Laboratory Audit Processes and TÜRKAK Accreditation

The number of accredited laboratories in Türkiye grows every year, yet the number of laboratory managers who genuinely understand how the accreditation process works remains limited. Most laboratories switch into panic mode a few weeks before the assessment. The classic scenario: files are pulled out, gaps are discovered, the quality manager works overtime, and missing calibrations are rushed through at the last minute.

Accreditation is not an exam, however. It is a process meant to be lived continuously. This article walks through the accreditation journey end to end — from application to surveillance assessment, from the most frequently raised findings to practical preparation advice. The aim is to remove the anxiety of “what do we do when the assessor arrives?”

TÜRKAK and Accreditation: The Basics

TÜRKAK (the Turkish Accreditation Agency) has been accrediting conformity assessment bodies in Türkiye since 2001. Thanks to mutual recognition arrangements with the European co-operation for Accreditation (EA) and the International Laboratory Accreditation Cooperation (ILAC), TÜRKAK accreditation carries international standing. A report issued by a TÜRKAK-accredited laboratory is therefore accepted in Germany or Japan as well.

The current figures: 2,317 accredited bodies operate under TÜRKAK, of which 474 are testing laboratories and 81 are calibration laboratories. The assessment ecosystem is supported by 1,663 registered assessors. These numbers indicate how broad the accreditation infrastructure in Türkiye has become.

Accreditation demonstrates a laboratory’s competence to perform specified tests or calibrations in accordance with international standards. The core standard for testing and calibration laboratories is ISO/IEC 17025:2017; for inspection bodies it is ISO/IEC 17020. Update (August 2026): the 2012 edition of ISO/IEC 17020 was withdrawn on 27 March 2026; the edition in force is ISO/IEC 17020:2026, with a transition deadline of 27 March 2029 for accredited inspection bodies. See our article on the publication of ISO/IEC 17020:2026 for details. Both standards cover management system requirements alongside technical competence.

The Application Process, Step by Step

Applying for accreditation is less complex than it appears from the outside — but it demands rigour. The process broadly follows these stages:

Stages of the application

1. Preparation and management system setup: The quality manual, procedures, work instructions and forms are prepared in line with ISO/IEC 17025. Most laboratories complete this stage in three to six months. Starting from scratch, consultancy support significantly accelerates it.
2. Online application to TÜRKAK: The application form, scope table and supporting documents are uploaded through the online system. Fees vary by scope and laboratory type.
3. Document review: The assigned assessment team carries out a desk review of the quality documentation and reports back any deficiencies. Expect this feedback to take a few weeks.
4. On-site assessment (initial evaluation): The team visits the laboratory, typically for one to three days. Technical competence, equipment status, personnel competence, environmental conditions and management system practices are evaluated on site, including witnessed testing on real samples.
5. Closing out findings: The laboratory is given time to implement corrective actions. Major findings are typically allowed three months; minor findings, until the next surveillance visit.
6. Accreditation decision: Once corrective actions are accepted, the TÜRKAK Accreditation Committee issues the final decision. The certificate is valid for five years, with regular surveillance assessments during that period.

One point worth noting: the elapsed time from application to certificate averages six to twelve months. Most of that is spent on documentation and closing out findings — the better prepared the laboratory, the shorter the process.

Surveillance Assessments: How Often, and What Is Examined?

You have the certificate — what happens next? This is the part many laboratories overlook. Accreditation is not a document you obtain once and shelve. TÜRKAK continues to assess accredited bodies at regular intervals.

Surveillance assessments are generally annual, with the first taking place within 12 months of accreditation. Across the five-year cycle there are four surveillance assessments and one reassessment, the latter being as comprehensive as the initial evaluation.

What assessors focus on during surveillance

Corrective actions taken for previous findings, and their effectiveness.
Proficiency testing and interlaboratory comparison results.
Internal audit and management review records.
Complaints and feedback, together with the responses given.
Equipment calibration status and the metrological traceability chain.
Personnel changes and authorisation records for new staff.
Detailed technical review of selected test and calibration files, including witnessed testing.

Not the entire scope is assessed at each surveillance; assessors sample on a risk basis. The intent, however, is that the full accreditation scope is assessed at least once across the five-year cycle. Relaxing because “they did not ask about that this year” is therefore a strategic mistake.

The Most Frequently Raised Findings

Data accumulated from years of laboratory assessments shows the same subjects recurring. Knowing these statistics helps you identify the weak points in your own laboratory before an assessor does.

1. Equipment management — 38%

Thirty-eight per cent of findings raised during assessments concern equipment management, far ahead of every other category. Assessors look at the validity of calibration certificates, the justification behind calibration intervals, equipment identification and labelling, intermediate check records, maintenance plans and their execution, and the labelling and removal from service of defective or out-of-scope equipment.

The typical scenario: the laboratory holds 50 items of equipment, 47 with current calibration and three “forgotten”. The assessor asks for the certificates of precisely those three. Experienced assessors know which items tend to slip — ancillary equipment such as thermometers, hygrometers and stopwatches are usually the first to fall out of calibration tracking.

2. Externally provided products and services — 21%

Second at 21% is the management of external provision. Clause 6.6 of ISO/IEC 17025:2017 requires laboratories to evaluate and monitor externally provided services — subcontracted laboratories, calibration services, reference material suppliers.

Common problems: supplier evaluation forms left uncompleted, the accreditation scope of a subcontracted laboratory never verified, reference material certificates missing from the file. Many laboratories outsource calibration but forget to carry out the annual supplier evaluation — to an assessor, that signals a systemic weakness.

3. Personnel competence management

Clause 6.2 of ISO/IEC 17025 requires all personnel to be competent for their duties and that competence to be demonstrated. Frequent problems include out-of-date authorisation records, training effectiveness never evaluated, supervised working periods for new staff not documented, and competence matrices that do not reflect reality.

