Diagnostics as a Service and laboratory accreditation: how to check what a supplier's laboratory is accredited for
Every supplier says its laboratories are accredited. Accreditation is granted to one company, for named kinds of testing, at one named building, and Germany publishes all of it for free. The catch is that the list of tests on the annex is often only a set of examples. Here is how to check.
Written by
Robert Jakobson
Published on
September 24, 2026
A Diagnostics as a Service supplier will tell you its laboratories are accredited. That claim is narrower than a buyer assumes, because accreditation is granted to a named company, for named kinds of testing, at a named building. In this category one company handles the whole test while you sell the result under your own name. So the laboratory is the part you never see, which makes it the part you are trusting most.
The claim can be checked, because DAkkS publishes accreditations and their annexes for free. What you will be reading is the annex that comes with an accreditation certificate, a document far more specific than the claim. The annex does have one complication. The list of tests on it is sometimes only a set of examples, which the annex says in small print. This article explains what the annex says, why the list can be examples, what else German law requires of a laboratory, and how to run the check yourself.
What does a laboratory accreditation say?
It names a company, a place and a list of testing. The standard behind it is ISO 15189, whose current edition was published on 6 December 2022. That edition sets requirements for quality and competence in medical laboratories, including testing done at the point of care.1
German annexes and the DAkkS rule name that standard as DIN EN ISO 15189:2024. As we read the two documents, that is the German adoption of the same edition. So a date of 2024 on an annex is not a newer standard.4
Accreditation in Germany is granted by DAkkS, which is the national accreditation body. What DAkkS issues is a certificate with an annex, where the certificate carries the status and the annex carries the content.
The annex names the company, the specific building and the date from which it is valid. It then lists testing in three columns: the substance being measured, the material it is measured in, and the technique used.2
An accreditation annex names one company, one building and a start date, then lists testing as substance, material and technique. Each area also carries a flexibility level. Source: an accreditation certificate and annex issued by the Deutsche Akkreditierungsstelle on 28 April 2025, registration D-ML-13217-02-00.
That level of detail is why the general claim fails a buyer. "Our laboratories are accredited" cannot be checked as it stands. "Our laboratory holds D-ML-13217-02-00" can be, because that number is how the certificate and the annex are indexed.
What a Diagnostics as a Service buyer can check for free
The status and the annex, both of them online. DAkkS runs a public database of accredited bodies where anyone can search by name or number. The database shows whether an accreditation is active, suspended or withdrawn.3
The annexes are published in the same place as open PDFs.3 The database is the current record, because the printed certificate only shows the position on the day it was issued.2
Why is the list of tests sometimes only examples?
Because of an arrangement that the DAkkS rule for medical laboratories, R-15189, calls a flexible scope. Under a flexible scope a laboratory may add methods inside an area it is already accredited for, without telling DAkkS first.4
The flexibility comes in three levels. The rule names them A, B and C.4 On the published annexes we opened, the level is printed next to each area.5
The levels differ in how far the laboratory may go. At level A it may only move to newer versions of the methods already listed. At level B it may freely choose standard methods inside the named area. At level C it may also add methods it developed in-house.4
At level A the printed list is the list. At levels B and C the laboratory may add methods inside a named area without asking, so the printed methods are examples. Source: Deutsche Akkreditierungsstelle rule R-15189, revision 1.1 of 11 October 2024, section 7.8.4.
Levels B and C change what the annex can tell you. At those levels the rule says an annex will normally either list methods only as examples or describe the accredited area in summary form instead.4
Where the annex does list methods, it says in its own words that they are examples.5
The complete list still exists, just not on the annex. The rule requires the laboratory to keep a current method list of its own and to publish it on its own website.4
Two conclusions follow for a buyer. If the test you are buying is not printed on the annex, that does not mean it is unaccredited. If it is printed there, that does not prove the laboratory still runs it that way. The list the laboratory publishes is the document that answers the question. DAkkS is the body that settles whether an area is in scope at all.
What does the German quality guideline require of a laboratory?
A quality system, whether or not the laboratory is accredited.8 The guideline is the "RiliBÄK", the German medical association's rules on quality in laboratory testing. It was announced on 30 May 2023 and has been amended since.6
It sets minimum internal controls and compulsory participation in ring trials. Ring trials are the round-robin comparisons where laboratories test the same sample and their results are compared.6
The amendment since then is a board decision of 3 July 2025. It was announced in Deutsches Ärzteblatt volume 122, issue 16, on 8 August 2025. It has been in force since the day after publication.7 That amendment is narrow, and it leaves section 7.4.3 alone. Section 7.4.3 is the clause a buyer needs, so it is set out below.
