In plain English
ISO/IEC 17025 is a rulebook for laboratories that test or measure things. It asks whether the staff are trained, whether the methods work, whether the instruments are calibrated (checked against known standards) and whether the reports are clear [1, 3].
In Australia, an organisation called NATA (the National Association of Testing Authorities) checks laboratories against this standard. Experts from the same field visit and review the work. If the laboratory passes, NATA accredits it [2, 9].
Accreditation is test by test. A laboratory might be accredited for measuring water content but not for checking peptide identity. The list of accredited tests is called the scope of accreditation [2].
So “NATA accredited” on a certificate is only half the answer. The useful question is whether the particular test on that report is on the laboratory’s scope [8].
The short version
- ISO/IEC 17025 covers laboratory competence, not product quality [1, 2].
- NATA is Australia’s national accreditation body for it [2].
- Accreditation applies only to tests on the scope [2, 8].
- The NATA logo must not be used to imply a product is certified [8].
What is ISO/IEC 17025?
ISO/IEC 17025 sets general requirements for the competence of testing and calibration laboratories. It was first published in 1999 [3]. A second edition followed in 2005, and the current edition, ISO/IEC 17025:2017, updated the technical content and vocabulary and took account of the latest version of ISO 9001 [1].
The 2017 edition has eight clauses. After scope, normative references and definitions come five groups of requirements: general, structural, resource, process and management system requirements [4].
NATA lists the key technical elements a laboratory must show [1]:
| Element | What an assessor looks for | Example in a peptide laboratory |
|---|---|---|
| Valid, appropriate methods | Methods suited to the question, validated or verified for the sample type | An HPLC purity method shown to separate the target peptide from known impurities |
| Competent staff | Training and authorisation records for each analyst | Analysts signed off for the HPLC and Karl Fischer methods they run |
| Metrological traceability | Measurements linked to national or international standards | Balance and volumetric equipment calibrated by an accredited provider |
| Equipment | Suitability, calibration and maintenance | Calibration and maintenance records for each instrument |
| Handling of test items | Receipt, identification, storage and disposal of samples | A sample log linking each vial to its report number |
| Quality control and assurance | Ongoing checks that results stay valid | Control samples run with every sequence; proficiency testing |
| Reporting | Clear, complete, unambiguous reports | Each result shown with its method and units |
Impartiality
Everyone involved in the laboratory’s management system, internal or external, must act impartially. In this context, impartiality means objectivity, with no conflict of interest [4]. This is one reason the relationship between a testing laboratory and the seller of the product it tests is worth knowing when reading a certificate.
Method validation and verification
The standard requires explicit attention to method validation, traceability and measurement uncertainty [3]. One Australian analyst argued that the rigour applied should be driven by what the customer needs the result for [3]. Validation shows that a method is fit for its purpose; verification shows that an already validated method works in the laboratory’s hands. See Analytical Method Validation.
Measurement uncertainty
Every measured value has a range of doubt around it. Calibration results are stated as a value with its measurement uncertainty and a statement of metrological traceability [4].
Worked example. A specification requires HPLC purity of at least 98.0%.
- Batch A reads 98.6% with an expanded uncertainty of ±0.4% (coverage factor k = 2). The interval 98.2–99.0% lies wholly above the limit, so “Pass” is clear.
- Batch B reads 98.1% ± 0.4%. The interval 97.7–98.5% straddles the limit. Whether “Pass” is justified depends on how the laboratory handles that overlap, and the report should make this visible.
Metrological traceability
Metrological traceability is the property of a result that lets it be related to a reference through a documented, unbroken chain of calibrations, each contributing to the measurement uncertainty. ISO/IEC 17025:2017 uses this definition from the International Vocabulary of Metrology [5]. Traceability can also come through certified reference materials: materials whose certificates give a value, its uncertainty and a traceability statement [5]. See Reference Standards Explained.
Proficiency testing
In proficiency testing (PT), a provider sends the same material to many laboratories and compares their answers. NATA requires accredited and applicant facilities to take part in suitable PT where it is available, and encourages participation at least once every two years for each major area on the scope. Where no suitable PT exists, other checks such as interlaboratory comparisons are required [6]. PT providers can themselves be accredited, to ISO/IEC 17043 [4].
Reporting
Reports from accredited organisations describe the activities performed, the results, and where necessary the information needed to interpret them. Results from subcontracted tests must be clearly identified. Once a report is issued, any change must be made in a separate document that refers to the original report by its serial number, or in a new report that references the original [7].
