirements of ISO/IEC 17025:2017 as a normative reference and listing additional requirements for calibration laboratories to perform their tasks adequately.
The relationship between clauses in this document and ISO/IEC 17025:2017 are summarized in Annex A.
Examinations of properties with results reported on a nominal or ordinal scale are not included.
This document is not applicable to medical laboratories.
NOTE Requirements for medical laboratories are specified in ISO 15189[1].
- Standard16 pagesEnglish languagee-Library read for1 day
This document specifies principles and requirements for bodies performing validation and verification of environmental information statements.
Any programme requirements related to bodies are additional to the requirements of this document.
This document is a sector application of ISO/IEC 17029:2019, which contains general principles and requirements for the competence, consistent operation and impartiality of bodies performing validation/verification as conformity assessment activities.
This document includes sector-specific requirements in addition to the requirements of ISO/IEC 17029:2019.
- Standard40 pagesEnglish languagee-Library read for1 day
- Amendment8 pagesEnglish languagee-Library read for1 day
- Amendment13 pagesEnglish languagee-Library read for1 day
This document specifies general requirements for the competence, impartiality and consistent operation of biobanks including quality control requirements to ensure biological material and data collections of appropriate quality.
This document is applicable to all organizations performing biobanking, including biobanking of biological material from multicellular organisms (e.g. human, animal, fungus and plant) and microorganisms for research and development.
Biobank users, regulatory authorities, organizations and schemes using peer-assessment, accreditation bodies, and others can also use this document in confirming or recognizing the competence of biobanks.
This document does not apply to biological material intended for food/feed production, laboratories undertaking analysis for food/feed production, and/or therapeutic use.
NOTE 1 International, national or regional regulations or requirements can also apply to specific topics covered in this document.
NOTE 2 For entities handling human materials procured and used for diagnostic and treatment purposes ISO 15189 and other clinical standards are intended to apply first and foremost.
- Standard45 pagesEnglish languagee-Library read for1 day
This document defines terms used in documents in the fields of environmental management systems and tools in support of sustainable development. These include management systems, auditing and other types of assessment, communications, footprinting studies, greenhouse gas mitigation and adaptation to climate change.
- Standard81 pagesEnglish languagee-Library read for1 day
- Standard – translation131 pagesSlovenian and English languagee-Library read for1 day
This document specifies general terms and definitions relating to conformity assessment (including the accreditation of conformity assessment bodies) and to the use of conformity assessment to facilitate trade.
The general principles of conformity assessment and a description of the functional approach to conformity assessment are provided in Annex A.
Conformity assessment interacts with other fields such as management systems, metrology, standardization and statistics. The boundaries of conformity assessment are not defined in this document.
- Standard31 pagesEnglish languagee-Library read for1 day
- Standard31 pagesEnglish languagee-Library read for1 day
- Standard – translation89 pagesSlovenian, English, German and French languagee-Library read for1 day
ISO/IEC 17025:2017 specifies the general requirements for the competence, impartiality and consistent operation of laboratories.
ISO/IEC 17025:2017 is applicable to all organizations performing laboratory activities, regardless of the number of personnel.
Laboratory customers, regulatory authorities, organizations and schemes using peer-assessment, accreditation bodies, and others use ISO/IEC 17025:2017 in confirming or recognizing the competence of laboratories.
- Standard39 pagesEnglish languagee-Library read for1 day
- Standard – translation51 pagesSlovenian and English languagee-Library read for1 day
ISO/IEC 17011:2017 specifies requirements for the competence, consistent operation and impartiality of accreditation bodies assessing and accrediting conformity assessment bodies.
- Standard37 pagesEnglish languagee-Library read for1 day
- Amendment13 pagesEnglish languagee-Library read for1 day
- Amendment8 pagesEnglish languagee-Library read for1 day
This document gives guidelines to organizations for general principles, policy, strategy and activities relating to both internal and external environmental communication. It uses proven and well-established approaches for communication, adapted to the specific conditions that exist in environmental communication.
It is applicable to all organizations regardless of their size, type, location, structure, activities, products and services, and whether or not they have an environmental management system in place.
