Peptidetesting

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Accreditation

Accreditation scope

An accreditation scope is the official, itemized list of the tests, materials, and methods a laboratory has been independently assessed and confirmed as competent to perform. It shows which items on a lab report have accredited backing and which do not.

Also called: scope of accreditation, accredited scope, flexible scope, scope annex

An accreditation scope is the formal document attached to a laboratory's accreditation certificate. It lists the exact materials, parameters, and ISO/IEC 17025 test methods the lab has been assessed as competent to perform. Issued by independent bodies like NIST/NVLAP, UKAS, ANAB, or SCC, it defines the precise boundaries of what the laboratory is accredited for.

Concrete information provided in an accreditation scope

  • The specific product or material covered by each listed test.
  • The measured characteristic, such as identity, purity, or assay.
  • The technique or instrument used, such as HPLC-UV or LC-MS.
  • The assessment basis, including staff, equipment, validated methods, and quality systems.
  • On-site assessment and, where applicable, proficiency testing that support the scope.

Important distinctions and limits of the scope

An accreditation scope documents that a laboratory has demonstrated competence for specific tests, but it does not prove the quality of every individual result. It shows that staff, equipment, and methods were assessed, not that every measurement on every sample will meet expectations.

A result on a Certificate of Analysis (COA) is only considered accredited if that exact test appears in the laboratory's scope. A laboratory can hold a general ISO/IEC 17025 certificate without being accredited for the specific test you need, so the scope matters more than the certificate alone. The scope is also distinct from broad “ISO 17025” claims and ISO 9001 certifications, which verify management systems rather than technical competence for specific tests.

Sources

  1. What Are the FDA Requirements for Peptide Characterization? -
  2. Current Good Manufacturing Practice (CGMP) Regulations
  4. Slide 1
  5. ASCA-Accredited Testing Laboratories | FDA
  6. Protein & Peptide Testing for FDA compliance | Qalitex Labs — ISO 17025
  7. Guideline for describing Scopes of Accreditation
  8. ADMINISTRATIVE PROCESS RULE: ISO/IEC 17025 TESTING LABORATORIES PROGRAM SCOPING REQUIREMENTS
  9. Accreditation vs. Certification: What's the Difference? - Perry Johnson Laboratory Accreditation, Inc.
  10. SCC Requirements and Guidance for the Presentation of Laboratory Scopes of Accreditation
  11. Policy Statement on Scope Format for Testing Laboratories accredited to ISO/IEC 17025 PS34
  12. How to Read an ISO 17025 Accreditation Scope — What It Tells You About a Lab | Aurora TIC
  13. Accreditation vs. Certification | NIST
  14. ISO/IEC 17025:2017 Scope - ISO 17025 Store
  15. Laboratory Accreditation - ISO/IEC 17025
  16. ISO 17025 Accreditation Scope: Evaluation Guide | Element
  17. All you need to know about ISO 17025:2017 accredited ...
  18. RT-23 Rev05_bz24-03-2026 ENG