ELOT EN ISO standards: what the three names mean and where a laboratory meets them

A standard is a technical specification adopted by a recognised standardisation body for repeated use, with which compliance is not compulsory unless legislation requires it ^{[1] [2]}. The three names you see on a laboratory document, such as ISO/IEC 17025, EN ISO/IEC 17025 and ELOT EN ISO/IEC 17025, are not three standards. They are the same text at three stages: issued internationally by ISO, adopted as a European standard (EN), and published as a national standard by ELOT ^[2].

Who accredits laboratories and how an accreditation is checked we explain separately. This article is only about the names: what each prefix adds, which standards actually concern laboratory testing, where they appear on a certificate, and what it means when someone writes "in accordance with" a standard without being accredited.

What a standard is and who issues it

Regulation (EU) 1025/2012 on European standardisation defines a standard as a technical specification for repeated or continuous application with which compliance is not compulsory, and a European standard as one adopted by a European standardisation organisation ^[1]. Standards are issued at three levels, each with its own prefix:

• International level: ISO and IEC, with the prefixes ISO, IEC, or ISO/IEC for a joint standard.
• European level: CEN, CENELEC and ETSI, with the prefix EN ^[1].
• National level: ELOT, which is the Greek member of ISO, IEC, CEN, CENELEC and ETSI and takes part in their technical committees ^[3].

None of these bodies checks whether a laboratory actually applies what the standard says. They write the rule; assessing how it is applied is the job of the national accreditation body, which in Greece is ESYD and not ELOT ^[7].

The ISO → EN → ELOT EN chain

The two steps in the chain do not carry the same legal weight. As ELOT itself explains, adoption of international standardisation documents by a national body is voluntary, whereas adoption of European documents is mandatory and within a set period ^[3]. That is why an ISO standard that has not become an EN may circulate in Greece simply as ISO, whereas an EN always ends up as ELOT EN.

Regulation 1025/2012 adds a standstill rule for harmonised standards: while such a standard is being prepared or after it has been approved, national bodies may not publish in the same field a new national standard that is not completely in line with it, and conflicting national standards are withdrawn within a reasonable deadline ^[1]. The practical result is that two conflicting texts on the same subject rarely coexist in Europe.

Why the same standard has three names

ELOT explains its prefixes as follows ^[2]:

The year at the end of the name matters. ISO/IEC 17025:2017 replaced the 2005 edition ^[5], and a document that cites the old edition without explanation is either old or careless. In practice, the accreditation body cites the European form: EA records that ESYD is a signatory to the multilateral agreement for testing and calibration to EN ISO/IEC 17025 ^[4].

Which standards concern laboratory testing

A small number of standards appear very often in supplier and laboratory documents, and they are not all of the same kind. The fields in which ESYD is recognised by EA give a useful map ^[4]:

The last row is the source of the commonest misunderstanding. ISO 9001 sets requirements for a quality management system and applies to any organisation, whatever it produces ^[6]. A supplier certified to ISO 9001 has documented procedures. That says nothing about whether the purity figure on the certificate of analysis is correct.

Where they appear on a certificate

• In the header of a test report, beside the accreditation symbol: the accreditation standard, usually ELOT EN ISO/IEC 17025, with a certificate number ^[5].
• In the method column: the code of a standard test method where one exists, or the laboratory's own code where the method was developed in house.
• In a supplier's footer or company profile: management-system certification, usually ISO 9001, which concerns the organisation and not the result ^[6].
• In marketing copy: phrases such as "ISO standards" with no standard number, which cannot be checked.

What conformity without accreditation means

Because standards are voluntary ^[1], anyone can buy one and state that they apply it. The phrase "we operate in accordance with ISO/IEC 17025" is lawful and may be true. But it is the issuer's own statement: no third party has assessed how it is applied. Accreditation is exactly that third-party assessment, and Regulation 765/2008 assigns it exclusively to the national accreditation body ^[7].

There is also a confusion that exists only in Greek. The word πρότυπο means the standardisation document, but also the reference substance against which a measurement is calibrated, as in a "standard solution". When a certificate says identity was established "against a standard", it means the second sense, and checking it follows a different logic, the one set out in reference standards and system suitability checks. There is a third use too: a laboratory's internal standard operating procedure is not a standard in ELOT's sense, however rigorously it is written. Every laboratory needs such procedures regardless of the standards it cites, and how a standard operating procedure is written is a separate question.

• Where there is an accreditation number, check it in the national body's register and against the scope ^[7].
• Where there is only "in accordance with", ask in writing who assessed how it is applied; if the answer is "nobody", you have the issuer's own declaration.
• Where a standard is cited without a year of edition, ask for the year; the answer shows whether the document is current ^[5].
• Where a management-system standard is offered as proof of analytical correctness, correct it in your own assessment: it is not ^[6].

How to obtain a standard

Standards are not free texts. ELOT supplies national, European and international standards electronically, through the online shop on its website or on request to its sales service ^[2]. For a laboratory that wants to compare a report it received with the requirements of the standard, buying the text is often cheaper than repeating a test. For a buyer, it is usually enough to know which standard applies and who checked that it is applied.