It can be used in combination with any of the ISO 14000 family of standards, or on its own.
NOTE 1 A reference table to the ISO 14000 family is provided in Annex A.
NOTE 2 ISO 14020, ISO 14021, ISO 14024, ISO 14025 and ISO 14026 provide specific environmental communication tools and guidance relating to product labels and declarations.
- Standard42 pagesEnglish languagee-Library read for1 day
This document specifies general requirements for the competence, impartiality and consistent operation of biobanks including quality control requirements to ensure biological material and data collections of appropriate quality.
This document is applicable to all organizations performing biobanking, including biobanking of biological material from multicellular organisms (e.g. human, animal, fungus and plant) and microorganisms for research and development.
Biobank users, regulatory authorities, organizations and schemes using peer-assessment, accreditation bodies, and others can also use this document in confirming or recognizing the competence of biobanks.
This document does not apply to biological material intended for food/feed production, laboratories undertaking analysis for food/feed production, and/or therapeutic use.
NOTE 1 International, national or regional regulations or requirements can also apply to specific topics covered in this document.
NOTE 2 For entities handling human materials procured and used for diagnostic and treatment purposes ISO 15189 and other clinical standards are intended to apply first and foremost.
- Standard45 pagesEnglish languagee-Library read for1 day
This document defines terms used in documents in the fields of environmental management systems and tools in support of sustainable development. These include management systems, auditing and other types of assessment, communications, footprinting studies, greenhouse gas mitigation and adaptation to climate change.
- Standard81 pagesEnglish languagee-Library read for1 day
- Standard – translation131 pagesSlovenian and English languagee-Library read for1 day
This document gives guidelines to organizations for general principles, policy, strategy and activities relating to both internal and external environmental communication. It uses proven and well-established approaches for communication, adapted to the specific conditions that exist in environmental communication.
It is applicable to all organizations regardless of their size, type, location, structure, activities, products and services, and whether or not they have an environmental management system in place.
It can be used in combination with any of the ISO 14000 family of standards, or on its own.
NOTE 1 A reference table to the ISO 14000 family is provided in Annex A.
NOTE 2 ISO 14020, ISO 14021, ISO 14024, ISO 14025 and ISO 14026 provide specific environmental communication tools and guidance relating to product labels and declarations.
- Standard42 pagesEnglish languagee-Library read for1 day
This document specifies general terms and definitions relating to conformity assessment (including the accreditation of conformity assessment bodies) and to the use of conformity assessment to facilitate trade.
The general principles of conformity assessment and a description of the functional approach to conformity assessment are provided in Annex A.
Conformity assessment interacts with other fields such as management systems, metrology, standardization and statistics. The boundaries of conformity assessment are not defined in this document.
- Standard31 pagesEnglish languagee-Library read for1 day
- Standard31 pagesEnglish languagee-Library read for1 day
- Standard – translation89 pagesSlovenian, English, German and French languagee-Library read for1 day
This document contains general principles and requirements for the competence, consistent operation and impartiality of bodies performing validation/verification as conformity assessment activities.
Bodies operating according to this document can provide validation/verification as a first-party, second-party or third-party activity. Bodies can be validation bodies only, verification bodies only, or provide both activities.
This document is applicable to validation/verification bodies in any sector, providing confirmation that claims are either plausible with regards to the intended future use (validation) or truthfully stated (verification). However, results of other conformity assessment activities (e.g. testing, inspection and certification) are not considered to be subject to validation/verification according to this document. Neither are situations where validation/verification activities are performed as steps within another conformity assessment process.
This document is applicable to any sector, in conjunction with sector specific programmes that contain requirements for validation/verification processes and procedures.
This document can be used as a basis for accreditation by accreditation bodies, peer assessment within peer assessment groups, or other forms of recognition of validation/verification bodies by international or regional organizations, governments, regulatory authorities, programme owners, industry bodies, companies, clients or consumers.
NOTE This document contains generic requirements and is neutral with regard to the validation/verification programme in operation. Requirements of the applicable programmes are additional to the requirements of this document.