When an assessor asks a technician “since when have you been authorised to perform this test?”, the answer must match the quality records. “I learned on the job” is not sufficient. Training record, supervised work record, competence evaluation and authorisation decision — the chain must be complete.

4. Document control and records management

Control of management system documents is examined at every assessment. Superseded procedures still in use, withdrawn documents still accessible, revisions not recorded and distribution lists not updated are among the common findings.

The problem becomes chronic in paper-based document systems: revision 3 of a procedure is in force while copies of revision 2 still circulate in the laboratory. This is one of the most frequently written minor findings. Laboratories using an electronic document management system hold a clear advantage here.

Note on finding types: findings are classified as major or minor. A major finding indicates a serious gap in the system and, if not closed within the given period, can lead to suspension of accreditation. A minor finding is an isolated deficiency, generally expected to be closed by the next surveillance assessment. In both cases root cause analysis is required, and the corrective action must address the cause rather than the symptom.

Suspension and Withdrawal of Accreditation

Accreditation is not a guaranteed certificate. TÜRKAK may suspend or withdraw it under certain circumstances — a process that carries reputational damage and serious commercial consequences.

Grounds for suspension

Failure to close major findings within the period allowed.
Refusal or repeated postponement of a surveillance assessment.
Persistently unacceptable proficiency testing results.
Misuse of the accreditation mark.
Voluntary suspension at the laboratory’s own request.

A suspended laboratory cannot issue accredited reports within the affected scope for the duration of the suspension. Customers move to other laboratories, producing both revenue loss and reputational harm. Suspension decisions are published on the accreditation body’s website — meaning your customers will see them. Publicly available accreditation data shows that suspension and withdrawal decisions are genuinely enforced, including for university and public sector laboratories; being a public institution confers no privilege in the accreditation process.

Preparing for an Assessment: Practical Advice

The most successful laboratories we see in the field are the ones that do not “prepare” for assessments. That sounds contradictory, so let us explain: if your management system runs properly 365 days a year, you should not need special preparation beforehand. An assessment is a photograph of your daily operation — what appears in that photograph should be what you live every day.

That said, some preparation is normal and necessary in practice:

Three to four weeks before

Run an equipment sweep: Check calibration certificates and validity dates for all equipment. Send anything approaching expiry for calibration immediately. Complete intermediate check records.
Pull out the previous assessment report: Review past findings and corrective actions. Assessors will certainly ask about them.
Compile proficiency testing results: Have the reports and your evaluations from PT programmes ready.
Check internal audit and management review records: When was your last internal audit? Has the management review meeting taken place? Completeness of these records is critical.

One week before

Brief the team: Inform key personnel of the date, scope and expectations. Everyone should know their own area of responsibility. Do not panic — assessors grow suspicious of nervous people.
Review the physical environment: Laboratory layout, labelling, cleanliness, environmental condition records. Assessors begin observing the moment they walk in; first impressions matter.
Prepare for witnessed testing: Ensure the sample, equipment, reference standard and personnel required for the test the assessor will observe are ready.

A tip from the field: you do not want to be saying “one moment, let me find the file” during an assessment. Everything that might be asked for — calibration certificates, training records, PT results, CAPA records, supplier evaluations — should be retrievable within 30 seconds. If you are leafing through paper folders, that in itself signals a problem. Experienced assessors treat retrieval speed as an indicator of how mature your management system is.

On the day

A few golden rules when speaking with an assessor. First: answer the question asked, and no more. If the assessor asks when your last internal audit was, give the date. Do not launch into how excellently it went — that opens doors to subjects you had not planned to discuss.

Second: if you do not know, say “I don’t know, but I can find out and come back to you.” Misleading an assessor with incorrect information leaves a far worse impression than a gap in knowledge.

Third: do not argue with the assessor. If you disagree with a finding, state your position formally at the closing meeting.

The Role of Software: From Manual Systems to Digital

Look carefully at the findings statistics above and a pattern emerges: equipment tracking forgotten, supplier evaluation skipped, document revisions confused, personnel authorisation undocumented. Every one of these stems from a lack of tracking and reminders. In manual systems that tracking depends on the quality manager’s memory and diligence — and human memory is not a reliable management tool.

Laboratories using a laboratory information management system hold a clear advantage during assessments. Equipment approaching calibration expiry generates automatic alerts, document revisions are managed under version control, personnel authorisation records are held centrally, and the audit trail is created automatically. When an assessor asks for a record, retrieving it in a few clicks is both faster and more reliable than searching paper folders.

Sector-specific platforms such as WiseLIMS build ISO/IEC 17025 and ISO/IEC 17020 requirements directly into the software architecture. The equipment module tracks calibration intervals while the quality module brings CAPA processes, internal audit planning and management review together in one place — an approach that targets the 38% equipment finding rate and the 21% supplier management issue directly.

Conclusion

Accreditation is how a laboratory demonstrates its technical competence and reliability at international level. But the journey begins — it does not end — on the day the certificate arrives. Surveillance assessments, the expectation of continual improvement and evolving standard requirements all demand that your quality management system stays alive.

The statistics tell a clear story: the vast majority of findings arise not from technical incompetence but from gaps in tracking and record keeping. Laboratories that forget equipment calibration, skip supplier evaluation and fail to document personnel authorisation meet the same problems assessment after assessment.

Digital tools can break that cycle. Choosing the right tool is not enough, however — you have to integrate it genuinely into daily operations. Accreditation is a culture rather than a certificate, and building that culture is the most valuable investment a laboratory manager can make.

Laboratory Audit Processes and TÜRKAK Accreditation: Notes from the Field