Accreditation is not certification
These two words are often confused. NATA puts the distinction plainly: certification focuses on an organisation’s overall compliance with systems and product standards, while accreditation recognises technical competence to perform specific activities [2].
| Accreditation (ISO/IEC 17025) | Certification (for example ISO 9001) | |
|---|---|---|
| Question answered | Can this laboratory produce valid results for these tests? | Does this organisation run a compliant management system? |
| Assessed by | An accreditation body such as NATA, using technical peer assessors [2, 9] | A certification body |
| Unit of recognition | Specific tests, listed on a scope of accreditation [2] | The management system as a whole |
An ISO 9001 certificate on its own says nothing about whether a laboratory’s HPLC purity figure is right.
The scope of accreditation is the detail that matters
The activities for which accreditation is granted are described in a scope of accreditation, and these may not be all the activities a facility performs [2]. NATA’s rules on its emblem and endorsement follow from this [8]:
- The endorsement can only be used on reports issued under the name in which the facility holds accreditation.
- A report may carry the endorsement if it contains only in-scope results, or if any out-of-scope results, including work by external providers, are clearly and unambiguously identified.
- Nothing in a report or its attachments may imply that accreditation is held for a test when it is not.
- Facilities whose accreditation has been suspended or withdrawn cannot use the endorsement or refer to accreditation on reports.
- The NATA emblem or a reference to accreditation must not be fixed to a material, item or product, including its packaging, or used to imply that a product has been certified. Where a product’s literature or website mentions NATA accreditation, the statement must sit directly beside a reference to the accredited facility that did the testing.
Only reports with an appropriate endorsement are covered by the acceptance established through mutual recognition arrangements [8].
NATA in Australia
NATA was established in 1947. It is a government-endorsed, independent, not-for-profit company, owned by its members (every accredited organisation is a member) [2]. Under a Memorandum of Understanding, the Australian Government uses NATA-accredited facilities for its testing needs wherever possible and commits Commonwealth laboratories to obtain and keep NATA accreditation where appropriate [2].
NATA assessments are first and foremost peer review. Nearly 3,000 volunteer technical assessors work with NATA lead assessors, and an expert Accreditation Advisory Committee reviews recommendations before NATA makes the final decision [9]. NATA also represents Australia in the OECD Working Group on Good Laboratory Practice and is Australia’s GLP compliance monitoring authority [2].
Does accreditation change anything measurable? In a 2025 study of 44 laboratories in Saudi Arabia, the number of nonconformities found at periodic assessments fell by 46% for calibration laboratories and 41% for testing laboratories compared with initial assessments [10].
Mutual recognition: ILAC MRA and Global ACI
The ILAC Mutual Recognition Arrangement links accreditation bodies that have been peer evaluated against ISO/IEC 17011. Signatories agree to accept the results of each other’s accredited laboratories, which removes the need to retest across borders [11]. NATA is a signatory and offers accredited organisations the combined ILAC MRA mark [12].
On 1 January 2026, Global Accreditation Cooperation Incorporated (Global ACI) became operational and took over the activities previously run by ILAC and the International Accreditation Forum. The Asia Pacific Accreditation Cooperation (APAC) is its recognised regional body for the Asia-Pacific [13]. NATA’s competence as an accreditation body is evaluated by Global ACI and APAC for continued inclusion in the mutual recognition arrangements [2].
How to check a laboratory’s accreditation
- Find the laboratory’s name and accreditation number on the report.
- Search NATA’s directory. It can be searched by business name, accreditation number or standard, and filtered by product or material type, determination, technique and test standard [14].
- Confirm the specific test and site. The test on the report (for example peptide purity by HPLC) should be on the scope for the site that issued it [8].
- Check the endorsement. Out-of-scope results on an endorsed report should be clearly marked [8].
- For overseas laboratories, use the ILAC MRA signatory search, which links to each accreditation body’s own directory [11].
- Confirm directly. NATA recommends confirming a provider’s accreditation with the accreditation body rather than accepting a report or certificate at face value [12].
Worked example: which results on a certificate are accredited?
A certificate for a peptide batch carries the NATA endorsement and lists four results. The laboratory’s scope, checked in the directory, covers only two of the methods.
| Result on the certificate | On the scope? | Correct presentation |
|---|---|---|
| Purity by HPLC | Yes | Reported under the endorsement |
| Water content by Karl Fischer titration | Yes | Reported under the endorsement |
| Identity by LC-MS | No | Clearly marked as outside the scope [8] |
| Endotoxin by LAL (subcontracted) | Not this laboratory’s work | Clearly identified as a subcontracted result [7, 8] |
If the LC-MS identity result is not marked, the report implies an accreditation that does not exist [8]. See How to Read a Peptide COA.
What accreditation does not tell
- Anything outside the scope. Accreditation is test-specific [2].
- Anything about a product. NATA’s rules forbid using accreditation to imply that a product has been certified [8].
- Whether the right test was chosen. A well-run method can only see what it is designed to see. In a 2020 report, quantitative NMR found mannitol, a UV-transparent compound, making up 20% and 43% w/w of two commercially sourced custom peptides [15]. A UV-based HPLC purity result cannot detect such a constituent, however competently it is run.