- Standard40 pagesEnglish languagee-Library read for1 day
- Standard – translation70 pagesSlovenian and English languagee-Library read for1 day
This document specifies principles and requirements and provides guidance at the project level for the quantification, monitoring and reporting of activities intended to cause greenhouse gas (GHG) emission reductions or removal enhancements. It includes requirements for planning a GHG project, identifying and selecting GHG sources, sinks and reservoirs (SSRs) relevant to the project and baseline scenario, monitoring, quantifying, documenting and reporting GHG project performance and managing data quality.
The ISO 14060 family of standards is GHG programme neutral. If a GHG programme is applicable, the requirements of that GHG programme are additional to the requirements of the ISO 14060 family of standards.
- Standard37 pagesEnglish languagee-Library read for1 day
This document specifies principles and requirements and provides guidance for verifying and validating greenhouse gas (GHG) statements.
It is applicable to organization, project and product GHG statements.
The ISO 14060 family of standards is GHG programme neutral. If a GHG programme is applicable, requirements of that GHG programme are additional to the requirements of the ISO 14060 family of standards.
- Standard68 pagesEnglish languagee-Library read for1 day
This document contains general principles and requirements for the competence, consistent operation and impartiality of bodies performing validation/verification as conformity assessment activities.
Bodies operating according to this document can provide validation/verification as a first-party, second-party or third-party activity. Bodies can be validation bodies only, verification bodies only, or provide both activities.
This document is applicable to validation/verification bodies in any sector, providing confirmation that claims are either plausible with regards to the intended future use (validation) or truthfully stated (verification). However, results of other conformity assessment activities (e.g. testing, inspection and certification) are not considered to be subject to validation/verification according to this document. Neither are situations where validation/verification activities are performed as steps within another conformity assessment process.
This document is applicable to any sector, in conjunction with sector specific programmes that contain requirements for validation/verification processes and procedures.
This document can be used as a basis for accreditation by accreditation bodies, peer assessment within peer assessment groups, or other forms of recognition of validation/verification bodies by international or regional organizations, governments, regulatory authorities, programme owners, industry bodies, companies, clients or consumers.
NOTE This document contains generic requirements and is neutral with regard to the validation/verification programme in operation. Requirements of the applicable programmes are additional to the requirements of this document.
- Standard40 pagesEnglish languagee-Library read for1 day
- Standard – translation70 pagesSlovenian and English languagee-Library read for1 day
This document specifies principles and requirements at the organization level for the quantification and reporting of greenhouse gas (GHG) emissions and removals. It includes requirements for the design, development, management, reporting and verification of an organization's GHG inventory.
The ISO 14064 series is GHG programme neutral. If a GHG programme is applicable, requirements of that GHG programme are additional to the requirements of the ISO 14064 series.
- Standard58 pagesEnglish languagee-Library read for1 day
- Standard – translation60 pagesSlovenian languagee-Library read for1 day
This document specifies principles and requirements and provides guidance for verifying and validating greenhouse gas (GHG) statements.
It is applicable to organization, project and product GHG statements.
The ISO 14060 family of standards is GHG programme neutral. If a GHG programme is applicable, requirements of that GHG programme are additional to the requirements of the ISO 14060 family of standards.
- Standard68 pagesEnglish languagee-Library read for1 day
This document specifies principles and requirements and provides guidance at the project level for the quantification, monitoring and reporting of activities intended to cause greenhouse gas (GHG) emission reductions or removal enhancements. It includes requirements for planning a GHG project, identifying and selecting GHG sources, sinks and reservoirs (SSRs) relevant to the project and baseline scenario, monitoring, quantifying, documenting and reporting GHG project performance and managing data quality.
The ISO 14060 family of standards is GHG programme neutral. If a GHG programme is applicable, the requirements of that GHG programme are additional to the requirements of the ISO 14060 family of standards.
- Standard37 pagesEnglish languagee-Library read for1 day
This document specifies the requirements for competence to carry out reference measurement procedures in laboratory medicine, using the requirements of ISO/IEC 17025:2017 as a normative reference and listing additional requirements for calibration laboratories to perform their tasks adequately.
