Certification planner / ISO 17025

How to get ISO 17025 accreditation?

Competence of testing and calibration laboratories: impartiality, method validation, measurement uncertainty, proficiency testing. Core standard for accreditation. Answer the questions, and we'll map out the stages, timeline and documents you need to prepare for your business, with the reasoning behind each one.

6–12 monthstypical preparation time 41documents in the library 7stage

Your personal roadmap

Free · no sign-up required · about 2 minutes

Describe your main products and services, your customers and how you work in a few sentences.
E.g. metal processing, software, logistics, food production, consulting
Office, factory, warehouse, construction site — all addresses to be included in the certification scope.
Accreditation bodies and legal requirements vary by country.
E.g., sterility testing, bacterial endotoxin (LAL), active substance determination by HPLC, particle counting, cleanroom environmental monitoring.
Standard methods require verification (7.2.1.5); non-standard or laboratory-developed methods require validation (7.2.2).
Do you participate in proficiency testing (PT) or interlaboratory comparisons? Accreditation bodies expect PT participation for each sub-discipline in scope (ILAC P9).

Your answers are processed with AI solely to prepare your roadmap.

ISO 17025 accreditation steps

  1. Scope and gap analysisDefine the certification scope and locations, and identify the gaps between your current practices and the standard.
  2. Leadership, policy and objectivesTop management commitment, policy, roles and measurable objectives.
  3. Risks and standard-specific analysesRisks and opportunities; depending on the standard, environmental aspects, information security risks or business impact analysis.
  4. DocumentationPrepare, approve and publish procedures, work instructions, forms and lists tailored to your business.
  5. Implementation and recordsOperate the system; build up records such as training, calibration, suppliers and corrective actions.
  6. Internal audit and management reviewAudit the system yourself, close the findings and conduct the management review.
  7. Accreditation assessmentApplication to the accreditation body, document review, on-site assessment witnessing tests, and closure of findings; followed by the accreditation decision.

Documents required for ISO 17025

The mandatory set from the KaliteGO library. Each one is generated as docx/xlsx, filled in with your company details.

  • DD.10Laboratory Management System Manual
  • FR.30Training Attendance and Evaluation Form
  • FR.5Internal Audit Report
  • FR.56Work Environment Monitoring Form (Temperature/Humidity/Particles)
  • FR.75Test/Calibration Report Template
  • FR.76Measurement Uncertainty Budget Form
  • FR.77Method Verification/Validation Report Form
  • FR.78Intermediate Check Record Form
  • FR.79Impartiality Risk Assessment and Declaration Form
  • FR.8Corrective Action Form
  • LS.1Current Documents and Revision Tracking List
  • LS.11Supplier Tracking and Evaluation List.
  • LS.18Measuring Equipment Inventory and Calibration Plan
  • LS.29Personnel Authorization Matrix
  • LS.3External Document List
  • LS.30Method List and Verification/Validation Status
  • LS.7Corrective Action Tracking List
  • PL.1Internal Audit Plan
  • PL.14Proficiency Testing and Interlaboratory Comparison Plan
  • PL.2Annual Training Plan
  • PO.35Impartiality and Confidentiality Policy
  • PR.1Control of Documented Information and Records Procedure
  • PR.10Purchasing Procedure
  • PR.14Training and Awareness Management Procedure
  • PR.2Risk and Opportunity Management Procedure
  • PR.6Internal Audit Procedure
  • PR.64Personnel Competence and Authorization Procedure
  • PR.65Procedure for Facilities and Environmental Conditions Control
  • PR.66Laboratory Equipment and Metrological Traceability Procedure
  • PR.67Review of Requests, Tenders and Contracts Procedure (Laboratory)
  • PR.68Procedure for Selection, Verification and Validation of Methods
  • PR.69Procedure for Sampling and Handling of Test or Calibration Items
  • PR.7Management Review Procedure.
  • PR.70Evaluation of Measurement Uncertainty Procedure
  • PR.71Procedure for Ensuring the Validity of Results
  • PR.72Procedure for Reporting of Results
  • PR.73Laboratory Complaints Procedure
  • PR.74Nonconforming Work Procedure
  • PR.75Control of Data and Information Management Procedure
  • PR.8Improvement, Nonconformity and Corrective Action Procedure
  • PR.9Goals, Objectives and Performance Monitoring Procedure

Frequently asked questions

How long does ISO 17025 certification take?

For most SMEs, 6–12 months. The timeline depends on your headcount, locations and current practices. The system needs to run long enough to generate records (usually 2–3 months), followed by an internal audit, a management review and the certification body's Stage 1 and Stage 2 audits.

Which documents are required for ISO 17025?

The standard explicitly requires certain documented information: scope, policy, objectives, procedures and records. The KaliteGO library has 41 document templates for ISO 17025; the planner explains which of them your business needs, and why.

Does KaliteGO grant the accreditation?

No. Accreditation is granted by the national accreditation body (TÜRKAK in Turkey) following the assessment. KaliteGO prepares your laboratory for the assessment: documents, records, internal audit, and management review.

Can I prepare without a consultant?

Yes. Most small and medium-sized businesses can prepare with a guided roadmap and ready-made templates. Consultants also use KaliteGO to manage multiple clients.