ISO/IEC 17025:2017 accreditation is the formal recognition of a calibration or testing laboratory’s technical competence within an internationally accepted standard. In Turkey the only authorised body granting this accreditation is TÜRKAK (the Turkish Accreditation Agency). In this guide we share every stage of the accreditation process from our 16 years of field experience.
1. Preparation: Defining the Scope
Before applying for accreditation, the laboratory must clarify the measured quantities and ranges for which it wants to be accredited. When defining the scope, the following are considered:
- The reference standards the laboratory holds
- The technical competence areas of the personnel
- Customer demand intensity and market potential
- Environmental conditions and infrastructure adequacy
Starting with a narrow scope and growing through later scope extensions is generally the healthiest strategy for securing the first accreditation.
2. Setting Up the Management System
ISO/IEC 17025:2017 requires the laboratory to meet both technical and management requirements. There are two options for the management system:
- Option A: meeting all the requirements of clause 8 of the standard
- Option B: equivalent acceptance for laboratories with an ISO 9001-compliant management system
The vast majority of newly accredited laboratories choose Option A. In that case, procedures for the documentation structure, document control, control of records, addressing risks and opportunities, improvement, corrective action, internal audit and management review must be established.
3. Risk-Based Thinking
One of the most important novelties of the 2017 revision is the “risk-based thinking” approach. The laboratory must identify, assess and control all risks that could threaten its impartiality. Typical risk sources:
- Financial/family relationships between personnel and the customer
- Receiving both calibration and sales services from the same company
- Uncertainties in the traceability of reference standards
- Uncontrolled changes in ambient conditions
4. Quality Manual and Procedures
Although ISO/IEC 17025:2017 no longer requires a quality manual, many TÜRKAK lead assessors still look for one as a reference, so most laboratories choose to prepare it. The minimum documentation set:
- Quality policy and objectives
- Organisation chart and job descriptions
- Technical procedures (for each measured quantity)
- Uncertainty calculation sheets
- Equipment list and calibration tracking schedules
5. Internal Audit and Management Review
Before applying to TÜRKAK, the laboratory must have carried out at least one internal audit and one management review. The internal audit must be performed by an authorised auditor who is independent in the area being audited. Corrective actions must be opened for the nonconformities found, and the effectiveness of these actions must be demonstrated.
6. TÜRKAK Application and Preliminary Review
Once the preparations are complete, a formal application is made to TÜRKAK. After the application, TÜRKAK reviews the application documents and requests any missing items. A lead assessor is then assigned and the on-site audit date is set.
7. On-Site Audit
During the on-site audit, the lead assessor and technical assessors spend 2–5 days at the laboratory and:
- Review the scope, starting with an opening meeting
- Examine the documentation
- Conduct technical interviews with personnel
- Perform calibration witnessing
- Examine records and sample certificates
- Report nonconformities at the closing meeting
8. Corrective Actions and the Accreditation Decision
For the nonconformities found, the laboratory opens corrective actions within the given period and submits objective evidence proving their effectiveness to TÜRKAK. Once all nonconformities are closed, the TÜRKAK Decision Committee makes the accreditation decision and issues the certificate.
Important tip
The first accreditation process takes 12–18 months on average. Plan at least 6 months for setting up the management system, at least 3 months for gaining experience, and 6–9 months for the application-audit process.
Conclusion
Beyond being an international registration of technical competence, ISO/IEC 17025:2017 accreditation is a system that guarantees the discipline and quality of processes. With the right planning and experienced consulting support, the process can be run far more efficiently.