ISO/IEC 17025 Accredited Laboratory Setup
TS EN ISO/IEC 17025 is the international standard that demonstrates the competence, impartiality and consistent operation of testing and calibration laboratories. Thanks to international mutual recognition arrangements, the reports of an accredited laboratory are accepted both at home and abroad.
At KURASTECH, we set up your laboratory from scratch in terms of technical and quality management or bring your existing structure into compliance with the standard, and we stand by you at every stage of the TÜRKAK accreditation process. We bring the measurement experience we have gained as a meter test bench manufacturer to laboratory setup.
Technical Infrastructure of the Laboratory
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Facilities and Environmental Conditions
Laboratory layout; design, monitoring and recording of temperature, humidity, vibration, dust and electrical conditions (Clause 6.3).
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Equipment and Reference Standards
Selection of test equipment, reference meters and standards suited to the scope, acceptance checks, maintenance and intermediate check plans (Clause 6.4).
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Metrological Traceability
Traceability of measurement results to SI units through an unbroken calibration chain; establishing the calibration programme (Clause 6.5).
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Method Selection, Verification and Validation
Verification of standard methods, validation of laboratory-developed methods and preparation of the scope list (Clause 7.2).
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Measurement Uncertainty
Identifying sources of uncertainty for each test/calibration and calculating uncertainty budgets using the GUM approach (Clause 7.6).
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Ensuring the Validity of Results
Monitoring results through proficiency testing, interlaboratory comparisons, repeat measurements and control charts (Clause 7.7).
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Test Benches and Software
Installation of meter test benches, validation of automation and data software; data integrity and reporting (Clause 7.11).
Quality Management System
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Impartiality and Confidentiality
Impartiality risk analysis, commitments and confidentiality arrangements (Clause 4).
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Organisational Structure
Laboratory management, technical manager and quality manager roles; definition of duties, authorities and responsibilities (Clause 5).
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Personnel Competence
Competence criteria, training plans, authorisation and performance monitoring of personnel (Clause 6.2).
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Documentation Architecture
Preparation of the quality manual, procedures, instructions, forms and records; document and record control (Clauses 8.2–8.4).
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Requests, Tenders and Contracts
Review of customer requests, definition of decision rules and statements of conformity (Clause 7.1).
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Risks and Opportunities
Identification of risks and improvement opportunities related to laboratory activities (Clause 8.5).
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Nonconforming Work and Corrective Action
Complaints, nonconforming work and corrective action processes with root cause analysis (Clauses 7.9, 7.10, 8.7).
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Internal Audit and Management Review
Planned internal audits, a simulation audit before the TÜRKAK assessment and management review meetings (Clauses 8.8, 8.9).
Structure of the ISO/IEC 17025:2017 Standard
Our setup work covers every clause of the standard
Clause
4
General Requirements
Impartiality and confidentiality
Clause
5
Structural Requirements
Legal entity, organisation, responsibilities
Clause
6
Resource Requirements
Personnel, facilities, equipment, traceability, external supply
Clause
7
Process Requirements
Methods, sampling, uncertainty, validity, reporting
Clause
8
Management System Requirements
Documentation, risk, improvement, audit
Accreditation Roadmap
Step by step from pre-assessment to the accreditation decision
Pre-Assessment
Gap analysis of the current situation against the standard and definition of the scope.
Setup Plan
Work plan and schedule for the technical infrastructure and quality system.
Technical Infrastructure
Facilities, equipment, calibration, method and uncertainty studies.
Quality System
Preparing the documentation, training and implementing the system.
Proficiency and Internal Audit
Participation in proficiency tests, internal audit and management review.
TÜRKAK Application
Preparation of the application file and the document review process.
On-Site Assessment
Preparation for the on-site assessment and support during the audit.
Accreditation and Surveillance
Closing nonconformities, the accreditation decision and surveillance support.
The accreditation decision is made by TÜRKAK; KURASTECH provides consultancy and training support at every stage of the process.