The relationship between clauses in this document and ISO/IEC 17025:2017 are summarized in Annex A.
Examinations of properties with results reported on a nominal or ordinal scale are not included.
This document is not applicable to medical laboratories.
NOTE Requirements for medical laboratories are specified in ISO 15189[1].
- Standard16 pagesEnglish languagee-Library read for1 day
This document specifies principles and requirements at the organization level for the quantification and reporting of greenhouse gas (GHG) emissions and removals. It includes requirements for the design, development, management, reporting and verification of an organization's GHG inventory.
The ISO 14064 series is GHG programme neutral. If a GHG programme is applicable, requirements of that GHG programme are additional to the requirements of the ISO 14064 series.
- Standard58 pagesEnglish languagee-Library read for1 day
- Standard – translation60 pagesSlovenian languagee-Library read for1 day
ISO 14024:2018 establishes the principles and procedures for developing Type I environmental labelling programmes, including the selection of product categories, product environmental criteria and product function characteristics, and for assessing and demonstrating compliance. ISO 14024:2018 also establishes the certification procedures for awarding the label.
- Standard23 pagesEnglish languagee-Library read for1 day
This document provides guidance on auditing management systems, including the principles of auditing, managing an audit programme and conducting management system audits, as well as guidance on the evaluation of competence of individuals involved in the audit process. These activities include the individual(s) managing the audit programme, auditors and audit teams.
It is applicable to all organizations that need to plan and conduct internal or external audits of management systems or manage an audit programme.
The application of this document to other types of audits is possible, provided that special consideration is given to the specific competence needed.
- Standard56 pagesEnglish languagee-Library read for1 day
- Standard – translation81 pagesSlovenian and English languagee-Library read for1 day
- Amendment9 pagesEnglish languagee-Library read for1 day
This document provides guidance on auditing management systems, including the principles of auditing, managing an audit programme and conducting management system audits, as well as guidance on the evaluation of competence of individuals involved in the audit process. These activities include the individual(s) managing the audit programme, auditors and audit teams.
It is applicable to all organizations that need to plan and conduct internal or external audits of management systems or manage an audit programme.
The application of this document to other types of audits is possible, provided that special consideration is given to the specific competence needed.
- Standard56 pagesEnglish languagee-Library read for1 day
- Standard – translation81 pagesSlovenian and English languagee-Library read for1 day
- Amendment9 pagesEnglish languagee-Library read for1 day
ISO 14024:2018 establishes the principles and procedures for developing Type I environmental labelling programmes, including the selection of product categories, product environmental criteria and product function characteristics, and for assessing and demonstrating compliance. ISO 14024:2018 also establishes the certification procedures for awarding the label.
- Standard23 pagesEnglish languagee-Library read for1 day
ISO/IEC 17025:2017 specifies the general requirements for the competence, impartiality and consistent operation of laboratories.
ISO/IEC 17025:2017 is applicable to all organizations performing laboratory activities, regardless of the number of personnel.
Laboratory customers, regulatory authorities, organizations and schemes using peer-assessment, accreditation bodies, and others use ISO/IEC 17025:2017 in confirming or recognizing the competence of laboratories.
- Standard39 pagesEnglish languagee-Library read for1 day
- Standard – translation51 pagesSlovenian and English languagee-Library read for1 day
Frequently Asked Questions
An EU Regulation is a binding legislative act that must be applied in its entirety across the European Union. Unlike directives, regulations do not need to be transposed into national law and are directly applicable in all member states. Regulations are used when uniform application across all EU countries is essential.
Regulation 765/2008 covers "REGULATION (EC) No 765/2008 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93". This legislation has harmonized European standards (hENs) that provide a presumption of conformity with its essential requirements. There are 190 standards associated with this regulation.
Harmonized standards under 765/2008 are European standards (ENs) developed by CEN, CENELEC, or ETSI in response to a mandate from the European Commission. When these standards are cited in the Official Journal of the European Union, products manufactured in conformity with them benefit from a presumption of conformity with the essential requirements of 765/2008, facilitating CE marking and free movement within the European Economic Area.