The guideline reaches beyond the medical profession through the medical devices operating ordinance. The ordinance presumes a proper quality system where the guideline is followed. For that purpose it names the 2023 announcement as it stood.8 A presumption of that kind runs in the laboratory's favour. It does not make the guideline the only way to satisfy the ordinance.
So both dates matter to a reader. The wording the medical association now publishes and the wording the ordinance names are not the same document.
Section 7.4.3 matters when a laboratory does not do the work itself. Where a laboratory commissions testing from another laboratory outside the guideline's scope, it must satisfy itself that the competence is there and that a comparable quality system is in place.6
On the wording of that section the duty is on the commissioning laboratory rather than on a commercial buyer. So check who the clause binds before somebody quotes it at you.
Is accreditation even required in Germany?
Mostly no, which is the opposite of what the word suggests. The duty the ordinance puts on anyone running laboratory testing is to set up a quality system. It does not ask for an accreditation.8 Following the guideline earns the presumption described above, which is one way through that duty rather than the only one.
Accreditation itself is voluntary under European law. Under the European accreditation regulation, a national accreditation body assesses a body's competence when that body asks it to.9
German law still makes accreditation compulsory in one place we found. Genetic analyses to establish parentage may only be done by an accredited body. That accreditation is granted for the named kinds of analysis and lasts at most five years.10
How do you check an accreditation claim yourself?
You need one number from the supplier, but almost every step after that you can do without them.
The checklist to run before you call a Diagnostics as a Service supplier
Ask for the accreditation number of the laboratory that will run your panel, because nothing else can be checked without it.
Search that number in the public database and read whether the accreditation is active, suspended or withdrawn.
Open the annex and read which building it names, then compare that with where your samples would go.
Find the flexibility level printed beside the area your own markers fall into.
Open the laboratory's own published method list and look for your marker on it.
Ask for the accreditation number, open the published annex, look the number up in the public database, and read the laboratory's own method list. Sources: the Deutsche Akkreditierungsstelle database of accredited bodies and rule R-15189 of 11 October 2024.
One question is left over after the checklist, because only the supplier can answer it. If any testing is passed to another laboratory, you have to ask which one it is. You also have to ask what the supplier checked about that laboratory before sending work there.
Where Aniva is on this
One company runs the ordering, the kits, the collection and the results interface alongside the accredited laboratory work, all of it on one contract. The collection network is Aniva's own rather than a subcontracted one. The service is white label, so your customers see your name rather than ours.
The checks above apply to that laboratory work as much as to anyone else's. At levels B and C the annex is a set of examples rather than the full list. So ask for the accreditation number and the laboratory's published method list together, and check your own marker on the list.
Comparing suppliers is faster with the annexes already open, so bring the checklist above and book a demo.
Notes and sources
International Organization for Standardization, ISO 15189:2022, Medical laboratories, requirements for quality and competence, published 6 December 2022. Its scope states that the document is also applicable to point-of-care testing. www.iso.org/standard/76677.html
An example published annex carrying the flexibility marker and the sentence that the listed methods are examples, D-ML-13295-03-00, valid from 6 June 2025. www.dakks.de/files/data/as/pdf/D-ML-13295-03-00.pdf
Bundesärztekammer, decision of the board of 3 July 2025 amending the Richtlinie zur Qualitätssicherung laboratoriumsmedizinischer Untersuchungen, announced in Deutsches Ärzteblatt volume 122, issue 16, on 8 August 2025 and in force the day after publication. The amendment does not alter section 7.4.3.
Paragraph 10 of the German medical devices operating ordinance, which requires a quality system for laboratory testing and presumes one where the medical association's guideline is followed. www.gesetze-im-internet.de/mpbetreibv_2025/__10.html
Paragraph 5 of the German genetic diagnostics act, which requires accreditation for parentage analyses, granted for the named analysis types and limited to five years. www.gesetze-im-internet.de/gendg/__5.html
This article describes how laboratory accreditation works in Germany for companies buying blood testing. It is general information and not legal advice, and your own contract is a question for your own adviser.
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