- Anything beyond the sample tested. A report describes the sample the laboratory received. Linking it to a vial depends on the batch number. See Batch Numbers and Traceability.
- Regulatory status. A test report is evidence about quality; it does not make a product approved [16].
What this means in Australia
- National body. NATA is Australia’s national accreditation body, recognised by the Australian Government under a Memorandum of Understanding [2].
- When it is required. Accreditation to ISO/IEC 17025 may be required by state or federal regulators, industry bodies, local governments or individual customers [1].
- Products. NATA’s emblem and accreditation statements must not be placed on a product or its packaging or used to imply product certification [8].
- Regulatory status. The TGA has stated that a “research use only” disclaimer does not make supply lawful, change a product’s regulatory status, permit importation, or remove advertising or supply obligations [16]. A NATA-endorsed report does not change that.
This is general information, not legal advice. Laws change; check the current Poisons Standard and TGA guidance.
Frequently asked questions
What is ISO 17025?
ISO/IEC 17025 is the international standard setting general requirements for the competence of testing and calibration laboratories. The current edition was published in 2017 [1].
What is the difference between ISO 17025 and ISO 9001?
ISO/IEC 17025 accreditation recognises technical competence for specific tests. ISO 9001 certification concerns an organisation’s management system as a whole [2].
What does NATA accredited mean?
It means NATA has assessed the laboratory and found it competent for the tests listed on its scope of accreditation. It does not extend to other tests the laboratory performs [2].
How can a NATA accreditation be checked?
Search NATA’s online directory by laboratory name or accreditation number and check that the specific test is listed for that site [14]. For overseas laboratories, use the ILAC MRA signatory search [11].
Can a product be NATA certified?
No. NATA accredits organisations for specific activities, and its rules prohibit using the NATA emblem to imply that a product has been certified [8].
References
- National Association of Testing Authorities, Australia (NATA). ISO/IEC 17025 testing and calibration. nata.com.au. Accessed 25 October 2026.
- National Association of Testing Authorities, Australia (NATA). About NATA and accreditation. June 2026. nata.com.au. Accessed 25 October 2026.
- King B. Meeting the measurement uncertainty and traceability requirements of ISO/IEC standard 17025 in chemical analysis. Fresenius J Anal Chem. 2001;371(6):714–720. doi:10.1007/s002160100995. PMID: 11768456
- Krismastuti FSH, Habibie MH. Complying with the resource requirements of ISO/IEC 17025:2017 in Indonesian calibration and testing laboratories: current challenges and future directions. Accredit Qual Assur. 2022;27(6):359–367. doi:10.1007/s00769-022-01523-w. PMID: 36275871
- National Association of Testing Authorities, Australia (NATA). General accreditation criteria: metrological traceability. December 2020. nata.com.au. Accessed 25 October 2026.
- National Association of Testing Authorities, Australia (NATA). General accreditation criteria: proficiency testing policy. December 2021. nata.com.au. Accessed 25 October 2026.
- National Association of Testing Authorities, Australia (NATA). NATA test reports explained. nata.com.au. Accessed 25 October 2026.
- National Association of Testing Authorities, Australia (NATA). General accreditation criteria: use of the NATA emblem, NATA endorsement and references to accreditation. June 2025. nata.com.au. Accessed 25 October 2026.
- National Association of Testing Authorities, Australia (NATA). What is accreditation? nata.com.au. Accessed 25 October 2026.
- Alomair A, Alfayez M, Abuhaimed M, Alrabeh M. Impact of SAAC accreditation on laboratories in Saudi Arabia according to ISO/IEC 17025:2017. Sci Rep. 2025;16(1):589. doi:10.1038/s41598-025-30089-z. PMID: 41387811
- International Laboratory Accreditation Cooperation (ILAC). ILAC MRA and signatories. ilac.org. Accessed 25 October 2026.
- National Association of Testing Authorities, Australia (NATA). Use of logos. nata.com.au. Accessed 25 October 2026.
- Asia Pacific Accreditation Cooperation (APAC). Global Accreditation Cooperation Incorporated replaces IAF and ILAC. apac-accreditation.org. Accessed 25 October 2026.
- National Association of Testing Authorities, Australia (NATA). Search accredited organisations. nata.com.au. Accessed 25 October 2026.
- Choules MP, Bisson J, Simmler C, et al. NMR reveals an undeclared constituent in custom synthetic peptides. J Pharm Biomed Anal. 2020;178:112915. doi:10.1016/j.jpba.2019.112915. PMID: 31671336
- Therapeutic Goods Administration. Understanding your responsibilities when importing, compounding and supplying unapproved peptide products. Safety advisory, 13 April 2026. tga.gov.au. Accessed 25 October 2026.
